Minutesfor 275 TH Registration Board Meeting

Minutes for 275thRegistration Board Meeting held on 25-27th October, 2017.
Item No. Detail of Item Page No.
Item No.I Confirmation for minutes of 274thRegistration Board meeting 03 – 05
Item No.II Pharmacy Services Division 06 – 16
Item No.III Pharmaceutical Evaluation & Registration Division 17 –744
Item No.IV Biological Evaluation & Registration Division 745–792
Item No.V Additional agenda

A. Pharmaceutical Evaluation & Registration Division 793 – 795
Minutes for 275th Registration Board Meeting 1

275th meeting of Registration Board was held on 25-27th October, 2017 in the
Committee Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting
was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &
Registration Division, DRAP. The meeting started with recitation of the Holy Verses. The
meeting was attended by the following: -
1. Dr. Rafeeq Alam Khan Member
Meritorious Professor, Faculty of Pharmacy,
University of Karachi
2. Maj.Gen.Dr. Tahir Mukhtar Syed Member
Commandant AFIRM / Head Department of Medicine, Army
Medical College
3. Prof.Dr. Ghulam Sarwar, Dean, Member
Faculty of Pharmacy, Jinnah Women University, Karachi
4. Dr. Qurban Ali, Ex-Director General Member
National Veterinary Laboratory, Islamabad.
Expert Member Vetrinary Drugs
5. Dr.Aslam Shah Member
Senior Manager, Pharmacy and Purchase,
Indus Hospital, Karachi
6. Dr. Amanullah Khan Member
Director, Drugs Testing Laboratory, Quetta
Government of Baluchistan
7. Dr. Shafeeq-ur-Rahman Member
Director, Drugs Testing Laboratory, Lahore
Government of Punjab.
8. Mr. Abid Hayat, Member
Director, Drugs Testing Laboratory, Karachi,
Govt. of Sindh
9. Syed Muzaffar Ali Jafri, Member
Director, Drugs Testing Laboratory, Peshawar,
Govt. of Khyber Pakhtunkhwa
10. Mr. Muhammad Aslam Member
Assistant Draftsman-II, Ministry of Law & Justice
11. Dr. Noor-us-Saba
Director, Biological Evaluation & Registration Division, DRAP
12. Dr. Shaikh Akhter Hussain Member
Director, Medical Device Division, DRAP
Director, QA&LT Division, DRAP
13. Dr.Obaidullah, Additional Director (PE&R) Secretary
The officers of relevant sections assisted their Directors with agenda and deliberation
during the meeting.
Mr.Ehsan Awan, Hamid Raza and Nadeem Zafar (PPMA), Mr.Nadeem Hussain
Alamgeer and Dr.Haider Ali (Pharma Bureau) and Mr.Kamran Anwar (PCDA) attended the
meeting as observers.
Dr. Shafeeq-ur-Rehman, Abid Hayat and Dr. Shaikh Akhter Hussain did not attend the
meeting on 25.10.2017, 27.10.2017 and 25-26.10.2017, respectively.

Item No. I: Confirmation for minutes of 274thRegistration Boardmeeting.
274th meeting of Registration Board was held on 21-23rd September, 2017. The draft
minutes were circulated among the members of meeting on 14.10.2017 with the request to
forward their comments (if any). Director DTL Rawalpindi, Government of Punjab and
Director DTLQuetta, Government of Baluchistan forwarded some observations. A
presentation was given to the Board on all these points for deliberation and it was decided
points relevant to draft minutes shall be taken into consideration and will be part of minutes.
Accordingly, following points and corresponding discussion is as follows:
i.
Observations / Reservations Discussion in Registration Board

Director DTL, Rawalpindi, Government of Punjab.
It has been observed during the meeting that most Registration Board in 267th meeting held
of the local/national manufacturers applied for on 20-21st February, 2017 has already
registration has mentioned innovator‟s decided the matter. All non-
specifications for the testing of their finished Pharmacopeial products for which
pharmaceutical products and no official of DRAP applicants have not submitted
has verified that they are the innovators manufacturer‟s specifications are being
specification, how they get them the innovators registered with innovator‟s specifications,
and how they claim that these are innovators as approved by reference to ensure
specification manufacturing of quality drugs and thus
applicants are responsible for these
specification to be followed.
Currently not in practice by DRAP, while Registration Board in 249th meeting held
registering the combination of molecules, it on 18-19th May, 2015 decided to accept
should be thoroughly reviewed through the expert molecules/ formulations (in same dosage
members‟ panel about the safety, efficacy and form) and clinical trials approved by
potential toxicity of the combination of drugs. USFDA, Health Canada, EMA, TGA
Australia, PMDA Japan, United Kingdom,
Germany, France, Switzerland,
Netherlands, Austria, Denmark, Sweden
and Norway or drugs registered in at least
three European Union counties; as
authorities of these countries have robust
drug regulatory mechanisms and long
standing strong litigation systems.
However, Registration Board shall also
consider the safety and efficacy
parameters of the drug under domestic
circumstances / practices and decision
shall be made on case to case basis. So
Registration Board also takes expert
opinion if considers essential.
In agenda of meeting, a manufacturer has applied Registration Board has already rejected
for registration of Tribulus terestris extract with the application as applied formulation
Zinc, Vitamin E, and Selenium as drug. It is does not fall in the category of Drug.
herbal extract and comes under the health the
health and OTC product (non-drugs), so it should
not be considered in allopathic system of
medicines and its safe dosage is also not yet
defined by any foreign regulatory authority.
Although its safety and interactions with other
drugs like beta blockers, digoxin, calcium channel
blockers, diuretics, ACE Inhibitors and nitrates is
not still established. If someone is taking Diabetes
medications, Tribulus might decrease the blood
sugar level to dangerously dietary supplements,
however it treats them like food rather than
medication.
Saccharomyces Boulardii is probiotics and comes Registration Board has already rejected it
under the health and OTC products (non-drugs). as the product relates to Health & OTC as
In my opinion, these products should be enlisted per DRAP Act, 2012.
under the Health and OTC products.
A company has applied for the import of Registration Board has already deferred
medicine combination which is not available for the product for submission of CoPP‟s of
free sale in the country of origin and this the countries where the product is
combination is reformulated to improve its registered (as per decision of 249th
stability in tropical countries, and the medicine is meeting) for confirmation of free sale of
exclusively developed for the treatment of the product.
diseases which are not endemic in the exporting
country. This medicinal combination is not
present in any essential list of medicines provided
by WHO nor it is used in any Disaster conditions
therefore such combinations should not be
registered in Pakistan.
In many cases the manufacturer submitted the In such cases, Registration Board gives
data to the Registration Board for the registration opportunity of personal hearing to
of their products like stability data. Source of applicants including verification of
API, Batch numbers of APIs and upon evaluation submitted data through onsite
of the data it appears forged and the manufacturer investigation and decides cases as per
claims that this was a typographical mistake. Such provision of relevant law.
cases are very serious and legal action should be
taken against such firms.
I am of the opinion that at the time of registration Registration Board in 273rd meeting held
a new molecule / new dosage form the 6 months on 28-29th August, 2017 has already
accelerated and real time stability data is decided to adopt Summary of Product
submitted for the stability of product. After Characteristics (SPC) for registration of
registration is granted it should be ensured that drugs and advised to submit proposal for
the same source of APIs, excipients and container consideration of the Board. Instant
closure system should be used in the product proposal shall be made part of proposal
which was submitted along with the dossier.
Director DTL, Quetta, Government of Baluchistan.

In my personal opinion the board may not be Schedule-F pertains to fee which is under
involved in the deferment of the case(s) for a Drugs (LR & A) Rules, 1976 and is an
simple reason of administrative items such as integral part of application. Without
FEES, and to me it‟s very strange that the case(s) compliance of this statutory requirement;
are deferred on the basis of FEES, therefore it is the application cannot be finally
proposed that FEES may not become criteria for proceeded.
the deferment of the case(s).
Similarly, it was very strange that one of the Anti- Case was again deliberated in 273rd and
cancer drug case which was approved in DRB 274th meetings as another importer also
270-M with complete prerequisite formalities and applied for registration of same product
it was expected that the same on priority basis from same manufacturing site. Whereas;
will be forwarded to the pricing section for the the previous case has already been sent for
reason to give relief to the needed patient with pricing.
comparatively low price molecule , but again the
same approved case is brought back in 273-M
and 274-M without cogent reason for me it is
injustice to the patients suffering from cancer and
also wastage of precious time . If such things are
repeated then it means that we are not fulfilling
our duty in providing new and low price
molecules for the needed patients of the country
and in parallel encouraging and providing
monopoly to the present expensive therapy.
The Pharmaceutical Firm(s) with robust Registration Board has already taken up
capabilities may be waived off from onsite the matter.
verification of stability data as per dosage
form(s).
The molecules fall under Bio pharmaceutics Registration Board has already taken up
Classification System (BCS) Class IV, may be the matter.
subjected to Bioequivalence studies as per
Guidelines.
After above discussions, Registration Board confirmed / approved circulated draft

minutes of 274th meeting.

Item No.II: Pharmacy Services Division.
Case No.01: Request for approval of amendment in protocol, of already approved
clinical trial namely "An International Randomised, Double Blind
Placebo Controlled Trial (HALT - IT Trial)"
The subject cited Clinical Trial was approved by Drug Registration Board in its 253rd
meeting held on 05th& 06th October, 2015. The details of the trial are as under;
Title: Tranexamic Acid for the Treatment of Gastrointestinal
Haemorrhage: an International Randomized, Double Blind
Placebo Controlled Trial
Trial Acronym HALT-IT (Haemorrhage Alleviation With Tranexamic Acid –
Intestinal System)
Brief Summary Severe bleeding in the digestive system is a common symptom
of many diseases. Each year, about 50,000 people end up in
British hospitals because of this problem and about 5,000 of
them die. The most common cause of this bleeding is stomach
ulcers. In sub-Saharan Africa, schistosomiasis (parasitic
worms) is responsible for about 130,000 deaths from stomach
bleeding each year. From previous research in other bleeding
conditions such as surgery and trauma, we know that a drug
called Tranexamic acid can reduce bleeding and save lives. We
now want to do the HALT-IT trial to see if giving Tranexamic
acid can save lives and if there are any complications in people
with severe bleeding from the digestive system.
Trial Design Allocation: Randomized
Intervention Model: Parallel
Assignment Masking: Double blind
Primary Purpose: Treatment
Medical Condition Gastrointestinal Bleeding
Trial Phase Phase – III
Investigational Product Tranexamic Acid
Control No. 3-4/2015 DD (PS)
Approval Date 08th December, 2015 vide 253rd DRB dated 05th& 06th October,
2015
Duration of Trial 18 Months (Approx.)
Status Recruiting
Target Enrollment 8000
Total numbers of participants 7104
recruited till now
Participants recruited in 1112
Pakistan
Eligibility Criteria Inclusion Criteria:
 adult patients
 with acute significant upper or lower gastrointestinal
bleeding
 Where the responsible clinician is substantially
uncertain as to the appropriateness of anti-fibrinolytic
agents in the patient.
Exclusion Criteria:
 The fundamental eligibility criterion is the responsible
clinician's 'uncertainty' as to whether or not to use an
antifibrinolytic agent in a particular patient with upper

or lower gastrointestinal bleeding.
Sex/Gender All
Age Group 16 Years and older (Child, Adult, Senior)
Approved Study Sites in Holy Family Hospital, Rawalpindi
Pakistan Shifa International Hospital, Islamabad
Lady Reading Hospital, Peshawar
DHQ Hospital, Narowal
DHQ Hospital, Khuzdar
DHQ Hospital, Rawalpindi
Benazir Bhutto Hospital, Rawalpindi
Jinnah Hospital, Lahore
Liaquat National Hospital, Karachi
POF Hospital, Wah Cantt.
Services Hospital, Lahore
Shaukat Khanum Memorial Hospital, Lahore
Mardan Medical Complex, Mardan
Madinah Hospital, Faisalabad
Aziz Bhatti Shaheed Hospital, Gujrat
DHQ Hospital, Faisalabad
Hayatabad Medical Complex, Peshawar
Mayo Hospital, Lahore
Sir Ganga Ram Hospital, Lahore
Allied Hospital, Faisalabad
Asian Institute of Medical Sciences, Hyderabad
DHQ Hospital, Sargodha
Bolan Medical Complex, Quetta
Jinnah Postgraduate Medical Center, Karachi
Participating Countries More than 40 countries including Pakistan
Sponsor London School of Hygiene & Tropical Medicine, London, UK
Chief Investigator Prof. Ian G Roberts
Trial Coordinator in Pakistan Prof. Muttiullah Khan (Holy Family Hospital, Rawalpindi)
2. In 265th meeting dated 24th& 25th January, 2017, the Registration Board granted the
approval of amendment in the trial protocol submitted by the trial management, for extension
in trial period for further one year i.e till 30th November, 2017.”
3. A - Request by the Applicant:

i. Now the trial management has requested for further amendment in the protocol to
extend the recruitment period from 30th November, 2017 to 31st May, 2019.
ii. It has been stated by the applicant that previously the Primary Outcome of the trial
was based on “death due to any reason witfhin 28 days of randomization”, because it
was assumed that most deaths in the trial would be from bleeding but now the
accumulated data of the trial shows that substantial proportion of deaths are non-
bleeding related (e.g. Cancer, Pneumonia, Liver Failure). Therefore the sample size of
8000 patients is being increased to 12000 patients to analyze the effect of Tranexamic
Acid on death from haemorrhage which has been added as main secondary outcome.

iii. The summary of changes in protocol, is as under;
Protocol Section Description of Change
Addition of following:
Cause specific mortality will be described
Primary Outcome (Haemorrhage, Myocardial Infarction, Stroke,
Pulmonary Embolism, Pneumonia, Malignancy,
other).
Addition of the following:
Secondary Outcome
a. Death from haemorrhage
Trial Design Change of number of patients from 8000 to 12000
Change from 30th November, 2017 to 31st May,
Planned Date of Last Patient Enrolment
2019
Addition of the following:
Where fluid restriction is needed, the volume used
Method of Administration of Drug
to administer the maintenance dose can be reduced
to 500ml.
iv. The applicant has enclosed the copy of revised version of protocol along with revised
consent form and information sheet for patients and the copy of ethical approval from
National Bio-ethics Committee along with their application.
B - Request by the Applicant:
i. Trial Management has also requested for approval of following four additional trial
sites for the ongoing trial:
S. No. Name of the Hospital / Trial Site Name of the Principal Investigator
Ghulam Mohammad Mehar Medical College &
Dr. Saleh Muhammad Channa
01 Teaching Hospital, Sukkur, Sindh
MBBS, MCPS, FCPS (Medicine)
Department of Gastroenterology and Hepatology
Professor Abrar Ali Shaikh
02 Teaching Hospital, Sukkur, Sindh
MBBS, MRCP
Department of Medicine Unit – I
Liaquat University of Medical & Health Sciences,
Dr. Santosh Kumar
03 Department of Medicine Unit – II,
MBBS, FCPS (Medicine)
Jamshoro, Sindh
Lahore General Hospital
Prof. Ghaia Un Nabi Tayyab
04 Department of Medicine Unit – I
MBBS, MD, FCPS, FRCP
Ferozepur Road, Lahore
ii. Applicant has informed that aforesaid trial sites have been assessed by the Sponsor
(London School of Hygiene & Tropical Medicine, UK) and found satisfactory to
carry out the trial activities.
iii. The applicant has enclosed the CVs of the Principal Investigators of proposed trial
sites along with the processing fee, copies of GCP training certificates of Principal
Investigators and ethical approval of concerned Institutional Review Boards (IRB)
and requested for approval of above mentioned additional trial sites.
Decision: In the light of discussion and deliberation, the Board accorded the
approval for the following:
 Amendments as enlisted in the revised Protocol (Version 2.0) of
the trial, submitted by the applicant.
 Extension of the trial at following four new trial sites, under
the strict supervision of the relevant Principal Investigators;
S. No. Name of the Hospital / Trial Site Name of Principal Investigator
Dr.Saleh Muhammad Channa
01 Teaching Hospital, Sukkur, Sindh, Department
MBBS, MCPS, FCPS (Medicine)
of Gastroenterology and Hepatology
Professor Abrar Ali Shaikh
02 Teaching Hospital, Sukkur, Sindh, Department
MBBS, MRCP
of Medicine Unit – I
Liaquat University of Medical & Health
Dr. Santosh Kumar
03 Sciences, Department of Medicine Unit –
MBBS, FCPS (Medicine)
II,Jamshoro, Sindh
Lahore General Hospital
Prof. Ghaia Un Nabi Tayyab
04 Department of Medicine Unit–I, Ferozepur
MBBS, MD, FCPS, FRCP
Road, Lahore
Case No.02: Request for approval of amendment in protocol, of already approved

clinical trial namely “Tranexamic Acid For The Treatment Of
Significant Traumatic Brain Injury: An International Randomized,
Double Blind, Placebo Controlled Trial” (CRASH-3 Trial)
The subject cited clinical trial was approved by Registration Board in its 245 th
meeting held on 29th and 30th September, 2014. The details of the trial are as under;
Tranexamic Acid For The Treatment Of Significant Traumatic
Title: Brain Injury: An International Randomized, Double Blind,
Placebo Controlled Trial
Clinical Randomization of an Anti-fibrinolytic in Significant
Trial Acronym
Head Injury (CRASH-3)
The CRASH-3 trial will provide reliable evidence about the
effect of Tranexamic Acid on mortality and disability in patients
with traumatic brain injury. The effect of Tranexamic Acid on
the risk of vascular occlusive events and seizures will also be
assessed. Additionally, a nested study will be conducted in a
Brief Summary subset of CRASH-3 trial participants. This nested study
(CRASH-3 Intracranial Bleeding Sub-Study [CRASH-3 IBS])
will examine the effect of Tranexamic Acid on intracranial
hemorrhage and cerebral ischemia using CT Scans in
approximately 1,000 patients randomized into the CRASH-3
trial.
Allocation: Randomized
Double Blind (Participant,
Trial Design
Assignment Masking: Care Provider, Investigator,
Outcomes Assessor)
Trial Phase Phase – III
Investigational Product Tranexamic Acid
Control No. 2-11/2014 ADC (CT)
Approval Date 11th November, 2014
Duration of Trial 04 Years
Status Recruiting
Target Enrollment 13000
Total numbers of
participants recruited till
10051
now.

Participants recruited in
3306
Pakistan
Inclusion Criteria:
Adults with traumatic brain injury who
 are within eight hours of injury (limited to within 3 hours
from September, 2016)
 with any intracranial bleeding on CT scan or who have a
GCS of 12 or less, and
 have no significant extra-cranial haemorrhage The
Eligibility Criteria fundamental eligibility criterion is the responsible
clinician's 'uncertainty' as to whether or not to use
Tranexamic acid in a particular patient with traumatic
brain injury
Exclusion Criteria:
The fundamental eligibility criterion is the responsible clinician's
'uncertainty' as to whether or not to use Tranexamic acid in a
particular patient with traumatic brain injury.
Sex/Gender All
Age Group 16 Years and older (Child, Adult, Senior)
Aga Khan University Hospital, Karachi
DHQ Hospital, Rawalpindi
Jinnah Postgraduate Medical Centre, Karachi
Lady Reading Hospital, Peshawar
Lahore General Hospital, Lahore
Approved Study Sites in Services Hospital, Lahore
Pakistan Shifa International Hospital, Islamabad
DHQ Hospital, Khuzdar
DHQ Hospital, Narowal
Jinnah Hospital, Lahore
Liaquat National Hospital, Karachi
Liaquat University of Medical & Health Sciences, Jamshoro
Indonesia, Ireland, Jamaica, Papua New Guinea, Romania,
Egypt, Iraq, Cambodia, Zambia, El Salvador, Italy, Mexico,
Participating Countries Afghanistan, Cameron, Myanmar, United Arab Emirates, Japan,
Nepal, Albania, Nigeria, Colombia, Spain, Georgia, Malaysia,
United Kingdom, Pakistan
Sponsor London School of Hygiene & Tropical Medicine, London, UK
Global Trial Lead Haleema Shakur
Trial Coordinator in
Prof. Rizwana Chaudhary
Pakistan

2. In 265th meeting dated 24th& 25th January, 2017 the Registration Board granted
approval of amendment in the trial protocol submitted by the trial management, for extension
in trial period for further one year i.e from 31st December, 2016 to 31st December, 2017 and
increase in patient size from 10,000 to 13,000.
3. Request by the Applicant:
i. Now the Trial Management has submitted the request for approval of protocol
amendment for extension of trial recruitment period from 31st December, 2017 to 31st
December, 2018.
ii. Applicant has informed that due to slowdown in recruitment they have planned to
extend the recruitment period for further one year i.e till 31st December, 2018. Up till
now, 10,051 patients have been recruited globally whereas the target sample size is
13,000 patients. In Pakistan, 3306 patients have been enrolled so far.
iii. Applicant has submitted the revised protocol version 2.1 along with the approval for
trial extension from the Sponsor i.e London School of Hygiene & Tropical Medicine,
United Kingdom and the copy of ethical approval from National Bio-ethics
Committee.
Decision: In the light of discussion and deliberation, the Board accorded the approval
for amendments as enlisted in the revised Protocol (Version 2.1) of the trial
submitted by the applicant, to extend the recruitment period from 31 st
December, 2017 to 31stDecember, 2018.
Case No.03: Request for approval of amendment in protocol of alreacdy approved

clinical trial - “A Phase II Study To Evaluate The Safety, Tolerability
And Pharmacodynamics of Pegylated Interferon Lambda Mono-Therapy
In Patients With Chronic Hepatitis Delta (CHD) Virus Infection”.
A multi-country trial on the subject “To evaluate safety, tolerability and
pharmacodynamics of Pegylated Interferon Lambda Monotherapy in patients with chronic
hepatitis Delta Virus Infection”, already in execution, initially designed for study in USA,
Canada, New Zealand and Pakistan, was approved in 262nd meeting of DRB held on 20th
October, 2016. The details of the trial are as under;
A Phase 2 Study to Evaluate the Safety, Tolerability, and
Pharmacodynamics of Pegylated Interferon Lambda
Title:
Monotherapy in Patients With Chronic Hepatitis Delta Virus
Infection (LIMT)
Trial Acronym Lambda Interferon Monotherapy in HDV (LIMT)
Lambda is the Pegylated form of interferon lambda-1a (IFN-λ), a
conjugate of recombinant human interleukin 29 (rIL-29) and a
linear polyethylene glycol (PEG) chain. IFN-λ and interferon
alpha (IFN-α) share the common interferon (IFN)-stimulated
gene induction pathway that leads to broad-spectrum antiviral
activities. Since IFN-α has demonstrated anti-hepatitis delta
Brief Summary virus (HDV) activity in patients with chronic hepatitis delta
(CHD), it is postulated that pegylated IFN-λ could also induce
HDV ribonucleic acid (RNA) decline in patients with CHD.
Based on IFN-λ's more limited receptor distribution and previous
data from studies involving treatment with IFN-λ in patients with
hepatitis B virus (HBV) or hepatitis C virus (HCV), it is
postulated that Lambda treatment could be associated with fewer

adverse effects than IFN-α treatment. This Phase II study is
designed as randomized, open-label study of Lambda 120 or 180
μg subcutaneous (SC) injection weekly for 48 weeks in patients
with chronic HDV infection, and the primary objectives of the
study are as follows:
 To evaluate the safety and tolerability of treatment with 2
dose levels of Lambda over a 48-week treatment period.
 To evaluate the effect of treatment with 2 different doses
of Lambda on HDV RNA levels.
Allocation: Randomized
Trial Design Assignment Masking: None
Medical Condition Chronic Hepatitis D
Trial Phase Phase – II
Investigational Product Lambda {Pegylated form of interferon lambda-1a (IFN-λ)}
Control No. 3 – 4 / 2016 DDC (P.S)
Approval Date 01st December, 2016
Duration of Trial 21 Months (Approximately)
Status Ongoing
Target Enrollment
40
(Globally)
Enrollments Completed
33
(Globally)
Enrollments in Pakistan 15
Inclusion Criteria:
 Chronic HDV infection of at least 6 months' duration
documented by a positive HDV antibody (Ab) test, detectable
and quantifiable HDV RNA by qPCR at study entry
 Serum alanine aminotransferase (ALT) > upper limit of the
normal range (ULN) and <10 × ULN at screening
 Electrocardiogram (ECG) demonstrating no acute ischemia or
clinically significant abnormality and a QT interval corrected
for heart rate (QTcF) <450 ms for male patients and <460 ms
for female patients
 Thyroid-stimulating hormone (TSH) and/or free T4 within
0.8 to 1.2 × ULN, or adequately controlled thyroid function
as assessed by the investigator.
Eligibility Criteria  Dilated retinal examination ≤1 year before screening
 Female patients of childbearing potential and male patients
with partners of childbearing potential must agree to use
adequate methods of contraception during the study and
through 90 days after the last dose of study medication
Exclusion Criteria:
General Exclusions:
 Participation in a clinical trial with or use of any
investigational agent within 30 days before screening, or
treatment with interferon (IFNs) or immunomodulators
within 12 months before screening
 Previous use of Lambda. Patients who previously participated
in a clinical trial of Lambda but are confirmed to have
received placebo or other non-Lambda IFNs are allowed.

 History or evidence of any intolerance or hypersensitivity to
IFNs or other substances contained in the study medication.
 Female patients who are pregnant or breastfeeding. Male
patients must confirm that their female sexual partners are not
pregnant.
Exclusions Based on Disease
 Current or previous history of decompensated liver disease
(Child-Pugh Class B or C)
 Co-infected with human immunodeficiency virus (HIV) or
hepatitis C virus (HCV)
 Past history or current evidence of decompensated liver
disease, defined as any of the following at screening:
1. Bilirubin level ≥ 2.5 mg/dL unless due to Gilbert's
disease
2. Serum albumin level <3.5 g/dL
3. International normalized ratio (INR) ≥1.5
4. Alpha fetoprotein ≥100 ng/mL
 Evidence of significant portal hypertension; current presence
or history of variceal bleeding, ascites requiring diuretics or
paracentesis, or hepatic encephalopathy
 Any of the following abnormal laboratory test results at
screening:
1. Platelet count <90,000 cells/mm^3
2. White blood cell count <3,000 cells/mm^3
3. Absolute neutrophil count <1,500 cells/mm^3
4. Hemoglobin <11 g/dL for women and <12 g/dL for
men
5. Serum creatinine concentration ≥1.5× ULN
6. Confirmed creatinine clearance (CrCl) < 50 mL/min
by Cockcroft-Gault
 Evidence of another form of viral hepatitis or another form of
liver disease
 History of hepatocellular carcinoma
 Patients with any of the following:
1. Current eating disorder or alcohol abuse
2. Excessive alcohol intake
3. In the opinion of the investigator, an alcohol use
pattern that will interfere with study conduct
4. Drug abuse within the previous 6 months before
screening, with the exception of cannabinoids and
their derivatives
 Prior history or current evidence of any of the following:
1. Immunologically mediated disease
2. Retinal disorder or clinically relevant ophthalmic
disorder
3. Any malignancy within 5 years before screening
4. Cardiomyopathy or significant ischemic cardiac or
cerebrovascular disease.
5. Chronic pulmonary disease
6. Pancreatitis
7. Severe or uncontrolled psychiatric disorder
8. Active seizure disorder
9. Bone marrow or solid organ transplantation

 Other significant medical condition that may require
intervention during the study
Exclusions Based on Concurrent Medication Use
 Therapy with an immunomodulatory agent
 Use of telbivudine
 Current use of heparin or Coumadin
 Received blood products within 30 days before study
randomization
 Use of hematologic growth factors within 30 days before
study randomization
 Systemic antibiotics, antifungals, or antivirals for treatment of
active infection other than HBV within 14 days before study
randomization
 Any prescription or herbal product that is not approved by the
investigator
 Long-term treatment (> 2 weeks) with agents that have a high
risk for nephrotoxicity or hepatotoxicity unless it is approved
by the medical monitor
 Receipt of systemic immunosuppressive therapy within 3
months before screening
Sex/Gender All
Age Group 18 to 65 Years
Approved Study Sites in
Aga Khan University Hospital, Karachi
Pakistan
Participating Countries USA, Canada, New Zealand, Pakistan
Sponsor Eiger BioPharmaceuticals
Global Chief Investigator Eduardo B Martins
Principal Investigator in
Prof. Saeed Sadiq Hamid (Aga Khan University, Karachi)
Pakistan
Trial Coordinator in
Sadaf Khurram
Pakistan
2. After completion of formalities the authorization was conveyed to the applicant on
01st December, 2016. Trial management was allowed to import 750 prefilled syringes (PFS)
of the Pegylated Interferon Lambda for 10 patients (05 in each treatment group) using 120µg
or 180µg of the investigational product, as per their request.
3. The shipment details, as disclosed by the applicant, are as under;
Drug Imported
Quantities
(PEG Interferon Lambda (120µg & 180µg)
First Shipment (22nd December, 2016) 200 Syringes (100 each of 120µg & 180µg)
Second Shipment (16th March, 2017) 150 Syringes (75 each of 120µg & 180µg)
200 Syringes (100 each of 120µg & 180µg)
Third Shipment (22nd May, 2017)
Destroyed due to temperature excursion
Fourth Shipment (09th June, 2017) 100 Syringes (50 each of 120µg & 180µg)
Fifth Shipment (23rd June, 2017) 100 Syringes (50 each of 120µg & 180µg)
Total Quantity 750 Syringes

4. Principal Investigator contrary to the conditions of the approval has done the
following deviations;
(i) Amended the protocol twice, without formal approval of the DRAP.
(ii) They have unilaterally destroyed 287 PFS of the investigational product of various
strengths (quantity of each potency has not been disclosed) without approval of the
Authority.
(iii) It has been claimed that 87 PFS of the investigational product were destroyed due
to expiry but the Expiry Date of the same batch (B. No.3K77275) is mentioned in
the inventory sheet as June, 2018 and June, 2017 which is questionable.
(iv) As per submitted documents by the CRO, the destroyed quantities included 100
each of both strengths (120µg and 180µg) whereas the import documents reveal
that all the 200 syringes are of 180µg.
(v) The CRO/P.I has not furnished the required documents especially the invoices of
the shipments of the investigational product, imported and got cleared from the
DRAP, Karachi office.
5. Request of the Applicant:

i. Trial management has now submitted the application for permission to import
additional quantities of 600 prefilled syringes of Pegylated Interferon Lambda 180µg.
It has been stated that the destruction of 200 syringes of the study drug has resulted in
its shortage and now there is possibility that the recruited patients may withdraw from
the study due to non-availability of medication.
ii. The applicant has justified the quantity of 600 syringes for further import by
calculating that they have enrolled 15 patients and each patient is being provided with
05 syringes every month, which includes four syringes for weekly dose and one extra
syringe to cover any wastage or loss of the study drug. In this way, they require 75
syringes every month and for remaining eight months of treatment period from
October, 2017 to May 2018, they will require a total of 600 syringes.
6. Whereas the record reveals that;

i. The actual requirements in lieu of the destroyed stock and utilization of previously
imported quantities i.e 750 PFS, is supposed to be as under;
Total Number of Patients: 15
Recommended Dose: Once Weekly
Treatment period: 12 Months
ii. Utilization summary of previously imported quantity of Investigational Drug is
supposed to be as under;
Treatment Months Drug Utilized
Enrollment Month No. of Enrollments
Completed (PFS)
January 06 09 216
March 05 07 140
May 04 05 80
Drug Dispensed 436
Drug Destroyed Due to Temperature Excursion 200
Drug Destroyed Due to Expiry (12%) 87
Total Quantity Utilized 723
Balance in Hand 27
iii. As per above details, further requirement of Investigational Drug should be as under;
Treatment Months Drug Required
Enrollment Month No. of Enrollments
Remaining (PFS)
January 06 03 72
March 05 05 100
May 04 07 112
Total 284
Available Quantity 27
Total Quantity Required 284 – 27= 257
Excess Quantity 12% (As per Previous Record) 31
Final Quantity Required 288
The case was presented before the Board on first day of the meeting dated 25th
October, 2017 and after discussing the matter in detail, the Board decided to call the
representative of the Trial Management to appear before the Board and answer the queries to
justify the demanded quantities of the Investigational Drug.
In response, Dr. Abid, the representative of the CRO of the trial i.e M/s Clinserv
International, appeared before the Board on next day of the meeting i.e 26th October, 2017
and answered the questions of the Board members. He justified the quantity of 600 syringes
for further import by calculating that so far they have enrolled 15 patients and each patient is
being provided with 05 syringes every month, which includes four syringes for weekly dose
and one extra syringe to cover any wastage or loss of the study drug. Patients return all the
five syringes on their following monthly visit for verification and they are stored separately in
a disposal container. In this way, they require 355 syringes for remaining treatment period but
they want to import 255 extra syringes on precautionary measures so as to prevent any
shortage of the Investigational Drug in the future due to any unforeseen event as it happened
previously which resulted in destruction of 287 syringes. He also presented a letter addressed
to the Chairman Registration Board, on behalf of M/s Clinserv International, requesting to
allow the import of the Investigational Drug on immediate basis because the patients are
suffering due to none availability of the trial material and also making commitment that in
case, at the end of the trial, all the remaining/unused quantities of the Investigational Drug
will be destroyed with the prior approval from DRAP.
Decision: After hearing the opinion of the representative of the trial management
and in the light of discussion and deliberation, the Board decided the
matter as under;
i) Registration Board approved the submitted revised Protocol
(Amendment 3) and allowed the Trial Management to import the
requested quantity of 600 Pre-filled Syringes of Pegylated Interferon
Lambda 180µg, on immediate basis.
ii) Registration Board directed the Pharmacy Services Division for
strict monitoring of the Trial and utilization of the Investigational
Drug, on regular basis, till the completion of the trial.
iii) Registration Board also directed the Pharmacy Services Division to
communicate the above decision, immediately to the applicant,
without waiting for the approval of the minutes of the meeting.

Item No.III: Pharmaceutical Evaluation & Registration Division
A. Pharmaceutical Evaluation Cell.
S.No. Detail
Case No.01 Reference regulatory authorities
Case No.02 On site investigation of submitted data
Case No. 03 Previously deferred cases of Letrozole
Case No.04 Registration applications for local manufacturing of (Human) drugs
a. Registration applications submitted with full fee
i. New cases
ii. Deferred cases
b. Applications whose differential fee submitted upto 30th September, 2015
i. New cases
ii. Deferred cases
Case No.05 Registration applications of newly granted DML or New section
(Human)
a. DML (Drug Manufacturing License(s))
b. New section(s)
c. Remaining products of new DML /section
d. Deferred cases
Case No.06 Registration applications for local manufacturing of (veterinary) drugs
a. Applications of New DML/section
Case No.07 Registration applications of drugs for which stability studies data is
required to be verified
a. New cases of stability studies
b.Deferred cases of stability studies
c. Verification Of Genuineness / Authenticity Of Stability Data And
Associated Documents
Case No. 08 Registration applications of categories to be considered on priority
a. Local Manufacture
b. Finished Import
Registration applications of import cases
Case No. 09
a. Import routine cases (Human)
b. Import routine cases (Veterinary)
c. Import Deferred cases
d. Incomplete Files

Sr. No Name of Evaluator Title
1. Mr. Muhammad Tahir Waqas Evaluator PEC-I
2. Mr. Ammar Ashraf Awan Evaluator PEC-II
3. Mr. Muhammad Haseeb Tariq Evaluator PEC-III
4. Mst. Urooj Fatima Evaluator PEC-IV
5. Mst. Iqra Aftab Evaluator PEC-V
6. Mr. Muhammad Umar Latif Evaluator PEC-VI
7. Mst. Sidra Khalid Evaluator PEC-VII
8. Mst. Haleema Sharif Evaluator PEC-VIII
9. Mr. Farooq Aslam Evaluator PEC-X
10. Mst. Najia Saleem Evaluator PEC-XI
11. Syed Ajwad Bukhari Evaluator PEC-XII
12. Mst. Mehwish Javed Khan Evaluator PEC-XIII

13. Mr. Muhammad Ahsan Hafiz Evaluator PEC-XIV

Case No.01: Reference Regulatory Authorities.
A. Reference Regulatory Authorities for Human Drugs
Registration Board in 249th meeting held on 18-19th May, 2015 decided that in
addition to already accepted reference drug regulatory agencies i.e. USFDA, Health Canada,
EMA, TGA Australia and PMDA Japan, the molecules/ formulations (in same dosage form
and strength) alongwith clinical trials registered by the regulatory authoroties of United
Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and
Norway or drugs registered in atleast three European Union counties will also be taken as
reference for consideration of Registration Board, as authorities of these countries have
robust drug regulatory mechanisms and long standing strong litigation systems. However
Registration Board shall also consider the safety and efficacy parameters of the drug under
domestic circumstances / practices.
Registration Board in 274th meeting held on 21-23rd September, 2017 advised
stakeholders (PPMA, Pharma Bureau and PCDA) to give their proposals for consideration of
Registration Board. Following proposal was discussed in the meeting
Following is the list of currently approved reference regulatory authorities by the
Registration Board.
Sr. Country Regulatory authority Accessible Link for database
# database
1. USA Food & Drug Yes https://www.accessdata.fda.gov/scripts/c

Administration (FDA) der/daf/
2. Canada Health Canada Yes https://health-products.canada.ca/dpd-

bdpp/index-eng.jsp
3. Australia Therapeutic Goods Yes http://tga-

Administration (TGA) search.clients.funnelback.com/s/search.ht
ml?query=&collection=tga-artg
4. Japan Pharmaceuticals and Yes http://www.pmda.go.jp/PmdaSearch/iyak
Medical Devices Agency uSearch/
(PMDA)
5. UK Medicines and Healthcare Yes http://www.mhra.gov.uk/spc-pil/
Regulatory Agency
(MHRA)
6. France National Agency for the Yes http://agence-
Safety of Medicine and prd.ansm.sante.fr/php/ecodex/
Health Products (ANSM)
7. Germany Federal Institute for Drugs Yes http://www.dimdi.de/static/de/db/dbinfo/
and Medical Devices aj29.htm
8. Netherland Medicines Evaluation Yes http://www.geneesmiddeleninformatieba

Board nk.nl/nl

9. Switzerland Swissmedic Yes http://www.swissmedicinfo.ch/Accept.as
px?ReturnUrl=%2f
10. Austria Austrian Agency for Yes https://aspregister.basg.gv.at/aspregister/f

Health and Food Safety aces/aspregister.jspx?_afrLoop=5355900
7139362908&_afrWindowMode=0&_ad
f.ctrl-state=11ajcl0qd9_4
11. Denmark Danish Medicines Agency Yes http://www.produktresume.dk/docushare/
dsweb/View/Collection-256
12. Sweeden Medical Products Agency Yes https://lakemedelsverket.se/english/produ
ct/Medicinal-products/
13. Norway Norwegian Medicines Yes https://www.legemiddelsok.no/
Agency
14. Europe European Medicines Yes http://www.ema.europa.eu/ema/index.jsp

Agency (EMA) ?curl=pages/includes/medicines/medicin
es_landing_page.jsp&mid=
 PPMA proposed that European Union Member States that includes the 28 member states
of the European Union and countries which are members of the Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/s)
should also be made part of the reference countries. In addition to above, that a regulatory
authority which is a member of ICH which includes Korea and ICH observer namely
European Free Trade Association and aregulatory authority associated with an ICH
member through a legally-binding, mutual recognition agreement should also be
considered for registration in Pakistan.
 PPMA further proposed that all European countries covered under the EU follows the
same regulatory system as per European Medicines Agency (EMA) and it is not
mandatory that the market authorization for a particular product is obtained throughout
the EU. In fact, the majority of medicines authorized in the EU are authorized by national
competent authorities (NCAa) in the respective Member States, though they are not
authorized/applied for authorization across EU due to their own requirement. Even
though each EU Member State has its own national authorization procedures, however
the data requirements and standards governing the authorization of medicines are the
same in the EU. In addition to above, Ministry of Food and Drug Safety (MFDS) which is
the regulatory body of Korea is also a member of ICH as a Regulatory Member; hence
products approved by them may also be considered for registration in Pakistan.
 WHO has published new definition of Stringent Regulatory Authorities (SRA) as per
guidance document published in 15th February 2017. According to that document SRA is
defined as:
a) a member of ICH prior to 23 October 2015, namely: the US Food and Drug
Administration, the European Commission and the Ministry of Health, Labour and
Welfare of Japan also represented by thePharmaceuticals and Medical Devices
Agency; or
b) an ICH observer prior to 23 October 2015, namely: the European Free Trade
Association, asrepresented by Swissmedic and Health Canada; or
c) a regulatory authority associated with an ICH member through a legally-binding,
mutual recognitionagreement prior to 23 October 2015, namely: Australia, Iceland,
Liechtenstein and Norway.
 Registration Board deliberated the proposal of PPMA and after detailed discussion,
following countries were decided for inclusion in list of reference regulatory authorities

for acceptance of their approval status for molecules/ formulations (in same dosage form
and strength) along with clinical trials. Detail of these regulatory authorities is as
follows:
Sr. Country Regulatory Member Status in ICH Accessible Link for database
# authority of database
EC/EMA
1 Belgium Federal Member Member of Yes http://bijsluiters.fagg-
Agency for of EC ICH (as afmps.be/?localeValue=nl
Medicines and EMA member of
and Health EC) and SRA
Products
2 Finland Finnish Member Member of Yes http://www.fimea.fi/web/en/databas
Medicine of EC ICH (as es_and_registeries/spcs/human_med
Agency and EMA member of icinal_products
EC) and SRA
3 Italy Italian Member Member of Yes https://farmaci.agenziafarmaco.gov.i
Medicine of EC ICH (as t/bancadatifarmaci/
Agency and EMA member of
(AIFA) EC) and SRA
4 Ireland Health Member Member of Yes http://www.hpra.ie/
Products of EC ICH (as
Regulatory and EMA member of
Authority EC) and SRA
(HPRA)
5 Iceland Icelandic Member Classified as Yes https://www.serlyfjaskra.is/
Medicine of EMA SRA by WHO
Agency as per
guidance
document
published in
15th February
2017
6 Spain Spanish Member Member of Yes https://www.aemps.gob.es/cima/fich
Agency for of EC ICH (as asTecnicas.do?metodo=detalleForm
Medicines and EMA member of
and Health EC) and SRA
Products
7 WHO World NA Standing Yes https://extranet.who.int/prequal/cont
Health Observer ent/prequalified-lists/medicines
Organization
Decision: Registration Board discussed the matter in detail and decided that in
addition to already approved reference regulatory authorities, above
mentioned (7) regulatory authorities i.e., regulatory authority of Belgium,
Finland, Italy, Ireland, Iceland, spain and WHO prequalified formulation
shall also be considered as reference.Thus Registration Board decided to
consider following regulatory authorities / agencies as reference for
molecules/ formulations (in same dosage form and strength) alongwith
clinical trials for human purpose.
a. Food & Drug Administration (FDA) of USA
b. Health Canada of Canada
c. Therapeutic Good Administration (TGA) of Australia
d. Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
e. Medicines and Healthcare Regulatory Agency (MHRA) of UK

f. National Agency for the Safety of Medicine and Health Products
(ANSM) of France.
g. Federal Institute for Drugs and Medical Devices of Germany
h. Medicines Evaluation Board of Netherland
i. Swissmedic of Switzerland
j. Austrian Agency for Health and Food Safety of Austria
k. Danish Medicines Agency of Denmark
l. Medical Products Agency of Sweeden
m. Norwegian Medicines Agency of Norway
n. Federal Agency for Medicines and Health Products of Belgium
o. Finnish Medicine Agency of Finland
p. Italian Medicine Agency (AIFA) of Italy
q. Health Products Regulatory Authority (HPRA) of Ireland
r. Icelandic Medicine Agency of Iceland
s. Spanish Agency for Medicines and Health Products of Spain
t. European Medicines Agency (EMA) of Europe and
u. World Health Organization (WHO)
B. Reference Regulatory Authorities for Veterinary Drugs

Registration Board in its 274th meeting discussed the matter of reference regulatory
authorities for veterinary drugs and advised PPMA to submit proposal in forthcoming
meeting.
 PPMA has submitted that for Veterinary Drugs countries such as India, China, Brazil,
Argentina, Korea and Thailand where Veterinary Population is large and veterinary
diseases are similar to Pakistan due to hot and humid Weather and Farmers Practices
should be included as reference. This shall be done with approval and guidance from
Expert Veterinary Member already present in the Board. Veterinary Drugs and
Supplements go directly hand in hand as Food Security Plan for any country as they are
used in Food Producing Animals but are not restricted to only them but also for Pet
Animals having variety of species. Veterinary Drugs plays a vital and important role to
combat diseases and also encompasses many other varieties of drugs for species not
present in all countries such as Camels and Water Buffaloes. Newer and Wide Range of
Research based Molecules and combinations with varying concentrations are needed to
totally cover the range of various diseases.
 PPMA has further submitted that after recommendations from highly respected technical
recognized experts associated with Veterinary Agriculture Universities Faisalabad,
UVAS, Lahore, Technical experts DVM (Doctor of Veterinary Medicine) from
Veterinary Pharmaceutical Manufacturers and respected Expert Member of Registration
Board 2016-2018 DR. Qurban Ali, have formulated the following recommendations
1) Veterinary Drugs in many countries do not necessarily fall under Drug Regulatory
Regime and may be regulated and registered under Ministry of Health, Ministry of
Agriculture and Dairy. Ministry of Feed and Animal Resources.
2) Include list of 33 countries where databases are available in book form, veterinary
doctor guide books, and some on the web including Argentina, Austria, Australia,
Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United
Kingdom, Ireland, Israel, Italy, Japan, South Korea, Malta, Malaysia, Netherlands,
Norway, New Zealand, Sweden, Singapore, Thailand, Taiwan, United States, Saudia
Arabia, Turkey, Brazil, Indonesia, Poland and Portugal
Decision: Registration Board decided to further deliberate the matter. Meanwhile,
present practice of considering already registered generic versions as
reference shall be continued after being reviewed by veterinary expertof
the Board.
Case No.02: On site investigation of submitted data.

Registration Board in 240th meeting held on 07th November, 2013 decided that for
New Drug molecule / Dosage form / Strength / combination, applicant shall have to submit
stability study under the Zone IV-A conditions as per ICH / WHO guidelines. Later on, in
251st meeting held on 12-13th August, 2015 it was decided that manufacturer will provide
scientifically rational lab scale data as per following requirements:
 Certificate of Analysis of API.
 Approval of API by regulatory authority of country of origin or GMP certificate of
API manufacturer issued by regulatory authority of country of origin.
 Manufacturer will follow Drug Specification Rules, 1986.
 Protocols followed for conduction of stability study and details of tests.
 Data of 03 batches will be supported by attested respective documents like
chromatograms, laboratory reports, data sheets etc.
 Documents confirming import of API etc.
 All provided documents will be attested (name, sign and stamp) for ensuring
authenticity of data / documents.
 Shelf life of two years shall be granted based upon the results 06 month accelerated
and real time stability study data.
 Commitment to continue real time stability study till assigned shelf life of the product.
In 254th meeting Registration Board, Registration Board considered recommendations /

directions of Ministry of National Health Services, Regulation & Coordination and decided
for onsite investigation for the genuineness of submitted data should be adopted in future, for
all applications of generics of NCEs (New Chemical entities / New drugs generic versions)
where local long term data and experience is not available, to ascertain quality, safety and
efficacy profile of such drugs, in the larger public interest.
During various inspections carried out for verification of authenticity of submitted

stability study data it was noticed that pharmaceutical manufacturers have adopted scientific
procedures for product development, analytical method validation and stability studies to
ensure data authenticity and integrity and manufactuting of products. Thus based on
aforementioned experience of such inspections, Registration Board in 274th meeting held on
21-23rd September, 2017 advised stakeholders (PPMA, Pharma Bureau and PCDA) to give
their proposals for consideration of Registration Board.
Decision: Registration Board discussed the matter in detail and decided as follows:
 Firms can submit product development data including stability study
data along with related documents after completion of 3 months. These
shall be evaluated and shortcomings (if any) will be communicated to the

applicant. The case will be presented before the Board upon the
submission of 6 months stability study data after its necessary evaluation.
 Exemptions from verification of authenticity of submitted stability data
shall be granted to those firms which have already been granted approval
of one (01) similar dosage form by Registration Board on the basis of
panel inspection reports with no observation related to quality and
integrity of data and these applicants possesses following systems:
o 21 CFR compliant system and complete audit trail report for test/
analysis performed on HPLC, confirmed/reported by panel which
has specifically inspected the pharmaceutical unit for this purpose.
o Digital data logger for temperature and humidity monitoring of
stability chambers (real time and accelerated).
 Registration Board can constitute panel for product specific inspection for
verification of authenticity of submitted stability study data if it deems
necessaryto confirm any inconsistency in data etc.
Case No. 03: Previously deferred cases of Letrozole
Evaluator PEC-III
The case regarding manufacturing requirement of leterozole and other immunosuppresants
were discussed in 271st meeting of Registartion Board and the Board decided as follows:
Decision: Registration Board deliberated the matter in light of above information
and decided as under:
a) There is no need for segregated / dedicated / self contained premises / facilities for the
production of drugs belonging to the categories namely immunosuppressants,
aromatase inhibitors (letrozole, anastrozole) and clomiphene. However, drugs of these
classes are found highly hazardous for workers and personnel which remain in direct
contact or are involved in close handling of these drugs. Aforementioned drugs are
present in NIOSH (National Institute for Occupational Safety and Health, USA) list of
Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2016, prepared by
Center for Disease Control & Prevention and National Institute for Occupational
Safety and Health. Therefore, the safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these
drugs shall be required to be established by the manufacturers.
b) Registration Board decided to grant registration of these products in general
manufacturing areas with condition that manufacturer shall provide safety and
protective measures for workers and personnel which remain in direct contact or are
involved in close handling of these drugs.
c) Advised to compile data for already deferred cases of immunosuppressants, aromatase
inhibitors (letrozole, anastrozole) and clomiphene in the previous meetings of the
Registration Board and placed before Registration Board after completion of
application including fee, rectification of shortcomings final decision on these
application.
d) Registration Board also advised to issue an advisory for manufacturing units of
immunosuppressants, aromatase inhibitors (letrozole, anastrozole) and clomiphene to
provide safety and protective measures for workers and personnel which remain in
direct contact or are involved in close handling of these drugs.
e) Registration Board appreciated Pharmaceutical Evaluation Cell for adequate
compilation of all relevant information.
Fresh case of Leterozole
1. Name and address of manufacturer / M/s Winthrox Laboratories (Pvt) Ltd., K-219-A,
Applicant SITE Super Highway, Phase-II Karachi
Brand Name +Dosage Form + Strength Troza tablet 2.5mg
Composition Each film coated tablet contains
Letrozole………..2.5mg
Diary No. Date of R& I & fee Dy No. 392: 16-04-2015
PKR 20,000/-: 14-4-2015 (DUPLICATE)
Pharmacological Group Aromatase inhibitor
Type of Form Form 5
Finished product Specifications USP
Pack size & Demanded Price 1 x 10‟s: As per SRO
Approval status of product in Reference Femara by Novartis
Regulatory Authorities (MHRA Approved)
Me-too status Femara by Novartis
GMP status Last inspection report dated 22-03-2017 confirms
Good compliance to GMP
Decision:Registration Board decided to grant registration of above applied products in
general manufacturing areas with condition that manufacturer shall provide safety and

Previously deferred cases
Sr. Name of Brand Name Form Latest GMP Decision of Decision of 275th
Firm Composition Dy No./ inspection report previous Meeting
Pharmacological Fee meeting
group Pack
size/Dema
nded price
Specs
2. M/s Genix Estrol Tablets Form 5 Last GMP Deferred for Registration
Pharma (Pvt) Each film coated Routine Inspection of clarification Board decided to
Ltd.44,45-B, tablet Contains: Dy.#66 M/s Genix regarding grant registration
Korangi Letrozole(U.S.P) 14-9-2010 Pharmaceuticals requirement of above applied
Creek Road, ........ 2.5mg conducted on of separate products in
Karachi (Non Steroidal Rs.8,000/- 26.01.2017 with manufacturi general
Aromatase Rs.12,000/ conclusive ng facility. manufacturing
Inhibitor) - remarks of (M-241) areas with
10‟s /As acceptable level condition that
per PRC of cGMP manufacturer
compliance. shall provide
U.S.P safety and
protective
measures for
workers and
personnel which
remain in direct
contact or are
involved in close
handling of
these drugs.
3. M/s Letrowin 2.5 mg Form-5 Last inspection Deferred for Registration
WnsFeild Tablets conducted on clarification Board decided to
Pharmaceutic Fast Track 23.11.2016 for grant registration
als, Hattar. Each film coated As Per stating GMP manufacturi of above applied
tablet cntains:- SRO N.A. compliance ng facility of products in
Letrozole..2.5mg 26-7-2013 status the product general
Antineoplastics, Rs.20,000/ (M-242) manufacturing
immunomodulat = (2984) areas with
ors and drugs condition that
used in palliative 29-10-13 manufacturer
care) Rs.40,000/ shall provide
- (3315) safety and
(The tablet was protective
mentioned as measures for
uncoated in the workers and
agenda now it personnel which
has been remain in direct
corrected as film contact or are
coated.) involved in close
handling of
these drugs..

4. M/s Welmark Weletro Tablet Form-5 Last inspection Deferred for
Registration
Pharmaceutic Fast Track report.12-7- clarification
Board decided to
Each film coated
als, Hattar. As Per 2017 Overall of grant registration
tablet contains
SRO cGMP was manufacturi
of above applied
Letrozole..2.5mg
satisfactory as ng facility
products in
Antineoplastic
5-12-2013 per Drap for the general
(The tablet was
Rs.60000/ Guidelines product manufacturing
mentioned as
= (307) (M-242) areas with
uncoated in the
condition that
agenda now it
manufacturer
has been
shall provide
corrected as film
safety and
coated.)
protective
measures for
workers and
personnel which
remain in direct
contact or are
involved in close
handling of
these drugs.
5. M/s. Linear Litrozole Tablets Form-5 GMP inspection Deferred for Deferred for
Pharma, Plot 2.5mg Fast track of last 1 year clarification submission of
No 18, Stret Each film coated As Per could not be forrequireme latest GMP
No. S-4 tablet contains:- SRO per confirmed nt of inspection report
National Letrozole(U.S.P) 10‟s/ 30‟s manufacturi conducted
Industrial ……..2.5mg 31/10/13, ng for within a period
Zone (RCCI) Enzyme 6806 product. of last 1 year by
Rawat, inhibnitor (R&I) (M-242) DRAP.
Islamabad (Nonsteroidal 31/10/13
Aromatase Rs.
inhibitor)/Anti 60,000/-
cancer
6. M/s. Genome Rozole 2.5mg Form-5 Panel inspection Deferred for Registration
Pharmaceutic Tablets Fast track conducted on clarification Board decided to
als (Pvt. Ltd), As per 14.01.2017 and for grant registration
Plot # 16/I- Each film coated SRO / report concludes manufacturi of above applied
Phase IV, tablet contains:- 1x10‟s that firm is ng products in
industrial Letrozole following the requirement general
Estate Hattar, (U.S.P)……..2.5 11/4/2013, GMP of product. manufacturing
KPK. mg 221 (R&I) guidelines. (M-242) areas with
condition that
Non-steroidal 11/4/2013 manufacturer
aromatase Rs.20,000/ shall provide
inhibitor - safety and
02\5\2013 protective
Rs. measures for
40,000/- workers and
personnel which
remain in direct
contact or are
involved in close
handling of
these drugs.
7. M/s Pharmix Femroz Tablets Form-5 Last GMP Deferred for Registration
Laboratories Each film coated Fast Track Inspection clarification Board decided to
(Pvt) Ltd. 21 Tablet contains:- Rs.2906/1 Dated:10.04.20 for grant registration
Km Letrozole (USP) 0‟s 17(Good) requirement of above applied
Ferozepur ..…2.5mg 15-7-2013, of products in
Road Lahore. (Non steroidal (9006) manufacturi general
aromatase ng for manufacturing
inhibitor) 15-7-2013 product. areas with
(Rs.60000/ (M-242) condition that
-) manufacturer
shall provide
safety and
protective
measures for
workers and
personnel which
remain in direct
contact or are
involved in close
handling of
these drugs.
8. M/s Reliance LETOREL Form 5 GMP inspection Deferred for Deferred for
Pharma, Plot Letrozole Fast Track within last 1 clarification submission of
No.8 Street Each film coated As per year could not for latest GMP
No S-8 RCCI tablet contains: SRO/1x10 be confirmed requirement inspection report
Industrial letrozole 2.5mg ‟s & of conducted
Estate, Rawat, 3x10‟s. manufacturi within a period
Islamabad. Non steroidal Dy.4833 ng for of last 1 year by
aromatse 29/07/13 product. DRAP.
inhibitor (M-242)
9. M/s. Olive Febres 2.5mg Form 5 GMP inspection Deferred for Deferred for
Laboratories, Tablets Fast Track within last 1 clarification submission of
52-S6 Each film coated As per year could not for latest GMP
National Tablet contains: SRO 30‟s be confirmed requirement inspection report
Industrial Letrozole..2.5mg Dy.3260 of conducted
Zone, Rawat, Non-steroidal 21-5-2013 manufacturi within a period
Rawalpindi aromatase Rs.60,000/ ng for of last 1 year by
inhibitor - product. DRAP.
(M-242)
10. M/s.Mass Fempro Tablet Form-5 Last GMP Deferred for Registration
Pharma Each film coated Fast Track Inspection of clarification Board decided to
Health tablet contains:- Rs.290.68/ M/s Mass for grant registration
Pakistan, Letrozole..2.5mg - per tablet Pharma requirement of above applied
Lahore Non steroidal 2/8/2013 conducted on of products in
Aromatase 9420 R&I 04-11-2016 manufacturi general
inhibitor 2/8/2013 with concluding ng for manufacturing
(Rs. GMP compliant product. areas with
60,000/-) status. (M-242) condition that
manufacturer
shall provide
safety and
protective
measures for
workers and
personnel which
remain in direct
contact or are
involved in close
handling of
these drugs..

11. M/s Metro Metrazol 2.5mg Form-5 GMP inspection Me too Deferred for
Pharmaceutic tablets Newsectio within last 1 (Femara of submission of
als Rawat Each Tablet n year could not Novartis) latest GMP
contains:- As Per be confirmed (M-243) inspection report
Letrozole..2.5mg SRO conducted
Nonsteroidal 19.12.13 within a period
Dy.3051 of last 1 year by
aromatase Rs.20,000/ DRAP.
inhibitor -
BP
12. M/s Innvotek LETRO Tablets Form-5 According to Deferred till Registration
Pharmaceutic Each film coated Dy.1037/ last inspection decision on Board decided to
als tabletcontains: 20.10.10 report dated 09- the grant registration
Islamabad. Letrozole..2.5mg 20,000/- 03-2017; manufacturi of above applied
Non steroidal As per company is ng products in
aromatase PRC/ Pack complying with requirement general
Inhibitor of 10‟s the GMP for this manufacturing
USP guidelines product. areas with
(M-246) condition that
manufacturer
shall provide
safety and
protective
measures for
workers and
personnel which
remain in direct
contact or are
involved in close
handling of
these drugs.
13. M/s MeDLey LETRO Tablets Form-5 GMP certificate 1. Deferred Registration
Pharmaceutic 2.5mg Dy.873 is issued to the for Board decided to
als, Each film coated 10.11.10 firm based upon submission grant registration
Wah Cantt, tablet contains: 8000/- inspection of latest of above applied
Rawalpindi. Letrozole..2.5mg 10-11-10 report dated 8th GMP report. products in
Non-steroidal 12000/- June 2017. 2. Final general
aromatase dated: notice for manufacturing
inhibitor 19-07-13 rectification areas with
USP As per of condition that
SRO/ hortcomings manufacturer
Pack of / shall provide
30‟s observations safety and
(M-247) protective
Deferred for measures for
confirmation workers and
of personnel which
manufacturi remain in direct
ng contact or are
facility(M- involved in close
248) handling of
Deferred for these drugs.
confirmation Brand name of
of product shall be
manufacturi changed.
ng facility
(M-262)
Deferred for

decision
regarding
requirement
of
manufacturi
ng facility
for letrozole
(M-265)
14. M/s Allmed LetroleTablet Form-5 Last inspection Deferred for Registration
(Private) Each film coated Dy. No: report dated 13- clarification Board decided to
Limited, tablet contains: 5135 9-2017 confirms regarding grant registration
Lahore Letrozole..2.5mg Dated. satisfactory manufacturi of above applied
(Non steroidal 11-6-2012 compliance to ng products in
inhibitor of Rs.8000/- GMP requirement general
aromatase 11-10-12 (M-257) manufacturing
enzyme ) Rs.12,000/ areas with
Manufacturer - condition that
Specs. As per manufacturer
PRC shall provide
Prices 30 safety and
tabs protective
measures for
workers and
personnel which
remain in direct
contact or are
involved in close
handling of
these drugs.
Brand name of
product shall be
changed.
15. M/s Akson Letrozil tablet Form 5 Last inspection Deferred till Registration
Pharmaceutic 2.5mg 24-9-2013 conducted on decision on Board decided to
als Pvt Ltd, Each film coated Dy.# 6139 08-05-2017, manufacturi grant registration
Plot#9- tablet contains:- R&I “The company ng of above applied
B/1&2, Old Letrozole..2.5mg Rs.20,000. is found requirement products in
Industrial Cytostatic As per complying for general
Estate, Sector USP SRO GMP as of clomiphene. manufacturing
D-1, Mirpur Specifications today some (M-259) areas with
Azad minor condition that
Kashmir observations manufacturer
noted which shall provide
need safety and
rectifications.” protective
measures for
workers and
personnel which
remain in direct
contact or are
involved in close
handling of
these drugs.
16. M/s Valor Letroval 2.5mg Form 5 Last inspection Deferred for Registration
Pharmaceutic Tablets 24-02- was conducted decision Board decided to
als Islamabad Each film coated 2015 on 15.9.2017 regarding grant registration
tablet contains:- Dy. #1085 and the report manufacturi of above applied
Letrozole..2.5mg Rs.8000/= concludes good ng facility products in
(Non-Steroidal Rs.12,000/ compliance of for letrozole
general
Aromatase = GMP (M-265) manufacturing
inhibitor) 18-2-2015 guidelines. areas with
3*10‟s condition that
manufacturer
shall provide
safety and
protective
measures for
workers and
personnel which
remain in direct
contact or are
involved in close
handling of
these drugs.
17. M/s Shaigan Ltroze 2.5mg Form 5 Inspection Deferred for Deferred for
Pharmaceutic Tablets 27-3-2015 report dated 17- decision submission of
als (Pvt) Ltd, Each tablet Dy. #1962 08-2016 regarding latest GMP
Rawalpindi contains:- Rs.8000/= recommended requirement inspection report
Letrozole (USP) + for of conducted
…….2.5mg Rs.12,000/ the grant of manufacturi within a period
(Cytostatics) 25-3-2015 additional ng facility of last 1 year by
USP Specs 1x10‟s sections for DRAP.
3x10‟s Letrozole.
Price not
mentioned

Case No. 04: Registration applications for local manufacturing of (Human) drugs
a) Registration applications submitted with full fee
i. New cases
ii. Deferred cases
b) Applications whose differential fee submitted upto 30th September, 2015
i. New cases
ii. Deferred cases
a) Registration applications submitted with full fee
i. New cases
Evaluator PEC-III
18. Name and address of manufacturer / M/s Medizan Laboratories (Pvt) Ltd., Plot No. 313,
Applicant Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Tinex Tablets 4mg
Strength
Composition Each tablet contains:
Tizanidine (as hydrochloride)……..4mg
Diary No. Date of R& I & fee Dy No. 3025: 12-7-2016PKR 20,000/-: 4-7-2016
Pharmacological Group Alpha 2 receptor agonist: Muscle relaxant
Type of Form Form 5
Approval status of product in Tizanidine 4mg tablet by Actavis UK
Reference Regulatory Authorities (MHRA Approved)
Me-too status Lintiz tablet by Bosch
satisfactory compliance to GMP
Remarks of the Evaluator 
Decision: Registration Board was apprised of the observations related to GMP made by
panel of inspection for the product Sofomed (Sofosbuvir 400mg) Tablets and as recorded in
inspection report (dated: 18thJuly 2017) considered in 272ndmeeting of Registartion Board.
Registration Board deferred the case for clarification from QA&LT Division regarding
GMP status of the firm in the light of observations made by the panel of inspection for the
product Sofomed (Sofosbuvir 400mg) Tablets dated 18thJuly 2017.
Brand Name +Dosage Form + Tinex SR Tablets 6mg
Strength
Composition Each film coated sustained release tablet contains
Tizanidine (as hydrochloride)……..6mg
Pharmacological Group Alpha 2 receptor agonist: Muscle relaxant
Type of Form Form 5
Finished product Specifications Firm has claimed in house specification
Approval status of product in Could not be confirmed
Reference Regulatory Authorities
Me-too status Could not be confirmed
Remarks of the Evaluator  Evidence of approval of applied formulation in
reference regulatory authorities could not be
confirmed
 Evidence of me-too status could not be confirmed
Decision: Registration Board rejected the application as formulation is not approved by
any of the reference regulatory authorities and firm has not submitted any data to establish
safety, efficacy and quality of the product.

Brand Name +Dosage Form + Strength Profam tablets
Ibuprofen………800mg
Famotidine……..26.6mg
Pharmacological Group NSAID and H2 receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 90‟s: As per SRO
Approval status of product in Duexis tablets by Horizon Pharm
Reference Regulatory Authorities (USFDA Approved)
Remarks of the Evaluator  Evidence of me-too status could not be confirmed
Decision: Deferred for following:
 Registration Board was apprised of the observations related to GMP made by panel of
inspection for the product Sofomed (Sofosbuvir 400mg) Tablets and as recorded in
inspection report (dated: 18th July 2017) considered in 272nd meeting of Registartion
Board. Registration Board deferred the case for clarification from QA&LT Division
regarding GMP status of the firm in the light of observations made by the panel of
inspection for the product Sofomed (Sofosbuvir 400mg) Tablets dated 18th July 2017.
 Evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board shall
also be submitted.
Brand Name +Dosage Form + Strength Disin ER Tablet 50mg
Composition Each film coated extended release tablet contains
Desvenlafaxine succinate eq. to
Desvenlafaxine...50mg
Pharmacological Group Antidepressant
Type of Form Form 5
Approval status of product in Pristiq Tablet by Wyeth
Me-too status Desvel XR tablet by Hilton Pharma
Remarks of the Evaluator
Brand Name +Dosage Form + Strength Disin ER Tablet 100mg
Composition Each film coated extended release tablet contains
Desvenlafaxine succinate eq.to Desvenlafaxine....100mg
Type of Form Form 5
23. Name and address of M/s Medizan Laboratories (Pvt) Ltd., Plot No. 313,
manufacturer/Applicant Industrial Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Strength Lacomed Tablets 100mg
Composition Each film coated tablet contains:
Lacosamide……..100mg
Pharmacological Group Anticonvulsant
Type of Form Form 5
Approval status of product in Vimpat by UCB Inc.
Me-too status Lalap by Genix
Brand Name +Dosage Form + Strength Lacomed Tablets 150mg
Lacosamide……..150mg
Type of Form Form 5
Approval status of product in Vimpat by UCB Inc.
Me-too status Lalap by Genix
25. Name and address of manufacturer / M/s Asian Continental (Pvt) Ltd. Continental house,
Applicant D-133, Tipu Sultan Road, KDA Scheme-I, Karachi.
Brand Name +Dosage Form + Strength Asar 10mg Tablet
Rivaroxaban…….10mg
Pharmacological Group (Anticoagulant)
Type of Form Form 5
Finished product Specifications Firm has claimed in house specifications
Pack size & Demanded Price 14‟s: As per PRC
Approval status of product in Xarelto by Janssen Pharm
Me-too status Xarelto by Bayer
GMP status Last GMP Inspection of Asian Continental Conducted
on 28-12-16 with conclusive remarks of Good level of
cGMP compliance.
Remarks of the Evaluator  Firm has claimed in house specification and the
product monograph is not present in BP/USP.
Decision:Approved with innovator’s specification.
Brand Name +Dosage Form + Strength Asar 15 mg Tablet
Diary No. Date of R& I & fee Dy No. 237: 8-11-2016
PKR 20,000/-: 7-11-2016
Type of Form Form 5
cGMP compliance.
Decision: Approved with innovator’s specification.
Brand Name +Dosage Form + Strength Asar 20 mg Tablet
Type of Form Form 5

cGMP compliance.
28. Name and address of manufacturer / M/s Scilife Pharma (Pvt) Ltd., Plot # FD-57/58-A2,
Applicant Korangi Creek Industrial Park (KCIP) Karachi.
Brand Name +Dosage Form + Strength Lorno 8mg Tablet
Lornoxicam……..8 mg
Pharmacological Group (NSAIDS)
Type of Form Form 5
Approval status of product in Xefo 8 mg Filmtabletten by M/s Takeda Pharma AG,
Reference Regulatory Authorities (Swiss Medic approved)
Me-too status Acabel 8mg Tablet by M/s Continental Pharma
GMP status Inspection report dated 31-12-2016 with acceptable
level of GMP compliance
29. Name and address of manufacturer / M/s Nexus Pharmaceuticals (Pvt) Ltd., 4/19 – 4/36
Applicant Sector 21 Korangi Industrial Area Karachi
Brand Name +Dosage Form + Strength Aliskir 150mg Tablet
Aliskiren (as hemifumerate)………150mg
Diary No. Date of R& I & fee Dy No.984: 22-11-2016PKR 20,000/-: 22-11-2016
Pharmacological Group Renin inhibitors
Type of Form Form 5
Pack size & Demanded Price 1‟s, 7‟s, 10‟s/: As per SRO
Approval status of product in TEKTURNA tablets by M/s Noden Pharma
Me-too status Rasilez 150mg Tablets by M/s Novartis Pharma
satisfactory level of compliance to GMP
product monograph is not present in BP/USP
Brand Name +Dosage Form + Strength Aliskir 300mg Tablet
Pharmacological Group Renin inhibitors
Type of Form Form 5
Approval status of product in TEKTURNA tablets by M/s Noden Pharma
Me-too status Rasilez 300mg Tablets by M/s Novartis Pharma

Brand Name +Dosage Form + Strength Aliskir-HCT 150/12.5mg Tablet
Hydrochlorothiazide…12.5mg
Pharmacological Group Renin inhibitors and diuretic
Type of Form Form 5
Pack size & Demanded Price 10‟s/: As per SRO
Approval status of product in TEKTURNA HCT by M/s Noden Pharma
Me-too status Rasilez HCT Tablet by M/s Novartis Pharma
Brand Name +Dosage Form + Strength Aliskir-HCT 150/25mg Tablet
Hydrochlorothiazide..25mg
Type of Form Form 5
Pack size & Demanded Price 10‟s, 14‟s/: As per SRO
Brand Name +Dosage Form + Strength Aliskir-HCT 300/12.5mg Tablet
Hydrochlorothiazide..12.5mg
Type of Form Form 5
Brand Name +Dosage Form + Strength Betanex 8mg Tablet
Betahistine dihydrochloride…..8 mg
Pharmacological Group Anti vertigo
Type of Form Form 5
Finished product Specifications BP
Approval status of product in Betahistine 8 mg uncoated tablets by M/s Milpharm
Reference Regulatory Authorities Ltd (MHRA Approved)
Me-too status Balance 8mg Tablets by M/s Tabros Pharma
Decision:Approved.
Type of Form Form 5
Me-too status Balance 16mg Tablets by M/s Tabros Pharma
Decision:Approved.
Type of Form Form 5
Me-too status Enier 24mg Tablets by M/s Sami Pharmaceuticals
Decision:Approved.

Brand Name +Dosage Form + Strength Febunex 40mg Tablet
Febuxostat…………..40 mg
Pharmacological Group Preparations inhibiting uric acid production
Type of Form Form 5
Approval status of product in ULORIC film coated tablet by M/s Takeda Pharma
Me-too status Febhil Tablets by M/s Hilton Pharma
Febuxostat…….80 mg
Type of Form Form 5
Approval status of product in Febuxostat tablets by M/s Rivopharm UK Ltd.
Me-too status Febhil 80mg Tablets by M/s Hilton Pharma
Febuxostat…………..120 mg
Type of Form Form 5
Approval status of product in Febuxostat tablets by M/s Rivopharm UK Ltd.
Me-too status Febhil 120mg Tablets by M/s Hilton Pharma

Brand Name +Dosage Form + Strength Nicora 10mg Tablet
Nicorandil………….10 mg
Pharmacological Group Anti-angina drug (arterial vasodilator)
Type of Form Form 5
Approval status of product in Nicorandil 10 mg tablets by M/s Teva UK Limited
Me-too status Ikodil 10mg Tablets by M/s OBS Pakistan
Decision: Approved.
Brand Name +Dosage Form + Strength Nicora 20mg Tablet
Nicorandil………….20 mg
Pharmacological Group Anti-angina drug (arterial vasodilator)
Type of Form Form 5
Approval status of product in Nicorandil 20 mg tablets by M/s Teva UK Limited
Me-too status Ikodil 20mg Tablets by M/s OBS Pakistan
Decision: Approved.
Brand Name +Dosage Form + Strength Repaglin 0.5mg Tablet
Repaglinide……..0.5 mg
Pharmacological Group Antidiabetic
Type of Form Form 5
Approval status of product in Repaglinide Tablets by M/s Dr. Reddy‟s Laboratories
Me-too status Rapaglax Tablets 0.5mg by M/s Cirin Pharmaceuticals
Decision: Approved.
Repaglinide……..1mg
Type of Form Form 5
Me-too status Rapaglax Tablets 1mg by M/s Cirin Pharmaceuticals
Decision: Approved.
Repaglinide……..2mg
Type of Form Form 5
Me-too status Rapaglax Tablets 2mg by M/s Cirin Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Risedronex 5mg Tablet
Risedronate sodium….5mg
Pharmacological Group Bisphosphonate (drugs affecting bone structure and
mineralization)
Type of Form Form 5
Approval status of product in Actonel by M/s Warner Chilcott UK Limited
Me-too status Atconate 5mg Tablet by M/s Atco Laboratories
Decision: Approved.
Risedronate sodium….35mg
mineralization)
Type of Form Form 5
Approval status of product in Risedronate Sodium Tablets by M/s TEVA UK
Reference Regulatory Authorities Limited (MHRA Approved)
Decision: Approved.
Risedronate sodium…150mg
mineralization)
Type of Form Form 5
Approval status of product in ACTONEL tablets by M/s Warner Chilcott (US), LLC
Decision: Approved.
Brand Name +Dosage Form + Strength Simnex 10mg Tablet
Ezetimibe…10mg
Pharmacological Group Lipid modifying agent
Type of Form Form 5
Approval status of product in EZETROL Tablet by M/s Merck Sharp & Dohme
Reference Regulatory Authorities (TGA Approved)
Me-too status Tmib 10mg Tablet by M/s Bosch
Decision: Approved.
Brand Name +Dosage Form + Strength Simnex-Ezee 10/10mg Tablet
Ezetimibe…….10 mg
Simvastatin……..10 mg
Pharmacological Group HMG CoA reductase inhibitor in combination with
lipid modifying agent
Type of Form Form 5
Approval status of product in VYTORIN tablet by M/s Merck Sharp & Dohme
Me-too status Medivastin Plus 10/10mg by M/s Mediate
Remarks of the Evaluator Firm has claimed in house specifications and the
Type of Form Form 5
Me-too status Medivastin Plus 10/20mg by M/s Mediate
Type of Form Form 5
Pack size & Demanded Price 7‟s 10‟s/: As per SRO
Me-too status Neutrachol Plus Tablet by M/s Wilson Pharma
Type of Form Form 5
Pack size & Demanded Price 7‟s 10‟s/: As per SRO
Approval status of product in
VYTORIN tablet by M/s Merck Sharp & Dohme
Me-too status Neutrachol Plus tablet by M/s Wilson Pharma
Brand Name +Dosage Form + Strength Solinex 5mg Tablet
Solifenacin succinate…5mg
Pharmacological Group Antimuscarinic
Type of Form Form 5
Approval status of product in Giraxine 5 mg film-coated tablet by M/s Medreich Plc
Me-too status Solfin tablet 5mg by M/s Regal Pharmaceuticals
Remarks of the Evaluator  Firm has claimed in house specifications and the
Brand Name +Dosage Form + Strength Solinex 10mg Tablet
Solifenacin sujccinate…10mg
Pharmacological Group Antimuscarinic
Type of Form Form 5
Approval status of product in Giraxine 10 mg film-coated tablet by M/s Medreich
Reference Regulatory Authorities Plc (MHRA Approved)
Me-too status Solfine tablet 10mg by M/s Regal Pharmaceuticals
Brand Name +Dosage Form + Strength Tegaser 2mg Tablet
Tegaserod (as maleate)…2mg
Pharmacological Group 5-HT4 agonist
Type of Form Form 5
Pack size & Demanded Price 10‟s /: As per SRO
Approval status of product in Zelnorm tablet by M/s Novartis Pharmaceuticals

Me-too status Getibs 2mg Tablets by M/s Getz Pharma
satisfactory level of compliance to GMP.
Brand Name +Dosage Form + Strength Tegaser 6mg Tablet
Tegaserod (as maleate)…6mg
Pharmacological Group 5-HT4 agonist
Type of Form Form 5
Pack size & Demanded Price 30‟s /: As per SRO
Approval status of product in Zelnorm tablet by M/s Novartis Pharmaceuticals
Me-too status Zelax 6mg Tablets by M/s CCL Pharmaceuticals
57. Name and address of manufacturer / M/s Swiss Pharmaceuticals (Pvt) Ltd., A/159, S.I.T.E.,
Applicant Super Highway, Karachi
Brand Name +Dosage Form + Strength Roplex-F Chewable Tablet 100/0.35mg
Composition Each chewable tablet contains
Iron (III) Hydroxide Polymaltose Complex eq. to
elemental iron………………100mg
Folic acid………..0.35mg
Diary No. Date of R& I & fee 04-04-2011: (DUPLICATE) List-I No. (964)
PKR 8,000/-: 4-4-2011 +PKR 12,000/-: 31-7-2013
Pharmacological Group Haematinics
Type of Form Form 5
Pack size & Demanded Price 20‟s, 30‟s: As per PRC
Me-too status RBC-F tablets by Genix
GMP status Last inspection report dated 15-9-2017 confirms good
compliance to GMP
Remarks of the Evaluator Firm has submitted full fee 20,000/- challan dated
20.10.2017
Decision: Registration Board approved the case with innovator’s specification, since iron
preparations are not considered as drug by various reference regulatory authorities.
Moreover, fee shall be confirmed as per procedure adopted in 264th meeting.
58. Name and address of manufacturer / M/s Hygeia Pharmaceuticals, Plot # 295, Industrial
Applicant Triangle, Kahuta Road Islamabad
Brand Name +Dosage Form + Strength Linezolid Infusion 100ml
Composition Each 100ml vial contains:-
Linezolid………..200mg
Pharmacological Group Antibacterial for systemic use
Type of Form Form 5
Pack size & Demanded Price As per PRC
Approval status of product in Zyvox infusion by Pharmacia
Me-too status Linzol Infusion by Regal Pharma
Remarks of the Evaluator  Internationally available as LDPE bottle and the firm
has applied for type-II glass vial.
Decision:Registeration Board approved the case in the light of decision takein in its 271st
meeting wherein the BRegsitration Board in order to ensure, safety, efficacy and quality of
Linezolid infusion, decided as under;
i) All the Manufacturers of Linezolid Infusion shall follow the packaging instructions
of the innovator of the product i.e M/s Pfizer which has clearly mention the storage
precautions in its Product Information Leaflet (PIL). They will also make sure that
the solution is kept correctly in its box and foil wrapping in order to protect from
light.
ii) All the manufacturers of this product must implement the above mentioned
remedial measure (the solution is kept correctly in its box and foil wrapping) as per
innovator and submit the compliance within 60 days positively.
Evaluator PEC-II
59. Name and address of manufacturer / M/s Atco Lab. Karachi contract manufacturing by
Applicant M/s Opal Lab. Karachi
Brand Name +Dosage Form + Fixicef 200mg Tablet
Strength
Cefixime trihydrate eq. to Cefixime………..200 mg
Diary No. Date of R& I & fee Dy. No.1432; 22-07-2016; Rs.50,000/- (22-07-2016)
Pharmacological Group Anti biotic
Type of Form Form-5
Finished product Specification USP
Pack size & Demanded Price 5‟s &10‟s; As per approved price
Approval status of product in Approved by USFDA
Reference Regulatory Authorities.
Me-too status Cebosh 200mg tablet of M/s Bosch Pharmaceuticals
(Reg.# 042373)
GMP status Last inspection report conducted on 08-12-2016
recommends renewal of DML except for ophthalmic
products section.
Remarks of the Evaluator.
Decision: Approved.
60. Name and address of manufacturer / M/s. Wahabsons Pharmaceuticals Swat.
Applicant
Brand Name +Dosage Form + Rhunor 90 ml DS Suspension
Strength
Composition Each 5 ml Contains:
Ibuprofen …….…. 200 mg
Pharmacological Group NSAID, Antipyretic
Type of Form Form-5
Pack size & Demanded Price 90ml; Rs. 62.00
Approval status of product in Approved by MHRA of UK

Me-too status Brufen Suspension DS of M/s Abbott Karachi (Reg.#
070851)
GMP status Last GMP Inspection of on 23-1-17 with conclusive
remarks of Good level of cGMP compliance
Decision: Approved.
Applicant
Brand Name +Dosage Form + Wabzyl 60 ml Suspension
Strength
Composition Each 5 ml Contains:-
Metronadizole Benzoate …. 200 mg
Pharmacological Group Antiprotozoal
Type of Form Form-5
Me-too status Flagyl Suspension by M/s Sanofi Avenis
(Reg#001214)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Walordin Oral Syrup
Strength
Desloratidine ….. 2.5 mg
Pharmacological Group Antihistamine
Type of Form Form-5
Finished product Specification Manufacturer specifications
Approval status of product in Aerius For Children Syrup desloratadine 2.5mg/5mL
Reference Regulatory Authorities. oral liquid bottle by M/s Bayer Australia Ltd (TGA
approved)
Me-too status Desora0.5mg/ml syrup by M/s Continental Pharma.
(Reg.# 055192)
Remarks of the Evaluator. No USP or BP monograph is available for applied
formulation.
Applicant
Brand Name +Dosage Form + Wabdom 60 ml Suspension
Strength
Domperidone ….….. 5 mg
Pharmacological Group Antiemetic
Type of Form Form-5
Me-too status Domel 1mg/ml Oral Suspension by M/s Barrett
Hodgson (Reg#028758)
formulation.
Applicant
Brand Name +Dosage Form + Wapiron 120 ml Oral Syrup
Strength
Composition Each 5 ml contains:
Iron Polymaltose eq. to elemental Iron… 50 mg
Pharmacological Group Haematinic
Type of Form Form-5
Pack size & Demanded Price 120ml; Rs.140.00
Approval status of product in N/A
Me-too status Fe Aid Syrup of M/s Novartis, Karachi
(Reg.#070694)
Decision: Approved.
65. Name and address of manufacturer / M/s Hilton Pharma (Pvt) Ltd, Plot 13/14, Sector 15,
Applicant Korangi Industrial Area, Karachi, Pakistan.
Brand Name +Dosage Form + Cefim 200mg Tablet
Strength
Cefixime (as trihydrate) ……200 mg
Diary No. Date of R& I & fee Dy. No.1290; 22-06-2016; Rs.20,000/- (22-06-
2016)
Pharmacological Group Cephalosporin/ anti biotic
Type of Form Form-5
Finished product Specification Manufacturer‟s
Pack size & Demanded Price 5‟s & 10‟s; As per DPC
Approval status of product in USFDA Approved
Me-too status Caricef 200mg Tablet of M/s Sami Karachi (Reg.#
070790)
GMP status Last inspection was conducted on 17-10-2016 and
the report concludes good GMP compliance.
Decision: Deferred for submission of evidence of approval of section/manufacturing
facility of Tablet (Cephalosporin) section Board.
66. Name and address of manufacturer / M/s Paramount Pharamceuticals, Plot No. 36,
Applicant Industrial triangle Kahuta Road Islamabad
Brand Name +Dosage Form + Xitex tablets 100mg
Strength
Topiramate…….100mg
2016)
Pharmacological Group Anti convulsant
Type of Form Form-5
Pack size & Demanded Price As per SRO
Me-too status Topamid 100mg Tablets of M/s Fassgen
Pharmaceuticals, (Reg.# 062311)
GMP status Last GMP Inspection was Conducted on 05.5.2017
with conclusive remarks of Good cGMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Xitex tablets 50 mg
Strength
2016)
Type of Form Form-5
Decision: Approved.
Brand Name +Dosage Form + Xitex tablets 25 mg
Strength
2016)
Type of Form Form-5
Decision: Approved.
69. Name and address of manufacturer / M/s Cibex Pvt. Ltd. Karachi
Applicant
Brand Name +Dosage Form + Katafen 50mg Tablet
Strength
Composition Each sugar coated tablet contains:
th
Minutes for 275 Registration Board Meeting 51
Diclofenac potassium …50 mg
2016)
Pharmacological Group NSAID
Type of Form Form-5
Pack size & Demanded Price 20‟s; As per PRC
Me-too status Zumaflam-P 50mg by M/s Zumars Pharma, Karachi
(Reg.#048640)
GMP status Last GMP Inspection was conducted on 20-09-2017
concluding GMP compliant status.
Decision: Approved.
70. Name and address of manufacturer / M/s Medizan Laboratories (Pvt.) Ltd. Plot No. 313,
Applicant Industrial Triangle Kahuta Road Islamabad
Brand Name +Dosage Form + Lacomed Tablets 50mg
Strength
Lacosamide………….50mg
Diary No. Date of R& I & fee Dy No. 3030: 12-07-2016; RS. 20,000/-: (04-07-
2016)
Pharmacological Group Antiepileptic
Type of Form Form 5
Finished product Specification Manufacturer‟s specification
Pack size & Demanded Price 2 x 7‟s: As decided by Ministry of Health
Me-too status Lacolep by M/s Hilton (Reg.#073857)
GMP status Last inspection conducted on 10-4-2017 satisfactory
compliance to GMP
formulation.
panel of inspection for the product Sofomed (Sofosbuvir 400mg) Tablets and as recorded
in inspection report (dated: 18thJuly 2017) considered in 272ndmeeting of Registartion
Board. Registration Board deferred the case for clarification from QA&LT Division
regarding GMP status of the firm in the light of observations made by the panel of
inspection for the product Sofomed (Sofosbuvir 400mg) Tablets dated 18thJuly 2017.
71. Name and address of manufacturer / M/s Surge Labs Pvt. Ltd Sheikhupura
Applicant
Brand Name +Dosage Form + Rolac injection 10mg
Strength
Composition Each ml ampoule contains:
Ketorolac tromethamine ……10mg
2016)
Type of Form Form 5
Pack size & Demanded Price 5‟s & 10‟s: As per PRC
Approval status of product in US-FDA Approved.
Me-too status Tromit Injection of Standpharm
GMP status Last GMP Inspection of M/s. Surge Pharma
conducted on 4-1-17 with conclusive remarks of
Good level of cGMP compliance
Decision: Approved.
72. Name and address of manufacturer / M/s Surge Labs Pvt. Ltd Sheikhupura
Applicant
Brand Name +Dosage Form + Rolac injection 30mg
Strength
Composition Each ml ampoule contains:
Ketorolac tromethamine ……30mg
2016)
Type of Form Form 5
Pack size & Demanded Price 5‟s & 10‟s: As per PRC
Approval status of product in US-FDA Approved.
Me-too status Tromit Injection of M/s Standpharm (Reg.#049958)
GMP status Last GMP Inspection of M/s. Surge Pharma
Good level of cGMP compliance
Decision: Approved.
73. Name and address of manufacturer / M/s Safe Pharma. Karachi
Applicant
Brand Name +Dosage Form + Gcal 5mg/ml Injection
Strength
Composition Each ml contains:
Cholecalciferol………5mg
2016)
Pharmacological Group Vitamin D analogue
Type of Form Form 5
Finished product Specification Manufacturers specification
Approval status of product in VITAMIN D3 GOOD 200,000 IU / 1 ml IM solution
Reference Regulatory Authorities. for injection ANSM, France approved
Me-too status D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
GMP status Last inspection report dated 20-12-2016.The
company is complying with the GMP requirements.
Decision:Approved with innovator’s specifications
74. Name and address of manufacturer / M/s Maple Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Invine 7.5mg Tablet
Strength
Composition Each film coatedtablet contains:
Ivabradine (as hydrochloride)…………7.5 mg
2016)
Pharmacological Group Anti-anginal
Type of Form Form 5
Me-too status Ivabar 7.5mg Tablet by M/s Barret Hodgson, Karachi
(Reg#080286)
GMP status Last inspection 24-07-2017 acceptable level of
GMP compliance.
formulation.
75. Name and address of manufacturer / M/s Maple Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Invine 5mg Tablet
Strength
Composition Each film coatedtablet contains:
Ivabradine (as hydrochloride)…………5 mg
2016)
Pharmacological Group Anti hypertensive
Type of Form Form 5
Me-too status Ivabar 5mg Tablet by M/s Barret Hodgson, Karachi
(Reg#080287)
GMP status Last inspection 24-07-2017 acceptable level of
GMP compliance.
formulation.
76. Name and address of manufacturer / M/s Bajwa Pharmaceuticals (Pvt)Ltd, 36-km, GT
Applicant Road, khori Muridke (Sheikhupura)
Brand Name +Dosage Form + Neuro Curium 5 ml Injection
Strength
Composition Each 5.0ml contains:
Atracurium besylate…..50mg
2016)
Pharmacological Group Non depolarizing muscle relaxant
Type of Form Form 5
Approval status of product in Approved by MHRA
Me-too status Atrium Injections by M/s Searle Pakistan, Karachi
(Reg#053342)
GMP status Last inspection report dated 13-03-2017 and 24-03-
2017, the panel recommended the firm for production
resumption.
Decision: Approved.
77. Name and address of manufacturer / M/s Noa Hemis Plot #154, Sector 23, Korangi
Applicant industrial area Karachi.
Brand Name +Dosage Form + Dozido-D 10mg Tablet
Strength
Donepezil hydrochloride……….10mg
Diary No. Date of R& I & fee Dy.No. (R&I) 2641, 21-6-2016; Dy. No. R-II (690/1);
04-7-2016; Rs.20,000/- (21-06-2016)
Pharmacological Group Cholinesterase inhibitors
Type of Form Form-5
Pack size & Demanded Price 14‟s, 28‟s & 30‟s ; As per PRC
Me-too status Remembrin Tablets 10mg of M/s PharmEvo, Karachi
(Reg.# 045402)
GMP status Last GMP Inspection dated 17-11-16 with conclusive
remarks of cGMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Dozido 5mg Tablet
Strength
Donepezil hydrochloride……….5mg
04-7-2016; Rs.20,000/- (21-06-2016)
Type of Form Form-5
Pack size & Demanded Price 14‟s, 28‟s & 30‟s ; As per PRC
Me-too status Remembrin Tablets 5mg of M/s PharmEvo, Karachi
(Reg.# 045401)
Decision: Approved.
Brand Name +Dosage Form + Rivamer 1.5mg Capsule
Strength
Composition Each capsule contains:
Rivastigmine (hydrogen tartrate)……1.5 mg
04-7-2016; Rs.20,000/- (21-06-2016)
Type of Form Form-5
Pack size & Demanded Price 30‟s, 60‟s ; As per PRC
Me-too status Riveme 1.5mg Capsule of M/s Genix Karachi
(Reg.#079951)
Decision: Approved.
Brand Name +Dosage Form + Rivamer 3mg Capsule
Strength
Rivastigmine (hydrogen tartrate)……3 mg
04-7-2016; Rs.20,000/- (21-06-2016)
Type of Form Form-5
Me-too status Riveme 3mg Capsule of M/s Genix Karachi
(Reg.#079952)
Decision: Approved.
Brand Name +Dosage Form + Rivamer 6mg Capsule
Strength
Rivastigmine (hydrogen tartrate)……6 mg
04-7-2016; Rs.20,000/- (21-06-2016)
Type of Form Form-5
Me-too status Riveme 6mg Capsule of M/s Genix Karachi
(Reg.#079954)
Decision: Approved.
Brand Name +Dosage Form + Owenta 150mg SR Tablet
Strength
Composition Each sustained release tablet contains:
Bupropion hydrochloride ….150 mg
04-7-2016; Rs.20,000/- (21-06-2016)
Pharmacological Group Anti depressant
Type of Form Form-5
Me-too status Ropion SR 150mg Tablet of M/s Searle Pak. Karachi .
(Reg.#076185)
Decision: Approved.
Brand Name +Dosage Form + Cibacort Cream
Strength
Composition Each gm contains:
Diflucortolone valerate…….1mg
Isoconazole nitrate ..…10mg
04-7-2016; Rs.20,000/- (21-06-2016)
Pharmacological Group Anti fungal &corticosteroids
Type of Form Form-5
Pack size & Demanded Price As per policy
Approval status of product in Travocort cream of M/s Bayer Austria approved by
Reference Regulatory Authorities. AGES of Austria
Me-too status Difzole Cream of M/s Vega Pharmaceuticals
(Reg.#069084)
formulation.
Decision: Approved with Innovator’s specifications.
Brand Name +Dosage Form + Zema 0.1% Cream
Strength
Methylprednisolone aceponate……..1 mg
04-7-2016; Rs.20,000/- (21-06-2016)
Pharmacological Group Corticosteroid
Type of Form Form-5
Pack size & Demanded Price 5gm & 10gm; As per policy
Approval status of product in Adavantan cream of M/s Bayer approved by TGA of
Reference Regulatory Authorities. Australia
Me-too status Tan Creamof M/s Caraway Pharmaceuticals
(Reg.#070265)
Remarks of the Evaluator.  No USP or BP monograph is available for applied
formulation.
 Brand name resembles with Ciba Pharmaecuticals.
Decision: Approved with change of brand name & with innovator’s specifications.
85. Name and address of manufacturer / M/s Wilshire Laboratories Pvt Ltd Lahore
Applicant
Brand Name +Dosage Form + Leviq 200mg Tablet
Strength
Rifaximin ..……….200mg
Diary No. Date of R& I & fee Dy. No. 2999, 25-7-2016; Rs.20,000/- (25-07-2016)
Pharmacological Group Antibiotic
Type of Form Form-5
Pack size & Demanded Price 1‟s, 5‟s, 10‟s, 20‟s, 30‟s, 50‟s;As per SRO
Me-too status Nixaf 200mg Tablet of M/s Sami Karachi
(Reg.#076310)

remarks of satisfactory level of cGMP compliance.
formulation.
Applicant
Brand Name +Dosage Form + Nurotic 50mg Tablet
Strength
Lacosamide………50mg
Pharmacological Group Antieplieptic
Type of Form Form-5
Approval status of product in Vimpat 50mg Tablet of UCB, approved by USFDA
Me-too status Lacolep of M/s Hilton (Reg.#073857)
formulation.

Applicant
Strength
Type of Form Form-5
formulation.
Applicant
Strength
Type of Form Form-5
formulation.
Applicant
Brand Name +Dosage Form + Epitrol 7.5mg tablets
Strength
Composition Each film coated tablet contains:-
Ivabradine hydrochloride.……….7.5mg
Pharmacological Group Antianginal
Type of Form Form-5
Me-too status Ivatab 7.5mg Tablet of M/s Nabiqasim Karachi
(Reg.#076155)

formulation.
Applicant
Brand Name +Dosage Form + Epitrol 5mg tablets
Strength
Ivabradine hydrochloride.……….5mg
Pharmacological Group Antianginal
Type of Form Form-5
Me-too status Ivatab 5mg Tablet of M/s Nabiqasim Karachi
(Reg.#076154)
formulation.
91. Name and address of manufacturer / M/s Innvotek Pharmaceuticals Islamabad
Applicant
Brand Name +Dosage Form + Flurone 0.1% eye ointment
Strength
Fluorometholone …..1mg
2016)
Type of Form Form 5
Pack size & Demanded Price 1‟s ; Rs. 80/-
Me-too status Floroptic Eye Ointment 0.1% by M/s Vega
Pharmaceuticals (Pvt) Ltd, (Reg#067756)
GMP status According to last inspection report dated 09-03-2017
the company is complying with the GMP guidelines.
formulation
Applicant
Brand Name +Dosage Form + Dexone ophthalmic Suspension
Strength
Composition Each ml contain:
Dexamethasone……..1mg
2016)
Type of Form Form 5
Pack size & Demanded Price 1‟s x 10ml; Rs. 100/-
Approval status of product in MAXIDEX 0.1% of M/s Novartis Pharms Corp

Reference Regulatory Authorities. approved by USFDA
Me-too status Decacin Eye Drops 0.1% by M/s Mediceena Pharma
(Pvt) Ltd. (Reg#042542)
GMP status According to last inspection report dated 09-03-2017
the company is complying with the GMP guidelines.
Decision: Approved with change of brand name.
93. Name and address of manufacturer / M/s Rakaposhi Pharmaceutical (Pvt.) Ltd. contract
Applicant manufacturing by M/s. Weather Folds
Pharmaceuticals Hattar.
Brand Name +Dosage Form + Esorok 40 mg Injection
Strength
Composition Each Vial Contains:
Esomeprazole ………. 40 mg
Diary No. Date of R& I & fee Dy. No.245; 18-07-2016; Rs.20,000/- (18-07-2016);
Rs. 30,000 (26-07-2016)
Pharmacological Group Proton pump inhibitor
Type of Form Form 5
Pack size & Demanded Price As fixed by Government
Approval status of product in Nexium IV of M/s Astrazeneca Pharms approved by
Reference Regulatory Authorities. USFDA
Me-too status Nexum IV 40mg Injection by M/s Getz Pharma,
Karachi (Reg#050651)
GMP status Copy of inspection report of M/s Weather Folds

conducted on 15-09-2017 concluding GMP
compliant status.
94. Name and address of manufacturer / M/s. Weather Folds Pharmaceuticals Hattar.
Applicant
Brand Name +Dosage Form + Tyzalin 50 mg/5 ml
Strength
Composition Each Vial Contains:-
Tigecycline (Powder for reconstitution) …… 50 mg
Pharmacological Group Antibacterial
Type of Form Form 5
Pack size & Demanded Price As per SRO.
Approval status of product in Tygacil of M/s Pf Prism CV approved by USFDA
Me-too status Tygacil Injection by M/s Wyeth Pakistan
Limited,Karachi (Reg#045642)
GMP status Copy of inspection report of M/s Weather Folds
compliant status.
Remarks of the Evaluator.  Firm has “Dry powder injection (general)” section.
95. Name and address of manufacturer / M/s Highnoon Laboratories Ltd Lahore
Applicant
Brand Name +Dosage Form + Rivaro 2.5mg Tablets
Strength
Composition Each film coated tablets contains:
Rivaroxaban……...2.5mg
Pharmacological Group Antithrombic agent
Type of Form Form 5
Pack size & Demanded Price 10‟s, 14‟s, 20‟s, 30‟s; As per SRO.
Approval status of product in Xarelto of M/s Bayer healthcare approved by EMA
Me-too status Xarelto 2.5mg Tablet by M/s. Bayer Pakistan
(private) limited (Reg#074794)
GMP status GMP certificate based upon evaluation conducted on
06-07-2017.
formulation
Applicant
Brand Name +Dosage Form + Rivaro 15mg Tablets
Strength
Rivaroxaban……...15mg
Type of Form Form 5
Me-too status Xarelto 15mg Tablet by M/s. Bayer Pakistan
06.07.2017.
formulation
Applicant
Brand Name +Dosage Form + Rivaro 20mg Tablets
Strength
Rivaroxaban……...20mg
Type of Form Form 5
Me-too status Xarelto 20mg Tablet by M/s. Bayer Pakistan
06-07-2017.
formulation
98. Name and address of manufacturer / M/s. Caliph Pharmaceuticals, Risalpur
Applicant
Brand Name +Dosage Form + Clarycin ER 500 mg Tablets
Strength
Composition Each Extended Release tab. Contains:-
Clarithromycin ….. 500 mg
Type of Form Form 5
Pack size & Demanded Price As recommended by the PRC (MOH)
Approval status of product in BIAXIN XL of M/s Abbvie approved by USFDA
Me-too status Clarion XR Tablets by M/s Ferozsons Labs
(Reg#068466)
GMP status Last inspection conducted on 07-03-2017 declaring
satisfactory level of GMP compliance.
Decision: Approved.
Applicant
Brand Name +Dosage Form + Clarithro 250 mg Tablets
Strength
Composition Each Film Coated Tablet Contains:-
Type of Form Form 5
Approval status of product in BIAXIN of M/s Abbvie approved by USFDA
Me-too status Klarinor 250 mg Tablets by M/S Nortech
Pharmaceuticals (Pvt) Ltd (Reg#077969)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Clarithro 500 mg Tablets
Strength
Type of Form Form 5
Approval status of product in BIAXIN of M/s Abbvie approved by USFDA
Me-too status Klarinor 500 mg Tablets by M/s Nortech
Pharmaceuticals (Pvt) Ltd (Reg#077970)
Decision: Approved.
Applicant
Brand Name +Dosage Form + Fungizol 150 mg Capsules
Strength
Composition Each hard gelatin capsule contains:-
Fluconazole …….…. 150 mg
Pharmacological Group Antifungal
Type of Form Form 5
Finished product Specification BP
Pack size & Demanded Price 1‟s;As per SRO
Approval status of product in Azocan 150 of M/s FDC International Ltd. approved
Reference Regulatory Authorities. by MHRA of UK
Me-too status Fantizol Capsule by M/ Apex Karachi.
(Reg#073551)
Decision: Approved.

Applicant
Brand Name +Dosage Form + Linzole 600 mg Tablets
Strength
Linezolid …. 600 mg
Pharmacological Group Antibiotics
Type of Form Form 5
Pack size & Demanded Price As recommended by PRC
Me-too status Linexa Tablet 600mg by M/s. Cirin Pharmaceuticals,
(Reg. No. 073213)
formulation
Applicant
Brand Name +Dosage Form + Coxic 200 mg Capsule
Strength
Composition Each hard gelatin capsule contains:-
Celecoxib … 200 mg
Pharmacological Group Anti- inflammatory
Type of Form Form 5
Pack size & Demanded Price As recommended by PRC
Approval status of product in Celebrex 200mg capsule of M/s GD Searle approved
Reference Regulatory Authorities. by USFDA
Me-too status Lecob 200mg Capsule by M/s. Epharm Lab. Karachi
, (Reg. No. 07345801)
formulation
104. Name and address of manufacturer / Max Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Pregain 150mg Capsule
Strength
Composition Each Capsule contains:
Pregabalin……………..150mg
2016)
Pharmacological Group Anti-epileptics
Type of Form Form 5
Me-too status Gabica 150mg Capsule by M/s Getz Pharma
(Reg#048724)
GMP status Last inspection report conducted on 15-11-2016 &
16-11-2016 concluded satisfactory GMP
compliance sttaus.
Applicant
Brand Name +Dosage Form + Pregain 50mg Capsule
Strength
2016)
Type of Form Form 5
(Reg#048725)
compliance sttaus.
Applicant
Brand Name +Dosage Form + Strength Pregain 100mg Capsule
2016)
Type of Form Form 5
(Reg#047366)
compliance sttaus.
Applicant
Brand Name +Dosage Form + Strength Flamsil Cream 1%
Composition Each gram of contains:
Silver sulfadiazine (micronized) ….. 10mg
2016)
Type of Form Form 5
Pack size & Demanded Price 50gm x 1‟s As per SRO
Approval status of product in Silvadene 1% cream of M/s King Pharms LLC
Me-too status Burnhel Cream by M/s Danas Pharmaceutical (Pvt)
Ltd (Reg#038715)
compliance sttaus.
108. Name and address of manufacturer / M/s GT Pharma Pvt Ltd. Lahore
Applicant
Brand Name +Dosage Form + Strength Xanta Suspension
Composition Each 5ml Contains:-

Nitazoxanide………….100mg
2016)
Type of Form Form 5
Me-too status Izato 100 mg/5ml Suspension of M/s Sami
Pharmacetuicals, Karachi (Reg.# 076309)
GMP status Last inspection conducted on 08-08-2017 and
report concludes GMP compliance status
Remarks of the Evaluator.  No official monograph is available for applied
formulation in USP or BP.
109. Name and address of manufacturer / M/s Swan Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Axoff 40mg tablet
Febuxostat………..40mg
Diary No. Date of R& I & fee Dy.2685; 15-06-2016; Rs.20,000/- (15-06-2016)
Pharmacological Group Anti-Gout
Type of Form Form 5
Approval status of product in Reference Approved by USFDA
Regulatory Authorities.
Me-too status Febuxin by M/s AGP, Karachi (Reg. No. 081104)
GMP status Last inspection conducted on 21-12-2016.
Decision: Deferred for updated status of GMP from QA&LT Division.
Applicant
Brand Name +Dosage Form + Strength Axoff 80mg tablet
Febuxostat………..80mg
Pharmacological Group Anti-Gout
Type of Form Form 5
Approval status of product in Reference Approved by MHRA of UK
Applicant
Brand Name +Dosage Form + Strength Paradol tablets
Paracetamol………..325mg
Tramadol hydrochloride………37.5mg
Diary No. Date of R& I & fee Dy. No 2691; 15-06-2016; Rs.20,000/- (15-06-
2016)
Pharmacological Group Analgesic/ Opioid Analgesic
Type of Form Form 5
Approval status of product in Reference
Ultracet by Janssen (USFDA)
Me-too status Distalgesic Tablets by Atco laboratories, Karachi
(R. No. 073865)
Applicant
Brand Name +Dosage Form + Strength Levictam 500mg tablet
Composition Each film coated tablets Contains:
Levetiracetam……….500mg
2016)
Pharmacological Group Second generation antiepileptic
Type of Form Form 5
Me-too status Keppra Tablets 500mg by M/s AGP (Pvt.) Ltd,
Karachi (Reg. No. 045685)
Applicant
Brand Name +Dosage Form + Strength Levictam 250mg tablet
Levetiracetam……….250mg
2016)
Pharmacological Group Second generation antiepileptic
Type of Form Form 5
Me-too status Keppra Tablets 250mg by M/s AGP (Pvt.) Ltd,
Karachi (Reg. No. 045684)

Applicant
Brand Name +Dosage Form + Strength Vamlodip-DS tablets
Amlodipine as besylate…………10mg
Valsartan……..160mg
Diary No. Date of R& I & fee Dy. 2686; 15-06-2016; Rs.20,000/- (15-06-2016)
Pharmacological Group Anti-hypertensive
Type of Form Form 5
Me-too status Valpine Tablets 10/160mg by M/s Fassgen
Pharmaceuticals, (Reg. No. 073303)
Applicant
Brand Name +Dosage Form + Strength Sertowan 50 mg tablet
Sertraline (as hydrochloride) …… 50mg
2016)
Pharmacological Group Selective serotonin reuptake inhibitors
Type of Form Form 5
Me-too status Ertalin 50 mg Tablets of M/s Genome
pharmaceuticals, (Reg.#076844)
Applicant
Brand Name +Dosage Form + Strength Cyporin 0.05% Ophthalmic Emulsion
Cyclosporine……..0.5mg
2016)
Pharmacological Group Immunosuppresants
Type of Form Form 5
Pack size & Demanded Price 10 ml ; Rs. 200/-
Approval status of product in Reference Restasis ophthalmic emulsion of M/s Allergan
Regulatory Authorities. approved by USFDA
Me-too status Ristases Ophthalmic Emulsion of M/s Sante (Pvt.)
Ltd, Karachi (Reg.# 075811)
GMP status According to last inspection report dated 09-03-
2017 the company is complying with the GMP
guidelines.
Remarks of the Evaluator.  No USP or BP monograph is available for
applied formulation
117. Name and address of manufacturer / M/s The Schazoo Pharmaceuticals Pvt Ltd. Lahore
Applicant
Brand Name +Dosage Form + Strength Foierin 500mg Tablets
Ribavirin …….500mg
Pharmacological Group Anti-viral
Type of Form Form 5
Pack size & Demanded Price 2 x 5‟s ; Rs. 760/-
Me-too status Alcorib 500mg tablets by M/s Searle Pak, Karachi
(Reg#047386)
GMP status Last inspection conducted on 12-06-2017 and report
concludes that firm is found to be operating at good
level of GMP compliance.
Decision: Approved.
118. Name and address of manufacturer / M/s Akhai Pharmaceuticals, Baluchistan
Applicant
Brand Name +Dosage Form + Strength Kerol 10mg Tablet
Ketorolac tromethamine…..10 mg
Type of Form Form 5
Approval status of product in Reference USFDA Approved
Me-too status Kelac 10mg tablet of M/s Rotex Pharma (Reg.#
060804)
GMP status Last inspection conducted on 25-01-2017“Good
compliance.”
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Lowglo XR 500mg Tablet
Composition Each extended release tablet contains:
Metformin hydrochloride……500 mg
Type of Form Form 5
Approval status of product in Reference Glucophage XR of M/s Bristol Myers Squibb
Me-too status Xormet XR 500mg Tablet of M/s. Highnoon
Laboratories. (Reg.#076867)
compliance.”
Decision: Approved.
Applicant
Brand Name +Dosage Form + Strength Nopain Tablet
Composition Each uncoated tablet contains:
Paracetamol ……450mg
Orphenadrine citrate….35mg
Pharmacological Group Analgesic, snit-pyretics, muscle relaxant
Type of Form Form 5
Finished product Specification Manufacturer‟s specifications
Approval status of product in Reference Norgesic of M/s iNova Pharmaceuticals Australia
Regulatory Authorities. Pvt. Ltd. approved by TGA of Australia
Me-too status Rid-All Forte by M/s Stanley Pharma
(Reg.#069786)
compliance.”
Decision: Approved with change of brand name & with innovator’s specification.
Applicant
Brand Name +Dosage Form + Strength Terolam 20mg Tablet
Bambuterol hydrochloride…………20 mg
2016)
Pharmacological Group Beta-2 anatgonist
Type of Form Form 5
Pack size & Demanded Price 2 x 4‟s; As per SRO
Approval status of product in Reference Bambec tablets of M/s AstraZeneca UK Limited
Regulatory Authorities. approved by MHRA of UK
Me-too status Rid-All Forte by M/s Stanley Pharma
(Reg.#069786)

compliance.”
122. Name and address of manufacturer / M/s Barrett Hodgson Pakistan, F/423, S.I.T.E,
Applicant Karachi.
Brand Name +Dosage Form + Strength Dynaquin tablet 750mg
Levofloxacin (as hemihydrate)…….750 mg
Type of Form Form-5
Pack size & Demanded Price 5‟s; Rs. 300/-; 7‟s; Rs. 420/-
10‟s; Rs. 600/-; 14‟s; Rs. 840/-
Approval status of product in Reference Levaquin tablets of M/s Janssen Pharms approved
Regulatory Authorities. by USFDA
Me-too status Oliza 750 Tablets by M/s UniMark
Pharmaceuticals (Reg.#038004)

Applicant Karachi.
Brand Name +Dosage Form + Strength Ciclobar Ophthalmic Emulsion 0.05%
Cyclosporin……….0.5 mg
Pharmacological Group Immunosuppressive agent
Type of Form Form-5
Pack size & Demanded Price 5ml; Rs. 1250/- 10ml; Rs. 2500/-
Approval status of product in Reference Restasis ophthalmic emulsion of M/s Allergan
Me-too status Ristases Ophthalmic Emulsion of M/s Sante (Pvt.)
Ltd, Karachi (Reg.# 075811)
Remarks of the Evaluator. • No USP or BP monograph is available for
applied formulation
Applicant
Brand Name +Dosage Form + Strength Quixin 1.5% Opthalmic Solution
Levofloxacin (as hemihydrate) ….…15mg
2016)
Pharmacological Group Antibiotics
Type of Form Form 5
Pack size & Demanded Price 5ml ; Rs.50/-
Approval status of product in Reference Iquix 1.5% ophthalmic solution of M/s Santen
Me-too status Lequix Eye Drops by M/s M/s Schazoo
Laboratories (Reg#057284).

guidelines.
formulation
Applicant
Brand Name +Dosage Form + Strength Flurone forte 0.25% Ophthalmic suspension
Fluorometholone ….. 2.5mg
2016)
Type of Form Form 5
Pack size & Demanded Price 5ml ; As per SRO
Approval status of product in Reference FML Forte of M/s Allergan approved by USFDA
Me-too status Metholon Eye Drops by M/ Global Pharmaceuticals
(Reg#030546)
guidelines.
Decision: Approved.
126. Name and address of manufacturer / M/s Asian Continental Pvt. Ltd. D-133, Tipu sultan
Applicant road, KDA scheme-1, Karachi.
Brand Name +Dosage Form + Strength Lytax 20 mg capsule
Duloxetine (as hydrochloride) 20% w/w enteric
coated pellets …………. 20 mg
Source of pellets:
RA Chem Pharma Ltd. Telangana,India
2015)
Pharmacological Group Serotonin & adrenaline reuptake inhibitors
Type of Form Form-5
Me-too status Dulan capsules of M/s Hilton Pharma (Pvt.)
Limited Karachi (Reg.# 055446)
GMP status Last GMP Inspection of Asian Continental
Conducted on 28-12-16 with conclusive remarks of
Good level of cGMP compliance.
Decision: Approved.
Brand Name +Dosage Form + Strength Lytax 60 mg capsule
Source of pellets:
2015)
Type of Form Form-5
Decision: Approved.
Brand Name+Dosage Form + Strength Lytax 30 mg capsule
Source of pellets:
2015)
Type of Form Form-5
Decision: Approved.
129. Name and address of manufacturer / M/s Pakrisen Pharmaceuticals, Hattar contract
Applicant manufacturing by M/s Caraway Pharmaceuticals
Rawat.
Brand Name +Dosage Form + Strength Pakxime 400mg capsule
Cefixime (as trihydrate)………….400 mg
2015)
Pharmacological Group Cephalosporin, antibiotic
Type of Form Form-5
Pack size & Demanded Price 5‟s; As per SRO
Me-too status Dispel Capsules 400 mg of M/s Fynk
Pharmaceuticals (Reg.# 062702)
GMP status Last inspection of M/s Caraway Pharmaceuticals
conducted on 9-12-2016 and report concludes that
firm is found to be operating at good level of GMP
compliance.
Decision: Approved
Applicant Karachi.
Brand Name +Dosage Form + Strength Opsilk Lubricant eye drops
Polyethylene Glycol 400 …… 4 mg
Propylene Glycol …….. 3 mg
Pharmacological Group Ocular lubricant
Type of Form Form-5
Pack size & Demanded Price 10ml; Rs.33.35/-15ml; Rs.19.55/-
30 ml; Rs. 575/-
Me-too status Systane Lubricant Eye Drops M/s Ali Gohar &
Company (Pvt) Ltd., Karachi (Reg.# 044834)
131. Name and address of manufacturer / M/s Obsons Pharmaceutical Lahore
Applicant
Brand Name +Dosage Form + Strength Obnol 300mg Tablets
Composition Each Tablet contains:Allopurinol ………….300mg
Pharmacological Group Antigout
Type of Form Form 5
Pack size & Demanded Price 20 tablets; As per SRO
Me-too status Zyuric-300 Tablet of M/s Rasco Pharma.
(Reg.#067966)
with remarks as under:
“The management agreed and requested for some
time to overcome the shortcomings and will inform
to the authorities and the re-inspection will be
conducted accordingly.”
Remarks of the Evaluator.  In contrary to reference product approved by
USFDA & MHRA of UK, which is available as
uncoated tablet, firm has applied for film coated
tablet.
Decision:Deferred for
 Updated status of GMP from QA&LT Division as submitted inspection
report does not conclude GMP compliant status.
 Clarification of dosage form as reference product is available as uncoated
tablet whereas firm has applied for film coated tablet.
132. Name and address of manufacturer / M/s Benson Pharma
Applicant
Brand Name +Dosage Form + Strength Pregab 150mg capsule
Pregablin …….150mg
Diary No. Date of R& I & fee Dy.No.3091;14-07-2016; Rs.20,000/- (14-07-
2016)
Type of Form Form 5
(Reg#048724)
concluding satisfactory level of GMP compliance
Applicant
2016)
Type of Form Form 5
Approval status of product in Reference Lyrica 75mg Capsule by M/s PF Prism CV,
Regulatory Authorities. (USFDA approved)
Me-too status Lyrica 75mg Capsule by M/s Pfizer Pakistan Ltd.
(Reg#044817)
Applicant
2016)
Type of Form Form 5
(Reg#048725)
Applicant
Brand Name +Dosage Form + Strength Azoben 250mg Capsule

Azithromycin (as dihydrate) ………250mg
2016)
Type of Form Form 5
Approval status of product in Reference Zithromax 250mg capsule by M/s Pfizer
Regulatory Authorities. Ltd.(MHRA approved)
Me-too status Azomax 250mg capsule by M/s Sandoz
Pharmaceuticals.(Reg#022200)
Decision: Approved.

Applicant
Brand Name +Dosage Form + Strength Fluoxoben 12/125mg Capsule
Olanzapine……….12mg
Fluoxatine (as hydrochloride) ………….25mg
Pharmacological Group Antipsychotic /Antidepressants in combination with
psycholeptics
Type of Form Form – 5
Pack size & Demanded Price 30‟s / As per SRO
Approval status of product in Reference Symbyax 12mg/25mg capsule by Eli Lilly (USFDA
Regulatory Authorities. Approved)
Me-too status Olanco 12/25mg Capsule by M/s Nabi Qasim
Pharmaceuticals Pvt.Ltd. (Reg#064014)
137. Name and address of manufacturer / M/s McOlson Research Laboratories Sheikhupura
Applicant
Brand Name +Dosage Form + Strength Dulosoft 20mg Csapsule
Duloxetine (as hydrochloride)…20mg
(Enteric coated pellets 17%)
Source of pellets: M/s Spansules formulations
(India).
Pharmacological Group Serotonin and Nor-adrenaline reuptake inhibitor
Approval status of product in Reference Cymbalta (Duloxetine Delayed-Release Capsules)
Regulatory Authorities. 20mg by M/s Eli Lilly, (USFDA Approved)
Me-too status D-Lex DR 20 mg Capsule by M/s Ciba
Pharmaceuticals, Karachi. (Reg#081577)
GMP status Last GMP inspection report was conducted on 10
& 24.04.2017 and it concludes fair GMP
compliance.
Remarks of the Evaluator. Source of pellets is not of USP grade.
Decision: Registration Board deferred for clarification assubmitted source of pellets is
not of USP grade.

Evaluator PEC-VI
138. Name and address of manufacturer / M/s Sanofi Aventis, Karachi
Applicant
Brand Name +Dosage Form + Strength Enterozinc syrup
Composition Each 5ml contains:
Zinc Sulfate Heptahydrate eq. to elemental
zinc……...20mg
Pharmacological Group Anti-diarrhoeal
Type of Form Form-5
Finished product Specification Manufacturer‟s Specification
Pack size & Demanded Price 120ml, Rs.120/-
Approval status of product in Reference WHO Approved
Me-too status Zincat oral solution of M/s Atco Labs Karachi
GMP status Last inspection report 25-10-2016. The scope of this
inspection report is verification of manufacturing
facility for sustained release granules.
Remarks of the Evaluator. CGMP certificate is issued(25-1-2017) for all
sections on the basis of inspection report (25-10-
2016) which is only for the verification of
manufacturing facility for sustained release granules.
Product monograph is present in IP
 Updated GMP status by QA&LT Division as submitted inspection report
does not conclude GMP compliant status.
 Clarification of Heptahydrate salt.
139. Name and address of manufacturer / M/s Sanofi Aventis, Karachi

Applicant
Brand Name +Dosage Form + Strength Enterozinc syrup
Zinc Sulfate Heptahydrate eq to elemental
zinc……...20mg
Type of Form Form-5
Me-too status Zincat oral solution of M/s Atco Labs Karachi
GMP status Last inspection report 25-10-2016. The scope of this
inspection report is verification of manufacturing
facility for sustained release granules.
Remarks of the Evaluator. CGMP certificate is issued(25-1-2017) for all
sections on the basis of inspection report (25-10-
2016) which is only for the verification of
manufacturing facility for sustained release granules.
Product monograph is present in IP
 Updated GMP status by QA&LT Division as submitted inspection report
does not conclude GMP compliant status.
 Clarification of Heptahydrate salt

140. Name and address of manufacturer / M/s WeatherFold, Hattar
Applicant
Brand Name +Dosage Form + Strength Terbifold 125mg tablet
Terbinafine HCl…..125mg
Pharmacological Group Anti-fungal
Type of Form Form-5
Finished product Specification USP Specification
Pack size & Demanded Price 10‟s, As per SRO
Approval status of product in Reference Terbinafine 125 mg tablets by M/s Genus
Regulatory Authorities. (MHRA approved)
Me-too status Onyfine 125mg Tablet by M/s Medisure
GMP status Firm has submitted copy of inspection report
conducted on 15-09-2017 concluding GMP compliant
status.
Decision: Approved
141. Name and address of manufacturer / M/s WeatherFold, Hattar
Applicant
Brand Name +Dosage Form + Strength Sitafold 50/1000mg ta+blet
Sitagliptin as Sitagliptin phosphate
monohydrate…..50mg
Metformin HCl………………….1000mg
Pharmacological Group Anti-diabetic
Type of Form Form-5
Pack size & Demanded Price 2x7‟s, As per SRO
Approval status of product in Reference Janumet 50/1000mg (approved by US-FDA)
Me-too status Treviamet 50/1000mg tablets of M/s Getz pharma
GMP status Firm has submitted copy of inspection report
conducted on 15-09-2017 concluding GMP compliant
status.
142. Name and address of manufacturer / M/s CKD Pharmaceutical Pakistan. Karachi
Applicant
Brand Name +Dosage Form + Strength Amlovast 10/10 tablet
Atorvastatin as calcium….10mg
Amlodipine as besylate……10mg
Pharmacological Group Lipid-altering agent, calcium channel blocker
Type of Form Form-5
Pack size & Demanded Price 10‟s. Rs.200/-
14‟s. Rs.280/-
Approval status of product in Reference USFDA
Me-too status Orava Plus by Bosch
acceptable compliance to GMP.
Applicant
Brand Name +Dosage Form + Strength Clind Lotion 1%
Clindamycin….10mg
Pharmacological Group Anti-biotic
Type of Form Form-5
Approval status of product in Reference MHRA
Me-too status Austaclin-T lotion 1% by Bloom
Remarks of the Evaluator. Product monograph is present in USP.
Cream/Ointment/Gel section is present according to
last inspection report.
Applicant
Brand Name +Dosage Form + Strength Clind Gel 1%
Clindamycin…….10mg
Type of Form Form-5
Pack size & Demanded Price 10gm Rs.100/-; 15gm Rs.150/- 25gm
Rs.250/-
Me-too status Uniclin Gel by M/s Kaizen Pharma, Karachi (Reg.
No. 076304)
Remarks of the Evaluator. Cream/Ointment/Gel section is present according to
last inspection report.
Decision: Approved.
145. Name and address of manufacturer / M/s Saffron Pharmaceuticals, Faislabad

Applicant
Brand Name +Dosage Form + Strength Sonnet Injection IV
Composition Each vial contains:
Ceftriaxone as sodium……250mg
Pharmacological Group Cephalosporin
Type of Form Form-5
Pack size & Demanded Price 1‟s ; As per SRO
Approval status of product in Reference Rocephin Injection by Roche
Regulatory Authorities. (MHRA Approved)
Me-too status Rocephin by Martin Dow
GMP status Last GMP inspection conducted on 28-11-2016 and
the report concludes that the firm is considered to be
operating at good level of compliance with GMP
guidelines.
Decision: Deferred for confirmation of manufacturing facility.
Applicant
Brand Name +Dosage Form + Strength Oravast 10mg tablet
Atorvastatin as calcium trihydrate…….10mg
Pharmacological Group Lipid altering agent
Type of Form Form-5
Pack size & Demanded Price 10‟s; Rs.660/- 14‟s; Rs.924/-
Approval status of product in Reference Lipitor tablets by Pfizer
Me-too status Lipitor tablets by Pfizer
Decision: Approved with innovator‟s specification.
Applicant
Brand Name +Dosage Form + Strength Clind capsule 300mg
Clindamycin as HCL…….30mg
Type of Form Form-5
Pack size & Demanded Price 10‟s; Rs.300/-; 20‟s; Rs.375/-
Me-too status Clindamycin 300mg by ICON
Decision: Approved.
148. Name and address of manufacturer / M/s Adamjee Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Tweet capsules 6/25
Olanzapine as Citrate..…..6mg
Fluoxetine as HCl………25mg
Pharmacological Group SSRI
Type of Form Form-5
Pack size & Demanded Price 2x7‟s; As per SRO
Approval status of product in Reference Symbyax by Eli Lilly
Regulatory Authorities. (USFDA Approved)
Me-too status Co-Depricap by Nabiqasim
GMP status Last inspection report 14-7-2017 Firm is considered
to be operating at satisfactory level of compliance
with GMP.
Decision: Deferred for clarification of salt form of Olanzapine as firm has applied as citrate

but approved by USFDA as olanzapine
149. Name and address of manufacturer / M/s Adamjee Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Tweet capsules 3/25
Olanzapine as Citrate..…..3mg
Fluoxetine as HCl………25mg
Pharmacological Group SSRI
Type of Form Form-5
Approval status of product in Reference Symbyax capsule by Eli Lilly
Regulatory Authorities. (USFDA Approved)
Me-too status Co-Depricap capsule by Nabiqasim
to be operating at satisfactory level of compliance
with GMP.
Decision: Deferred for clarification of salt form of Olanzapine as firm has applied as citrate
but approved by USFDA as olanzapine
Evaluator PEC-VII
150. Name and address of manufacturer / M/s Medera Pharmaceuticals (Pv) Ltd., plot#2,national
Applicant industrial zone, Rawat applied for contract
manufacturing by M/s Bio Labs (Pvt) Ltd, Islamabad.
Brand Name +Dosage Form + Strength Avezone 250mg Injection IM
Composition Each vial contains:-
Ceftriaxone Sodium eq. to Ceftriaxone………..250mg
Diary No. Date of R& I & fee Dy.No. 1986, 27-03-2015, Rs.50,000/-
Type of Form Form-5
Finished Product Specification USP
Pack size & Demanded Price 1‟s vial / As Per PRC
Approval status of product in Reference Ceftriazone of sandoz (USFDA)
Me-too status Aczone of Global pharma
GMP status Last GMP Inspection of by M/s Bio Labs Conducted
on 15-12-2016 with conclusive remarks cGMP
compliance.
Remarks of Evaluator  Firm has two plants kahuta and national
industrial zone.
 This National industrial zone plant possesses 5
sections
The firm has got registration of no products on contract
manufacturing as per information verified from the
registration section. In 273 meeting they got approval
of 5 new products on this plant.
Decision: Approved.
Brand Name +Dosage Form + Strength Avecef 400mg Capsules
Composition Each capsule contains:-
Cefixime……….400mg

Type of Form Form-5
Pack size & Demanded Price 1x5‟s / As Per SRO
Approval status of product in Reference Suprex of Lupin (USFDA)
Me-too status Cefiget of Getz
compliance.
Remarks of Evaluator Remarks:
 Firm has two plants kahuta and national industrial
zone.
sections
Decision: Approved.
Brand Name +Dosage Form + Strength Avecef 100mg Dry Susp.
Composition Each 5ml contains:-
Cefixime (as Trihydrate)……….100mg
Type of Form Form-5
Pack size & Demanded Price 30ml / As Per SRO
Me-too status Tyson of Himont
compliance.
 Firm has two plants kahuta and national
industrial zone.
sections
Decision: Approved.

153. Name and address of manufacturer / M/s Medera Pharmaceuticals (Pv) Ltd.,plot#2,national
Brand Name +Dosage Form + Strength Avecef 200mg Dry Susp.
Cefixime (as Trihydrate)……….200mg
Type of Form Form-5
Me-too status Cefiget of Getz
compliance.
industrial zone.
sections
Decision: Approved.
154. Name and address of manufacturer / M/s Medera Pharmaceuticals (Pv) Ltd.,plot#2,national
Brand Name +Dosage Form + Strength Becomin 500mcg Ampoule
Composition Each ampoule contains:-
Mecobalamin………500mcg
Pharmacological Group Vitamin-B
Type of Form Form-5
Finished Product Specification As per innovator
Approval status of product in Reference PMDA
Me-too status Melamine by Reliance Pharma
compliance.
industrial zone.
sections

Brand Name +Dosage Form + Strength Bioket 30mg Ampoule
Ketorolac Tromethamine……..30mg
Type of Form Form-5
Pack size & Demanded Price 1mlx5‟s / As Per SRO
Approval status of product in Reference Ketoroac of Hospira (USFDA)
Me-too status K-Dol of Akson
compliance.
industrial zone.
sections
Decision: Approved.
Brand Name +Dosage Form + Strength Biolac 10mg Ampoule
Ketorolac Tromethamol……..10mg
Type of Form Form-5
Pack size & Demanded Price 1mlx5‟s /As Per SRO

Approval status of product in Reference Toradol of Atnahs pharma (TGA Australia)
Me-too status K-Dol of Akson
compliance.
industrial zone.
sections

Decision: Approved.
Brand Name +Dosage Form + Strength OMED 40mg Injection
Omeprazole (as Sodium)……….…40mg
Pharmacological Group Proton Pump Inhibitor
Type of Form Form-5
Pack size & Demanded Price 1‟s / As Per SRO

Approval status of product in Reference Omeprazole IV of sandoz (TGA)
Me-too status Loprot of Nabiqasim
compliance.
industrial zone.
sections
Decision: Approved.
Brand Name +Dosage Form + Strength ES-Amazole 40mg Injection
Esomeprazole (as Sodium)…………..40mg
Type of Form Form-5
Pack size & Demanded Price 1‟s /As Per SRO

Approval status of product in Reference Esomeprazole of Consilient pharma (EMC)
Me-too status Brince of ACE
compliance.
industrial zone.
sections
159. Name and address of manufacturer / M/s.Pharma Lord (Pvt) Ltd, Layyah applied for
Applicant contract manufacturing by M/s. bloom Pharma Lahore
Plot # 30, phase I & II, industrial estate, Hattar.
Brand Name +Dosage Form + Strength Frix Injection 500mg I.M
Ceftriaxone (as sodium) …..500mg
Pharmacological Group Cephalosporin Antibiotic
Type of Form Form-5
Me-too status 3-zone of Zeb
GMP status Last GMP Inspection of by M/s blooms Conducted on
21-3-2017 with conclusive remarks cGMP compliance.
 The Pharma lord plant possesses 3 sections.
registration section.
 The firm requested to change their manufacturer
from M/S Novamed pharma Lhr to M/S Blooms
pharma Hattar.
Decision: Approved with USP specification.
Applicant contract manufacturing by M/s. bloom Pharma Lahore
Plot # 30, phase I & II, industrial estate, Hattar.
Brand Name +Dosage Form + Strength Frix Injection 500mg I.V
Ceftriaxone (as sodium) …..500mg
Type of Form Form-5

 The Pharma lord plant possesses 3 sections
pharma Hattar.

Decision: Approved.
Applicant contract manufacturing by M/s. bloom Pharma
LahorePlot # 30, phase I & II, industrial estate, Hattar.
Brand Name +Dosage Form + Strength Frix Injection 1g I.V
Ceftriaxone (as sodium) …..1 g
Type of Form Form-5

pharma Hattar.
Decision: Approved.
Brand Name +Dosage Form + Strength Frix Injection 250 mg I.M
Ceftriaxone (as sodium) …..250 mg
Type of Form Form-5
The Pharma lord plant possesses 3 sections
pharma Hattar.

Decision: Approved.
Brand Name +Dosage Form + Strength Frix Injection 250 mg I.V
Ceftriaxone (as sodium) …..250 mg
Type of Form Form-5

 The firm has got registration of no products on
contract manufacturing as per information verified
from the registration section.
pharma Hattar.
Decision: Approved.
Brand Name +Dosage Form + Strength Xim 200 mg/5 ml dry powder suspension
Composition Each 5 ml contains:-
Cefixime (as Trihydrate)…..200 mg
Type of Form Form-5
Pack size & Demanded Price 30 ml / As per SRO

Approval status of product in Reference Cefixime By Aurobindo Pharma Ltd (USFDA)
Me-too status AG-FIX by Saydon Pharma
pharma Hattar.
Decision: Approved.
Brand Name +Dosage Form + Strength Xim 100 mg/5 ml dry powder suspension
Composition Each 5 ml contains:-
Cefixime (as Trihydrate)…..100 mg
Type of Form Form-5
Approval status of product in Reference SUPRAX 100mg/5ml dry powder suspension by M/s
Regulatory Authorities. LUPIN LTD (USFDA)
Me-too status Cefamax 100mg/5ml dry suspension by M/s Pulse
Pharma
pharma Hattar.
Decision: Approved.
Brand Name +Dosage Form + Strength Xim 400 mg capsules
Cefixime (as Trihydrate) …..400 mg
Type of Form Form-5
Finished Product Specification Manufacturer specifications
Pack size & Demanded Price 1x5‟s / As per SRO
Approval status of product in Reference SUPRAX Capsule 400mg by M/s LUPIN LTD
Regulatory Authorities. (USFDA)
Me-too status Cefiget 400mg Capsules by M/s Getz Pharma, (Reg#
045118)
pharma Hattar.
Decision: Approved with innovator’s specifications
167. Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals, Plot # 122, Block A,
Applicant Phase V. Hattar
Brand Name +Dosage Form + Strength Sevelawin 400 mg Tablets
Sevelamer (as HCl)……..….. 400 mg
Pharmacological Group Anti-hyperphosphatemia
Type of Form Form-5
Finished Product Specification Manufacturer
Pack size & Demanded Price 3x10‟sAs per SRO

Approval status of product in Reference Renagel 400 mg of Genzyme (USFDA)
Me-too status Renavel of Genome Pharmaceuticals (Pvt) Ltd
GMP status Last GMP Inspection of Wnsfeild Pharmaceuticals
cGMP compliance.
Remarks of Evaluator
168. Name and address of manufacturer / M/s Genix Pharma, 44, 45-B, Korangi Creek Road
Applicant Karachi
Brand Name +Dosage Form + Strength Tigcil 50mg Injection
Composition Each dry powder vial contains:
Tigecycline……50 mg
Pharmacological Group Anti-bacterial
Type of Form Form-5
Approval status of product in Reference Tygacil 50mg powder for solution for infusion by M/s
Regulatory Authorities. Pfizer Limited (MHRA)
Me-too status Tygacil By M/s. pfizer
GMP status Last GMP Inspection conducted on 8-8-2017 with
conclusive remarks of satisfactory cGMP compliance.
Remarks of Evaluator Dry powder injection section present.
Decision:Approved. Reference will be sent to Budget & Accounts Division for verification of
challan and Board authorized its Chairman for the issuance of registration letter.
169. Name and address of manufacturer / M/s Fresh Pharmaceuticals, Plot # 7, street # S-6,
Applicant National industrial zone, RRCI, Rawat, Islamabad
Brand Name +Dosage Form + Strength P-Gab 50mg Capsule
Pregablin …………50mg
Type of Form Form-5
Approval status of product in Reference Lyrica by Pfizer Prism CV (USFDA)
Me-too status Gabica by Getz Pharma

GMP status Last GMP Inspection dated 9-5 17 with conclusive
remarks of Good cGMP compliance.
Brand Name +Dosage Form + Strength P-Gab 25 mg Capsule
Pregablin …………25 mg
Type of Form Form-5
Me-too status Pregy of sami
Type of Form Form-5
Brand Name +Dosage Form + Strength P-Gab 150mg Capsule
Type of Form Form-5

Type of Form Form-5

Brand Name +Dosage Form + Strength Amlosar Tablet 5mg /160mg
Composition Each Film coated tablet contains

Amlodipine besylate (eq. to Amlodipine)…..5mg
Valsartan…………160mg
Type of Form Form-5
Approval status of product in Reference Amlodipine Besylate and Valsartan of Par Pharm
Me-too status Avcard of Hilton
Decision: Approved.
Brand Name +Dosage Form + Strength Bonevic Tablet 150mg
Ibandronate (as sodium)…..150mg
Pharmacological Group Bone density regulator
Type of Form Form-5


Approval status of product in Reference Boniva of Hoffmann la Roche (USFDA)
Me-too status Bonviva of Roche Pakistan Ltd.
Decision: Approved with change of brand name & innovator’s specification.
Brand Name +Dosage Form + Strength Fucid H Cream
Composition Each gram contains:
Fusidic Acid …………..20mg
Hydrocortisone (as Acetate)…..10mg
Pharmacological Group Antibacterial/Corticosteroid
Type of Form Form-5
Pack size & Demanded Price 10 g / As per SRO

Approval status of product in Reference Fucidin® H cream of Leo pharma (MHRA)
Me-too status Ambrodic-H of Ambrosia Pharmaceuticals
Decision: Approved with change of brand name & with innovator’s specification.
Brand Name +Dosage Form + Strength Chemset 8mg tablet
Ondansetron (as HCl)…….8mg
Pharmacological Group Serotonin (5HT3) antagonists
Type of Form Form-5

Approval status of product in Reference Ondansetron Hydrochloride of Dr Reddys Labs Ltd
Me-too status Ambrodic-H of Ambrosia Pharmaceuticals
Decision: Approved.
178. Name and address of manufacturer / M/s Zafa Pharmaceuticals, L-1/B, Block 22, Federal B
Applicant Industrial area Karachi.
Brand Name +Dosage Form + Strength Irofit 50mg/5ml Syrup
Iron as iron polymaltose………50mg
Pharmacological Group Anti-anemic preparations
Type of Form Form-5
Finished Product Specification Manufacturer‟s specifications.

Approval status of product in Reference NA
Me-too status BISLERI of Sami pharmaceutics
GMP status --
Remarks of Evaluator Latest GMP inspection report is required
Decision:Deferred for submission of latest GMP inspection report conducted within a period
of last 1 year by DRAP.
179. Name and address of manufacturer / M/s UDL Pharmaceuticals, Plot # E-44-45, North
Applicant western industrial zone, Port Qasim authority Karachi
Brand Name +Dosage Form + Strength Elargin 20mg Tablet
Ebastine……….20 mg
Pharmacological Group Anti-histamine
Type of Form Form-5
Finished Product Specification JP
Approval status of product in Reference Kastine tablet approved by Netherland
Me-too status Atmos of Scotmann Pharmaceuticals
GMP status Last GMP Inspection dated 12-May 2017 with
conclusive remarks of cGMP compliance.
Decision: Deferred for confirmation of GMP status from QA & LT Division.
180. Name and address of manufacturer / M/s UDL Pharmaceuticals, Plot # E-44-45, North
Applicant western industrial zone, Port Qasim authority Karachi
Brand Name +Dosage Form + Strength Elargin 10mg Tablet
Ebastine……….10 mg
Type of Form Form-5
Approval status of product in Reference EBASTINE ALMIRALL 10 mg film-coated tablet
Regulatory Authorities. (ANSM)
Me-too status Atmos of Scotmann Pharmaceuticals
GMP status Last GMP Inspection dated 12-May 2017 with
Decision: Deferred for confirmation of GMP status from QA & LT Division.
181. Name and address of manufacturer / M/s ISIS Pharmaceuticals and chemicals 25/1-3 sector
Applicant 12-C, North Karachi industrial area, Karachi
Brand Name +Dosage Form + Strength Istrose Infusion (100 ml)
Dextrose…….5% 100ml
Diary No. Date of R& I & fee Dy.No.1716, 30-8-2016, Rs.20,000/-
Pharmacological Group Dextrose supplement
Type of Form Form-5
Approval status of product in Reference Dextrose 5% 100 ml infusion (Health Canada)
Me-too status Dextrose of Elko pharma
remarks of good cGMP compliance.
Brand Name +Dosage Form + Strength Ebas 10mg Tablet
Composition Each tablet contains:Ebastine………….10 mg
Pharmacological Group Anti-allergic
Type of Form Form-5
Approval status of product in Reference Kestine 10mg tablet by M/s Almirall Pharmaceuticals,
Regulatory Authorities. (ANSM France Approved)
Me-too status Ebofor 10mg Tablet by M/s Genome Pharmaceutical
Decision: Approved with JP specification.
Brand Name +Dosage Form + Strength Ezad 2mg Tablet
Tizanidine (As Tizanidine Hydrochloride) eq. to
base………..2 mg
Pharmacological Group Muscle relaxant
Type of Form Form-5
Approval status of product in Reference Tizadine of Sandoz (USFDA)
Me-too status Analar by AGP
Decision: Approved.

Brand Name +Dosage Form + Strength Lortec 5mg/5ml Syrup
Loratadine……………5 mg
Type of Form Form-5
Approval status of product in Reference Loratadine 5mg/5ml oral solution by M/s Cipla (EU)
Regulatory Authorities. Limited (MHRA Approved)
Me-too status Victrin 1mg/ml Liquid Syrup by M/s Barret Hodgson
(Reg#027277)
Decision: Approved
Brand Name +Dosage Form + Strength Rithro 500mg Tablet
Clarithromycin…….500mg
Type of Form Form-5

Approval status of product in Reference Biaxin by M/s Abbvie Inc (USFDA).
Me-too status Claritek by M/s. Getz Pharmaceuticals
Decision: Approved with change of brand name

Brand Name +Dosage Form + Strength Isaline 0.9% 100ml Infusion
Normal Saline…………….5% 100ml
Pharmacological Group Electrolyte solution
Type of Form Form-5
Finished Product Specification BP

Approval status of product in Reference Sodium Chloride 0.9% Intravenous Infusion by M/s
Regulatory Authorities. Eastgate Way (MHRA)
Me-too status Lifesol IV Infusion by M/s Geofman
Decision: Deferred for calrification of composition as firm has mentioned Normal saline
instead of Sodium chloride in Form 5 and master formulation. Details of container closure
system (glass or plastic)is required.
Brand Name +Dosage Form + Strength Iflocin 500mg Tablet
Levofloxacin……..500 mg
Type of Form Form-5
Approval status of product in Reference Levofloxacin of Teva (USFDA)
Me-too status Levofaz, Fozan Pharma
Decision: Approved
Brand Name +Dosage Form + Strength Isgesic Forte Tablet
Composition Each Film coated tablet contains:
Paracetamol……..450 mg
Orphenadrine…..35 mg
Pharmacological Group Muscle relaxant with analgesic.
Type of Form Form-5
Finished Product Specification Manufacturing
Approval status of product in Reference Norgesic by M/s iNova Pharmaceuticals, Australia
Regulatory Authorities. (TGA)
Me-too status Acetor of Neomedix

Brand Name +Dosage Form + Strength Isvil 25mg/ml Injection
Pheniramine maleate…25 mg
Pharmacological Group Anti-Allergy
Type of Form Form-5
Pack size & Demanded Price 1 ml ampoule / As per SRO

Approval status of product in Reference Could not be confirmed
Me-too status Avil Injection by Sanofi Aventis
Remarks of Evaluator Evidence of approval of applied formulation in
reference regulatory authorities/agencies not found.
Reference provided is of India (Avil)
Decision: Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies
Brand Name +Dosage Form + Strength Ismal Tablet
Composition Each Film coated tablet contains:
Tramadol………37.5 mg
Paracetamol…..325 mg
Pharmacological Group Opiate analogue + Analgesic.
Type of Form Form-5
Approval status of product in Reference Tramacet 37.5 mg/ 325 mg film-coated tablets of
Regulatory Authorities. Grunanthal (USFDA)
Me-too status ZULTRACET of WILSHIRE
Decision: Approved.
Brand Name +Dosage Form + Strength Ispidon 175mg/25mg Tablet
Propyphenazone….175 mg
Caffeine………….25 mg

Pharmacological Group NSAID, CNS Stimulant
Type of Form Form-5

Approval status of product in Reference Could not be confirmed
Me-too status Optalidon Of Novartis Pharma
Remarks of Evaluator Evidence of approval of applied formulation in
reference regulatory authorities/agencies can‟t be
verified.
authorities/agencies.
Brand Name +Dosage Form + Strength Isgab 300mg Capsule
Gabapentin……….300 mg
Pharmacological Group Anti epileptic
Type of Form Form-5
Pack size & Demanded Price 1 ml ampoule / As per SRO

Approval status of product in Reference USFDA approved
Me-too status Gab of TG pharma
Brand Name +Dosage Form + Strength Isflox 400mg Tablet
Norfloxacin hemihydrates eq. to Norfloxacin.....400mg
Type of Form Form-5

Approval status of product in Reference NOROXIN of Merck (USFDA)
Me-too status Bacnor by Dyson Reg no. 078844

Brand Name +Dosage Form + Strength Iscam 20mg Tablet
Piroxicam………..20 mg
Pharmacological Group Anti-inflammatory
Type of Form Form 5

Me-too status Jaldin 20mg Capsule by M/s Irza Phama, Lahore
Remarks of Evaluator Evidence of formulation is only in Capsule (Feldene
(Piroxicam) 20mg Capsule by M/s Pfizer, USA)
Decision: Deferred for clarification of salt form of API & applied dosage form in comparison
to reference product.
195. Name and address of manufacturer / M/s AGP Ltd., B-23, SITE, Karachi
Applicant
Brand Name +Dosage Form + Strength Rivarox 20mg Tablet
Rivaroxaban……..20 mg
Pharmacological Group Anticoagulant
Type of Form Form 5
Pack size & Demanded Price 7‟sRs.5,860/-; 10‟s Rs.8,370/-; 14‟s Rs.11,134/-
Approval status of product in Reference Xarelto 20mg Tablet by M/s Janssen Pharms, USA.
Me-too status Xarelto 20mg Tablet by M/s Bayer Healthcare,
Karachi.
GMP status Latest inspection report on 18-9-2017. Overall
compliance was good
Applicant
Brand Name +Dosage Form + Strength Rivarox 15mg Tablet

Type of Form Form 5
Pack size & Demanded Price 7‟sRs.4630/-; 10‟sRs.6614/-; 14‟s Rs.8797/-

Approval status of product in Reference Xarelto Tablet by M/s Janssen Pharms, USA.
Me-too status Xarelto Tablet by M/s Bayer Healthcare, Karachi.
GMP status Latest inspection report on 18-9-2017. Overall
compliance was good
Applicant
Brand Name +Dosage Form + Strength Rivarox 10 mg Tablet
Type of Form Form 5
Pack size & Demanded Price 10‟s Rs.5,023/- 30‟s Rs.13,864/-

Approval status of product in Reference Xarelto Tablet by M/s Janssen Pharms, USA.
Me-too status Xarelto Tablet by M/s Bayer Healthcare, Karachi.
GMP status Latest inspection report on 18-9-2017.Overall
compliance was good
198. Name and address of manufacturer / M/s. Wellborne Pharmachem & Biological Plot# 51/1,
Applicant 52/2, Phase I & II industrial state Hattar.
Brand Name +Dosage Form + Strength Amvazide 10/160/12.5 mg Tablet
Amlodipine …….... 10 mg
(as Amlodipine Besylate)
Valsaratan …….. 160 mg
Hydrochlorothiazide…… 12.5 mg
Type of Form Form 5
Pack size & Demanded Price 14‟s & 28‟s /As per SRO
Approval status of product in Reference Exforge HCT by Novartis Pharma
Me-too status Exforge by Novartis Pharma
GMP status Last inspection conducted on 27-02-2017“Strictly
following the GMP compliance.”

Brand Name +Dosage Form + Strength Amvazide 5/160/12.5 mg Tablet
Hydrochlorothiazide…… 12.5 mg
Type of Form Form 5
Pack size & Demanded Price 14‟s & 28‟s / As per SRO
Approval status of product in Reference Exforge by Novartis Pharma
Brand Name +Dosage Form + Strength Amvazide 10/160/25 mg Tablet
Hydrochlorothiazide…… 25 mg
Type of Form Form 5

Type of Form Form 5
Type of Form Form 5
Pack size & Demanded Price 14‟s & 28‟s/ As per SRO

Evaluator PEC-VIII
203. Name and address of Manufacturer / M/s CCL Pharma Pvt Ltd
Applicant
Brand Name+DosageForm+Strength Pulmonol Ace Syrup 125mg/5ml
Composition Each 5ml contains
AcefyllinePiperazine… 125mg
Diary No. Date of R&I & fee Dy No.422; 10-03-2015; Rs.20,000/-
Pharmacological Group Antitussives
Type of Form Form-5
Pack Size & Demanded Price 60 ml,90ml,120ml/ As per brand leader
Approval status of product in Not provided
Me-too status Acefyl Syrup 125mg/5ml by Nabiqasim Industries Pvt
Ltd
GMP status GMP inspection conducted on 08-03-2017 & 31-03-
2017 rated satisfactory level of GMP compliance.
Remarks of Evaluator  Evidence of approval status of applied formulation in
reference agencies is required.
 Firm has claimed manufacturer specifications but has
not submitted the data as required by the decision of
267th R.B meeting and the applied formulation is not
present in available USP and B.P
Decision: Deferred for further deliberation.
204. Name and address of Manufacturer / M/s Barrett Hodgson Pakistan Pvt Ltd, F/423, SITE,
Applicant Karachi.
Brand Name+DosageForm+Strength Ocudine Plus Eye Drops
Composition Each ml contains
Olopatadine (as hydrochloride)……. 1mg
Ketorolac Tromethamine ……. 4mg
Diary No. Date of R&I & fee Dy No.307;13-03-015; Rs.20,000/-
Pharmacological Group Mast cell stabilizer with antihistaminic activity/NSAID
Type of Form Form-5
Finished Product Specification Manufacturer‟s Specifications
Pack Size & Demanded Price 5 ml/ Rs. 385.50
Approval status of product in Acupat by Allergan India(as provided by the firm)
Me-too status Not provided
GMP status GMP inspection conducted on rated 08-08-2017 rated
Remarks of Evaluator  Evidence of approval status of applied
formulation in reference agencies is required.
 Evidence of Me too is required.
Decision: Registration Board rejected the application as formulation is not approved by
any of the reference regulatory authorities and firm has not submitted data to establish
safety, efficacy and quality of the product.
205. Name and address of Manufacturer / M/s Barrett Hodgson Pakistan Pvt Ltd, F/423, SITE,
Applicant Karachi.
Brand Name+DosageForm+Strength GantafOpthalmic Solution 0.0015%
Tafluprost ……… 0.015 mg
Pharmacological Group Ocular Hypotensive agent/Prostaglandin Analogs
Type of Form Form-5
Finished Product Specification Supplier Specifications
Pack Size & Demanded Price 2.5 ml/Rs. 900
Approval status of product in Approved in USFDA
Reference Regulatory Authorities Zioptan By Merck Sharp, USA
Me-too status Taflusan by Sante Pvt Ltd
GMP status GMP inspection conducted on rated 08-08-2017 rated
Remarks of Evaluator Firm has claimed manufacturer specifications but has
267th R.B meeting and the applied formulation is not
present in available USP and B.P
Decision:Deferred for confirmation of (generic / me-too status) of applied formulation
206. Name and address of Manufacturer / M/s Fynk Pharmaceuticals, 19km GT Road,
Applicant KalashahKaku, Lahore.
Brand Name+DosageForm+Strength Fyprox Tablet 20 mg
Paroxetine (as hydrochloride)…. 20 mg
Pharmacological Group Selective Serotonin Reuptake Inhibitor;
Antidepressant.
Type of Form Form-5
Finished Product Specification U.S.P Specifications
Pack Size & Demanded Price 10‟s/ As per PRC
Approval status of product in Approved in US-FDA
Me-too status Seroxat 20 mg tab by GSK Pharma
GMP status GMP inspection conducted on 20-09-2017 cocncluding
GMP compliant status at satisfactory level.
Remarks of Evaluator ----
Decision:Approved.
Brand Name+DosageForm+Strength Lispril tablet 10 mg
Lisinopril ….10 mg
Pharmacological Group Angiotensin Converting Enzyme Inhibitor/
Cardiovascular Drug
Type of Form Form-5
Finished Product Specification U.S.P. Specifications
Pack Size & Demanded Price 2 ×10‟s/ As per PRC
Me-too status Zestril tablet 10 mg by ICL Pharma
GMP status GMP inspection conducted on 20-09-2017cocncluding
Remarks of Evaluator Box warning in USFDA: ACE inhibitors may cause
death to the developing fetus.
Decision:Deferred for clarification of applied composition as reference product is available
as Lisinopril (as dihydrate) whereas firm has applied with Lisinopril only.
Brand Name+DosageForm+Strength Faxmin tablet 200 mg
Rifaximin….. 200 mg
Type of Form Form-5
Finished Product Specification Manufacturer specification
Pack Size & Demanded Price 1×10‟s/ As per PRC
Me-too status Nimix 200 mg tablet by Getz Pharma
Brand Name+DosageForm+Strength Ketofen Liquid Syrup 0.2 mg /ml
Composition Each ml of syrup contains:
Ketotifen (as fumerate)... 0.2 mg
Pharmacological Group Antihistamines.
Type of Form Form-5
Pack Size & Demanded Price 60 ml/ As per PRC
Approval status of product in Approved by ANSM of France
Me-too status Ambrotifen Syrup by Ambrosia Pharmaceuticals
Brand Name+DosageForm+Strength Tramol Tablet 37.5mg/325mg
Composition Each film coated tablet contains…
Tramadol hydrochloride. … 37.5 mg
Paracetamol … 325 mg
Pharmacological Group Tramadol Hydrochloride
Opioid Analgesic
Paracetamol
Analgesics, Antipyretics
Type of Form Form-5
Pack Size & Demanded Price 1x10‟s;2x10‟s/ As per PRC
Approval status of product in Approved in ANSM
Me-too status Tramapar tablet of Efroze chemical
Brand Name+DosageForm+Strength Buprofam tablet 800 mg + 26.6 mg
Ibuprofen….800 mg
Famotidine ….. 26.6 mg
Pharmacological Group Ibuprofen
Analgesics; Anti-Inflammatory Drugs and Antipyretics
Famotidine
H2 receptor antagonists
Type of Form Form-5
Finished Product Specification Manufacturerspecifications
Pack Size & Demanded Price 1x10‟s;100‟s (Loose)/As per PRC
Me-too status Duexis Tablet by Horizon Pharma
Decision: Deferred for confirmation of (generic / me-too status) of applied formulation
Brand Name+DosageForm+Strength G-Faxin Tablet 320 mg
Gemifloxacin(as mesilate)… 320 mg
Type of Form Form-5
Finished Product Specification Fynk‟s Specifications
Pack Size & Demanded Price 1x7‟s/ As per PRC
Me-too status Gemwel 320mg tablet of welmarkpharmceuticals
Brand Name+DosageForm+Strength Quitapin tablet 100 mg
Quetiapine(as fumarate)… 100 mg
Pharmacological Group Anxiolytic Sedatives Hypnotics and Antipsychotics.
Type of Form Form-5
Finished Product Specification Manufacturer‟s specifications
Pack Size & Demanded Price 10‟s;30‟s/ As per PRC
Me-too status Ziapin 100mg tablet of English Pharma
Brand Name+DosageForm+Strength Faxmin Tablet 550 mg
Rifaximin… 550 mg
Pharmacological Group Antibacterial.
Type of Form Form-5
Finished Product Specification Manufacturer‟s Specification
Me-too status Nimixa 550 mg tablet by Getz Pharma
215. Name and address of Manufacturer / M/s AGP Ltd.( formerly AGP Health care) D-109
Applicant S.I.T.E, Karachi
Brand Name+DosageForm+Strength Steadier Capsule 300 mg
Composition Each capsule contains…
Cefdinir (as monohydrate)…. 300mg
Pharmacological Group Cephalosporin antibiotic
Type of Form Form-5
Finished Product Specification USP Specifications
Pack Size & Demanded Price 10‟s/ As per PRC
Approval status of product in Omnicef of USA
Reference Regulatory Authorities OmnicefUK
Me-too status Zaply capsule 300mg of Wilshire
GMP status GMP inspection conducted on 12-06-2017 of M/s. AGP
Pharmaceuticals rated good level of GMP compliance
Remarks of Evaluator Firm has applied for Cefdinir as monohydrate while in
reference agencies it is approved as Cefdinir only
Decision: Deferred for clarification of salt of API in comparison to reference product.
Brand Name+DosageForm+Strength Freglin Capsule 150 mg
Composition Each capsule contains…
Pregabalin…. 150 mg
Type of Form Form-5
Approval status of product in Approved in MHRA
Me-too status Gabica 150 mg Capsule by Getz Pharma
GMP status GMP inspection conducted on 03-05-2016 of M/s. Fynk
Pharmaceuticals shows that firm is complying most of
cGMP guidelines and exhibit positive approach towards
compliance.
217. Name and address of manufacturer / M/s Adamjee Pharmaceuticals (Pvt) Ltd, Plot 39, Sector
Applicant 15, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Lanza Capsule 10mg
Strength (Other proposed brand names: Zypine capsule, Lanzin
Capsule)
Olanzapine (as citrate)….10mg
Diary No. Date of R& I & fee Dy No.1205; 30-12-2015; Rs.20,000/-
Pharmacological Group Thienobenzodiazepine
Type of Form Form-5
Me-too status Olanziscot capsule 10mg of Scotmann Pharmaceuticals
(Reg.#028270)
GMP status GMP inspection conducted on 14-07-2017 rated GMP
compliance level as good.
Remarks of the Evaluator.  Evidence of international availability
 Firm has claimed USP specs and the product is
not present in USP.
Decision: Deferred for confirmation of approval of applied formulation in reference
regulatory authorities/agencies
218. Name and address of manufacturer M/s Adamjee Pharmaceuticals (Pvt) Ltd, Plot 39, Sector
/ Applicant 15, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Lanza Capsule 5mg
Strength (Other proposed brand names: Zypine capsule, Lanzin
Capsule)
Olanzapine (as citrate)….5mg
Pharmacological Group Thienobenzodiazepine
Type of Form Form-5
Me-too status Olanziscot capsule 5mg of Scotmann Pharmaceuticals
(Reg.#028269)
Remarks of the Evaluator.  Evidence of international availability
 Firm has claimed USP specs and the product is
not present in USP.
regulatory authorities/agencies
219. Name and address of manufacturer / M/s Adamjee Pharmaceuticals (Pvt) Ltd, Plot 39,
Applicant Sector 15, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Hapicit-E tablet 5mg
Composition Each film coated contains:
Escitalopram(as oxalate)….5mg
Pharmacological Group Selective Serotonin Reuptake Inhibitors
Type of Form Form-5
Me-too status Estar tablet 5mg of PharmEvo
Decision: Approved.
Brand Name +Dosage Form + Strength Hapicit-E tablet 20mg
Escitalopram(as oxalate)….20mg
Pharmacological Group Selective Serotonin Reuptake Inhibitors
Type of Form Form-5
Approval status of product in Approve in MHRA
Me-too status Estar tablet 20mg of PharmEvo
Decision: Approved.
Brand Name +Dosage Form + Strength Tiapin tablet 200mg
Quetiapine (as Fumerate)…200mg
Pharmacological Group Antipsychotic
Type of Form Form-5
Pack size & Demanded Price 3×10‟s; As per PRC
Me-too status Etal tablet 200mg of Shawan Pharmaceuticals
Decision: Approved.
Brand Name +Dosage Form + Strength Tweet capsule 6/50mg
Olanzapine (as citrate)…6mg
Fluoxetine(as hydrochloride)…50mg
(Other proposed brand names: Lanzac capsule, Cozac
Capsule)
Pharmacological Group Anti psychotic/SSRIs
Type of Form Form-5
Pack size & Demanded Price 2×7‟s; As per PRC
Me-too status Symbyax of Eli Lilly(not verified)
Remarks of Evalutor Evidence of me too
Decision: Deferred for confirmation of (generic / me-too status) of applied formulation and
clarification of salt form of olanzapine
223. Name and address of manufacturer / M/s Getz Pharma, 29-30/27, Korangi Industrial Area,
Applicant Karachi.
Contract manufactured by:M/s Pharma Health
Pakistan, 17km, Ferozepur Road, Lahore.
Brand Name +Dosage Form + Strength Dydro tablets 10mg
Dydrogesterone ….10mg
Pharmacological Group Pregnadien derivatives
Type of Form Form-5
Finished Product Specification BP Specifications
Pack size & Demanded Price 20‟s; Rs. 500/-(25/- per tablet)
Approval status of product in Approved in USFDA(but discontinued) however it is
Reference Regulatory Authorities. written that Federal Register determination that product
was not discontinued or withdrawn for safety or
efficacy reasons)
Me-too status Danilon tablet 10mg of samipharma
GMP status Latest GMP inspection report of 13-11-2016 with GMP
compliant status.
Decision: Deferred for further deliberation regarding isomeric form of Dydrogesterone
224. Name and address of manufacturer / M/s Barrett Hodgson Pakistan, F/423, S.I.T.E, Karachi.
Applicant
Brand Name +Dosage Form + Strength Barotrop capsule 18mcg DPI
Tiotropium (as bromide monohydrate)…18mcg
Pharmacological Group Long acting anti-muscarinic agent
Type of Form Form-5
Finished Product Specification Manufacturer Specifications
Pack size & Demanded Price 6‟s, 10‟s, 15‟s, 20‟s; Rs.120/-,250/-,375/-,500/-, or As
per PRC
Me-too status Tiovairrotacaps of Highnoon Laboratories.

Applicant
Brand Name +Dosage Form + Strength Barotrop-F capsule 18mcg DPI
Tiotropium (as bromide monohydrate)…18mcg
Formoterolfumerate (as dihydrate)….12mcg
Pharmacological Group Long acting anti-muscarinic agent/long acting selective
beta 2 adrenergic agonist
Type of Form Form-5
Pack size & Demanded Price 10‟s, 15‟s, 20‟s; Rs. 300/-,450/-,600/-, or As per PRC
Approval status of product in Not verifiable
Me-too status Tiovair-Frotacaps of Highnoon Laboratories
Applicant
Brand Name +Dosage Form + Strength Barinez 50mcg Nasal sprays
Composition Each spray contains:
Mometasonefuroate…50mcg
Type of Form Form-5
Pack size & Demanded Price 60 sprays, 120 sprays, 140 sprays; Rs. 300/-,600/-,700/-
, or As per PRC
Me-too status Rinelonof Schering plough
Decision: Deferred for clarification ofsalt form of API as reference product is available as
Mometasonefuroate (as monohydrate)
Applicant
Brand Name +Dosage Form + Strength Cefbeck Injection(IV/IM) 1g
Sterile Cephradine with (sterile L-Arginine)… 1g
Pharmacological Group First generation cephalosporin broad spectrum
antibiotics
Type of Form Form-5
Pack size & Demanded Price 1‟s; Rs.107.01/- or As per PRC
Approval status of product in Approved in USFDA(discontinued)
Me-too status Velosef of GSK.

Remarks of the Evaluator.  Approval status of product in Reference
Regulatory Authorities not confirmed.
Applicant
Brand Name +Dosage Form + Strength Cefbeck Injection(IV/IM) 500mg
Sterile Cephradine with (sterile L-Arginine)… 500mg
antibiotics
Type of Form Form-5
Me-too status Velosef of GSK
Applicant
Brand Name +Dosage Form + Strength Cefbeck Injection(IV/IM) 250mg
Sterile Cephradine with (sterile L-Arginine)… 250g
Diary No. Date of R& I & fee Dy No.1189 ; 28-12-2015; Rs.20,000/-
antibiotics
Type of Form Form-5
230. Name and address of manufacturer / M/s Avant Pharmaceutical (Previously Umema
Applicant Pharmaceuticals) Plot No. M 28 Hub Industrial Estate,
Balochistan.
Contract Manufactured by:M/s Mediate
Pharmaceuticals Plot150-151, Sector 24, Korangi
Industrial
Area, Karachi
Brand Name +Dosage Form + Strength Utriaxone Injection 1g IV
Ceftriaxone (as sodium)…..1g
Type of Form Form-5
Approval status of product in Rocephin 1 g of Roche Products Ltd. UK (MHRA)
Me-too status Rocephin 1 g I.V by Roche (Pak) Ltd.
GMP status
Remarks of the Evaluator.  13% overage in master formulation.
 Firm will deliver 5ml wfi.but in MHRA it should be
10ml
 Justification on scientific basis for addition of 13% overage of API in master
formulation.
 Clarification of instructions for reconstitution of injection in comparison to
reference product.
Balochistan.
Pharmaceuticals Plot 150-151, sector 24, Korangi
Industrial area, Karachi
Brand Name +Dosage Form + Strength Utriaxone Injection 500mg IV
Ceftriaxone (as sodium)…..500mg
Type of Form Form-5
Approval status of product in Rocephin 500 mg of Roche Products Ltd. UK (MHRA)
Me-too status Signum 500mg Injection IV of Cherwel
pharmaceuticals.
GMP status
Remarks of the Evaluator.  13% overage in master formulation.
Decision: Deferred for justification on scientific basis for addition of 13% overage of API in
master formulation.
Balochistan.
Brand Name +Dosage Form + Strength U-Span Capsule 400mg
Cefixime(astrihydrate)…..400mg
Type of Form Form-5
Approval status of product in Suprax 400 mg of Lupin Ltd. USA (USFDA)
Me-too status Obpan 400mg capsules of Obsonspharma
GMP status
Remarks of the Evaluator.  Firm has claimed manufacturer specifications
but has not submitted the data as required by
the decision of 267th meeting and applied
formulation is not present in available USP and
B.P
 Incorrect master formulation.
Decision: Deferred for submission of correct master formulation
Applicant Pharmaceuticals) Plot No.M 28 Hub Industrial Estate,
Balochistan.
Brand Name +Dosage Form + Strength U-Span Dry Suspension 100mg/5ml
Cefixime(as trihydrate)…100mg
Type of Form Form-5
Pack size & Demanded Price 1‟s of 30ml; As per PRC
Approval status of product in USFDA approved.
Me-too status CEFSPAN by Barrett Hodgson Pakistan (Pvt) ltd.
GMP status
Remarks of the Evaluator.  Incorrect master formulation.
 Manufacturing method is of injection instead
of suspension.
Decision: Deferred for submission of following:
 Correct master formulation
 Manufacturing method for applied product.
Balochistan.
Brand Name +Dosage Form + Strength U-Span Dry Suspension 200mg/5ml
Cefixime(as trihydrate)…200mg
Type of Form Form-5
Pack size & Demanded Price 1‟s of 30ml; As per PRC
Approval status of product in USFDA approved.
Me-too status CEFSPAN by Barrett Hodgson Pakistan (Pvt) ltd.
GMP status
Remarks of the Evaluator.  Incorrect master formulation.
 Manufacturing method is of injection instead
of suspension.
 Correct master formulation
 Manufacturing method for applied product.
235. Name and address of manufacturer / M/s Rasco Pharma 5.5km Raiwind Road Lahore
Applicant
Brand Name +Dosage Form + Strength Rotol Forte Tablet.
Paracetamol ….650mg
Orphenadine citrate…50mg
Pharmacological Group Antipyretic/analgesic
Central anticholinergic
Type of Form Form-5
Pack size & Demanded Price 3×5 tablets; As per PRC
Approval status of product in Not verified.
Me-too status Samerol-N forte by M/s Sami Pharmaceuticals
GMP status
Remarks of the Evaluator. Evidence of international availability.

Evaluator PEC-V
236. Name and address of manufacturer / M/s. Winthrox Laboratories Plot # K-219-A, SITE,
Applicant Super Highway Phase II, Karachi
Brand Name +Dosage Form + Lotinol Eye Drops 5mg/ ml
Strength
Diary No. Date of R& I & fee Diary No: 522, 17/11/2016 , Rs. 20,000/-
Composition Each ml of ophthalmic suspension contains:
Loteprednol Etabonate…5mg
Type of Form Form-5
Finished Product Specification Mfg.
Me-too status Lotepred Forte eye drops by M/s. Elko Organization Pvt
Ltd, Karachi.
GMP status 14-9-2017 / Routine GMP Inspection
Good Compliance.
Remarks of Evaluator DOSAGE AND ADMINISTRATION:
Shake Vigorously Before Using.
Brand Name +Dosage Form + Lotinol-T Eye Drops 5mg/3mg per ml
Strength
Diary No. Date of R& I & fee Diary No: 511 , 17/11/2016 , Rs. 20,000/-
Composition Each ml of ophthalmic suspension contains:
Loteprednol Etabonate…5mg
Tobramycin…3mg
Pharmacological Group Corticosteroid+ Antibiotic
Type of Form Form-5
Me-too status Lotepred-T eye drops by M/s. Elko Organization Pvt
Ltd, Karachi.
Good Compliance.
Remarks of Evaluator DOSAGE AND ADMINISTRATION:
Shake Vigorously Before Using.
Brand Name +Dosage Form + Wapival Syrup 250mg/5ml
Strength

Sodium Valproate eq. to Valproic Acid…250mg
Type of Form Form-5
Finished Product Specification USP specifications
Pack size & Demanded Price As per SRO / 120ml

Me-too status Epival by M/s. Abbott Laboratories, Karachi.
Good Compliance.
Remarks of Evaluator Approved in USFDA with box warning.
Warning: Life Threatening Adverse Reactions
Decision: Approved with box warning.
Brand Name +Dosage Form + Winkidofen Ds Suspension 200mg/5ml
Strength
Ibuprofen…200mg
Type of Form Form-5
Pack size & Demanded Price As per SRO / Pack size As per SRO
Me-too status Brufen Suspension 200mg/5ml by M/s. Abbott
LABORATORIES, Karachi.
Good Compliance.
Decision: Approved
Brand Name +Dosage Form + Mebawin Capsules 200mg
Strength
Diary No. Date of R& I & fee Diary No: 520 ,17/11/2016 Rs.20,000/-
Mebeverine as HCl (prolong release pellets)…200mg
Pharmacological Group Antispasmodic
Type of Form Form-5
Pack size & Demanded Price As per SRO / 10‟s
Approval status of product in MHRA Approved
Me-too status Mebever MR by M/s. Getz Pharmaceuticals, Karachi.
Good Compliance.
241. Name and address of manufacturer / M/s. Winthrox Laboratories
Applicant Plot # K-219-A, SITE, Super Highway Phase II,
Karachi
Brand Name +Dosage Form + MuscowinCapsules 4mg
Strength
Thiocolchicoside…4mg
Pharmacological Group Muscle Relaxant
Type of Form Form-5

Approval status of product in ANSM approved
Me-too status Muscodid Capsule 4mg by M/s. Regal.
GMP status 14-9-2017/ Routine GMP Inspection; Good
Compliance.
Brand Name +Dosage Form + Wincy SR Capsules 200mg
Strength
Diary No. Date of R& I & fee Diary No: 524,17/11/2016 ,Rs.20,000/-
Aceclofenac (pellets)…200mg
Type of Form Form-5
Approval status of product in Acec SR 200mg Capsule. CANADA (Not Confirmed)
Me-too status Aceclo by M/s Maple
Good Compliance.
Remarks of Evaluator International availability could not be confirmed.
Firm has requested to consider their application of
Aceclofenac 100 mg tablets as the above applied
formulation of Aceclofenac 200mg capsules is not
approved by any reference regulatory authority.
Firm has submitted Form 5 for Aceclofenac 100mg
tablets along with fee of Rs. 20,000/- details of which
are as under.
Name and address of manufacturer / M/s. Winthrox Laboratories Plot # K-219-A, SITE,
Brand Name +Dosage Form + Aceclowin100mg tablets
Strength
Diary No. Date of R& I & fee Rs.20,000/- (10-10-2017)
Aceclofenac..…..100mg
Type of Form Form-5
Pack size & Demanded Price As per DRAP policy
Me-too status Acfonac 100mg Tablets by M/s Medicraft
Pharmaceuticals (Pvt) Ltd., (Reg.#081743)
Good Compliance.
Remarks of Evaluator Alternate brand names :
 Wincy tablet
 Acecol tablet
 Aclo tablet.
Decision: Registration Board acceded with firm’s request and approved the application of
Aceclowin100mg tablets (Aceclofenac 100 mg) & the application of Wincy SR Capsules
200mg (Aceclofenac 200 mg) is declared as disposed off.

Brand Name +Dosage Form + Flupine Capsules 6mg/25mg
Strength
Olanzapine…6mg
Fluoxetine HCl..25mg
Pharmacological Group Antipsychotic + SSRI
Type of Form Form-5
Me-too status Co-Depricap by M/s. Nabiqasim Industries, Karachi
Good Compliance..
Warnings: Suicidal Thoughts And Behaviors; and
Increased Mortality in Elderly Patients with
Dementia-Related Psychosis
Decision: Approved with Box warning.
Brand Name +Dosage Form + Flupine Capsules 3mg/25mg
Strength
Diary No. Date of R& I & fee Diary No: 515, 17/11/2016, Rs.20,000/-
Olanzapine…3mg
Fluoxetine HCl…..25mg
Pharmacological Group Antipsychotic + SSRI
Type of Form Form-5
Me-too status Co-Depricap Capsule by M/s Nabiqasim
Good Compliance.
Warnings: Suicidal Thoughts And Behaviors; and
Increased Mortality In Elderly Patients with
Dementia-Related Psychosis

245. Name And Address Of Manufacturer / M/S. Winthrox Laboratories Plot # K-219-A, Site,
Applicant Super Highway Phase Ii, Karachi
Brand Name +Dosage Form + Prejab Capsules 50mg
Strength
Diary No. Date of R& I & fee Diary No: 863 ,21/11/2016 ,Rs. 20,000/-
Pregabalin…50mg
Pharmacological Group Anticonvulsant / Anti-epileptic
Type of Form Form-5

Me-too status Gabica By M/S. Getz Pharmaceuticals, Karachi.
Good Compliance.
Brand Name +Dosage Form + Paroxil Tablet 20mg
Strength
Composition Each film coated Tablet contains:
Paroxetine as HCl…20mg
Pharmacological Group SSRI / Antidepressant
Type of Form Form-5
Me-too status Paroxin by M/s. Amarant Pharma, Karachi.
GMP status 14-9-2017
Routine GMP Inspection
Good Compliance.
Suicidality and Antidepressant Drugs
Decision: Approved with Box warning

Brand Name +Dosage Form + Paroxil CR Tablet 25mg
Strength
Composition Each enteric coated controlled release tablet contains:
Paroxetine as HCl…25mg
Type of Form Form-5
Me-too status Paroxin CR Tablet by M/s. Amarant Pharma, Karachi.
Good Compliance.

Brand Name +Dosage Form + Paroxil CR Tablet 12.5mg
Strength
Paroxetine as HCl …12.5mg
Type of Form Form-5
Me-too status Paroxin CR 12.5mg Tablet by M/s. Amarant Pharma,
Karachi.
Good Compliance.

Brand Name +Dosage Form + Wintek Tablet 250mg
Strength
Diary No. Date of R& I & fee Diary No: 513, 17/11/2016, Rs 20,000
Clarithromycin…250mg
Pharmacological Group Macrolide Antibiotic
Type of Form Form-5
Me-too status Claritek by M/s. Getz Pharmaceuticals, Karachi.
Good Compliance.
Decision: Approved.
Brand Name +Dosage Form + Wintek Tablet 500mg
Strength
Diary No. Date of R& I & fee Diary No: 514, 17/11/2016, Rs 20,000
Clarithromycin…500mg
Type of Form Form-5
Me-too status Claritek by M/s. Getz Pharmaceuticals, Karachi.
Good Compliance.
Decision: Approved.
Brand Name +Dosage Form + Zurich Tablet 80mg
Strength
Febuxostat…80mg
Pharmacological Group Xanthine Oxidase Inhibitor/ Antigout
Type of Form Form-5
Pack size & Demanded Price As per SRO / Pack size as per SRO
Me-too status Zurig 80mg Tablet by M/s. Getz Pharmaceuticals,
Karachi.
GMP status 14-9-2017/Routine GMP Inspection
Good Compliance.
Decision: Approved as pe innovator’s specifications

Brand Name +Dosage Form + Womic-D Tablet 830mg+400IU
Strength
Composition Each Tablet contains:
Ossein MineralComplex…830mg
Vitamin D………………..400 I.U
Pharmacological Group Mineral + Vitamin
Type of Form Form-5
Pack size & Demanded Price As per SRO / Pack size as per SRO
Approval status of product in Wellese Calcium and Vitamin D3 Tablet by Botanical
Reference Regulatory Authorities. Laboratories, USA.
Me-too status Bonmin Tablet by M/s. S J & G Fazal Elahi Pvt Ltd,
Karachi.
Good Compliance.
Remarks of Evaluator Evidence of international availability provided by firm
could not be confirmed in reference regulatory
authority.
 Evidence of approval in reference regulatory authorities.
 Evidence of availability of atomic absorption spectrophotometer
253. Name and address of manufacturer / M/s Semos Pharmaceuticals Pvt. Ltd; Plot No
Applicant 11,Sector 12-A NorthKarachi Industrial Area
Brand Name +Dosage Form + Cefdim Injection 250mg IM/IV
Strength
Ceftazidime as pentahydrate ….250mg
Diary No. Date of R& I & fee Dy. No. 1396, 30-9-2016 , Rs.20,000/- (30-9-2016)
Type of Form Form-5
Pack size & Demanded Price Glass vial, Rs. 150.00/-vial
Me-too status Cefcom by Barrett Hodgson Pharmaceutical
GMP status 15-12-17, Good
Remarks of the Evaluator.  Required section is present.
Decision: Approved
254. Name and address of manufacturer / M/s. Bosch Pharmaceuticals, Manufacturers of
Applicant Pharmaceuticals Specialties, 209, Sector 23,
KorangiIndustrial Area, Karachi
Brand Name +Dosage Form + Lignocaine Solution 1 %
Strength
Composition Each 3.5ml ampoule contains:
Lignocaine Hydrochloride….35mg
Pharmacological Group Local Anesthetic
Type of Form Form-5
Pack size & Demanded Price 3.5ml Ampoule, Free of Cost
Approval status of product in Pfizer Australia
Me-too status Lignocaine HCl by Linza Pharma
GMP status 20-03-2017, Acceptable level of compliance
Remarks of the Evaluator.  Provided international availability and in 3.5ml
pack size could not be confirmed.
Decision: Deferred for evidence of applied formulation in 3.5 ml filled volume in reference
regulatory authorities.

255. Name and address of manufacturer / M/s. Bosch Pharmaceuticals, Manufacturers of
Applicant Pharmaceuticals Specialties, 209, Sector 23, Korangi
Industrial Area, Karachi
Brand Name +Dosage Form + Lignocaine Solution 1 %
Strength
Composition Each 2ml ampoule contains:
Lignocaine Hydrochloride….20mg
Pharmacological Group Local Anesthetic
Type of Form Form-5
Pack size & Demanded Price 2ml Ampoule, Free of Cost
Approval status of product in TGA approved
Me-too status Lignocaine HCl by Linza Pharma
GMP status 20-03-2017, Acceptable level of compliance
Decision: Approved
256. Name and address of manufacturer / M/s. Pharmevo Limited, Plot A-29, North
Applicant WesternIndustrial Zone, Port Qasim , Karachi
Brand Name +Dosage Form + Iprol Tablet 2.5mg
Strength
Bisoprolol Fumarate…..2.5mg
Pharmacological Group Antihypertensive
Type of Form Form-5
Me-too status Beslol by Searle
GMP status Last inspection conducted on 27.01.17 and report
concludes that overall compliance status is found
competing well within prevailing bracket of acceptable
compliance level.
Decision: Approved
257. Name and address of manufacturer / M/s. Pharmevo Limited, Plot A-29, North Western
Applicant Industrial Zone, Port Qasim , Karachi
Brand Name +Dosage Form + Iprol Tablet 5mg
Strength
Bisoprolol Fumarate…..5mg
Type of Form Form-5
compliance level.
Decision: Approved

258. Name and address of manufacturer / M/s. Pharmevo Limited, Plot A-29, North Western
Applicant Industrial Zone, Port Qasim , Karachi
Brand Name +Dosage Form + Iprol Tablet 10mg
Strength
Bisoprolol Fumarate…..10mg
Type of Form Form-5
compliance level.
Decision: Approved
259. Name and address of manufacturer / M/s. Mediate Pharmaceuticals, 150-151, Sector
Applicant 24,Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Medisonate Injection 120mg
Strength
Composition Each vial contains
Artesunate …120mg
Pharmacological Group Antiprotozoal, Antimalarial
Type of Form Form-5
Finished product Specification International Pharmacopoeia
Approval status of product in WHO recommended formulation
Me-too status Gen-M by Genix pharma
GMP status 08-06-2017, The firm has demonstrated both the drive
and ability to implement appropriate corrective actions.
It is further concluded that the central goal of a quality
system should be the consistent production of safe and
effective products and ensuring that the activities are
sustainable.
Decision: Approved
Brand Name +Dosage Form + Medisonate Injection 30mg
Strength
Artesunate …30mg
Pharmacological Group Antiprotozoal, Antimalarial
Type of Form Form-5
Me-too status Gen-M by Genix pharma
sustainable.
Decision: Approved.
Brand Name +Dosage Form + CT Med Injection IM/IV 250mg/2ml
Strength
Composition Each 2 ml ampoule contains:
Citicoline Sodium eq. to citicoline ….250mg
Pharmacological Group Nootropics & Neurotonic.
Type of Form Form-5
Finished product Specification Not provided
Pack size & Demanded Price Rs. 275/unit
Approval status of product in ANSM Approved
Me-too status CT-Nol 250mg Injection M/s Uni-Tiech
Pharmaceutials, Karachi (Reg.#047049)
sustainable.
Brand Name +Dosage Form + CT Med Injection IM/IV 1g/4ml
Strength
Citicoline Sodium eq. to citicoline 1g
Pharmacological Group Nootropics & Neurotonic.
Type of Form Form-5
Finished product Specification Not provided
Pack size & Demanded Price Rs. 345/unit
Approval status of product in Spain
Me-too status Neurotec by Schazoo
sustainable.
Decision: Approved with innovator specifications.

Brand Name +Dosage Form + Strength Osin D Tablet
Ossein Mineral Complex…… 830mg
Vitamin D…..400IU
Equivalent to:
Calcium…177.6mg*
Phosphorus….82.2mg
Residual Mineral Salt…24.9mg
Collagen….224mg
Other Protein…66.4mg
(Fi, Mg, Fe, Zn, Cu, Ni)
*Corresponding to approximately 440mg
Hydroxyapatite
Pharmacological Group Minerals and Electrolytes
Type of Form Form-5
Finished product Specification Manufacturer
Approval status of product in Wellesse Calcium & Vitamin D3 Suspension, US
Me-too status Osam D by Getz Pharmaceuticals
and ability to implement appropriate corrective
actions. It is further concluded that the central goal of
a quality system should be the consistent production
of safe and effective products and ensuring that the
activities are sustainable.
Remarks of the Evaluator.  International availability could not be confirmed.
 Evidence of presence of Atomic Absorption
Spectrophotometer could not be confirmed.
264. Name and address of manufacturer / M/s. Mediate Pharmaceuticals, 150-151, Sector 24,
Applicant Korangi Industrial Area, Karachi
Brand Name +Dosage Form + Strength Osin D Suspension
Ossein Hydroxyapatite Compound (Anhydrous)
….400mg
Equivalent to :
Calcium…85.59mg
Phosphorus….39.61mg
Residual Mineral Salt…12mg
Collagen….107.95mg
Other Protein…32mg
Vitamin D..400IU
(Fi, Mg, Fe, Zn, Cu, Ni)
Pharmacological Group Minerals and Electrolytes
Type of Form Form-5
Pack size & Demanded Price 120 ml Glass Bottle, As per SRO
Approval status of product in Wellesse Calcium & Vitamin D3 Suspension, US
Me-too status Osnate D Suspension by AGP Pharmaceuticals
and ability to implement appropriate corrective
actions. It is further concluded that the central goal of
a quality system should be the consistent production
of safe and effective products and ensuring that the
activities are sustainable.
Remarks of the Evaluator.  International availability could not be
confirmed.
 Evidence of presence of Atomic Absorption
Spectrophotometer could not be confirmed.
 Alternative coloring agent should be used as
tartarzine is not recommended.
265. Name and address of manufacturer / M/s. Reign Pharmaceuticals, TBIC Building –I,
Applicant PCSIR Laboratories Complex, Shahrah-E-Dr.
Salimuz Zaman Siddiqui Road, Off University Road,
Karachi
Brand Name +Dosage Form + Strength Renmont Sachet 4mg
Composition Each sachet contains:
Montelukast Sodium eq. to Montelukast …4mg
Diary No. Date of R& I & fee 163, 8-11-16, Rs. 20,000/-
Pharmacological Group Bronchodilator
Type of Form Form 5
Me-too status Montika by Sami
GMP status Last inspection report 27-1-2017 overall GMP
compliance level is rated as good.
Remarks of the Evaluator. Sachet section is present.
Decision: Approved
Applicant PCSIR Laboratories Complex, Shahrah-E-Dr. Salim
uz Zaman Siddiqui Road, Off University Road,
Karachi
Brand Name +Dosage Form + Strength Renmont Tablet 5mg
Composition Each chewable tablet contains:
Montelukast Sodium eq. to Montelukast …5mg
Pharmacological Group Bronchodilator
Type of Form Form 5
Me-too status Montekast 5mg Tablets of M/s Legacy
Pharmaceuticals (Pvt) Ltd. (Reg.# 069785)
Decision: Approved.
Karachi
Brand Name +Dosage Form + Strength Folic acid Tablet 5mg
Folic Acid…5mg
Pharmacological Group erythropoitics
Type of Form Form 5
Approval status of product in Apo Folic Acid Tab 5mg By Apotex Inc
Reference Regulatory Authorities. Health Canada Approved
Me-too status Foly by Pride
Decision: Approved
Karachi
Brand Name +Dosage Form + Strength Renzith Tablet 500mg
Azithromycin as dihydrate…..500mg
Type of Form Form 5
Me-too status Azomax tablets by Novartis
Decision: Approved
Applicant PCSIR Laboratories Complex, Shahrah-E-Dr. Salimuz
Zaman Siddiqui Road, Off University Road, Karachi
Brand Name +Dosage Form + Strength Renzith Tablet 250mg
Azithromycin as dihydrate…..250mg
Type of Form Form 5
Me-too status Azomax tablets by Novartis
Decision: Approved
Applicant PCSIR Laboratories Complex, Shahrah-E-Dr.
Salimuz Zaman Siddiqui Road, Off University Road,
Karachi
Brand Name +Dosage Form + Strength Rentanic Tablet 150mg+0.5mg
Ferrous Fumarate…150mg
Folic Acid….0.5mg
Type of Form Form 5
Finished product Specifications USP (Not present in USP)
Approval status of product in N/A
Me-too status U-Fol by Healer
Decision: Registration Board approved as innovator’s specification.
271. Name and address of manufacturer / M/s. Winbrains Research Laboratories, Plot No. 69/1,
Applicant Block B, Phase I & II, Industrial Estate , Hattar
Brand Name +Dosage Form + Strength Fexobrain Film Coated Tablets 120mg
Fexofenadine HCl….120mg
Diary No. Date of R& I & fee Dy. No. 437, 24-08-2015 , Request for Fee adjustment
of Rs. 150,000/- extra paid due to not conveying
contract extension decision of our contract products.
Pharmacological Group H1 Receptor Antagonist
Type of Form Form-5
Pack size & Demanded Price 1x10‟s, Alu-Alu Blister, As per SRO
Me-too status Fexo by Hilton Pharma
GMP status Last inspection conducted on 03-02-2017, “DML
Renewal and grant of additional section”.
Remarks of the Evaluator. Evidence of fee adjustment not provided by the firm.
Decision: Deferred for evidence of fee adjustment.
272. Name and address of manufacturer / M/s. Pakistan Pharmaceutical Products Pvt.
Applicant LTD, D-122, S.I.T.E, Karachi
Brand Name +Dosage Form + Strength Cinnie Tablets 1mg
Cinitapride…1mg
Diary No. Date of R& I & fee Dy. No. , 745,4-05-2016 , Rs.20,000/- (28-04-2016)
Pharmacological Group Gastroprokinetic, Anti-ulcer agent
Type of Form Form-5
Approval status of product in Cidine (Spain)
Me-too status Sitip by Sami
GMP status 1-08-2017, During the inspection some critical /major
and other observations were also noted which need to
be addressed promptly for attaining a better level of
compliance and for product safety.
Remarks of the Evaluator.  International availability couldn‟t be confirmed.
 Not in USFDA, ANSM, Health Canada, MHRA,
PMDA, Germany, EMA, TGA,
Decision:
 Updated GMP status by QA&LT Division as GMP inspection report dated 1-8-
2017 highlighted critical /major and other observations.
 Also evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board shall be
submitted.
273. Name and address of manufacturer / M/s. Scilife Pharma Pvt. Ltd. Plot FD-57/58-
Applicant A2,Korangi Creek Industrial Park, Karachi
Brand Name +Dosage Form + Strength Trezo Tablet 500mg
Azithromycin (as dihydrate)….500mg
Pharmacological Group Semi synthetic Antibiotic
Type of Form Form-5
Me-too status Biozith Tablets by M/s. Bio Labs (Pvt) Ltd, (Reg. No.
069912)
GMP status 30-12-2016,Acceptable
Decision: Approved
274. Name and address of manufacturer / M/s. Scilife Pharma Pvt. Ltd. Plot FD-57/58-A2,
Applicant Korangi Creek Industrial Park, Karachi
Brand Name +Dosage Form + Strength Trezo Tablet 250mg
Azithromycin (as dihydrtae)….250mg
Pharmacological Group Semi synthetic Antibiotic
Type of Form Form-5
Me-too status Aziomak Tablets 250 mg by M/s. Makson
Pharmaceuticals. (Reg. No. 070015)
Decision: Approved
Brand Name +Dosage Form + Strength Tenovir Tablet 300mg
Tenofovir Disoproxil (as fumarate)….300mg
Pharmacological Group Nucleoside Reverse Transcriptase Inhibitor
Type of Form Form-5
Me-too status Hilten 300mg Tablet of M/s Hilton Karachi. (Reg.#
073735)
Remarks of the Evaluator. Approved in USFDA with box warning.
Warnings: Lactic Acidosis/Severe Hepatomegaly
with Steatosis and Post Treatment Exacerbation of
Hepatitis

Brand Name +Dosage Form + Strength V- Pride M SR Tablet 1/500mg
Composition Each bilayered tablet contains:
Glimepiride….1mg
Metformin HCl….500mg (as sustained release)
Pharmacological Group Anti-Diabetic
Type of Form Form-5
Approval status of product in Not found
Me-too status Not found
Decision: Deferred forconfirmation of approval status of formulation in reference
regulatory authorities and its generic / me-too status.
Brand Name +Dosage Form + Strength V- Pride M SR Tablet 2/500mg
Composition Each bilayered tablet contains:
Glimepiride….2mg
Metformin HCl….500mg (as sustained release)
Pharmacological Group Anti-Diabetic
Type of Form Form-5
Approval status of product in Not found
Me-too status Not found
Decision: Deferred for confirmation of approval status of formulation in reference
Brand Name +Dosage Form + Strength Co-Amstan Tablet 5/80/12.5mg
Amlodipine as besylate…5mg
Valsartan… 80mg
Hydrochlorothiazide……12.5mg
Pharmacological Group Anti-Hypertensive
Type of Form Form-5
Pack size & Demanded Price 14‟s,28‟s As per SRO
Approval status of product in Not found in this strength
Me-too status Lodis HCT by Tabros
Remarks of the Evaluator. International availability and Me too in above strength
could not be found.
Decision: Deferred for confirmation of approval status of formulation in reference

Brand Name +Dosage Form + Strength Scitin Tablet 24mg
Betahistine Dihydrochloride….24mg
Pharmacological Group Anti-Vertigo
Type of Form Form-5
Pack size & Demanded Price 14‟s,28‟s As per SRO
Approval status of product in MHRA approved
Me-too status Serc by Abott
280. Name and address of manufacturer / M/s. Martin Dow Ltd, Plot 37, Sector 19, Korangi
Applicant Industrial Area, Karachi
Brand Name +Dosage Form + Strength Selocure Tablets 5mg
Sodium Picosulfate Monohydrate eq. to Sodium
Picosulfate …5mg
Pharmacological Group Stimulant laxative
Type of Form Form-5
Pack size & Demanded Price 30‟s,60‟s, 100‟s, As per brand leader
Approval status of product in Could not be confirmed.
Me-too status U-Salax by Usawa (Reg. 075548)
GMP status 7-06-2017, 8-06-2017, Good level of compliance
281. Name and address of manufacturer / M/s. Martin Dow Limited, Plot 37, Sector 19, Korangi
Applicant Industrial Area, Karachi
Brand Name +Dosage Form + Strength Selocure Liquid 5mg/5ml
Sodium Picosulfate….. 5mg
Pharmacological Group Stimulant laxative
Type of Form Form-5
Pack size & Demanded Price 60ml, 120ml, Bottle As per brand leader
Me-too status Skilax by Highnoon Pharma
GMP status 7-06-2017, 8-06-2017, Good level of compliance
Decision: Approved
282. Name and address of manufacturer / M/s. Atco Laboratories Ltd, B-18, S.I.T.E, Karachi
Applicant
Brand Name +Dosage Form + Strength Brimo Opthalmic Solution 0.2% w/v
Brimonidine tartrate….2mg/ml
Pharmacological Group Antiglaucoma
Type of Form Form-5
Pack size & Demanded Price 5ml/ Rs. 625/-10ml/ Rs. 1250/-
15ml/ Rs. 1875/-
Me-too status Alphagon by Barrett Hodgson
GMP status 21-7-17, Good level; of compliance
Remarks of the Evaluator. Section is available
283. Name and address of manufacturer / M/s. Sami Pharmaceuticals, F-95, Block 6, P.E.C.H.S,
Applicant Karachi
Brand Name +Dosage Form + Strength Sevia-H Tablets 160mg+12.5mg
Valsartan…160mg
Hydrochlorothiazide…..12.5mg
Pharmacological Group Angiotensin II Receptor Antagonist in combination
with thiazide diuretic
Type of Form Form-5
Me-too status Vasatan by Medicraft
GMP status 04-05-2017,Good
Warning: Avoid Use In Pregnancy
Applicant Karachi
Brand Name +Dosage Form + Strength Glymo XR Tablets 750mg
Metformin HCl….750mg.
Pharmacological Group Biguanide
Type of Form Form-5
Me-too status Glucophage by Merck
Decision: Approved.
Applicant Karachi
Brand Name +Dosage Form + Strength Zoldro Solution of Infusion 5mg/100ml
Zoldronic acid Monohydrate eq. to Zoledronic
acid….5mg
Pharmacological Group Bisphosphonates
Type of Form Form-5
Pack size & Demanded Price 100ml glass vial, As per SRO
Me-too status Zoldric by Searle
Remarks of the Evaluator.  Firm was asked to clarify the use of activated
charcoal in infusion.
The firm provided the following clarification.
“Activated charcoal is used as a decolorizing agent in
infusion.”
 Shelf life Unopened bottle: 2 years After
opening: 24 hours at 2°C - 8°C.
 Large volume parenteral section present
confirmed from FID GMP inspection report.
286. Name and address of manufacturer / M/s. Barrett Hodgson Pakistan, F/423, SITE,
Applicant Karachi
Brand Name+Dosage Form+Strength Barresten Cream 1 %
Composition Each g contains:
Clotrimazole….10mg
Diary No. Date of R& I & fee Dy. 1242, 28-11-2016 , Rs.20,000/- (24-11-2016)
Pharmacological Group Azole Antifungal
Type of Form Form-5
Pack size & Demanded Price 10g/Rs. 75.0/-, 20g/Rs. 140.00/-
Approval status of product in USFDA approved
Me-too status Canesten Topical, by Bayer Health Care
GMP status 8-8-17, Satisfactory
Decision: Approved.
287. Name and address of manufacturer / M/s. Barrett Hodgson Pakistan, F/423, SITE, Karachi
Applicant
Brand Name +Dosage Form + Barresten Vaginal Cream 2 %
Strength
Type of Form Form-5
Pack size & Demanded Price 20g/Rs. 150.0/-, 35g/Rs. 250.00/-
Me-too status Clotrinor by Nortech
Decision: Approved.
Applicant
Brand Name +Dosage Form + Barresten Vaginal Cream 10 %
Strength
Type of Form Form-5
Pack size & Demanded Price 5g/Rs. 200.0/-
Me-too status Clotrinor by Nortech
Decision:Approved.
Applicant Karachi
Brand Name +Dosage Form + Barimove Capsules 50mg
Strength
Diacerin…….50mg
Diary No. Date of R& I & fee Dy. No. 1356, 28-11-2016 , Rs. 20,000/-
Pharmacological Group Anti-Inflammatory
Type of Form Form-5
Pack size & Demanded Price 10‟s/Rs. 400.0/-, 30‟s/1200/-
Approval status of product in Austria, Spain, Czech Republic, Slovenia
Me-too status Omefast of M/s Efroz Pharmaceuticals,
Karachi (Reg.# 058506)
Applicant
Brand Name +Dosage Form + Nitabar Suspension 100mg/5ml
Strength
Composition Each 5ml of suspension contains:
Nitazoxanide…100mg
Pharmacological Group Anti-Infective, Antiprotozoal
Type of Form Form-5
Finished product Specification
Pack size & Demanded Price 30ml/Rs. 100.0/-, 60ml/Rs. 180/-
Me-too status NT-Tox by Genix
Applicant Karachi
Brand Name +Dosage Form + Acicon Plus Chewable Tablet
Strength
Composition Each chewable tablet contain:
Famotidine….10mg
Magnesium Hydroxide….165mg
Calcium Carbonate……800mg
Pharmacological Group H2 Antagonist/Antacid
Type of Form Form-5
Finished product Specification Mfg.
Pack size & Demanded Price 6‟s/Rs. 90.0/-, 12‟s/Rs. 180/-
Me-too status Famcet DA by Freinds
Applicant Karachi
Brand Name +Dosage Form + Seradep Oral Drops 20mg/ml
Strength
Escitalopram oxalate eq. to Escitalopram…20mg
Diary No. Date of R& I & fee Dy. No.1244, 28-11-2016 , Rs.20,000/- (23-11-2016)
Pharmacological Group Antidepressent/SSRI
Type of Form Form-5
Pack size & Demanded Price 15ml/Rs. 390.0/-
20ml/Rs. 520.00/-
30ml/Rs. 780.00/-
Me-too status Cipralex by Lundbeck
Decision: Approved
Applicant Karachi
Brand Name +Dosage Form + Seradep Tablet 20mg
Strength
Escitalopram oxalate eq. to Escitalopram…20mg
Diary No. Date of R& I & fee Dy. No.1246, 28-11-2016 , Rs.20,000/- (23-11-2016)
Pharmacological Group Antidepressent/SSRI
Type of Form Form-5
Pack size & Demanded Price 10‟s/Rs. 450.0/-; 14‟s/Rs. 630.00/-
20‟s/Rs. 900.00/-; 28‟s/Rs. 1260.00/-
30‟s/Rs. 1350.00/-
Me-too status Cipralex by Lundbeck
Decision: Approved
Applicant Karachi
Brand Name +Dosage Form + Febugout Tablet 40mg
Strength
Febuxostat…..40mg
Diary No. Date of R& I & fee Dy. No.104, 27-10-2016 , Rs. 20,000/-
Pharmacological Group Inhibitor of xanthine oxidase
Type of Form Form-5
Pack size & Demanded Price 20‟s/Rs. 594.00/-30‟s/Rs. 804.00/-
Applicant
Strength
Febuxostat…..80mg
Type of Form Form-5
Pack size & Demanded Price 20‟s/Rs. 900.00/-30‟s/Rs. 1240.00/-
Me-too status Zurig 80mg Tablet by M/s Getz Pharma, Karchi
Applicant
Strength
Febuxostat…..120mg
Type of Form Form-5
Me-too status Gouric by Pharmevo
Applicant
Brand Name +Dosage Form + Valbar Tablet 40mg
Strength
Valsartan…..40mg
Diary No. Date of R& I & fee Dy. No.688, 18-11-2016 , Rs. 20,000/-,18-11-2016
Pharmacological Group Angiotensin II Receptor Antagonist
Type of Form Form-5
Pack size & Demanded Price 10‟s/Rs. 180.00/-; 14‟s/Rs. 252.00/
20‟s/Rs. 360.00/-; 28‟s/Rs. 504.00/-
30‟s/Rs. 540.00/-
Me-too status Diovan by Novartis
WARNING: FETAL TOXICITY
Applicant
Strength
Valsartan…..80mg
Diary No. Date of R& I & fee Dy. No.686, 18-11-2016 , Rs. 20,000/-, 18-11-2016
Type of Form Form-5
20‟s/Rs. 720.00/-; 28‟s/Rs. 1008.00/-
30‟s/Rs. 1080.00/-
299. Name and address of manufacturer / M/s. Barrett Hodgson Pakistan, F/423, SITE,Karachi
Applicant
Strength
Valsartan…..160mg
Type of Form Form-5
20‟s/Rs. 1000.00/-; 28‟s/Rs. 1400.00/-
30‟s/Rs. 1500.00/-
Decision: Approved with box warning
Applicant
Strength
Valsartan…..320mg
Type of Form Form-5
20‟s/Rs. 2000.00/-; 28‟s/Rs. 2800.00/-
30‟s/Rs. 3000.00/-
Decision: Approved with box warning
Applicant
Brand Name +Dosage Form + Rivaclot Tablet 2.5 mg
Strength
Rivaroxaban…..2.5mg
Pharmacological Group Oral Anticoagulant
Type of Form Form-5
10‟s/Rs. 2700.00/-; 14‟s/Rs. 3780.00/
20‟s/Rs. 5400.00/-; 28‟s/Rs. 7560.00/-
30‟s/Rs. 8100.00/-
Approval status of product in ANSM Approved
Me-too status Xarelto by Bayer Reg no. 074794
Warning: (A) Premature Discontinuation of
Xarelto Increases the Risk of Thrombotic
Events,(B) Spinal/Epidural
Decision: Approved with box warning & with innovator’s specification.
Applicant
Brand Name +Dosage Form + Rivaclot Tablet 10 mg
Strength
Rivaroxaban…..10mg
Type of Form Form-5
10‟s/Rs. 7250.00/-; 14‟s/Rs. 10150.00/
20‟s/Rs. 14500.00/-; 28‟s/Rs. 20300.00/-
30‟s/Rs. 21750.00/-
Warning: (A) Premature Discontinuation Of
Xarelto Increases The Risk Of Thrombotic

Applicant
Brand Name +Dosage Form + Strength Rivaclot Tablet 15 mg
Diary No. Date of R& I & fee Dy. 1250, 28-11-2016 , Rs. 20,000/-, 25-11-2016
Type of Form Form-5
10‟s/Rs. 7500.00/-; 14‟s/Rs. 10500.00/
20‟s/Rs. 15000.00/-; 28‟s/Rs. 21000.00/-
30‟s/Rs. 22500.00/-
Warning: (A) Premature Discontinuation Of
Xarelto Increases The Risk Of Thrombotic
Applicant
Brand Name +Dosage Form + Strength Rivaclot Tablet 20 mg
Diary No. Date of R& I & fee Dy. 1249, 28-11-2016 , Rs. 20,000/-, 25-11-2016
Type of Form Form-5
10‟s/Rs. 8500.00/-; 14‟s/Rs. 11900.00/
20‟s/Rs. 17000.00/-; 28‟s/Rs. 23800.00/-
30‟s/Rs. 25500.00/-
Warning: (a) premature discontinuation of xarelto
increases the risk of thrombotic events,(b)
spinal/epidural

Evaluator PEC-XI
305. Name and address of manufacturer / M/s Valor Pharmaceuticals (Pvt.) Ltd.,124/A Kahuta
Applicant Road, Industrial Triangle Zone, Islamabad.
Brand Name +Dosage Form + Strength T-prost 0.004% ophthalmic solution
Travoprost……..….0.04mg
Pharmacological Group Prostaglandin analogue
Type of Form Form-5
Pack size & Demanded Price 10ml; Not demanded
Approval status of product in Reference Travatan-Z ophthalmic solution/drops (USFDA
Regulatory Authorities approved)
Me-too status (with strength and dosage Ravat ophthalmic solution of M/s Bosch pharma
form)
GMP status Last GMP inspection report dated 15-09-2017; the
panel unanimously recommended for the grant of
cGMP certificate.
Decision: Approved
306. Name and address of manufacturer / M/s Biogen Pharma, 8-Km Chak Beli road, Rawat,
Applicant Rawalpindi.
Brand Name +Dosage Form + Strength Quetogen 25mg tablets
Quetiapine (as fumarate)…………..25mg
Pharmacological Group Anti-psychotic
Type of Form Form-5
Pack size & Demanded Price 10‟s; Not demanded
Approval status of product in Reference Approved in Health Canada
Regulatory Authorities
Me-too status (with strength and dosage Evokalm 25mg tablet of M/s PharmEvo
form)
GMP status Last GMP inspection dated 18-08-2017; Good
Decision: Approved
Type of Form Form-5
form)
Decision: Approved

Type of Form Form-5
form)
Decision: Approved
Brand Name +Dosage Form + Strength Lorciam 8mg tablets
Lornoxicam…………..8mg
Type of Form Form-5
Finished product Specifications As per innovator‟s
Approval status of product in Reference Xefo (EMA approved)
Me-too status (with strength and dosage Xika rapid 8mg tablet of M/s Hilton pharma
form)
Brand Name +Dosage Form + Strength Minogen tablets
Minocycline (as hydrochloride)…………..100mg
Pharmacological Group Tetracycline
Type of Form Form-5
Me-too status (with strength and dosage Minoderm tablet of M/s GSK
form)
Decision: Approved.
Brand Name +Dosage Form + Strength Linzogen 600mg tablets
Linezolid…………..600mg
Type of Form Form-5
Approval status of product in Reference Zyvox (USFDA approved)
Me-too status (with strength and dosage Ecasil tablet of M/s Sami
form)
Brand Name +Dosage Form + Strength Zolgen 2.5mg tablets
Letrozole…………..2.5mg
Pharmacological Group Non-steroidal aromatase inhibitor
Type of Form Form-5
Pack size & Demanded Price 3x10‟s; Not demanded
Approval status of product in Reference Femara (MHRA approved)
Me-too status (with strength and dosage Femara tablet of M/s Novartis pharma
form)
Remarks of the Evaluator  Same brand name as for linezolid 600mg tablets
was proposed. Now the firm has requested to
change the proposed brand name of Linzogen
2.5mg tablets to Zolgen 2.5mg tablets
Decision: Registration Board decided to grant registration of above applied products in
Brand Name +Dosage Form + Strength Omgen 40mg tablets
Composition Each enteric coated tablet contains:
Omeprazole…………..40mg
Type of Form Form-5
Approval status of product in Reference Acimax (TGA approved)
Me-too status (with strength and dosage Magser 40mg tablet of M/s Panacea pharmaceuticals
form)
Remarks of the Evaluator The firm has claimed USP specifications but the
official monograph of formulation is available in JP.
Decision: Deferred for clarification of formulation technology whether as per Innovator or
otherwise.
Brand Name +Dosage Form + Strength Omgen 20mg tablets
Omeprazole…………..20mg
Type of Form Form-5
Approval status of product in Reference Acimax (TGA approved)
Me-too status (with strength and dosage Adzol 20mg tablet of M/s Glitz pharma
form)
Remarks of the Evaluator The firm has claimed USP specifications but the
official monograph of formulation is available in JP.
otherwise.
Brand Name +Dosage Form + Strength Valagen 400mg tablets
Sevelamer hydrochloride…………..400mg
Pharmacological Group Polymeric Phosphate binder
Type of Form Form-5
Approval status of product in Reference Renagal 400mg tablets (USFDA approved)
Me-too status (with strength and dosage Renavel tablets of M/s Genome pharma
form)
Decision: Approved with innovator’s specifications.
Brand Name +Dosage Form + Strength Baclofen 10mg tablets
Baclofen…………..10mg
Pharmacological Group GABA analogue
Type of Form Form-5
Pack size & Demanded Price 14‟s, 28‟s and 42‟s; As per SRO
Approval status of product in Reference Lioresal tablets of M/s Novartis pharma (MHRA
Me-too status (with strength and dosage Lioresal tablets of M/s Novartis pharma Pakistan
form)
Decision:Approved
Brand Name +Dosage Form + Strength Alendrogen Plus tablets
Alendronate (as sodium)…………..70mg
Cholecalciferol……………………..70mcg
Pharmacological Group Polymeric amine/ Bisphosphonate, vitamin D
Type of Form Form-5
Approval status of product in Reference Fosamax plus D 70mcg/70mg tablets (approved by
Regulatory Authorities US-FDA)
Me-too status (with strength and dosage Endro plus 70mcg/70mg tablets of M/s Goodman
form) Labs.
Drate plus D of M/s SJ & G Fazal Elahi
Decision: Approved
318. Name and address of manufacturer / M/s. Noa Hemis Pharmaceuticals, Plot No. 154,
Applicant Sector
23, Korangi industrial area, Karachi.
Brand Name +Dosage Form + Strength Racona 100mg capsules
Itraconazole……………….100mg
Type of Form Form-5
Finished product Specifications Manufacturer‟s specifications
Pack size & Demanded Price 1x4‟s; As per PRC
Approval status of product in Reference Sporanox (USFDA approved)
Me-too status (with strength and dosage Icon of M/s Ferozsons laboratories
form)
GMP status Latest GMP inspection conducted on 17-11-2016
and report concludes that the management is in
process of continuous up-gradation as compared and
noticed by referring previous inspection reports.
Decision: Deferred for submission of source of pellets, along with stability studies data,
GMP certificate of manufacturer and differential fee in case of imported pellets.
319. Name and address of manufacturer / M/s. Noa Hemis Pharmaceuticals, Plot No. 154,
Applicant Sector-
23, Korangi industrial area, Karachi.
Brand Name +Dosage Form + Strength Trozo 2.5mg tablets
Letrozole……………….2.5mg
Pharmacological Group Ovulatory stimulant
Type of Form Form-5
Pack size & Demanded Price 10‟s and 30‟s; As per PRC
Approval status of product in Reference Femara (UK-MHRA approved)
Me-too status (with strength and dosage Femara tablet of M/s Novartis pharma
form)
and report concludes that the management is in
process of continuous up-gradation as compared and
noticed by referring previous inspection reports.

Decision: Registration Board decided to grant registration of above applied products in
320. Name and address of manufacturer / M/s. Brookes pharma (Pvt.) Ltd., 58 & 59, Sector-15,
Applicant Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Eflor cream 13.9%
Eflornithine hydrochloride as eflornithine hydrochloride
monohydrate……………….139mg
Diary No. Date of R& I & fee Duplicate dossier; Rs.20,000/- (03-07-2014)
Duplicate fee challan attached
Pharmacological Group Anti-hirsutism agent
Type of Form Form-5
Pack size & Demanded Price 15gram; As per brand leader price
Approval status of product in Reference Vaniqa 13.9% cream (USFDA)
Me-too status (with strength and dosage Depilus cream of M/s Atco.
form)
and report concludes that the panel unanimously
recommends the grant of GMP certificate for local
and export purpose.
Decision: Approved with innovator’s specifications. Reference will be sent to Budget &
Accounts Division for verification of challan and Board authorized its Chairman for the
issuance of registration letter.
321. Name and address of manufacturer / M/s. Brookes pharma (Pvt.) Ltd., 58 & 59, Sector-15,
Brand Name +Dosage Form + Strength Pimpal plus gel
Composition Each 100 gram contains:
Adapalene……………..……….0.10gm
Benzoyl peroxide……………….2.50gm
Diary No. Date of R& I & fee Duplicate dossier; Rs.20,000/- (03-07-2014)
Duplicate fee challan attached
Pharmacological Group Anti-acne
Type of Form Form-5
Finished product Specifications Manufacturer‟s specification
Pack size & Demanded Price 15 gram; As per brand leader price
Approval status of product in Reference Epiduo gel (USFDA A)
Me-too status (with strength and dosage Ada Plus gel of M/s Biogen
form)
and report concludes that the panel unanimously
recommends the grant of GMP certificate for local
and export purpose.
Decision: Approved with innovator’s specifications. Reference will be sent to Budget &
Accounts Division for verification of challan and Board authorized its Chairman for the
322. Name and address of manufacturer / M/s WnsField Pharmaceuticals, Plot # 122, Block-A,
Applicant Phase-V, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Seron 3mg Tablet

Paliperidone…………3mg
Pharmacological Group Atypical antipsychotic
Type of Form Form-5
Pack size & Demanded Price As per SRO; As fixed by Govt.
Approval status of product in Reference Invega Extended Release by Johnson & Johnson
Regulatory Authorities Pharmaceutical (USFDA)
Me-too status (with strength and dosage Invega by M/s. Johnson & Johnson Pakistan (pvt.)
form) Ltd (Manufactured by Janssen Cilag Manufacturing
L.L.C., Gurabo, Puerto Rico (00778-9629)/ Labeling,
Packing & Release by M/s. Janseen Cilag Spa.,
Latina, Italy (04010)
(R. No. 072599)
the report concludes that overall the firm is
following cGMP compliance.
Remarks of the Evaluator  The firm was communicated that their applied
formulation is not as per innovator, as the
approval in reference regulatory agencies like
TGA, FDA and EMA is in tri-layer core,
manufactured by using “OROS Push-pull
technology”.
 Applicant responded that it has been discussed
that method of manufacturing will be accepted
that of competitor/innovator. You are therefore
requested to accept the method of manufacturing
submitted by us for our product Paliperidone
3mg and 6mg tablet.”
Decision: Registration Board deferred for submission of method of manufacturing as per
innovator or comparator formulation
323. Name and address of manufacturer / M/s WnsField Pharmaceuticals, Plot # 122, Block-A,
Applicant Phase-V, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Seron 6mg Tablet

Paliperidone…………6mg
Pharmacological Group Atypical antipsychotic
Type of Form Form-5
Pack size & Demanded Price As per SRO; As fixed by Govt.
Approval status of product in Reference Invega Extended Release by Johnson & Johnson
Regulatory Authorities Pharmaceutical (USFDA)
Me-too status (with strength and dosage Invega by M/s. Johnson & Johnson Pakistan (pvt.)
form) Ltd (Manufactured by Janssen Cilag Manufacturing
L.L.C., Gurabo, Puerto Rico (00778-9629)/ Labeling,
Packing & Release by M/s. Janseen Cilag Spa.,
Latina, Italy (04010)
(R. No. 072599)
the report concludes that overall the firm is
following cGMP compliance.
Remarks of the Evaluator  The firm was communicated that their applied
formulation is not as per innovator, as the
approval in reference regulatory agencies like
TGA, FDA and EMA is in tri-layer core,
manufactured by using “OROS Push-pull
technology”.
 Applicant responded that it has been discussed
that method of manufacturing will be accepted
that of competitor/innovator. You are therefore
requested to accept the method of manufacturing
submitted by us for our product Paliperidone
3mg and 6mg tablet.”
Decision: Registration Board deferred for submission of method of manufacturing as per
innovator or comparator formulation
324. Name and address of manufacturer / M/s Simz Pharmaceuticals 574-575 Sunder Industrial
Applicant Estate Lahore.
Brand Name +Dosage Form + Strength Atorsim 20mg tablets
Atorvastatin (as calcium)…..20mg
Pharmacological Group Lipid lowering agent
Type of Form Form-5
Approval status of product in Reference Lipitor (USFDA approved)
Me-too status (with strength and dosage Lipiget of M/s Getz pharma
form)
the report concludes that the firm is GMP compliant
on the day of inspection.
325. Name and address of manufacturer / M/s Scilife Pharma (Pvt.) Ltd., Plot No. FD-57/58 –
Applicant A2,
Korangi Creek Industrial park, Karachi.
Brand Name +Dosage Form + Strength Brandin 5mg tablets
Ivabradine (as hydrochloride)……….5mg
2016)
Type of Form Form-5
Pack size & Demanded Price 14‟s; As per DPC
Approval status of product in Reference Corlanor (USFDA)
Me-too status (with strength and dosage Sivab 5mg tablets of M/s Getz
form)
GMP status 30-12-16
Grant of GMP certificate, GMP compliance was
acceptable
Applicant A2,
Brand Name +Dosage Form + Strength Brandin 7.5mg tablets

Ivabradine (as hydrochloride)……….7.5mg
2016)
Type of Form Form-5
Approval status of product in Reference Corlanor (USFDA)
Me-too status (with strength and dosage Sivab 7.5mg tablets of M/s Getz
form)
GMP status 30-12-16
acceptable
Applicant A2,
Brand Name +Dosage Form + Strength Provel-DIU 300/12.5mg tablets
Irbesartan………………….300mg
Hydrochlorothiazide……….12.5mg
2016)
Pharmacological Group Angiotensin receptor blockers/diuretics
Type of Form Form-5
Approval status of product in Reference Avalide (USFDA)
Me-too status (with strength and dosage Co-Aprovel 300/12.5mg tablets of M/s Sanofi
form) Aventis
GMP status 30-12-16
acceptable
Remarks of the Evaluator  Approved in USFDA with boxed warning of fetal
toxicity.
Applicant A2,
Brand Name +Dosage Form + Strength Provel-DIU 300/25mg tablets
Irbesartan……………….….300mg
Hydrochlorothiazide……….25mg
2016)
Type of Form Form-5
Me-too status (with strength and dosage Co-Aprovel 300/25mg tablets of M/s Sanofi Aventis
form)

GMP status 30-12-16
acceptable
Remarks of the Evaluator  Approved in USFDA with boxed warning of fetal
toxicity.
 Marketing status:Discontinued in USFDA but not
for safety and efficacy reasons.
Applicant A2,
Brand Name +Dosage Form + Strength Provel-DIU 150/12.5mg tablets
Hydrochlorothiazide……….12.5mg
2016)
Type of Form Form-5
Me-too status (with strength and dosage Co-Aprovel 150/12.5mg tablets of M/s Sanofi
form) Aventis
GMP status 30-12-16
acceptable
Remarks of the Evaluator  Approved in USFDA with boxed warning of fetal
toxicity.
Applicant A2,
Brand Name +Dosage Form + Strength Provel 150mg tablets
2016)
Pharmacological Group Angiotensin receptor blockers
Type of Form Form-5
Approval status of product in Reference Avapro (USFDA)
Me-too status (with strength and dosage Aprovel 150mg tablets of M/s Sanofi Aventis
form)
GMP status 30-12-16
acceptable
toxicity.
Applicant A2,
Brand Name +Dosage Form + Strength Provel 300mg tablets
2016)
Pharmacological Group Angiotensin receptor blockers
Type of Form Form-5
Approval status of product in Reference Avapro (USFDA)
Me-too status (with strength and dosage Aprovel 300mg tablets of M/s Sanofi Aventis
form)
GMP status 30-12-16
acceptable
toxicity.
Applicant A2,
Brand Name +Dosage Form + Strength Lacosa 50mg tablets
Lacosamide……….50mg
2016)
Pharmacological Group Anti-epileptic
Type of Form Form-5
Approval status of product in Reference Vimpat (USFDA)
Me-too status (with strength and dosage Lacolep 50mg tablets of M/s Hilton
form)
GMP status 30-12-16
acceptable
Applicant A2,
2016)
Type of Form Form-5
form)
GMP status 30-12-16

acceptable
Applicant A2, Korangi Creek Industrial park, Karachi.
2016)
Type of Form Form-5
form)
GMP status 30-12-16
acceptable
2016)
Type of Form Form-5
form)
GMP status 30-12-16
acceptable
Brand Name +Dosage Form + Strength Wilda 50mg tablets
Vildagliptin……….50mg
2016)
Type of Form Form-5
Pack size & Demanded Price 14‟s and 28‟s; As per DPC
Approval status of product in Reference Galvus (TGA)
Me-too status (with strength and dosage Vildos 50mg tablets of M/s High-Q pharma
form)
GMP status 30-12-16; Grant of GMP certificate, GMP
compliance was acceptable
337. Name and address of manufacturer / M/s Akhai Pharmaceuticals (Pvt.) Ltd., Plot No. A-
Applicant 248 &A-259, H.I.T.E. Lasbela, Balochistan.
Brand Name +Dosage Form + Strength Mecomin 500 mcg tablets
Mecobalamin……………...….500mcg
2016)
Pharmacological Group Vitamin
Type of Form Form-5
Pack size & Demanded Price 2x10‟s and 5x10‟s; As per PRC
Approval status of product in Reference Neu-Methicol tablet 500mcg (PMDA approved)
Me-too status (with strength and dosage Cobolmin tablets of M/s Macter International
form) Limited
GMP status Certificate of cGMP based on detailed inspection
conducted on 03-08-2017 is provided by the firm.
338. Name and address of manufacturer / M/s Cibex (Pvt.) Ltd., F-405, S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form + Strength Cibtaz 4mg tablets
Tizanidine (as hydrochloride)…..….4mg
2016)
Type of Form Form-5
Approval status of product in Reference Zanaflex (USFDA approved)
Me-too status (with strength and dosage Musidin of M/s Martin Dow pharmaceuticals
form)
GMP status Certificate of cGMP based on evaluation conducted
on 20-09-17 is provided.
339. Name and address of manufacturer / M/s Astellas Pharmaceutical (Pvt.) Ltd., 15-C,
Applicant Industrial Estate Hayatabad, Peshawar.
Brand Name +Dosage Form + Strength Astexone 2gm injection IV
Ceftriaxone (as sodium)……………..……..….2gm
Type of Form Form-5
Approval status of product in Reference Ceftriaxone 2g (as sodium) powder for injection vial
Regulatory Authorities (TGA approved)
Me-too status (with strength and dosage Chroncef of M/s English pharma
form)
concludes that firm is operating at very good level
of compliance with GMP.
340. Name and address of manufacturer / M/s Martin Dow Limited, Plot No. 37, Sector
Applicant 19,Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Vair tablets 37.5mg
Venlafaxine (as hydrochloride)…………….37.5mg
2016)
Pharmacological Group Serotonin and norepinephrine reuptake inhibitor
Type of Form Form-5
Pack size & Demanded Price 14‟s and 20‟s; As per brand leader‟s price
Approval status of product in Reference Almus (UK)
Me-too status (with strength and dosage Venix of M/s CCL pharmaceuticals
form)
GMP status Last inspection conducted on 07-06-2017 and 08-
06-2017, report concludes that firm is operating at
Good level of compliance with GMP.
Decision: Approved
Brand Name +Dosage Form + Strength Vair tablets 75mg
Venlafaxine (as hydrochloride)…………….75mg
2016)
Type of Form Form-5
Approval status of product in Reference Almus (UK)
Me-too status (with strength and dosage Venix of M/s CCL pharmaceuticals (Pvt.) Ltd.
form)
Decision: Approved
Brand Name +Dosage Form + Strength Vair XR tablets 75mg
2016)

Type of Form Form-5
Approval status of product in Reference Sunveniz XL (UK)
Me-too status (with strength and dosage Vela-XR of M/s Kurative Pakistan (Pvt.) Ltd.
form)
Brand Name +Dosage Form + Strength Vair XR tablets 150mg
2016)
Type of Form Form-5
Pack size & Demanded Price 10‟s, 14‟s and 20‟s; As per brand leader‟s price
Approval status of product in Reference Sunveniz XL (UK)
Me-too status (with strength and dosage Vela-XR of M/s Kurative Pakistan Pvt. Ltd.
form)
Brand Name +Dosage Form + Strength Lazin DR tablets 500mg
Sulfasalazine…………….500mg
2016)
Pharmacological Group Anti-arthritis
Type of Form Form-5
Pack size & Demanded Price 1‟s, 10‟s and 100‟s; As per brand leader‟s price/PRC
Approval status of product in Reference Azulfidine EN (USFDA approved)
Me-too status (with strength and dosage Salazodine-EC of M/s Ferozsons
form)
GMP status Last inspection conducted on 7-6-2017 and 8-6-
2017, report concludes that firm is operating at
Decision: Approved
345. Name and address of manufacturer / M/s Hilton Pharma (Pvt.) Ltd., Plot 13-14, Sector 15,
Brand Name +Dosage Form + Strength Xenglu-5mcg prefilled cartridge

Exenatide……………..……..….250mcg
2016)
Type of Form Form-5
Pack size & Demanded Price 1.2ml x 1‟s; As per DPC
1.2ml x 5‟s; As per DPC
Approval status of product in Reference Byetta (USFDA approved)
Me-too status (with strength and dosage Byetta of M/s Eli Lilly (Reg. No. 052206)
form)
concludes that firm is operating at satisfactory level
Remarks of the Evaluator The firm has provided the commercial invoice of
cartridge filling machine as an evidence of facility for
pre-filled cartridges.
 Confirmation of source of API whether of synthetic or natural origin.
 Temperature requirements during manufacturing
 To confirm whether cartridge filling machine is installed in biological or general
injection section.
Brand Name +Dosage Form + Strength Xenglu-10mcg prefilled cartridge
Exenatide……………..……..….250mcg
2016)
Type of Form Form-5
Pack size & Demanded Price 2.4ml x 1‟s; As per DPC
2.4ml x 5‟s; As per DPC
Approval status of product in Reference Byetta (USFDA approved)
Me-too status (with strength and dosage Byetta of M/s Eli Lilly (Reg. No. 052207)
form)
Remarks of the Evaluator The firm has provided the commercial invoice of
cartridge filling machine as an evidence of facility for
pre-filled cartridges.
 Confirmation of source of API whther of synthetic or natural origin.
 Temperature requirements during manufacturing
 To confirm whether cartridge filling machine is installed in biological or general
injection section.
Brand Name +Dosage Form + Strength Hilfovir 200mg tablets
Tenofovir disoproxil fumarate…….…..….200mg

2016)
Pharmacological Group Antiretroviral agent
Type of Form Form-5
Pack size & Demanded Price 10‟s, 20‟s and 30‟s; As per DPC
Approval status of product in Reference Viread (USFDA approved)
Me-too status (with strength and dosage Tenof 200mg tablets of M/s A‟raf pharma (Reg. No.
form) 041118)
Decision: Approved as per International Pharmacopoea specifications
348. Name and address of manufacturer / M/s Sami Pharmaceuticals, (Pvt.) Ltd., F-95, Off.
Applicant Hub
River Road, S.I.T.E., Karachi.
Brand Name +Dosage Form + Strength Fungone 100mg/50ml infusion
Fluconazole..................…….100mg
Type of Form Form-5
Pack size & Demanded Price 50ml; As per DPC
Approval status of product in Reference Fluconazole 2mg/ml solution for infusion (MHRA
Me-too status (with strength and dosage Diflucan 2mg/ml infusion of M/s Pfizer Laboratories
form) Ltd.
guidelines.
Decision: Approved
Brand Name +Dosage Form + Strength Mesita 50/500mg tablets
Sitagliptin (as phosphate monohydrate)…..50mg
Metformin hydrochloride………………….500mg
Pharmacological Group Dipeptidyl peptidase-4 inhibitor/Biguanide
Type of Form Form-5
Finished product Specifications Manufacyurer‟s specifications
Approval status of product in Reference Janumet (USFDA approved)
Me-too status (with strength and dosage Sitaglu met of M/s Hilton pharma
form)
the report concludes that the firm is GMP compliant
Remarks of the Evaluator  Approved in USFDA with boxed warning of
lactic acidosis.

350. Name and address of manufacturer / M/s Barrett Hodgson Pakistan (Pvt.) Ltd., F-
Applicant 423,S.I.T.E., Karachi.
Brand Name +Dosage Form + Strength Prisec plus capsule 20mg + 1100mg
Omeprazole..................…….20mg
Sodium bicarbonate..........….1100mg
2016)
Pharmacological Group Proton pump inhibitor/antacid
Type of Form Form-5
Pack size & Demanded Price 7‟s; Rs. 126.00/- ; 10‟s; Rs. 180.00/-
14‟s; Rs. 252.00/-
Or as per DRAP‟s pricing policy
Approval status of product in Reference Zegerid (USFDA approved)
Me-too status (with strength and dosage Zoltar Insta of M/s Pharmevo
form)
operating at satisfactory level of compliance with
GMP guidelines.
Decision: Approved withUSP specification.
Brand Name +Dosage Form + Strength Prisec plus capsule 40mg + 1100mg
Omeprazole..................…….40mg
Sodium bicarbonate...............1100mg
2016)
Type of Form Form-5
14‟s; Rs. 364.00/-
Me-too status (with strength and dosage Zoltar Insta of M/s Pharmevo
form)
GMP guidelines.
Brand Name +Dosage Form + Strength Prisec plus sachet 20mg + 1680mg
Omeprazole..................…….20mg
Sodium bicarbonate..................…….1680mg
2016)
Type of Form Form-5
14‟s; Rs. 280.00/-
Me-too status (with strength and dosage Ruling Plus of M/s High-Q
form).

GMP guidelines.
Brand Name +Dosage Form + Strength Prisec plus sachet 40mg + 1680mg
Omeprazole..................…….40mg
Sodium bicarbonate..................…….1680mg
2016)
Type of Form Form-5
Pack size & Demanded Price 7‟s; Rs. 182.00/- ; 10‟s; Rs. 260.00/-; 14‟s;
Rs.364.00/-
Me-too status (with strength and dosage Ruling Plus of M/s High-Q
form)
GMP guidelines.
354. Name and address of manufacturer / M/s. Ray Pharma (Pvt.) Ltd., S-58, S.I.T.E., Karachi.
Applicant
Brand Name +Dosage Form + Strength Aclic 5mg/100ml infusion
Zoledronic acid……………….5mg
Pharmacological Group Bisphosphonate
Type of Form Form-5
Pack size & Demanded Price 100ml; As per PRC
Approval status of product in Reference Reclast (USFDA approved)
Me-too status (with strength and dosage Drozic of M/s Searle IV solutions
form)
GMP status Last GMP inspection conducted on 08-08-17 and the
report concludes that the firm is considered to be
GMP guidelines.
355. Name and address of manufacturer / M/s Macter International Ltd., F-216, S.I.T.E.
Applicant Karachi.
Brand Name +Dosage Form + Strength Salmicort DPI capsules
Fluticasone propionate (micronised)……….100mcg
Salmeterol as xinafoate (micronised)………50mcg
Pharmacological Group Long acting beta2 adrenergic agonists/ inhaled
corticosteroid
Type of Form Form-5
Pack size & Demanded Price 20‟s; Rs.452.00/-
Me-too status (with strength and dosage Seretide Diskus of M/s GSK
form)
guidelines.
Applicant Karachi.
Fluticasone propionate (micronised)…………250mcg
Salmeterol as xinafoate (micronised)…50mcg
corticosteroid
Type of Form Form-5
Pack size & Demanded Price 20‟s; Rs.494.00/-
form)
guidelines.
Applicant Karachi.
Fluticasone propionate (micronised)……….500mcg
Salmeterol as xinafoate (micronised)………50mcg
corticosteroid
Type of Form Form-5
Pack size & Demanded Price 20‟s ;Rs.555.00/-
form)
guidelines.

Evaluator PEC-XIII
358. Name and address of manufacturer / M/s Nabi Qasim Industries (Pvt) Ltd; 17/24, Korangi
Applicant Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Lusidone Tablet 20mg
Composition Each film-coated tablet contains:
Lurasidone Hydrochloride eq. to Lurasidone…..20mg
Type of Form Form-5
Pack size & Demanded Price 10‟s, 14‟s, 30‟s; as per PRC
Approval status of product in Reference Approved by TGA of Australia.
Me-too status Not available
GMP status Last GMP inspection was conducted on 03-08-2017
which concludes an acceptable level of GMP
compliance.
Remarks of the Evaluator.  Submission on Form-5D.
 Submission of differential fees.
 Submission of stability data according to 251st
DRB meeting.
i. Clarification from QA&LT Division regarding GMP status of the firm in the light of
observations made by the panel of inspection for the product SOVIR-C 400mg tablet
and those recorded by area FID in inspection report dated 03-08-2017.
ii. Confirmation of generic / me-too status of applied formulation
359. Name and address of manufacturer / M/s Nabi Qasim Industries (Pvt) limited;
Applicant 17/24,Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Lusidone Tablet 40mg
Lurasidone Hydrochloride eq. to Lurasidone…….40mg
Diary No. Date of R& I & fee Dy.No.436; 30-03-2015; Rs.20,000/-(21-02-
2015)(Duplicate Dossier)
Type of Form Form-5
compliance.
 Submission of stability data according to 251st DRB
meeting.
 As the dossier is duplicate so fee-challan needs
verification.
 The proposed shelf-life is 4 years.
 Original sign on form and application.
360. Name and address of manufacturer / M/s Nabi Qasim Industries (Pvt) limited; 17/24,
Brand Name +Dosage Form +Strength Lusidone Tablet 80mg
Lurasidone Hydrochloride eq. to
Lurasidone…….80mg
2015)(Duplicate Dossier)
Type of Form Form-5
compliance.
 Submission of stability data according to 251st
DRB meeting.
 As the dossier is duplicate so fee-challan needs
verification.
 The proposed shelf-life is 4 years.
 Original sign on form and application.

ii. Deferred Cases
Evaluator PEC-III
361. Name and address of manufacturer / M/s English Pharmaceutical Industries Link Kattar
Applicant Bund Road, Thokar Niaz Baig, Multan Road,
Lahore
Brand Name +Dosage Form + Strength Rivo 20mg Tablet
Rivaroxaban….20mg
Diary No. Date of R& I & fee Dy.No.1079: 10-09-2015Fee.20,000/-: 09-10-2015
Type of Form Form 5
Approval status of product in Xarelto by Bayer
Me-too status Xarelto tablets by Bayer
GMP status
Remarks of the Evaluator  Latest GMP inspection report (which should have
been conducted within the period of last one year)
is not provided
Decision of previous meeting Deferred for GMP inspection report conducted
within a period of last 1 year (M-273)
Evaluation by PEC Firm has submitted last GMP inspection report
dated 24-11-2016, confirming satisfactory
compliance to GMP
362. Name and address of manufacturer / M/s Zeta Pharmaceuticals Plot No. 494, Sunder
Applicant Industrial Estate Multan Road Lahore
Brand Name +Dosage Form + Strength Gabazet Capsule
Composition Each Capsule Contains:-
Pregablin……...75mg
Type of Form Form 5
Pack size & Demanded Price 2 x 7‟s: Rs. 260/-
Approval status of product in Lyrica by PF Prism
Me-too status Gabica by Getz
GMP status
Remarks of the Evaluator Latest GMP inspection report (which should have
within a period of last 1 year. (M-273)
Evaluation by PEC Firm has submitted last GMP inspection report
dated 03-01-2017 confirming satisfactory
compliance to GMP
363. Name and address of manufacturer / M/s Medicaids Pak (Pvt) Ltd., Plot No. 10, Sector-
Applicant 27 Korangi Industrial Area Karachi
Brand Name +Dosage Form + Strength Alpazol 40mg Injection
Omeprazole sodium eq. to Omeprazole……..40 mg

Type of Form Form 5
Pack size & Demanded Price 1‟s: Rs. 350/-
Approval status of product in Losec powder for solution for infusion by
Reference Regulatory Authorities Astrazaneca
(MHRA Approved)
Me-too status Risek by Getz
GMP status GMP Certificate issued based on inspection report
dated 10-05-2016
Evaluation by PEC  Firm has submitted copy of GMP certificate based
on inspection conducted on 18th May 2017
 Firm do not have approved facility for dry powder
vial (General)
Decision: Registration Board rejected the application as firm does not have requisite
manufacturing facility.
Brand Name +Dosage Form + Strength Ribazin 400mg Tablet
Ribavirin…………..400 mg
Pharmacological Group Antiviral
Type of Form Form 5
Approval status of product in Copegus by Roche
Me-too status Ribavil by Genix
dated 10-05-2016
Evaluation by PEC Firm has submitted copy of GMP certificate based
Decision: Approved.
Brand Name +Dosage Form + Strength Arteblax-L HD Tablet
Artemether…………80 mg
Lumefantrine…….480 mg
Pharmacological Group Anti malarial
Type of Form Form 5
Finished product Specifications International Pharmacopoeia
Approval status of product in WHO PQ formulation
Me-too status Artem plus by Hilton
dated 10-05-2016
Evaluation by PEC Firm has submitted copy of GMP certificate based
Decision: Approved
366. Name and address of manufacturer / M/s Barrett Hodgson Pakistan (Pvt) Ltd. F/423,
Applicant S.I.T.E., Karachi
Brand Name +Dosage Form + Strength Moodset 50mg XR Tablet
Diary No. Date of R& I & fee Dy. No. 206: 6-8-2015Rs. 20,000/-: 5-8-2015
Desvenlafaxine succinate eq. to Desvenlafaxine
……..…50mg
Pharmacological Group Anti-depressant-SNRI
Type of Form Form 5
Finished Product Specification Firm has claimed innovator specification
Pack size & Demanded Price 14‟s: Rs.364/-
Reference Regulatory Authorities. (USFDA Approved)
GMP status Last inspection report dated 18 to 21st January and
2nd February 2016, recommended the renewal of
DML
Remarks of the Evaluator.  The inspection report of the firm is older than 1
year
Decision of previous meeting Deferred for latest GMP inspection report conducted
within past one year. (M-272)
Evaluation by PEC Firm has submitted last inspection report of
08.8.2017 confirming satisfactory compliance to
GMP
Decision:Approvedwith change of brand name & with innovator’s specifications
Brand Name +Dosage Form + Strength Moodset 100mg XR Tablet
Desvenlafaxine succinate eq.to Desvenlafaxine
……...100mg
Pharmacological Group Anti-depressant-SNRI
Type of Form Form 5
Finished Product Specification Firm has claimed innovator specifications
Pack size & Demanded Price 14‟s: Rs.462/-
DML
year
Evaluation by PEC Firm has submitted last inspection report of 8-8-
2017 confirming satisfactory compliance to GMP
Decision:Approvedwith change of brand name & with innovator’s specifications
Brand Name +Dosage Form + Strength Barilol-H 2.5mg/6.25mg Tablet
Bisoprolol fumarate……2.5mg
Hydrochlorothiazide…..6.25mg
Pharmacological Group (Antihypertensive combination)
Type of Form Form 5
Pack size & Demanded Price 10‟s: Rs.60/-; 14‟s: Rs.84/-; 20‟s: Rs.120/-
28‟s: Rs.168/-; 30‟s: Rs.180/-
Approval status of product in Ziac Tablets by Teva Pharms
Me-too status Actim-H by Sami
DML
year
Evaluation by PEC Firm has submitted last inspection report dated
GMP
Decision: Approved
Brand Name +Dosage Form + Strength Barilol-H 5mg/6.25mg Tablet
Bisoprolol fumarate….5mg
Hydrochlorothaizide…6.25mg
Pharmacological Group (Anti-hypertensive combination)
Type of Form Form 5
28‟s: Rs.252/-; 30‟s: Rs.270/-
DML
year
Evaluation by PEC Firm has submitted last inspection report dated
GMP
Decision: Approved
Brand Name +Dosage Form + Strength Barilol-H 10mg/6.25mg Tablet
Bisoprolol fumarate….10mg
Hydrochlorothaizide…6.25mg
Pharmacological Group (Anti-hypertensive combination)
Type of Form Form 5
28‟s: Rs.420/-; 30‟s: Rs.450/-
DML
year
Evaluation by PEC Firm has submitted last inspection report
of08.8.2017 confirming satisfactory compliance to
GMP
Decision: Approved
371. Name and address of manufacturer / M/s Obsons Pharmaceuticals 209-S, Industrial
Applicant Estate, Kotlakhpat, Lahore
Brand Name +Dosage Form + Strength Obsartan-K 50mg Tablets
Losartan potassium…….50mg
Diary No. Date of R& I & fee Dy. No.1368: 4-11-2015Fee. 20,000/-: 4-11-2015
Type of Form Form 5
Approval status of product in Cozaar by MSD
Me-too status Cozaar by OBS
GMP status
within a period of last 1 year. (M-273).
Evaluation by PEC Firm has provided latest GMP inspection report
dated 27-04-2017 which do not conclude GMP
status
Decision: Deferred for updated GMP status by QA&LT Division as last inspection report
conducted within one year by DRAP does not conclude GMP compliant status.
Brand Name +Dosage Form + Strength Obmycin Capsule 500mg
Lincomycin as hydrochloride…….500mg
Diary No. Date of R& I & fee Dy. No. 1365: 4-11-2015Fee. 20,000/-: 4-11-2015
Type of Form Form 5
Approval status of product in FDA Discontinued
Me-too status Lincocin by Pfizer
GMP status
 Evidence of approval of applied formulation in
reference regulatory authorities which were
approved by Registration Board in its 249th
meeting
Decision of previous meeting GMP inspection report conducted within a period
of last 1 year.
Evidence of approval in reference regulatory
authorities (M-273)
Evaluation by PEC Firm has provided latest GMP inspection report
status
The formulation is approved by ANSM France
Brand Name +Dosage Form + Strength Obsamide Capsule 2mg
Loperamide Hydrochloride…….2mg
Diary No. Date of R& I & fee Dy. No. 1366: 4-11-2015Fee. 20,000/-: 4-11-2015
Pharmacological Group Antipropulsive
Type of Form Form 5
Approval status of product in Imodium by McNeil
Me-too status Imodium by Janssen
GMP status
Evaluation by PEC Firm has provided latest GMP inspection report
status
374. Name and address of manufacturer / M/s NovaMed Pharmaceuticals Pvt. Ltd., 28-Km
Applicant Ferozepur Road, Lahore
Brand Name +Dosage Form + Strength Vitaglyptin M tablet
Metformin hydrochloride……….500mg
Sitagliptin as Phosphate Monohydrate …..50mg
Type of Form Form 5
Approval status of product in Janumet by MSD
Me-too status Janumet by OBS
GMP status
 Justify the formulation of uncoated tablet while the
product approved by reference regulatory
authorities is film coated tablet
Decision of previous meeting Deferred for following submission
 GMP inspection report conducted within a period
of last 1 year.
 Clarification/justification of the applied
formulation as uncoated tablet while the product
approved by reference regulatory authorities is as
film coated tablet (M-273)
Evaluation by PEC Firm has provided following submissions
 Last inspection report dated 8-2-2017 confirming
good compliance to GMP
 Firm has provided formulation of film coated
tablet
Decision: Approved with innovator’s specificatiopns.
Brand Name +Dosage Form + Strength Vitasartan 160 tablets
Valsartan……….160mg
Type of Form Form 5
Approval status of product in Cuenca tablets by Laboratories Liconsa
Me-too status Sevia by Sami
GMP status
GMP inspection report conducted within a period
of last 1 year. (M-273)
Decision: Approved
Brand Name +Dosage Form + Strength Vitamet Forte XR Tablet 1000mg
Composition Each Film coated Extended Release Tablet
contains:-
Metformin hydrochloride……….1000mg
Type of Form Form 5
Approval status of product in Glucient SR tablets by Consilient Health
Me-too status Dowphage by Martin Dow
GMP status

Decision: Approved
Brand Name +Dosage Form + Strength Vitagablin 75mg Capsule
Composition Each Capsule contains:-
Pregablin……….75mg
Diary No. Date of R& I & fee Dy. No.813: 21-9-2015 Fee. Rs.20,000/-: 21-9-2015
Type of Form Form-5
Approval status of product in Lyrica by PF Prism
Me-too status Gabica by Getz
GMP status
378. Name and address of manufacturer / M/s, Reign Pharmaceuticals PCSIR-KLC (Pvt.) Ltd,
Applicant Karachi
Brand Name +Dosage Form + Strength Spastol Tablet
Phloroglucinol ……80 mg
Trimethylphloroglucinol…..80 mg
Diary No. Date of R& I & fee Dy.No.529, Rs.20,000/-
21-05-2013
Pharmacological Group (Antispasmodic)
Type of Form Form 5
Finished product Specifications
Pack size & Demanded Price As per PRC / 3 x 30‟s
Approval status of product in Spasfon Tablets (ANSM Approved)
Me-too status Spasfon Tablets by Himont
GMP status Last GMP inspection report dated 27-01-2017
confirms Good compliance to GMP
Decision of previous meeting Deferred for Review committee (M-239)
Deferred for expert opinion (M-250)
Deferred for evaluation as per checklist approved in
251st RB meeting (M-268)
Deferred for submission of revised formulation and
method of manufacturing in line with the
innovator‟s product (M-269)
Evaluation by PEC Firm has submitted the formulation of sugar coated
tablet as per the innovator‟s product
Decision: Approved with change of brand name& with innovator’s specification.
379. Name and address of manufacturer / M/s Surge Laboratories (Pvt) Ltd., 10 KM,
Applicant Faisalabad Road Bikhi, District Sheikhupura
Brand Name +Dosage Form + Strength Ledronic IV 5mg/100ml Solution for infusion
Zoledronic Acid monohydrate eq to zoledronic
acid…………..5mg
Pharmacological Group Bisphosphonates
Type of Form Form 5
Pack size & Demanded Price 100ml x 1‟s: As per PRC
Approval status of product in Aclasta by Novartis
Me-too status Aclasta by Novartis
GMP status
Evaluation by PEC Firm has submitted GMP inspection report dated
22.11.2016 and 4-01-2017 confirming good
compliance to GMP
380. Name and address of manufacturer / Jenner Pharmaceuticals (Pvt.) Ltd. 26-Km Lahore
Applicant Sharaqpur Road Sheikhupura
Brand Name +Dosage Form + Strength Dulux Capsules 30mg
Composition DUPLICATE : 20-10-2015
PKR 20,000/- + 80,000/- : 14-10-2015
Diary No. Date of R& I & fee Each capsule contains
Enteric coated pellets of Duloxetine hydrochloride
(17.06%) equivalent to
Duloxetine……………30mg
Pharmacological Group Anti-depressant
Type of Form Form-5
Finished product Specifications USP Specifications
Approval status of product in Cymbalta Capsules by Lilly
Me-too status Dulan 30mg Capsules by Hilton
GMP status Last inspection report 25.11.2016 confirms that firm
being a newly licensed unit, have required facility,
equipment and procedures to manufacture drugs
under provision of Drug Act, 1976. However GMP
is a continuous process in which up gradation is
warranted, hence firm is advised to strengthen its
internal audit system for future advancements.
Remarks of the Evaluator Source of pellets: M/s Spansules Formulations
Telangana State India
 Real time stability data provided is not according
to the requirements of zone IV-A
 Original fee chalan is missing, the submiited
dossier is duplicate
Decision of previous meeting Deferred for submission of real time stability data of
pellets since the signatures on the
submitted stability data sheet are not original. (M-
271)
Evaluation by PEC  Firm has submitted original signed real time and
accelerated stability study data sheets of M/s
Spansules Formulations 154/A-4, IDA Bollaram,
Medak Distt, Hyderabad.
 Original fee chalan is missing, the submitted
dossier was duplicate
 20mg strength of same product is applied with
different brand name
Decision: Registration Board deferred the case for clarification as submitted source of
pellets is not of USP grade. Verification of fee challan of Rs. 20,000 shall also be
submitted.
381. Name and address of manufacturer / Jenner Pharmaceuticals (Pvt.) Ltd. 26-Km Lahore
Applicant Sharaqpur Road Sheikhupura
Brand Name +Dosage Form + Strength Dewel Capsules 20mg
Composition Each capsule contains
(17.06%) equivalent to Duloxetine …………..20
mg
Diary No. Date of R& I & fee Dy No. 717 (20-03-2017) PKR 20,000/- (10-3-
2017) +PKR 80,000/- : 16-03-2017
Type of Form Form-5
Finished product Specifications USP Specifications
Me-too status Dulan 20mg Capsules by Hilton
GMP status Last inspection report 25.11.2016 confirms that firm
being a newly licensed unit, have required facility,
equipment and procedures to manufacture drugs
under provision of Drug Act, 1976. However GMP
is a continuous process in which up gradation is
warranted, hence firm is advised to strengthen its
internal audit system for future advancements.
Remarks of the Evaluator Source of pellets: M/s Spansules Formulations
Telangana State India
 Real time stability data provided is not according
to the requirements of zone IV-A
Decision of previous meeting Deferred for submission of real time stability data of
pellets since the signatures on thesubmitted stability
data sheet are not original.(M-271)
Evaluation by PEC  Firm has submitted original signed real time and
accelerated stability study data sheets of M/s
Spansules Formulations 154/A-4, IDA Bollaram,
Medak Distt, Hyderabad.
 30mg strength of same product is applied with
different brand name
Decision: Registration Board deferred the case for clarification as submitted source of
pellets is not of USP grade.
382. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Plot 122, Block-B,
Applicant Phase-V, Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Apre 80mg Capsule
Aprepitant…………80mg
Type of Form Form 5
Approval status of product in Emend Capsule by Merck
Me-too status Apritus 80mg capsule by S.J. &G
Remarks of the Evaluator  The name of production manager and QC manager
on commitments are different from that provided in
the inspection report (12-01-2017). Firm has
submitted request for change of technical person i.e.
production and QC manager but have not yet
received the approval of technical persons.
Decision of previous meeting Deferred for clarification regarding confirmation of
the names of production manager and quality control
manager on commitments and GMP inspection report
from the Licensing, Division.(M-272)
Evaluation by PEC Firm has submitted that they have mistakenly
submitted the undertaking of their old technical staff
and they have now submitted new undertakings and
have submitted the application for change of
technical staff to licensing division. Copies of letter
received in licensing division is also provided. Firm
has also submitted new inspection report dated 16-
09-2017 confirming the availability of new technical
staff at the plant.
Decision: Approved
383. Name and address of manufacturer / M/s Welmark Pharmaceuticals, Plot 122, Block-B,
Applicant Phase-V, Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Wellinez 600mg Tablets
Linezolid……………..600mg
Pharmacological Group Synthetic Antibiotics
Type of Form Form 5
Finished product Specifications Firm has claimed USP Specifications
Approval status of product in Zyvox by Pharmacia
Me-too status Volinza by Wilshire
Remarks of the Evaluator Firm has claimed USP specifications and the product
is not present in BP or USP
 The name of production manager and QC manager
on commitments are different from that provided in
the inspection report (12-01-2017). Firm has
submitted request for change of technical person i.e.
production and QC manager but have not yet
received the approval of technical persons.
Decision of previous meeting Deferred for clarification regarding confirmation of
the names of production manager and quality control
manager on commitments and GMP inspection report
from the Licensing, Division.(M-272)
Evaluation by PEC Firm has submitted that they have mistakenly
submitted the undertaking of their old technical staff

and they have now submitted new undertakings and
have submitted the application for change of
technical staff to licensing division. Copies of letter
received in licensing division is also provided. Firm
has also submitted new inspection report dated 16-
09-2017 confirming the availability of new technical
staff at the plant.
Decision: Approved

384. Name and address of manufacturer / M/s OBS Pakistan (Pvt) Ltd, C-14, SITE, Karachi
Applicant
Brand Name +Dosage Form + Strength Zevia-XR 850mg Tablet
Metformin hydrochloride….850mg
Diary No. Date of R& I & fee Dy No. 153, 10-02-2015; PKR 20,000/-, 09-02-2015
Pharmacological Group Oral anti-hyperglycemic – Biguanide (ATC Code:
A10BA02)
Type of Form Form 5
Pack size & Demanded Price 30‟s: As per DPC
Me-too status Metwil XR 850mg by Wilson
GMP status Last inspection report dated 07-11-2016 concluded
that “overall GMP compliance towards maintenance
of equipment/area, QC facilities/activities,
documentation & record keeping found in good
condition at the time of visit
Remarks of the Evaluator Evidence of approval in reference regulatory
authorities could not be confirmed
Decision of previous meeting Deferred for evidence of approval in reference
regulatory authorities approved by Registration
Board in 249th meeting (M-269)
Evaluation by PEC Firm has requested to consider the application to
Zevia-XR 750mg tablet, firm has also submitted
complete dossier for 750mg XR tablet.
Firm has also submitted fee PKR 20,000/- dated 17-
10-2017 for 750mg strength . Detailsof new dossier
are as under:
Name and address of manufacturer / M/s OBS Pakistan (Pvt) Ltd, C-14, SITE, Karachi
Applicant
Brand Name +Dosage Form + Strength Zevia-XR 750mg Tablet
Metformin hydrochloride….750mg
Diary No. Date of R& I & fee Dy No. 18330, 17-10-2017;
PKR 20,000/-, 17-10-2017
Pharmacological Group Oral anti-hyperglycemic – Biguanide (ATC Code:
A10BA02)
Type of Form Form 5
Pack size & Demanded Price 30‟s: As per DPC
Me-too status Dowphage ER 750mg Tablet of M/s Martin Dow
Ltd. Karachi (Reg.# 081128)
GMP status Last inspection report dated 07-11-2016 concluded
that “overall GMP compliance towards maintenance
of equipment/area, QC facilities/activities,
documentation & record keeping found in good
condition at the time of visit
Remarks of the Evaluator Evidence of approval in reference regulatory
authorities could not be confirmed
Decision: Registration Board acceded with firm’s request and approved the application of
Zevia-XR 750mg tablets (Metformin hydrochloride 750 mg) & the application of Zevia-
XR 850mg tablets (Metformin hydrochloride 850 mg) is declared as disposed off.
385. Name and address of manufacturer / M/s Bio Labs (Pvt) Ltd, Plot No. 145, Industrial

Brand Name +Dosage Form + Strength Bio-Mir 15mg Tablets
Mirtazapine……….15mg
Type of Form Form 5
Pack size & Demanded Price 2 x 10‟s: As per PRC
Approval status of product in Mirtazapine tablet by Actavis
Me-too status Elaxine tablet by Standpharm
GMP status Last inspection conducted on 15-12-2016 and the
panel unanimously recommends for the issuance of
GMP certificate.
Remarks of the Evaluator Following documents are not provided
Decision of previous meeting Deferred for following submissions
 Clarification/justification of the formulation of
uncoated tablet since the product approved by
reference regulatory authorities is as film coated
tablet (M-273)
Evaluation by PEC Firm has provided formulation of film coated tablet
Decision: Approved
Brand Name +Dosage Form + Strength Bio-Mir 30mg Tablets
Mirtazapine……….30mg
Type of Form Form 5
Approval status of product in Mirtazapine tablet by Actavis
Me-too status Elaxine tablet by Standpharm
GMP certificate.
 Latest GMP inspection report (which should have
tablet (M-273)
Brand Name +Dosage Form + Strength Bio-Fubuzo 40mg Tablets
Febuxostat……….40mg
Pharmacological Group (Anti-Gout)
Type of Form Form 5
Approval status of product in Uloric tablets by Takeda
Me-too status Zurig by Getz
GMP status Last inspection on 15-12-2016 and panel
unanimously recommends for issuance of GMP
certificate.
product approved by reference regulatory authorities
is film coated tablet
tablet (M-273)
Brand Name +Dosage Form + Strength Bio-Fubuzo 80mg Tablets
Febuxostat……….80mg
Pharmacological Group (Anti-Gout)
Type of Form Form 5
Approval status of product in Uloric tablets by Takeda
Me-too status Zurig by Getz
GMP certificate.
product approved by reference regulatory authorities
is film coated tablet
tablet (M-273)
Brand Name +Dosage Form + Strength Bio-Zolemiptan 2.5mg Tablets
Zolmitriptan………..2.5mg
Pharmacological Group Anti-migraine preparation
Type of Form Form 5
Pack size & Demanded Price 1 x 3‟s: As per DPC
Approval status of product in Zomig tablets by IPR Pharma
Me-too status Engzol Tablet by English Pharma
GMP certificate.
 Finished product specification to be submitted in
the light of decision taken by the Registration
Board in its 267th meeting
Clarification/justification of the formulation of
tablet
Finished product specification (M-273)
and finished product specification
Brand Name +Dosage Form + Strength Bio-Zolemiptan 5mg Tablets
Zolmitriptan………..5mg
Pharmacological Group Anti-migraine preparation
Type of Form Form 5
Pack size & Demanded Price 1 x 3‟s: As per DPC
Approval status of product in Zomig tablets by IPR Pharma
Me-too status Engzol Tablet by English Pharma
GMP certificate.
Board in its 267th meeting
tablet
Brand Name +Dosage Form + Strength Bio-Levocit 5mg Tablets
Levocetirizine dihydrochloride……..5mg
Type of Form Form 5
Firm has claimed in house specification while the
product is present in USP
Approval status of product in Levocetirizine tablets by Actavis
Me-too status Invocet tablet by Aries Pharma
GMP certificate.
Board in its 267th meeting, since the product is
present in USP
tablet
Decision: Approved.
Brand Name +Dosage Form + Strength Bio-Clindacin 2% Cream
Composition Each gram of vaginal cream contains:-
Clindamycin (as phosphate)……..…..2% w/w
Pharmacological Group Antibiotic for topical use
Type of Form Form 5
Firm has claimed USP while the product is not
present in USP
Pack size & Demanded Price 40 gm tube: As per PRC
Approval status of product in Dalacin cream 2% for vaginal use by Pfizer
Me-too status Clindanor 2% cream by Nortech Pharma
GMP certificate.
 Clarify the use and route of administration since
the product approved by reference regulatory
authorities is for vaginal use only
Board in its 267th meeting along with copy of
official monograph
 Clarification regarding the intended use of the
product since the reference regulatory authorities
has approved this for vaginal use only.
 Finished product specification (M-273)
Evaluation by PEC Firm has submitted the intended use as vaginal
cream and submitted finished product specification
as per USP.
Decision: Approved with USP specifications
393. Name and address of manufacturer / M/s Dyson Research Laboratories (Pvt) Ltd,28 KM
Applicant Ferozepur Road Lahore
Brand Name +Dosage Form + Strength Perimo Tablets 10mg
Composition Dy. No. 97: 13-7-2015PKR 20,000/-: 13-07-2015
Diary No. Date of R& I & fee Each film coated tablet contains:
Domperidone maleate equivalent to domperidone
….10mg
Type of Form Form 5
Finished product Specifications B.P
Approval status of product in Motilium Tablets
Reference Regulatory Authorities (MHRA Approved) with blackbox warning
Me-too status Motilium tablet by Janssen
GMP status Last inspection report dated 14-10-2015 and 03-11-
2015 recommends the renewal of DML
Remarks of the Evaluator  The inspection report of the firm is older than 1
year, however firm has provided proof of
applications submitted in DRAP requesting
issuance of GMP certificate for export purpose with
R. 5000/- dated 17th January 2017 and then
reminders on 4th March 2017 and 19th May 2017.
Decision of previous meeting  Deferred for latest GMP inspection report
conducted within past one year. (M-272)
Evaluation by PEC Firm has submitted GMP inspection report dated 1-
8-2017 confirms satisfactory level of compliance to
GMP
Decision: Approved with Black Box warning

Evaluator PEC-II
394. Name and address of manufacturer / M/s Pakrisen Pharmaceuticals, Hattar.
Applicant Contract manufacturing by M/s Caraway
Pharmaceuticals Rawat.
Brand Name +Dosage Form + Strength Pakxime 200mg / 5 ml powder for oral suspension
Cefixime (as trihydrate)………….200 mg
Pharmacological Group Cephalosporin, antibiotic
Type of Form Form-5
Me-too status Refspan Suspension 200mg of M/s Rasco Pharma
(Reg.# 038950)
concludes that firm is found to be operating at good
Previous remarks of the Evaluator.  Following reference stated by firm has been
verified:
“FELDENE 20mg CAPSULES approved by
MHRA of UK.”
 Firm has submitted revised master formulation
mentioning composition same as that of above
cited reference product.
 Revised composition submitted by firm is as
under:
“Each capsule contains:-
Piroxicam …....20mg”
Previous decision Deferred in 274th meeting of Registration Board for
confirmation of remaining fee.
Evaluation by PEC  The original fee challan of Rs. 50,000 (Deposit
slip# 0317935 date 29-06-2015) has been verified
from submitted dossier.
Decision:Approved.
395. Name and address of manufacturer / M/s Mission Pharmaceutical, Karachi

Applicant
Brand Name +Dosage Form + Strength Iodoclens Topical Solution
Composition Each 100ml Contains:
Povidone Iodine…..7.5%
Diary No. Date of R& I & fee Dy. No.725; 28-10-2015; Rs.20,000/-
Pharmacological Group Antiseptic
Type of Form Form-5
Pack size & Demanded Price 60ml; Rs. 70/-; 450ml; Rs. 348/-
Approval status of product in Availability in SRA is not confirmed
Me-too status Povex Surgical Scrub of M/s Indus Pharma, Karachi
(Reg.# 055743)
GMP status Inspection conducted on 21-12-2016, concluding
good GMP compliant status.
Previous remarks of the Evaluator. Availability in SRA is not confirmed
Previous decision Deferred in 259th for confirmation of approval status
by reference regulatory authorities.

Evaluation by PEC Following reference has been verified for applied
formulation:
“Povidone-Iodine 7.5% w/w Surgical Scrub of
M/s Ecolab Ltd approved by MHRA of UK.”
Decision:deferred for confirmation of manufacturing facility
396. Name and address of manufacturer / M/s CKD Pharmaceuticals Pakistan (Pvt.) Ltd, 50/28,
Applicant Korangi Industrial Area, Korangi, Karachi
Brand Name +Dosage Form + Strength Zi-ate Syrup 20mg/5ml
Composition Rs.20,000/- vide Dy.# 106 dated 01-02-2013
Diary No. Date of R& I & fee Each 5ml contains:-
Zinc sulphate monohydrate eq.to elemental
Zinc.20mg
Pharmacological Group Antidiarrhoeal
Type of Form Form 5
Pack size & Demanded Price Pack size of30ml / Rs. 37/-; 60ml / Rs. 60/-
100ml / Rs. 75/-; 120ml / Rs. 100/-
Me-too status Zincat-Atco
GMP status --
Previous remarks of the Evaluator.  Applied formulation has been verified from
International Pharmacopoeia of WHO
 GMP inspection report is required.
Previous decision Deferred in 271st meeting of Registration Board for
submission of latest GMP inspection report conducted
within last one year.
Evaluation by PEC Firm has submitted copy of inspection report
conducted on 13-07-2017 & 16-07-2017 concluding
acceptable level of GMP compliance.
Decision: Approved with International pharmacopoeia specifications
397. Name and address of manufacturer / M/s. Lowitt Pharmaceuticals, Peshawar
Applicant
Brand Name +Dosage Form + Strength Calcidol 0.25mcg Tablets
Composition Each tablet contains:-
Alfacalcidol…...0.25mcg
Diary No. Date of R& I & fee 26-10-2010, Dy No. 1220, Rs.8000/,
Rs.12,000/-,16-07-2014
Type of Form Form-5
Finished product Specification Manufacturer‟s Specs
Pack size & Demanded Price 10‟s,20‟s,40‟s (As per SRO)
Me-too status Albone-D by Alliance Pharma
GMP status Last inspection report 20-07-2016 GMP is strictly
followed by the firm.
Previous remarks of the Evaluator. Firm has referred to 270th meeting wherein
Registration Board has approved formulation
Alfacalcidol tablets 0.25µg , 0.5 µg and 1 µg based on
the approval status by PMDA of Japan.
submission of latest inspection report conducted
within one year by DRAP.
conducted on 07-7-2017 concluding GMP compliance
status.
Decision: Approved with Innovator’s specification.

Applicant
Brand Name +Dosage Form + Strength Calcidol 0.5mcg Tablets
Alfacalcidol…...0.5mcg
Rs.12,000/-,17-07-2014
Type of Form Form-5
Pack size & Demanded Price 10‟s,20‟s,40‟s / As per SRO
GMP status Last inspection report 20-07-2016 GMP Is strictly
Alfacalcidol tablets 0.25µg , 0.5 µg and 1 µg based on
compliance status.
Decision of 275th meeting: Approved with Innovator’s specification.
Applicant
Brand Name +Dosage Form + Strength Calcidol 1mcg Tablets
Alfacalcidol…...1mcg
Rs.12,000/-,17-07-2014
Type of Form Form-5
Pack size & Demanded Price 10‟s,20‟s,40‟s / As per SRO
GMP status Last inspection report 20-07-2016 GMP Is strictly
Alfacalcidol tablets 0.25µg, 0.5 µg and 1 µg based on
compliance status.
400. Name and address of manufacturer / M/s Lowitt Pharma (Pvt.) Ltd, 24- Industrial Estate,
Applicant Hayatabad, Peshawar. Priority # 2062
Brand Name +Dosage Form + Strength Tablet Spaslow
Composition Each sugar coated tablet contains
Phloroglucinol Hydrate……. 80mg
Trimethylphloroglucinol…... 80mg
Diary No. Date of R& I & fee Dy. # 1053, 18-12-2012
PKR 20,000/-
Pharmacological Group Antispasmodics/anticholinergic
Type of Form Form 5
Pack size & Demanded Price 3 x 10‟s: Rs 550/-2 x 10‟s: Rs 370/-
Approval status of product in Spasfon Tablets (ANSM Approved)
Me-too status Spasfon Tablets by Himont
GMP status Last inspection report dated 07-07-2017 concluding
GMP compliance status.
Previous remarks of the Evaluator.  The innovator product is sugar coated while firm
has submitted formulation of film coated tablets
 Firm has claimed in house specifications without
the relevant documents required as per the
decision of Registration Board in its 267th
meeting, the product is not present in available
versions of BP, USP and JP
submission of revised formulation and method of
manufacturing in line with the innovator‟s product
Evaluation by PEC Firm has submitted master formulation &
manufacturing method for sugar coating tablets.
401. Name and address of manufacturer / M/s Hiranis Pharmaceuticals,pLot no. E-145-E-149,
Applicant North Western Industrial Zone, Port Qasim, Karachi
Brand Name +Dosage Form + Strength Refluxin Plus Sachet
Composition Each Sachet contains:
Omeprazole ….40 mg
Sodium bicarbonate..1680mg
Diary No. Date of R& I & fee Dy. # 386, 30-04-2014; PKR 20,000/-
Pharmacological Group PPI, ANTACID
Type of Form Form 5
Pack size & Demanded Price As per PRC/10‟s Sachet
Approval status of product in Zegerid sachet approved by USFDA
Me-too status Risek Insta Powder by Getz Pharma (Pvt.)
GMP status License renewal Inspection report dated 23-09-2013
showing compliance of GMP as Good”.
Previous remarks of the Evaluator.
Previous decision Deferred in 262nd meeting of Registration Board
submission of COA of pellets, GMP certificate of
supplier& stability studies of pellets as per Zone IV-A
conditions. Fee of pellets if imported
Evaluation by PEC  Firm has referred to 267th meeting of registration
Board wherein keeping in view the approval
status of above formulations in USFDA,
Registration Board approvedformulations of
Omperazole, Sodium Bicarbonate Sachet
40mg/1680mg without requirement of source of
pellets as omeprazole is included in powder form.

Firm has submitted copy of inspection report
conducted on 07-09-2017 concluding satisfactory
Decision: Approved with change of brand namew & with USP specification.
402. Name and address of manufacturer / M/s Genome Pharmaceuticals (Pvt.) Limited., Plot No.
Applicant 16/I Phase IV, Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Ovulin Tablet
Composition Each tablet contains
Clomiphene Citrate …… 50mg
Diary No. Date of R& I & fee Dy. # N/A, 17-08-2010; PKR 20,000/-
Pharmacological Group Anti estrogen
Type of Form Form 5
Approval status of product in Clomid of sanofi (USFDA)
Me-too status Clomicil Tablets of M/s Lowitt pharma
(Reg.#073205)
GMP status Panel inspection conducted on 14-01-2017 and
report concludes that firm is following the GMP
guidelines.
confirmation of requirement of manufacturing facility
Evaluation by PEC Firm has referred to 271st meeting of Registration
Board wherein Board deliberated the matter regarding
separate manufacturing facility requirements for
immunosuppressants and decided as under:
 There is no need for segregated / dedicated / self-
contained premises / facilities for the production
of drugs belonging to the categories namely
immunosuppressants, aromatase inhibitors
(letrozole, anastrozole) and clomiphene.
However, drugs of these classes are found highly
hazardous for workers and personnel which
remain in direct contact or are involved in close
handling of these drugs. Aforementioned drugs
are present in NIOSH (National Institute for
Occupational Safety and Health, USA) list of
Antineoplastic and Other Hazardous Drugs in
Healthcare Settings 2016, prepared by Center for
Disease Control & Prevention and National
Institute for Occupational Safety and Health.
Therefore, the safety and protective measures for
workers and personnel which remain in direct
contact or are involved in close handling of these
drugs shall be required to be established by the
manufacturers.
 Registration Board decided to grant registration of
these products in general manufacturing areas
with condition that manufacturer shall provide
safety and protective measures for workers and
personnel which remain in direct contact or are
involved in close handling of these drugs
Decision:Registration Board decided to grant registration of above applied products in

403. Name and address of manufacturer / M/s Genome Pharmaceuticals (Pvt.) Limited., Plot No.
Applicant 16/I Phase IV, Industrial Estate, Hattar
Brand Name +Dosage Form + Strength Myfetil 500mg Tablets
Mycophenolate mofetil ….500mg
Diary No. Date of R& I & fee Dy.#513(26-9-2011) Rs.8000+Rs.12,000/-(26-11-
2014)
Pharmacological Group Immunosuppressive agent
Type of Form Form 5
Me-too status Mypheno 500mg Tablets of M/s WelMark
Pharmaceutical (Reg.# 068328)
GMP status Panel inspection conducted on 14-01-2017 and
report concludes that firm is following the GMP
guidelines.
Previous decision Deferred in 264th meeting of Registration Board till
decision on the manufacturing requirement for this
product.
manufacturers.
Decision of 275th meeting:Registration Board decided to grant registration of above
applied products in general manufacturing areas with condition that manufacturer shall
provide safety and protective measures for workers and personnel which remain in direct
contact or are involved in close handling of these drugs.
404. Name and address of manufacturer / M/s Medisave Pharmaceuticals, Plot No. 578-579,
Applicant Sundar Industrial Estate, Sundar Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Joyfin Capsule
Clomiphene citrate…. 50mg
Diary No. Date of R& I & fee Fast track; 15/05/2013; Rs 60,000/-
Pharmacological Group Anti-estrogen
Type of Form Form 5
Pack size & Demanded Price 20„s; As per SRO
Approval status of product in Clomid of sanofi (USFDA)
Me-too status Clomicil Tablets of M/s Lowitt pharma
(Reg.#073205)
GMP status Last inspection report 09-5-2016 The overall status
of the firm was found to be satisfactory.
Previous remarks of the Evaluator.  Firm has submitted copy of panel inspection
report conducted on 22-12-2009 for grant of new
drug Manufacturing License, whereas the panel of
experts have recommended grant of DML for
General tablet/ Capsule Section.
 Moreover the firm has stated that they have been
granted registration for other capsule products.
 Firm has also stated alternate brand name of
Clomisave.
decision regarding requirement of manufacturing facility
for clomiphene citrate.
manufacturers.

Decision: Deferred for submission of latest inspection report conducted within one year by
DRAP.

405. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt) Ltd.
Applicant
Brand Name +Dosage Form + Strength Tacrozemus 0.1% Ointment
Composition Each gm contains:-
Tacrolimus (as monohydrate) … 1mg
Diary No. Date of R& I & fee Dy.No. 42; 06-02-2014; Rs.20,000/-
Pharmacological Group Immuno modulating agent
Type of Form Form 5
Approval status of product in Protopic ointment by M/s Leo Pharma AS approved
Me-too status Aimus Ointment by M/s Aims Pharmaceuticals
(Reg No:069939)
concluding satisfactory level of GMP compliance.
clarification whether separate manufacturing facility is
required for immunosuppressant or otherwise
immunosuppressant and decided as under:
• There is no need for segregated / dedicated /
self-contained premises / facilities for the production
immunosuppressants, aromatase inhibitors (letrozole,
anastrozole) and clomiphene. However, drugs of these
classes are found highly hazardous for workers and
Aforementioned drugs are present in NIOSH
(National Institute for Occupational Safety and
Health, USA) list of Antineoplastic and Other
Hazardous Drugs in Healthcare Settings 2016,
prepared by Center for Disease Control & Prevention
and National Institute for Occupational Safety and
Health. Therefore, the safety and protective measures
for workers and personnel which remain in direct
manufacturers.
• Registration Board decided to grant
registration of these products in general
manufacturing areas with condition that manufacturer
shall provide safety and protective measures for
workers and personnel which remain in direct contact
or are involved in close handling of these drugs
Decision of 275th meeting: Registration Board decided to grant registration of above
applied products with Innovator’s specifications in general manufacturing areas with
condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs.
406. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt) Ltd.
Applicant
Brand Name +Dosage Form + Strength Tacrozemus 0.03% Ointment
Composition Each gm contains:-
Tacrolimus (as monohydrate) …… 0.3mg
Diary No. Date of R& I & fee Dy.No. 32; 06-02-2014; Rs.20,000/-
Pharmacological Group Immuno modulating agent
Type of Form Form 5
Approval status of product in Protopic ointment by M/s Leo Pharma AS approved
Me-too status Aimus Ointment by M/s Aims Pharmaceuticals
(Reg No:069940).

concluding satisfactory level of GMP compliance.
clarification whether separate manufacturing facility is
required for immunosuppressant or otherwise
immunosuppressant and decided as under:
• There is no need for segregated / dedicated /
self-contained premises / facilities for the production
immunosuppressants, aromatase inhibitors (letrozole,
anastrozole) and clomiphene. However, drugs of these
classes are found highly hazardous for workers and
Aforementioned drugs are present in NIOSH
(National Institute for Occupational Safety and
Health, USA) list of Antineoplastic and Other
Hazardous Drugs in Healthcare Settings 2016,
prepared by Center for Disease Control & Prevention
and National Institute for Occupational Safety and
Health. Therefore, the safety and protective measures
for workers and personnel which remain in direct
manufacturers.
• Registration Board decided to grant
registration of these products in general
manufacturing areas with condition that manufacturer
shall provide safety and protective measures for
workers and personnel which remain in direct contact
or are involved in close handling of these drugs.
Decision of 275th meeting: Registration Board decided to grant registration of above
applied products with Innovator’s specifications in general manufacturing areas with
condition that manufacturer shall provide safety and protective measures for workers and
personnel which remain in direct contact or are involved in close handling of these drugs.
407. Name and address of manufacturer / M/s. Unison Chemical works lahore
Applicant
Brand Name +Dosage Form + Strength Mon 5mg Tablets
Montelukast sodium…..5mg
Diary No. Date of R& I & fee 14-06-2011, Dy. No. 2100/ , Rs. 8,000/-, Rs.12000/,
30.03.2015
Pharmacological Group Leukotriene receptor antagonist
Type of Form Form 5
Pack size & Demanded Price 14‟s, 30‟s, Rs 210/14‟s, Rs. 540/30‟s
Approval status of product in Singulair by MSD USFDA
Me-too status Aerotel of M/s Highnoon Labs
GMP status Copy of GMP inspection report conducted on 12-07-
2017 conducting on GMP compliance status.
Previous remarks of the Evaluator.  Firm has claimed Mfg Specifications while the
product is present in available pharmacopoeia (BP
2016, USP39).

clarification of dosage form as reference product is
available as chewable tablet whereas firm has applied
for film coated tablet.
Evaluation by PEC Firm has submitted revised dossier for with master
formulation and manufacturing method for chewable
tablets.
Decision: Deferred for submission o ffee of Rs.20,000/- for change of formulation.
408. Name and address of manufacturer / M/s. Jaens Pharmaceutical Industries (Pvt) Ltd. Lahore
Applicant Contract manufactured by M/s. English Pharma,
Lahore
Brand Name +Dosage Form + Strength Gaxime 400mg Capsule
Composition Each Capsule contains:-
Cefixime (as trihydrate) ….. 400mg
Diary No. Date of R& I & fee Dy No. 3094; 15-05-2013Rs.50000/-; 15-05-2013
Type of Form Form-5
Finished product Specification Manufacturer specifications.
Pack size & Demanded Price 5‟s , As Per SRO
Me-too status Cefspan 400 mg by M/s Barret Hodgson
GMP status Last inspection report Dated 24-11-2016 confirms

satisfactory compliance to GMP.
Previous remarks of the Evaluator.  Firm has submitted copy contract agreement
made on 21-07-2017 between M/s. Jaens
Pharmaceutical Industries (Pvt) Ltd. Lahore &
M/s. English Pharma, Lahore.
Previous decision Deferred in 273rd meeting of Registration Board for
submission of GMP inspection report of M/s English
Pharma, Lahore during last 1 year
Evaluation by PEC Copy of inspection report of M/s English Pharma,
Lahore conducted on 24-11-2016 confirms
satisfactory compliance to GMP.
Decision: Approved a sper Innovator’s specifications.
409. Name and address of manufacturer / M/s Weather Folds PharmaceuticalPlot No 69/2 Phase
Applicant 2, Industrial Estate, Hattar.
(Capsule section) (Cephalosporin)
No. F.3-8/2007-Lic dated (11.10.2008)
Brand Name +Dosage Form + Strength Weclor 250mg Capsule
Cefaclor monohydrate equivalent to Cefaclor….250mg
Diary No. Date of R& I & fee Dy. No.9348 20-07-2017Rs.20,000/- (12-06-2017)
Pharmacological Group (Second generation Cephalosporin antibiotic)
Type of Form Form-5
Pack size & Demanded Price As per policy of MOH/2 x 6‟s
Me-too status Pefaclor Capsule 250 mg of M/s Pearl
Pharmaceuticals, (Reg.#072726)
GMP status Copy of inspection report conducted on 04-08-2016
recommending renewal of DML.
Previous remarks of the Evaluator. Firm has stated as under;
“We have mistakenly applied for Cefaclor 375 mg
capsules. Now we have submitted correct revised
form 5 for Cefaclor 250mg capsules with maser
formulation, manufacturing procedure, Finished
[product specifications & also revised fee of Rs.
20,000/- for Cefaclor 250 mg capsule. You are
requested to treat this application as Cefaclor 250mg
capsule.
Previous decision Deferred in 273rd meeting of Registration Board for
submission of GMP inspection report of during last 1
year
Evaluation by PEC Copy of inspection report of conducted on 15-09-
2017 confirms GMP compliant status.
Decision: Approved
410. Name and address of manufacturer / M/s Weather Folds PharmaceuticalPlot No 69/2 Phase
Applicant 2, Industrial Estate, Hattar.
(Capsule section) (Cephalosporin)
No. F.3-8/2007-Lic dated (11.10.2008)
Brand Name +Dosage Form + Strength Weclor 500mg Capsule
Cefaclor monohydrate equivalent to Cefaclor...500
mg
Diary No. Date of R& I & fee (Dy. No.118) 14-03-2014Rs.20,000/-
Pharmacological Group (Second generation Cephalosporin antibiotic)
Type of Form Form-5
Pack size & Demanded Price As per policy of MOH/2 x 6‟s
Approval status of product in Cefaclor Capsule by Strides
Reference Regulatory Authorities. (MHRA Approved)
Me-too status Ceclor by AGP
GMP status Copy of inspection report of conducted on 15-09-
2017 confirms GMP compliant status
Previous remarks of the Evaluator. Evidence of Approval of Technical staff from
Licensing section is required.
1.Evidence of approval of technical staff from
licensing section.
2. Decision of CLB for renewal of DML.
Evaluation by PEC  Firm has submitted following:
i. Copy of DML stating date of issue as 27-09-
2013.
ii. A copy of letter No. F.3-6/2007-Lic (Vol-1),
dated 09-03-2017, issued by Assistant Director
(Lic.) stating the approval of technical staff as
under:
“QC Incharge: Mr. Muhammad Ismail S/o
Muhammad Aziz.”

Decision: Approved
411. Name and address of manufacturer / M/s. Unison Chemical Works.Lahore
Applicant
Brand Name +Dosage Form + Strength Xodium 50mg Capsule
Composition Each Capsule contains
Diclofanec sodium (as Pellets)…......... 50mg
Diary No. Date of R& I & fee 14-06-2011, Dy. No. 2045/, Rs. 8,000/-, 14-06-2011,
Rs.12000/, 27.03.2015
Pharmacological Group Phenyl Acetic Acid
Type of Form Form 5
Finished product Specification Mfg
Pack size & Demanded Price 2*10‟s, Rs. 165/20 capsules
Approval status of product in Not Provided
Me-too status D-Cap by English pharma

Previous remarks of the Evaluator.  Source of pellets is Vision Pharm, Islamabad
 Stability studies of pellets are provided.
 GMP Certificate of vision pharma is valid upto
Feb 2018.
 International availability cannot be confirmed
 Firm has claimed Mfg Specifications while the
product is present in available pharmacopoeia (BP
2016)
evidence of approval, of applied formulation, by
reference regulatory authorities as approved by
Registration Board in its 249th meeting.
Evaluation by PEC Firm has requested to grant registration of Diclofenac
sodium SR 100 mg tablets instead of Dicofenac
sodium 50mg capsules.
Firm has revised dossier for Dicolfenac sodium SR
100mg tablets along with Rs. 20,000/- fee. Details of
dossier are as under.
Name and address of manufacturer / M/s. Unison Chemical Works.Lahore
Applicant
Brand Name +Dosage Form + Strength Macdafin SR 100mg tablets
Diclofanec sodium…......... 100mg
Diary No. Date of R& I & fee Dy. No. 15596/-; 20-09-2017; Rs.20,000/ (20-09-
2017)
Type of Form Form 5
Approval status of product in VOLTAREN-XR of M/s Novartis approved USFDA
Me-too status Fist SR Tablets 100 mg of M/s Shaigan
Pharmaceuticals (Reg.# 066582)
Remarks of the Evaluator.  Firm has used methylene chloride as coating
solvent
Decision of 275 meeting: Registration Board acceded with firm’s request and approved
th
the application of Macdafin SR 100mg tablets (Diclofanec sodium 100 mg) & the

application of Xodium 50mg Capsule (Diclofanec sodium 50 mg) is declared as disposed
off.

 Following cases of M/s Akson Pharmaceuticals (Pvt.) Ltd. Ere deferred in 265th meeting
of registration Board for confirmation of GMP status from QA Division. Now firm has
submitted copy of inspection report conducted on 08-05-2017 stating conclusion as “The
Company is found complying GMP as of today, some minor observations noted which
need rectifications.”
The cases are now presented before the Board for consideration:
Sr.# Name and Brand Name Type of Remarks on Remarks of Decision of Decision of
address of (Proprietary Form formulation (if the 265th meeting 275th
manufactur name + Initial date, any) including Evaluator. meeting
er / Dosage Form diary International
Applicant + Strength) Fee status in
Composition including stringent drug
Pharmacologi differential regulatory
cal Group fee agencies /
Finished Demanded authorities
product Price / Me-too status
Specification Pack size GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
412. M/s. Akson Dexofen 300 Form 5 Seractil by Gebro Firm claimed Deferred for Approved
Pharmaceuti Tablets 13-05-2015 Pharma (MHRA Manufacturer confirmation with
cals Mirpur Dy.No.3356 Approved) Specification of GMP Innovator‟s
Azad Each tablet Rs.8000/= , and product status from
Tercica tablet by specification.
Kashmir contains:- Rs.12,000/= is not present QA Division
Sami Pharma
Dexibuprofen 13-05-2015 in available
….300mg 3x10‟s Last inspection versions of
Rs.398.00 report pharmacopei
(Analgesic 5-11-2016 a (BP 2013
Anti- GMP status is and USP 39)
inflammatory not clear.
413. M/s. Akson Dexofen 400 Form 5 Seractil by Gebro Firm claimed Deferred for Approved
Pharmaceuti Tablets 13-05-2015 Pharma (MHRA Manufacturer confirmation with
calsMirpur Dy.No.3374 Approved) Specification of GMP Innovator‟s
Azad Each tablet Rs.8000/= , and status from
Tercica tablet by specification.
Kashmir contains:- Rs.12,000/= product is QA Division
Sami Pharma
Dexibuprofen 13-05-2015 not present in
….400mg 3x10‟s Last inspection available
Rs.480.00 report dated versions of
(Analgesic 5-11-2016 pharmacopei
Anti- GMP status not a (BP 2013
inflammatory) clear. and USP 39)
414. M/s. Akson Afenac-100 Form 5 Aceclofenac by Firm claimed Deferred for Approved
Pharmaceuti Tablets 13-05-2015 Accord Manufacturer confirmation with
cals Mirpur Each tablet Dy.No.3357 Healthcare Specification of GMP Innovator‟s
Azad contains:- Rs.8000/= (MHRA , and product status from
specification.
Kashmir Aceclofenac Rs.12,000/= Approved) is not present QA Division
…..100mg 13-05-2015 in available
(NSAID) 2x10‟s Acemed by versions of
Rs.227.00 Novartis pharmacopei
a (BP 2013
Last inspection
and USP 39)
report
5-11-2016
GMP status not
clear.
415. M/s. Akson Nil-Clotes Form 5 Apo- Firmclaimed Deferred for Deferred for
Pharmaceuti Tablets 13-05-2015 Clopidogrel/As Manufacturer confirmation deliberation
cals Mirpur Dy.No.3367 pirin Specification of GMP on

Azad Each tablet Rs.8000/= (TGA , and product status from formulation
Kashmir contains:- Rs.12,000/= Approved) is not present QA Division of
Clopidogrel 13-05-2015 in available Clopidogrel+
Bisulfate 10‟s Ascard Plus by versions of Aspirin
97.86mg Rs.205.00 Atco pharmacopei tablets in the
equivalent to a (BP 2013 light of
Clopidogrel Last inspection and USP 39) reference
…...75mg report product
Aspirin 5-11-2016
…...75mg GMP status not
(Thienopyridi clear.
ne
antiplatelet)
416. M/s. Akson B-1 Tablets Form 5 Boniva by Firm claimed Deferred for Approved
Pharmaceuti 13-05-2015 Hoffmann La Manufacturer confirmation with
cals Mirpur Each tablet Dy.No.3361 Roche Specification of GMP Innovator‟s
Azad contains: Rs.8000/= (USFDA , and product status from
specification.
Kashmir Ibandronate Rs.12,000/= Approved) is not present QA Division
(as 13-05-2015 in available
Adronil by
Sodium)…..1 1‟s versions of
Searle
50mg Rs.2000.00 pharmacopei
Last inspection a (BP 2013
(Aminobispho report and USP 39)
phonate) 5-11-2016
GMP status not
clear.
417. M/s. Akson Parasol Extra Form 5 Paracaff Firm claimed Deferred for Approved
Pharmaceuti Tablets 13-05-2015 (TGA Mfg. confirmation with USP
cals Mirpur Dy.No.3366 Approved) Specification of GMP specification.
Azad Each tablet Rs.8000/= , while it is status from
Kashmir contains:- Rs.12,000/= Calpol Plus by present in QA Division
Paracetamol 13-05-2015 GSK USP39
…500mg 10x10‟s Last inspection
Caffeine…..6 Rs.270.00 report
5mg 5-11-2016
(Non Narcotic GMP status not
analgesic) clear.
418. M/s. Akson G-Stril 5mg Form 5 Zestril by Firm claimed Deferred for Approved
Pharmaceuti Tablets 13-05-2015 Alvogen Malta Mfg. confirmation with USP
cals Mirpur Dy.No.3358 (USFDA Specification of GMP specification.
Azad Each tablet Rs.8000/= Approved) , while status from
Kashmir contains:- Rs.12,000/= Zestril by ICI product is QA Division
Lisinopril (as 13-05-2015 Last inspection present in BP
Dihydrate)… 2x10‟s report 2013 and
……..5mg Rs.140.00 5-11-2016 USP 39.
GMP status not
(ACE clear.
inhibitor)
419. M/s. Akson G-Stril 10mg Form 5 Zestril by Firm claimed Deferred for Approved
Pharmaceuti Tablets 13-05-2015 Alvogen Malta Mfg. confirmation with USP
calsMirpur Dy.No.3359 (USFDA Specification of GMP specification.
Azad Each tablet Rs.8000/= Approved) , while status from
Lisinopril (as 13-05-2015 Zestril by ICI present in BP
Dihydrate)… 2x10‟s Last inspection 2013 and
….10mg Rs.228.00 report USP 39.
5-11-2016
(ACE GMP status not
inhibitor) clear.
420. M/s. Akson C-Statin 10 Form 5 Lipitor by Firm claimed Deferred for Approved
Pharmaceuti Tablets 13-05-2015 Pfizer Manufacturer confirmation with
calsMirpur Dy.No.3363 (USFDA Specification, of GMP Innovator‟s
Azad Each tablet Rs.8000/= Approved) and product status from specification.
Atorvastatin 13-05-2015 Lipitor by in available
(as Calcium 10‟s Pfizer versions of
Trihydrate)… Rs.662.81 Last inspection pharmacopeia
………10mg report (BP 2013 and
5-11-2016 USP 39)
(Statin) GMP status not
clear.
421. M/s. Akson C-Statin 20 Form 5 Lipitor by Firm claimed Deferred for Approved
Pharmaceuti Tablets 13-05-2015 Pfizer Manufacturer confirmation with
calsMirpur Dy.No.3364 (USFDA Specification, of GMP Innovator‟s
Azad Each tablet Rs.8000/= Approved) and product status from
specification.
Atorvastatin 13-05-2015 Lipitor by in available
(as Calcium 10‟s Pfizer versions of
Trihydrate)… Rs.1128.60 Last inspection pharmacopeia
………20mg report (BP 2013 and
5-11-2016 USP 39)
(Statin) GMP status not
clear.
422. M/s. Akson Calcipine-5 Form 5 Norvasc by Firm claimed Deferred for Approved
Pharmaceuti Tablets 13-05-2015 Pfizer Mfg. confirmation with USP
Azad Each tablet Rs.8,000/= Approved) while status from
Amlodipine 13-05-2015 Norvasc by present in
Besilate 2x10‟s Pfizer USP 39
equivalent to Rs.238.50
Amlodipine… Last inspection
.5mg report
5-11-2016
(Calcium GMP status not
channel clear.
blocker)
423. M/s. Akson Calcipine-10 Form 5 Norvasc by Firm claimed Deferred for Approved
Pharmaceuti Tablets 13-05-2015 Pfizer Mfg. confirmation with USP
Azad Each tablet Rs.8000/= Approved) while status from
Kashmir contains:- Rs.12,000/= Norvasc by product is QA Division
Amlodipine 13-05-2015 Pfizer present in
Besilate eq. to 2x10‟s Last inspection USP 39
Amlodipine… Rs.466.50 report
..10mg 5-11-2016
(Calcium GMP status not
channel clear.
blocker)
424. M/s. Akson Dolofen Form 5 Mefenamic Firm has Deferred for Approved
Pharmaceuti Forte Tablets 13-05-2015 Acid 500mg claimed Mfg. confirmation with BP
calsMirpur Dy.No.3354 Tablets by Specification of GMP specification.
Azad Each tablet Rs.8000/= Teva UK while status from
Kashmir contains:- Rs.12,000/= (MHRA product is QA Division
Mefenamic 13-05-2015 Approved) present in BP
Acid….500m 10x10‟s 2013
g Rs.475.00 Ponsac
byBrookesPhar
(NSAID) ma
Last inspection
report
5-11-2016
GMP status not
clear.
 Following cases of M/s M/s FAAS Pharmaceuticals (Pvt.) Ltd, F-748L, S.I.T.E, Karachi
were deferred for clarification and details of already approved/deferred applications since
grant of DML.
Now Firm has submitted as under:
“We would like to inform you that we have three sections, our quota of two sections i.e.
tablet & capsule is completed only sachet section is remaining. We hereby request you to
consider our deferred products in queue for upcoming meetings.”
 The cases are now presented before the Board for consideration:
S/N Name and address Brand Name Type of Form International Decision of
of manufacturer / (Proprietary name + Initial date, status in stringent 275th meeting
Applicant Dosage Form + diary regulatory
Strength) Fee including agencies
Composition differential fee Me-too status
Pharmacological Demanded GMP status as
Group Price / Pack depicted in
Finished product size inspection report
Specification (dated)
425. M/s FAAS Tablet Rostin10mg Form 5 with Crestor-MHRA Approved with
Pharmaceuticals Each film coated tablet fee Rs 20,000/- innovator‟s
(Pvt.) Ltd, F-748L, contains vide Dy. # 506 Pasage by Werrick specification.
S.I.T.E, Karachi Rosuvastatin (as dated
calcium) 10mg 11.04.2016
Lipid regulating drug Pack of blister
Manufacture 1 x 10s as per
Specification PRC
426. M/s FAAS Tablet Rostin 20mg Form 5 with Crestor-MHRA Approved with
Pharmaceuticals Each film coated tablet fee Rs 20,000/- innovator‟s
(Pvt.) Ltd, F-748L, contains vide Dy. # 507 Pasage by Werrick specification.
S.I.T.E, Karachi Rosuvastatin (as dated
calcium) 20mg 11.04.2016
Lipid regulating drug Pack of blister
Manufacture 1 x 10s as per
Specification PRC
427. M/s FAAS Tablet Sgliptin 50mg Form 5 with Januvia by MSD- Approved with
Pharmaceuticals Each film coated tablet fee Rs 20,000/- MHRA USP
(Pvt.) Ltd, F-748L, contains vide Dy. # 510 Sita-CCl specification.
S.I.T.E, Karachi Sitagliptin phosphate dated
monohydrate eq to 11.04.2016
sitagliptin 50mg Pack of blister
Anti-diabetic 2 x 10s as per
USP Specification PRC
428. M/s FAAS Tablet Sgliptin 100mg Form 5 with Januvia by MSD- Approved with
Pharmaceuticals Each film coated tablet fee Rs 20,000/- MHRA USP
(Pvt.) Ltd, F-748L, contains vide Dy. # 511 Sita-CCl specification.
S.I.T.E, Karachi Sitagliptin phosphate dated
monohydrate eq to 11.04.2016
sitagliptin 100mg Pack of blister
Anti-diabetic 2 x 10s as per

429. M/s FAAS Tablet Hepavir 0.5mg Form 5 with Baraclude-MHRA Approved with
Pharmaceuticals Each film coated tablet fee Rs 20,000/- Local Availability: USP
(Pvt.) Ltd, F-748L, contains vide Dy. # 505 Obee by Genome specification.
S.I.T.E, Karachi Entecavir ( as dt:11-04-2016 pharma.
monohydrate) 0.5mg Pack of blister
Anti-viral 3 x 10s as per
430. M/s FAAS Tablet Hepavir 1mg Form 5 with Baraclude-MHRA Approved with
Pharmaceuticals Each film coated tablet fee Rs 20,000/- Local Availability: USP
(Pvt.) Ltd, F-748L, contains vide Dy. # 503 Obee by Genome specification.
S.I.T.E, Karachi Entecavir (as dated pharma
monohydrate) … 1mg 11.04.2016
Anti-viral Pack of blister
USP Specification 3 x 10s as per
PRC
431. M/s FAAS Tablet Sitamet 50/500 Form 5 with TGA approved Approved
Pharmaceuticals Each film coated tablet fee Rs 20,000/- Janumet -Australia with
(Pvt.) Ltd, F-748L, contains vide Dy.# 1048 Tagipmet - innovator‟s
S.I.T.E, Karachi Sitagliptin phosphate dated Highnooon specification.
monohydrate 50 mg 24-05-2016
Metformin HCl 500mg Pack size &
Anti-diabetic price as per
Manufacture SRO
Specification
432. M/s FAAS Tablet Pantocid 20mg Form 5 with MHRA approved Approved with
Pharmaceuticals Each enteric coated fee Rs 20,000/- pantoloc - USP
(Pvt.) Ltd, F-748L, tablet contains vide Dy. # Novartis specification.
S.I.T.E, Karachi Pantoprazole (as 1053 dated Zopent - Hilton
sodium Sesquihydrate) 23.05.2016
20mg Pack size &
Anti ulcerant / PPI price as per
USP Specification SRO
433. M/s FAAS Tablet Boncidol Form 5 with Approved by Approved
Pharmaceuticals 0.5mcg fee Rs 20,000/- PMDA with
(Pvt.) Ltd, F-748L, Each tablet contains vide Dy. # Adela - Getz innovator‟s
S.I.T.E, Karachi Alfacalcidol 0.5 mcg 1049 dated specification.
Vitamin D analogue 23.05.2016
Manufacture Pack size &
Specification price as per
SRO
434. M/s FAAS Tablet Boncidol 1mcg Form 5 with Approved by Approved
Pharmaceuticals Each tablet contains fee Rs 20,000/- PMDA with
(Pvt.) Ltd, F-748L, Alfacalcidol 1.0 mcg vide Dy. # Adela - Getz innovator‟s
S.I.T.E, Karachi Vitamin D analogue 1054 dated specification.
Manufacture 23.05.2016
Specification Pack size &
price as per
SRO
435. M/s FAAS Tablet Faasfodine Form 5 with ALLEGRA HIVES- Approved with
Pharmaceuticals 60mg fee Rs 20,000/- USFDA USP
(Pvt.) Ltd, F-748L, Each film coated tablet vide Dy. # 740 Adine 60 mg Pfizer specification
S.I.T.E, Karachi contains dated 4-5-2016 lab
Fexofenadine HCl Pack size of
60mg 10‟s Rs. 76/-
Antihistamine Per tablet
USP Specification Rs.7.6/-

436. M/s FAAS Tablet Faasfodine Form 5 with Fexofenadine 120 Approved with
Pharmaceuticals 120mg fee Rs 20,000/- mg USP
(Pvt.) Ltd, F-748L, Each film coated tablet vide Dy. # 740 (MHRA) specification
S.I.T.E, Karachi contains dated 4-5-2016 Adine 120 mg Pfizer
Fexofenadine HCl Pack size of lab
120mg 10‟s Rs. 266/-
Antihistamine Per tablet
437. M/s FAAS Tablet Naprosin Form 5 with Naproxen 500mg Approved with
Pharmaceuticals 550mg fee Rs 20,000/- Tablets- Accord USP
(Pvt.) Ltd, F-748L, Each delayed release vide Dy. # 741 Healthcare (MHRA) specification
S.I.T.E, Karachi tablet contains dated 4-5-2016 Anex -Pharmevo
Naproxen Sodium Pack size 2 x
550mg eq to Naproxen 10s as per SRO
500 mg
NSAID
USP Specification
438. M/s FAAS Tablet Telsartin 40mg Form 5 with MHRA approved Approved
Pharmaceuticals Each tablet contains fee Rs 20,000/- Tolura – with USP
(Pvt.) Ltd, F-748L, Telmisartan 40mg vide Dy. # 504 Consilient specification
S.I.T.E, Karachi Anti-hypertensive dated Normisar –
USP Specification 11.04.2016 Nabiqasim
Pack of blister
1 x 10s as per
PRC
439. M/s FAAS Tablet Telsartin 80mg Form 5 with MHRA approved Approved
Pharmaceuticals Each tablet contains fee Rs 20,000/- Tolura – with USP
(Pvt.) Ltd, F-748L, Telmisartan 80mg vide Dy. # 519 Consilient specification
S.I.T.E, Karachi Anti-hypertensive dated Normisar –
USP Specification 11.04.2016 Nabiqasim
Pack of blister
1 x 10s as per
PRC
440. M/s FAAS Tablet Lidzol 400 mg Form 5 with FDA approved Approved
Pharmaceuticals Each film coated tablet fee Rs 20,000/- Zyvox -Pfizer with
(Pvt.) Ltd, F-748L, contains vide Dy. # 742 Bisca - innovator‟s
S.I.T.E, Karachi Linezolid 400mg dated Pharmedics specification
Antibiotics 11.04.2016
12‟s pack
Rs.650/-
Per tablet
Rs.54.16
441. M/s FAAS Tablet Linezolid 600 Form 5 with FDA approved Approved
Pharmaceuticals mg fee Rs 20,000/- Zyvox -Pfizer with
(Pvt.) Ltd, F-748L, Each film coated tablet vide Dy. # 737 Bisca - innovator‟s
S.I.T.E, Karachi contains dated 3-5-2016 Pharmedics specification
Linezolid 600mg 12s pack
Antibiotics Rs.960/-
Per tablet
Rs.80/-
442. M/s FAAS Tablet Dempride 2mg Form 5 with MHRA approved Approved
Pharmaceuticals Each tablet contains fee Rs 20,000/- brand of Accord with USP
(Pvt.) Ltd, F-748L, Glimepiride 2mg vide Dy. # 507 Amaryl –Sanofi specification
S.I.T.E, Karachi Anti-diabetic dt: 11-04-2016
USP Specification Pack size 2 x
10‟s as per
SRO

443. M/s FAAS Tablet Dempride 4mg Form 5 with MHRA approved Approved
(Pvt.) Ltd, F-748L, Glimepiride 4mg vide Dy. # 507 Amaryl –Sanofi specification
S.I.T.E, Karachi Anti-diabetic dt: 11-04-2016
USP Specification Pack size 2 x
10‟s as per
SRO
444. M/s FAAS Tablet Clarifaas Form 5 with MHRA approved Approved
Pharmaceuticals 250mg fee Rs 20,000/- brand of with USP
(Pvt.) Ltd, F-748L, Each film coated tablet vide Dy. # 733 aurobindo specification
S.I.T.E, Karachi contains dt: 04-05-2016 Klaricid – Abbott
Clarithromycin 250mg Pack size 1 x
Antibacterial 10‟s Rs.
USP Specification 199.50/-
Per tablet Rs.
19.95/-
445. M/s FAAS Tablet Clarifaas Form 5 with MHRA approved Approved
Pharmaceuticals 500mg fee Rs 20,000/- brand of with USP
(Pvt.) Ltd, F-748L, Each film coated tablet vide Dy. # 732 aurobindo specification
S.I.T.E, Karachi contains dt: 04-05-2016 Klaricid – Abbott
Clarithromycin 500mg Pack size of
Antibiotics 10‟s
Per tablet
Rs.38.951/-
446. M/s FAAS Tablet Delobid 500mg Form 5 with FDA approved Approved
Pharmaceuticals Each film coated tablet fee Rs 20,000/- Dolobid- Merck with USP
(Pvt.) Ltd, F-748L, contains vide Dy. # USA specification
S.I.T.E, Karachi Diflunisal 500mg 1053 dated Dolobis – Genome
NSAID 23.05.2016
USP Specification Pack size &
price as per
SRO
447. M/s FAAS Tablet Faasrox 250mg Form 5 with MHRA approved Approved
(Pvt.) Ltd, F-748L, Naproxen 250mg vide Dy. # 736 Dolonap - specification
S.I.T.E, Karachi NSAID dt: 04-05-2016 platinum
USP Specification Pack size
30s  Rs.145/-
Per
tabletRs.4.83/-
448. M/s FAAS Tablet Detoxib 60mg Form 5 with MHRA approved Approved
Pharmaceuticals Each film coated tablet fee Rs 20,000/- brand Arcoxia with
(Pvt.) Ltd, F-748L, contains vide Dy. # 734 Starcox - Getz innovator‟s
S.I.T.E, Karachi Etoricoxib 60mg dt: 04-05-2016 specification.
COX II inhibitor Pack size 10s
Manufacture Rs. 100/-
Specification
449. M/s FAAS Tablet Florofen 100 Form 5 with FDA approved Approved
Pharmaceuticals mg fee Rs 20,000/- Ansaid - Pfizer with USP
(Pvt.) Ltd, F-748L, Each film coated tablet vide Dy. # Ansaid -Pfizer specification
S.I.T.E, Karachi contains 1045 dated
Flurbiprofen 100mg 24.05.2016
NSAID Pack size &
USP Specification proce as per
SRO

450. M/s FAAS Tablet Cynofen Form 5 with A Brand of eisai, Approved
Pharmaceuticals 500mcg fee Rs 20,000/- Japan with JP
(Pvt.) Ltd, F-748L, Each sugar coated Dy. # 1051 dt: Incobal -indus specification
S.I.T.E, Karachi tablet contains 24.05.2016
Mecobalamin 500 mcg Pack size &
Vitamin B-12 price as per
Manufacture SRO
Specification
451. M/s FAAS Tablet Spasmin 135 Form 5 with MHRA approved Approved
Pharmaceuticals mg fee Rs 20,000/- Colofac with BP
(Pvt.) Ltd, F-748L, Each sugar coated vide Dy. # Colofac - specification
S.I.T.E, Karachi tablet contains 1044 dated Highnoon
Mebeverine BP 135mg 24.05.2016
antispasmodic Pack size &
Manufacture price as per
Specification SRO
452. M/s FAAS Capsule Faasgablin Form 5 with USFDA approved Approved
Pharmaceuticals 50mg fee Rs 20,000/- Gabica - Getz with
(Pvt.) Ltd, F-748L, Each capsule contains vide Dy. # 734 innovator‟s
S.I.T.E, Karachi Pregabalin 50mg dated specification.
Anti-epileptic 24.05.2016
Manufacture Pack size 14‟s
Specification Rs.175/-
453. M/s FAAS Capsule Faasgablin Form 5 with USFDA approved Approved
Pharmaceuticals 100mg fee Rs 20,000/- Gabica - Getz with
(Pvt.) Ltd, F-748L, Each capsule contains vide Dy. # 738 innovator‟s
S.I.T.E, Karachi Pregabalin 100mg dt: 24-05-2016 specification.
Anti0epileptic Pack size 14s
Manufacture ;Rs. 175/-
Specification
454. M/s FAAS Capsule Hicerin 50mg Form 5 with Approved by Approved
Pharmaceuticals Each capsule contains fee Rs 20,000/- AGES of Austria with
(Pvt.) Ltd, F-748L, Diacerin 50mg Dy. # 1047 dt: innovator‟s
S.I.T.E, Karachi Anti-rheumatic 24-05-2016 Omefast of M/s specification.
Manufacture Pack size & Efroz
Specification price as per Pharmaceuticals,
SRO Karachi

Evaluator PEC-VII
455. Name and address of manufacturer / M/s Amarant Pharmaceuticals, 158 D. tore, /Gadap road,
Applicant superhighway Karachi.
Brand Name +Dosage Form + Strength Itoride SR 150mg Capsule
Composition Each sustained release capsule contains:
Itopride HCl…….150 mg
Pharmacological Group Gastrointestinal drugs
Type of Form Form-5
Finished Product Specification NA
Pack size & Demanded Price 10‟s / 14‟s / 20‟s ; As per PRC
Me-too status Neogerd SR by Helix pharma
GMP status Last GMP Inspection of Amarant Pharmaceuticals
cGMP compliance
Remarks of the Evaluator.  Letter was issued on 12 April 2017
 Itopride 150 mg is rejected as per decision of Board in
250th meeting due to unavailability in reference
regulatory authority.
Previous decision of 273 meeting: Deferred due to paucity of time
Remarks:Itopride 150 mg is rejected previously as per decision of Board in 250th meeting due to
unavailability in reference regulatory authority.
Decision of 275th meeting: Deferred for evidence of approval of applied formulation in
reference regulatory authorities/agencies the Registration Board.
456. Name and address of manufacturer / M/s Amarant Pharmaceuticals, 158 D. tore, /Gadap road,
Applicant superhighway Karachi.
Brand Name +Dosage Form + Strength Facal D 1mcg Tablet
Alfacalcidol……..1 mcg
Type of Form Form-5
Finished Product Specification As per manufacturer
Pack size & Demanded Price 10‟s / 20‟s As per PRC

Approval status of product in Reference PMDA
Me-too status Adela by Getz Pharma
GMP status Last GMP Inspection of Amarant Pharmaceuticals
cGMP compliance
Remarks of the Evaluator.  Letter was issued on 12 April 2017
 Firm provide undertaking to provide
shortcomings after performing stability.
Previous decision of 273 meeting: Deferred due to paucity of time
Decision of 275th meeting: Approved with innovator’s specification
457. Name and address of manufacturer / M/s. Dyson Research Labs 28 km, Ferozpur road Lahore
Applicant
Brand Name +Dosage Form + Strength Rifaxidine Tablets 550mg
Composition Each film tablet contains:-
Rifaximin…..550mg
Pharmacological Group Non-aminoglycoside antibiotic
Type of Form Form-5
Pack size & Demanded Price 10‟s / As Per SRO
Approval status of product in Reference Xifaxan by salix (USFDA)
Me-too status Nixaf by Sami
GMP status Last GMP Inspection of Dyson Research Labs
renewal of license.
Remarks of the Evaluator.  Inspection report is not within the period of 1 year.
 Firm requested for inspection for export purpose in
January 2017. They give 2 reminder in March and
May and requested to consider the same in front of
the registration board.
Previous decision of 271 meeting: Deferred for latest GMP inspection report conducted within past
one year.
Remarks:Latest inspection is of 1-8-2017, with conclusive remarks of satisfactory level f GMP
compliance.
458. Name and address of manufacturer / M/s. Dyson Research Labs 28 km, Ferozpur road Lahore
Applicant
Brand Name +Dosage Form + Strength Rifaxidine Tablets 200 mg
Composition Each film tablet contains:-
Rifaximim…..200 mg
Pharmacological Group Non-aminoglycoside antibiotic
Type of Form Form-5
Pack size & Demanded Price 10‟s ; As Per SRO
Approval status of product in Reference Xifaxan by salix (USFDA)
Me-too status Nixaf by Sami
GMP status Last GMP Inspection of Dyson Research Labs
renewal of license.
Remarks of the Evaluator.  Inspection report is not within the period of 1 year.
 Firm requested for inspection for export purpose in
January 2017. They give 2 reminder in March and
May 2017, and requested to consider the same in
front of the registration board.
Previous decision of 271 meeting
Deferred for latest GMP inspection report conducted within past one year.
Remarks:
Latest inspection is of 1-8-2017, with conclusive remarks of satisfactory level of GMP compliance.
459. Name and address of manufacturer / M/s. Weather Fold Pharmaceuticals, 69/2, phase II,
Applicant industrial area Hattar
Brand Name +Dosage Form + Strength Cetfold Syrup
Composition Each ml contains:-
Cetirizine HCl……….1mg
Type of Form Form-5

Pack size & Demanded Price 60 ml; As Per SRO

Approval status of product in Reference Cetirizine by Taro (USFDA)
Me-too status Netset by surge
GMP status Last GMP Inspection of M/s Weather Fold
Pharmaceuticals Conducted on 4-8-2016 with
Remarks of the Evaluator. •Inspection report is not within the past 1 year
Decision of 273 meeting:
Remarks:
Latest inspection report dated 15th sep 2017 is provided with conclusive remarks of cGMP
compliance.
Decision of 275th meeting: Approved
Brand Name +Dosage Form + Strength Gratron 1mg Syrup
Granisetron HCl……..1mg
Type of Form Form-5
Finished Product Specification Manufacturers
Pack size & Demanded Price 30 ml / 60 ml/ 120 ml

As Per SRO
Approval status of product in Reference Kytril by Roche (USFDA)
Me-too status Graniset syrup by SJG pharma
Remarks of the Evaluator. •Inspection report is not within the past 1 year
Remarks:
Latest inspection report dated 15th sep 2017 is provided with conclusive remarks of cGMP
compliance.
Brand Name +Dosage Form + Strength Zotifold 0.25mg Syrup
Pizotifen……………0.25 mg
Pharmacological Group benzocycloheptene-based drug
Type of Form Form-5
Pack size & Demanded Price 1 x 120ML / 1 x 60 ml
As Per SRO
Me-too status COFSYL By POLYFINE CHEMPHARMA (PVT)

LTD.
Remarks of the Evaluator. Rejected in 255 meeting for:
• The board observed that off label use of pizotifen syrup
is appetite stimulant which is not indicated in any
literature.
• Pizotifen is indicated in cluster headache which is not
present among children that‟s why pizotifen is not
required in syrup dosage form.
• The board also advised to issue the show cause notice
to already
registered pizotifen syrups
•Inspection report is not within the past 1 year
Decision of 273 meeting:Deferred for latest GMP inspection report conducted within past one year.
Remarks:
 Latest inspection report dated 15th sep 2017 is provided with conclusive remarks of cGMP
compliance.
 The board observed that off label use of pizotifen syrup is appetite stimulant which is not
indicated in any literature.
• Pizotifen is indicated in cluster headache which is not present among children
that‟s why pizotifen is not required in syrup dosage form. In previous meeting the
board also advised to issue the show cause notice to already registered pizotifen
syrups
Decision: Deferred for clarification as firm has mentioned correct pharmacological group but
mention apetite stimulant in indications.
462. Name and address of manufacturer / M/s.Alen Pharmaceuticals (Pvt) Ltd, Plot # 138,
Applicant Nowshera industrial estate, Risalpur
Brand Name +Dosage Form + Strength Clomotil Tablets
Clomiphene Citrate…..50mg
Pharmacological Group Anti-oestrogens
Type of Form Form-5
Pack size & Demanded Price 1x10‟s /As Per SRO

Approval status of product in Reference Clomid of sanofi (USFDA)
Me-too status Clocit by Cirin
GMP status Last GMP Inspection of M/s Alen pharma Conducted on
14-10-2016 with conclusive remarks of cGMP
compliance.
Remarks of the Evaluator. Letter dated, 16, August, 2017
•Commitments required as per decision of Registration
Board taken in its 251st meeting, since the commitment
pertaining to follow Drugs (Specification) Rules, 1978 is
missing.
•Latest GMP inspection report (which should have been
conducted within the period of last one year).
•Evidence of pharmacopoeial reference of finished
product specification. In case, the product is non
pharmacopoeial, submit product specification in the
light of decision taken in 267th meeting of Registration
Board.

•Approval of section/manufacturing facility by the
Central Licensing Board. However, you may submit
panel inspection report for renewal of DML verifying
the section/manufacturing facility.
Deferred due to paucity of time.
Remarks:
 Latest inspection report dated 14-10-2016 for Routine GMP Inspection. Overall GMP was
well maintained.
Registration Board deliberated the matter in light of above information and decided as under:
a) There is no need for segregated / dedicated / self-contained premises / facilities for the
production of drugs belonging to the categories namely immunosuppressants, aromatase inhibitors
(letrozole, anastrozole) and clomiphene. However, drugs of these classes are found highly
hazardous for workers and personnel which remain in direct contact or are involved in close
handling of these drugs. Aforementioned drugs are present in NIOSH (National Institute for
Occupational Safety and Health, USA) list of Antineoplastic and
 Draft Minutes for 271st Registration Board Meeting 15
 Other Hazardous Drugs in Healthcare Settings 2016, prepared by Center for Disease Control &
Prevention and National Institute for Occupational Safety and Health. Therefore, the safety and
protective measures for workers and personnel which remain in direct contact or are involved in
close handling of these drugs shall be required to be established by the manufacturers.
Decision of 275th meeting: Registration Board decided to grant registration of above applied
products in general manufacturing areas with condition that manufacturer shall provide
safety and protective measures for workers and personnel which remain in direct contact or
are involved in close handling of these drugs.
463. Name and address of manufacturer / M/s. Usawa pharma, 146, special industrial zone, Risalpur
Applicant
Brand Name +Dosage Form + Strength Afixim Forte Dry Suspension
Diary No. Date of R& I & fee Dy No.274, 11-4-2013, Rs.20000/-
Cefixime (as trihydrate)…….200mg
Type of Form Form-5
Finished Product Specification USP Specs
Pack size & Demanded Price As Per SRO / 30 ml

Approval status of product in Cefixime By Aurobindo Pharma Ltd (USFDA)
Me-too status AG-FIX by Saydon Pharma
GMP status Last GMP Inspection of conducted on 22-3-17 with
conclusive remarks of grant of renewal of drug
manufacturing license by way of formulation.
Remarks of the Evaluator. Undertaking as per recommendation of 251 meeting not
provided.
Decision of 269th Meeting
Deferred as Undertaking as per recommendation of 251 meeting not provided although
shortcomings were conveyed to the firm.
Remarks:
All the short comings are rectified.
464. Name and address of manufacturer / M/s Ciba Pharmaceuticals, A-371, Nooriabad site
Applicant industrial area, superhighway (Hyderabad) Karachi.
Brand Name +Dosage Form + Strength Cidine 4mg Tablet

Tizanidine as HCl…………4mg
Composition Dy.No.1708, 30-8-2016, Rs.20,000/-
Type of Form Form-5

Approval status of product in Tizanidine 4mg Tablets by M/s Actavis UK Ltd
Reference Regulatory Authorities. (MHRA)
Me-too status Musidin 4mg Tablet by M/s Martin Dow (Reg#037105)
remarks of Good level of cGMP compliance.
Decision of 274 meeting:Deferred for latest GMP inspection report conducted within past one
year.
Remarks:Latest GMP inspection report has been provided.
Brand Name +Dosage Form + Strength Cibamin 500mcg Tablet
Diary No. Date of R& I & fee Each sugar coated tablet contains:
Mecobalamin………500 mcg
Pharmacological Group Form of Vitamin B
Type of Form Form-5

Approval status of product in PMDA
Me-too status Anacobin by Epharm
year.
Decision: Approved with innovator’s specification
Brand Name +Dosage Form + Strength Lorocam 8mg Tablet
Lornoxicam………8 mg
Pharmacological Group Anti-Inflammatory
Type of Form Form-5

Approval status of product in Xefo 8 mg (ANSM approved)

Remarks:
Latest GMP inspection report has been provided.
Brand Name +Dosage Form + Strength Dico-P 75mg Tablet
Diary No. Date of R& I & fee Each tablet contains:
Diclofenac potassium…75mg
Pharmacological Group Analgesic, anti-inflammatory
Type of Form Form-5

Me-too status Artimov-K by Barrett Hodgson
Remarks of the Evaluator. Diclofenac Potassium is not registered in any reference
country in dose more than 50mg, thus Registration
Board in its 258th meeting decided to issue show cause
notices to manufacturers of Diclofenac Potassium (75
and 100mg) for de-registration of these products.
Decision of 274:Deferred due to latest GMP and following reason
Diclofenac Potassium is not registered in any reference country in dose more than 50mg, thus
Registration Board in its 258th meeting decided to issue show cause notices to manufacturers of
Diclofenac Potassium (75 and 100mg) for de-registration of these products.
Decision of 275th meeting: Deferred for evidence of approval of applied formulation in

reference regulatory authorities/agencies.
Brand Name +Dosage Form + Strength Dico-SR Tablet
Diary No. Date of R& I & fee Each sustained release tablet contains:
Diclofenac sodium…..100 mg
Type of Form Form-5

Approval status of product in Diclofenac sodium of VPNA (USFDA)
Me-too status Catafen of Cibex pharma

Remarks of the Evaluator. Latest GMP inspection report (which should have been
conducted within the period of last one year) missing
Remarks:

Brand Name +Dosage Form + Strength Tromid-P Tablet
Diary No. Date of R& I & fee Each sustained release tablet contains:
Tramadol…….37.5mg
Paracetamol……325 mg
Pharmacological Group Opiate analogue + Analgesic.
Type of Form Form-5

Approval status of product in Ultra Cet by Janssen pharma (USFDA)
Me-too status Acetra by Amarents
Brand Name +Dosage Form + Strength Tromid SR Tablet
Diary No. Date of R& I & fee Each film coated sustain released tablet contains:
Tramadol…….100mg
Pharmacological Group Opiate analogue
Type of Form Form-5

Approval status of product in Tilodol of Sandoz (MHRA)
Me-too status Callfina by AGP

Brand Name +Dosage Form + Strength Ferona Capsule
Diary No. Date of R& I & fee Each capsule contains:
Iron polymaltose complex eq.to Elemental Iron…100mg
Folic acid………..350 μg
Pharmacological Group Erythropoietics , haematinics
Type of Form Form-5

Approval status of product in NA
Me-too status Cress-F of Zephyr pharma
Decision of 275th meeting: Approved with innovator’s specification.

Brand Name+Dosage Form + Strength Oxicam 20mg Tablet
Piroxicam betacyclodextrain eq. to Piroxicam … 20mg
Type of Form Form-5

Approval status of product in CYCLADOL 20 Mg Tablets by Chiesi SAS
Reference Regulatory Authorities. (ANSM France)
Me-too status Ripax 20mg by Hilton
Brand Name+Dosage Form + Strength Olanza-Plust Capsule
Olanzapine ………12 mg
Fluoxetine (as HCl)………..25 mg
Pharmacological Group SSRI, Anti-Psychotopic
Type of Form Form-5

Approval status of product in Symbyax by Eli Lilly (USFDA Approved)
Me-too status Olanco by Genome
year.
Brand Name +Dosage Form + Strength Lindacin V-Cream
Clindamycin phosphate eq. to Clindamycin……20 mg
Type of Form Form-5

Approval status of product in Cleocin of Pharmacia (USFDA)
Me-too status Calimax of Medisure
Remarks:
Brand Name +Dosage Form + Strength Hista 10mg Tablet
Ebastine………….10 mg
Type of Form Form-5

Approval status of product in Kestine 10mg tablet by M/s Almirall Pharmaceuticals,
Reference Regulatory Authorities. (ANSM France Approved)
Me-too status Ebofor 10mg Tablet by M/s Genome Pharmaceutical
476. Name and address of manufacturer / M/s Baxter Pharmaceuticals, a-1/A, Phase I, SITE,
Applicant Karachi.
Brand Name +Dosage Form + Strength Dinar 125mg/5ml Dry suspension
Diary No. Date of R& I & fee Dyn:327, 18-12-2014, Rs.20,000/-
Cephradine….125 mg
Type of Form Form-5
Pack size & Demanded Price 120 ml / As Per SRO
Approval status of product in VELOSEF '125' of Apothecon (USFDA) “Discontinud”
GMP status Last GMP Inspection dated 5 April 2017 with
conclusive remarks of Acceptable level of cGMP
compliance.
Remarks of the Evaluator.  Latest GMP inspection report (which should have
missing
 Discontinued; reason for discontinuation not
mentioned.
Decision of 274:Deferred for latest GMP inspection report conducted within past one year.
Remarks: Product is discontinued in USFDA, reason of discontinuation not mentioned.
Decision of 275th meeting:Deferred for evidence of approval of applied formulation in

reference regulatory authorities/agencies.
477. Name and address of manufacturer / M/s. Wilshire Labs 124/1, Quaid-e-Azam industrial
Applicant estate, Lahore
Brand Name +Dosage Form + Strength Pizoto 50 mg Injection
Diary No. Date of R& I & fee Dyn:2178, 9-5-2016, Rs.20,000/-
Pethidine hydrochloride….50mg
Pharmacological Group Narcotic analgesic
Type of Form Form-5

As per SRO
Approval status of product in Pethidine Inj. by M/s Martindale Pharmaceuticals
Reference Regulatory Authorities. (MHRA)
Me-too status Alodine by M/s. Siza, Pakistan.
Decision of 274:Deferred for the confirmation of section
Remarks:Section proof for injectable ampoule (Narcotic) provided
Evaluator PEC-XI
478. Name and address of manufacturer / M/s Weather Folds Pharmaceuticals, 69/2, Phase II,
Applicant Industrial area, Hattar.
Brand Name +Dosage Form + D-Sodium injection
Strength
th
Diclofenac sodium…..75mg
Type of Form Form-5
Pack size & Demanded Price 3ml; As per SRO
Approval status of product in Diclofenac 75 mg / 3 ml Solution for Injection (UK-
Reference Regulatory Authorities MHRA)
Me-too status (with strength and Defnac 75mg/3ml of M/s Searle Pakistan Pvt. Ltd.
dosage form)
GMP status Last inspection for the renewal of DML was
conducted on 04-08-2016 and report concludes that
panel recommended the renewal of DML.
Remarks of the Evaluator  Shortcomings
 Latest GMP inspection report conducted within
the period of last one year.
 Commitments required as per decision of
Registration Board taken in its 251st meeting.
 Undertaking to conduct & submit stability
studies along with data as per
guidelines/requirements approved by the
Registration Board.
 Undertaking that the applied brand name is not
similar or has no resemblance (look alike-
sound alike) with already registered drugs.
 Undertaking that the contents mentioned in the
dossier are correct and nothing has been
concealed.
 Undertakings and enclosures of form-5 are not
signed.
Previous Decision: The registration Board in its 273rd meeting deferred the
product for latest GMP inspection report conducted
within the period of last one year.
Evaluation by PEC: Firm has now submitted the latest GMP inspection
report dated 15-09-2017 with conclusive remarks
overall the firm was GMP compliant as per DRAP
guidelines.
479. Name and address of manufacturer / M/s Hiranis Pharmaceuticals (Pvt.) Ltd. E- 145-149,
Applicant North Western Industrial Zone, Port Qasim, Karachi.
Brand Name +Dosage Form + Loxam 8mg Tablet
Strength
Composition Dy. No.238; 02-03-2015; Rs.20,000/- (02-03-2015)
Lornoxicam………8 mg
Type of Form Form-5
Finished product Specifications As per innovator‟s specifications
Pack size & Demanded Price As per PRC; As per PRC
Approval status of product in Xefo (EMA)
Me-too status (with strength and Spedicam by PharmEvo
dosage form)
GMP status Last inspection conducted on 15-02-2017 by
Provincial inspector of drugs Karachi VI, and report
concludes that the overall GMP compliance of
manufacturing and testing facilities were found
satisfactory.
Previous Decision: The registration Board in its 271st meeting deferred the
report dated 07-09-2017; satisfactory level of GMP
compliance as per DRAP guidelines.
Brand Name +Dosage Form + Simgrel 75mg tablets
Strength
Clopidogrel (hydrogen sulphate) equivalent to
clopidogrel……75mg
Diary No. Date of R& I & fee Dy. No. 20, 01-07-2014, Rs. 20,000/- (18-06-2014)
Pharmacological Group Anti-platelet
Type of Form Form-5
Pack size & Demanded Price 1x10„s /As per SRO
Approval status of product in Plavix 75mg tablets
Reference Regulatory Authorities MHRA approved
Me-too status (with strength and Isteblix 75 mg tablets by Pfizer Laboratories
dosage form)
GMP status The firm is GMP compliant as per inspection
conducted on08-12-2015.
Remarks of the Evaluator Latest GMP inspection report is missing. However, the
firmhas also applied for issuance of cGMP certificate
on
12.11.2016.
Previous Decision: The registration Board in its 270th meeting deferred the
report dated 19-08-2017; firm is GMP compliant on
the day of inspection.
Decision: Approved.
Brand Name +Dosage Form + Atelosim 50 mg tablets
Strength
Atenolol…..50mg
Pharmacological Group Beta blocker
Type of Form Form-5
Approval status of product in Atenolol 50 mg tablets (UK-MHRA)
Me-too status (with strength and Cardi 50mg tablets of M/s Benson pharma.
dosage form)
conducted on 08-12-2015.
firm has also applied for issuance of cGMP certificate
on 12-11-2016.
Previous Decision: The registration Board in its 272nd meeting deferred the
Decision: Approved.
Brand Name +Dosage Form + Simdex 400mg tablet
Strength
Dexibuprofen…..400mg
Type of Form Form-5
Finished product Specifications As per innovator
Approval status of product in Seractil 400 mg film-coated tablets (UK-MHRA)
Me-too status (with strength and Dexib 400mg tablet of M/s Tabros pharmaceuticals
dosage form)
on 12-11-2016.
Brand Name +Dosage Form + Simrose 5mg Tablets
Strength
Rosuvastatin (as calcium)…..5mg
Pharmacological Group Statin (lipid lowering agent)
Type of Form Form-5
Approval status of product in Crestor 5mg film-coated tablets (UK-MHRA)
Me-too status (with strength and Rovista 5mg tablet of M/s Getz pharma
dosage form)
on 12-11-2016.
Strength
Type of Form Form-5
Approval status of product in Crestor 10 mg film-coated tablets (UK-MHRA)
dosage form)
on 12-11-2016.
Strength
Type of Form Form-5
Approval status of product in Crestor 20 mg film-coated tablets (UK-MHRA)
dosage form)
on 12-11-2016.
Brand Name +Dosage Form + Glipsim 50mg Tablets
Strength
Pharmacological Group Anti-diabetic/Dipeptidyl peptidase-4 inhibitor
Type of Form Form-5
Approval status of product in Januvia 50mg tablets (USFDA)
Me-too status (with strength and Nuvia 50mg tablet of M/s Werrick pharmaceuticals
dosage form)
on 12-11-2016.

Brand Name +Dosage Form + Glipsim 100mg Tablets
Strength
Pharmacological Group Anti-diabetic/Dipeptidyl peptidase-4 inhibitor
Type of Form Form-5
Approval status of product in Januvia 100mg tablets (USFDA)
Me-too status (with strength and Nuvia 100mg tablet of M/s Werrick pharmaceuticals
dosage form)
Remarks of the Evaluator Latest GMP inspection report is missing. However,
the firm has also applied for issuance of cGMP
certificate on 12-11-2016.
Previous Decision: The registration Board in its 272nd meeting deferred
the product for latest GMP inspection report
conducted within the period of last one year.
Brand Name +Dosage Form + Simetol 50mg Tablets
Strength
Metoprolol (as tartrate)…..50mg
Pharmacological Group Beta-blocker
Type of Form Form-5
Approval status of product in Lopresor 50mg tablets (UK-MHRA)
Me-too status (with strength and Carsel 50mg tablet of M/s Unimark pharmaceuticals
dosage form)

Brand Name +Dosage Form + Simetol 100mg Tablets
Strength
Metoprolol (as tartrate)…..100mg
Pharmacological Group Beta-blocker
Type of Form Form-5
Approval status of product in Lopresor 100mg tablets (UK-MHRA)
Me-too (with strength/dosage form) Carsel 100mg tablet of M/s Unimark pharmaceuticals
490. Name and address of manufacturer / M/s Barrett Hodgson (Pvt.) Ltd., F/423 S.I.T.E.
Applicant Karachi
Brand Name +Dosage Form + Megaklar 125mg/5ml Drops
Strength
Composition Duplicate dossier; Rs.20,000/- (03-03-2015)
Diary No. Date of R& I & fee Each 5ml contains:
Clarithromycin……125mg
Pharmacological Group Macrolide antibiotic
Type of Form Form-5
Pack size & Demanded Price 25ml x 1‟s; Rs.135/- or As per DRAP‟s pricing
policy
Approval status of product in Biaxin (USFDA)
Me-too (with strength/dosage form) Claritek by Getz pharma
GMP status Panel inspection for consideration of renewal of
DML conducted on 18 to 21 January & 02-02-2016
Remarks of the Evaluator  GMP inspection not within last one year.
 Duplicate fee challan is submitted.
 Source of pellets: Vision pharmaceuticals.
Previous Decision: Deferred in 271st meeting of Registration Board for
latest GMP inspection report conducted during last
one year and verification of fee from B & A,
Division.
report dated 08-08-2017 with conclusive remarks of
satisfactory level of GMP compliance. Moreover, the
firm has also provided verified fee challan from the
concerned bank and an undertaking stating that this
challan (deposit slip No. 0237556) has not been and
shall not beused for any purpose/processing of
case(s), other than the registration of above
mentioned product.
Decision: Approved. Reference will be sent to Budget & Accounts Division for
verification of challan and Board authorized its Chairman for the issuance of registration
letter.
Evaluator PEC-XIII
491. Name and address of manufacturer / M/s Paramount Pharmaceuticals Plot No.36,
Applicant Industrial Triangle, Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength Xinta 60ml Syrup (20mg/5ml)
Zinc Sulphate Monohydrate eq. to Elemental
Zinc.…….20mg
Diary No. Date of R& I & fee Dy. No.2828, R&I Dated 17.04.2015, Rs. 20,000/-
Pharmacological Group Nutritional supplement
Type of Form Form-5
Pack size & Demanded Price 1x60ml; as per SRO
Me-too status Osiris Syrup of M/s Sami Pharma (066902)
GMP status Last GMP Inspection 05.01.2016 (GMP Compliant)
Previous remarks of the Evaluator. Undertaking of 251st meeting commitments are not
provided by the firm.SRA is unavailable.
Previous decision Deferred in 271st meeting of Registration Board for
latest GMP inspection report and correct
pharmacological group.
Evaluation by PEC  Firm has submitted copy of latest GMP
inspection report dated 05-05-2017
concluding good level of GMP compliance.
 Firm had claimed nutritional supplement as
pharmacological group and now has
rectified as mineral supplement.
Decision:Approved with International Pharmacopoeia specifications.
492. Name and address of manufacturer / M/s Indus Pharma (Pvt) Limited, Plots no.26, 27,
Applicant 63-67, sector-27, Korangi Industrial Area, Karachi.
Brand Name +Dosage Form + Strength Adecal Tablet 0.5mcg
Alfacalcidol ………….0.5 mcg
2015)
Pharmacological Group Vitamin- D Analogue
Type of Form Form-5
Finished product Specification In-house
Pack size & Demanded Price 10‟s, 30‟s; Rs.22/tablet
Approval status of product in PMDA approved (Japan)
Me-too status Adela Tablet 0.5mcg of M/s Getz Pharma (Reg.#
057894)
GMP status Last GMP inspection was conducted on 12-05-
2016 which concludes satisfactory level of GMP
compliance.
Previous remarks of the Evaluator.  The date of inspection report provided is old
and doesn‟t fall within one year.
Previous decision Deferred in 272nd meeting of Registration Board for
latest GMP inspection report.
Evaluation by PEC Firm has submitted copy of latest GMP inspection
report dated 16-08-2017 concluding an acceptable
493. Name and address of manufacturer / M/s Wnsfeild Pharmaceuticals, Plot no.122, Block A;
Applicant Phase-V, Industrial State Hattar Pakistan.
Brand Name +Dosage Form + Strength Flozip capsule 12/25 mg
Composition Dy. No.357, R&I Dated: 13.09.2014,Rs. 20,000
Diary No. Date of R& I & fee Each capsule contains
Olanzapine …………12mg
Fluoxetine (as HCl)…………25mg
Pharmacological Group Typical anti-psychotic and a selective serotonin
reuptake inhibitor
Type of Form Form 5
Finished product Specification U.S.P
Pack size & Demanded Price As per SRO, as per policy of MOH
Approval status of product in Olanzapine and Fluoxetine capsule by Teva (US-
Reference Regulatory Authorities. FDA approved)
Me-too status Co-Depricap by NabiQasim (12/25 mg)
GMP status Last GMP Inspection 23.11.2016 with overall rating
as “GOOD”.
Previous remarks of the Evaluator. Section details are provided.
Previous decision Deferred in 270th meeting for confirmation of salt.
Evaluation by PEC  The salt is confirmed as Fluoxetine HCl by
the firm.
Decision: Approved
494. Name and address of manufacturer / M/s Martin Dow Plot no.37, Sector 19, Korangi
Applicant Industrial area, Karachi.
Brand Name +Dosage Form + Strength Natalia DR Tablet 10mg/10mg
Composition Dy. No.197, R&I Dated 08.09.2014,Rs. 20,000
Diary No. Date of R& I & fee Each Delayed Release Tablet contains
Doxylamine as Succinate …………….10mg
Pyridoxine as Hydrochloride …………10mg
Pharmacological Group Anti-histamine and Vitamin B6 analogue
Type of Form Form 5
Pack size & Demanded Price 10‟s,20‟s, 30‟s and as per brand leaders‟ price
Approval status of product in Diclegis Tablets (USFDA Approved)
Me-too status Xyquil DR Tablet (076469) by Sami
GMP status Last GMP Inspection 16.02.2017 with overall rating
as “GOOD”.
Previous remarks of the Evaluator. Firm has approved section.
Previous decision Deferred in 270th meeting due to difference in the
type of tablet i.e. Delayed release and Extended
release.
Evaluation by PEC  The firm has submitted the reference of
Diclegis Tablets (USFDA Approved) which
are Delayed-release.
Decision: Approved with change of brand name & with Innovators specifications.
495. Name and address of manufacturer / M/s Pharmix Laboratories, 21km Ferozepur Road
Applicant Lahore.
Brand Name +Dosage Form + Strength Sundrop Oral Drops 5mg(/10ml or /ml; to be verified)
Composition Dy. No.625, R&I Dated 11.12.2014, Rs. 20,000/-
Diary No. Date of R& I & fee Each 10ml contains:
Cholecalciferol…..……….5mg
Pharmacological Group Vitamin
Type of Form Form-5
Pack size & Demanded Price 1x10ml,1x30ml &Rs.700/pack of 10ml,Rs.2000/pack
of 30ml
Approval status of product in Not available
Me-too status Not available in same strength (available in 40 I.U.
while proposed one is equal to 20,000 I.U./ml)
GMP status Last GMP Inspection:10.04.2017(Good)
Previous remarks of the Evaluator. The composition of the proposed drug is incorrectly
mentioned in Form-5 as “each 10 ml contains
cholecalciferol 5mg/10ml” is written. Moreover,
brand name resembles the other firms‟ drug.
Previous decision Deferred in 271st meeting for evidence of approval in
reference agencies and me-too status. Moreover, the
proposed composition of the drug needs to be verified
since both strengths 5mg/10ml and 5mg/ml are
mentioned in the dossier.
Evaluation by PEC  Firm has clarified the proposed strength as
5mg/10ml (eq. to 20,000 IU/ml or 0.5mg
cholecalciferol /ml).
 Me –too couldn‟t be verified; though firm has
submitted the reference of “Vigantol”.
 The proposed drug couldn‟t be searched in
the reference regulatory authorities though
the firm has submitted the reference of ema
and Sukl.
 The proposed brand name resembles the
other drug.
Decision: Deferred for confirmationof approval status of applied formulation in reference
regulatory authorities/agencies and their generic / me-too status
496. Name and address of manufacturer / Barrett Hodgson Pakistan (Pvt.) Ltd., F/423, SITE,
Applicant Karachi.
Brand Name +Dosage Form + Strength Nitabar Tablet 500mg
Composition Dy.No.383(Duplicate dossier), R&I Dated
29.12.2014,Rs. 20,000/-
Diary No. Date of R& I & fee Each film-coated tablet contains:
Nitazoxanide ………500mg
Pharmacological Group Anti-infective, anti-protozoal
Type of Form Form 5
Finished product Specification Innovator‟s specs
Pack size & Demanded Price 20‟s, Rs. 440/20‟s pack or as per DRAP‟s pricing
policy
Approval status of product in Alinia 500mg tablet
Reference Regulatory Authorities. USFDA approved
Me-too status NT-Tox by Genix pharma
GMP status Last GMP Inspection 04.03.2016 for DML renewal
with following conclusion “In view of the inspection
outcome assessment and local competitive
environment panel is of the opinion to recommend
the renewal of DML as a matter of principle and
justice.To keep an eye on momentum of progress
towards commited compliance , annual surveillence
inspection after 12 months is recommended.
Previous decision Decision of 269th Meeting
Deferred for the submission of last GMP inspection
report conducted within last one year.
Evaluation by PEC  Fee-challan was verified as the dossier was
duplicate.
 The firm has submitted following request;
“The re-inspection for verification of
authenticity of stability data of our product
Hepgard (Sofosbuvir) 400mg tablet was done
satisfactorily on 9th August, 2017.
The applied product i.e. Nitabar
Tablet 500mg (Nitazoxanide)was discussed
in 269th meeting and was deferred due to
latest inspection report.
We request you to kindly consider the
inspection report of Hepgard Tablet 400mg
(Sofosbuvir) and grant us registration of
products manufactured in the same facility
(Tablet section) as soon as possible.”
 The above mentioned inspection report
concludes:
“The panel recommends the facilities
of the firm for production and quality control
of Hepgard Tablet 400mg (Sofosbuvir).
The manufacturing and quality
control activities of the firm are also suitable
for manufacturing of other tablet
formulations if justified scientifically in other
respects.”
Decision:Approved. Reference will be sent to Budget & Accounts Division for verification
of challan and Board authorized its Chairman for the issuance of registration letter.
497. Name and address of manufacturer / M/s Crystolite Pharmaceuticals, Plot # 1&2, S-2,
Applicant National Industrial Zone, Rawat, Islamabad.
Brand Name +Dosage Form + Strength Venfex 37.5mg film-coated tablet
Venlafaxine as Hydrochloride ………37.5mg
Diary No. Date of R& I & fee Dy. No.130, R&I Dated 12.09.2014, Rs. 20,000/-
Pharmacological Group Anti-depressive agent
Type of Form Form 5
Pack size & Demanded Price 2x10‟s, as per SRO
Approval status of product in Reference provided by firm as MHRA
Me-too status Nodep by Schawan Pharma (080387)
GMP status Last GMP Inspection 18.01.2017with overall rating
as good.
Previous remarks of the Evaluator. Approved as un-coated tablet in MHRA and US-
FDA.
Previous decision Deferred in 270th meeting since the formulation is
not approved as film-coated in reference agencies.
Evaluation by PEC
Decision:Approved with innovator’s specification
498. Name and address of manufacturer / M/s Asian Continental, Continental House, D-133,
Applicant Tipu Sultan Road, KDA Scheme-I, Karachi;
Contract Manufactured by: M/s Pharm-Evo (Pvt) Ltd,
Plot#A-29, North Wester Industrial Zone, Port

Qasim, Karachi.
Brand Name +Dosage Form + Strength Ceficon Capsule 400mg
Cefixime as Trihydrate……………….400mg
Pharmacological Group Antibiotic (Third Generation Cephalosporin)
Type of Form Form 5
Finished product Specification U.S.P.
Pack size & Demanded Price 1x10‟s ; as per PRC or PAC
Approval status of product in Suprax Capsules by Lupin limited (USFDA
Reference Regulatory Authorities. Approved)
Me-too status Cefspan capsules 400mg of M/s Barrett Hodgson
(Reg.#013860)
GMP status Last inspection is dated as “2015-2016”& date of
signatures of panel inspectors is “27-01-2017”.The
report concludes acceptable level of GMP
compliance.
Previous remarks of the Evaluator.  Last inspection of Pharm-Evo (Manufacturer)
conducted is dated as “2015-2016” while the
date of signatures of panel inspectors is “27-
01-2017”.The provided report concludes
acceptable level of GMP compliance.
 The firm claimed U.S.P. specs while it is not
present in U.S.P.
Previous decision Deferred in 272nd meeting due to following reasons:
 The confirmation of address of the applicant.
 The dates on the inspection report provided
need verification.
Evaluation by PEC  The address of the firm is confirmed as M/s
Asian Continental, D-32, S.I.T.E. II, Super-
Highway, Karachi.
 The firm has submitted the latest inspection
report dated as 19-09-2017 which concludes
good compliance of GMP guidelines.
 As the dossier was duplicate; therefore, the
fee-challan was verified.
Contract Manufactured by:
M/s Pharm-Evo (Pvt) limited, Plot#A-29, North
Wester Industrial Zone, Port Qasim, Karachi.
Brand Name +Dosage Form + Strength Ceficon Dry Powder for Suspension 100mg/5ml
Cefixime as Trihydrate …………………….100mg
Type of Form Form 5
Pack size & Demanded Price 30ml &60ml ; as per PRC or PAC
Approval status of product in Cefixime by Aurobindo Pharma (USFDA Approved)
Me-too status Cefspan Suspension 100mg of M/s Barrett Hodgson
(Reg.#010429 )
compliance.
Previous remarks of the Evaluator. Last inspection of Pharm-Evo (Manufacturer)
conducted is dated as “2015-2016” while the date of
provided report concludes acceptable level of GMP
compliance.
 15% overage was included which; when
asked to justify, was justified for 5% overage
as:
“5% Cefixime excess is included to
compensate loss during granulation step of finished
pharmaceutical product, furthermore over initial
assay results are very close to standard limits.”

need verification.
 On justification of 15% applied overage, the
firm submitted the same for 5% which is not
on scientific grounds.
Asian Continental, D-32, S.I.T.E. II, Super-
Highway, Karachi.
Contract Manufactured by:
M/s Pharm-Evo (Pvt) limited,Plot#A-29,North
Wester Industrial Zone, Port Qasim, Karachi.
Brand Name +Dosage Form + Strength Ceficon DS Dry Powder for Suspension 200mg/5ml
Cefixime as Trihydrate …………………….200mg
Type of Form Form 5
Pack size & Demanded Price 30ml ; as per PRC or PAC
Approval status of product in Cefixime by Aurobindo Pharma (USFDA Approved)
Me-too status Cefspan Suspension DS 200mg of M/s Barrett
Hodgson (Reg.#024634)
compliance.
Previous remarks of the Evaluator. Last inspection of Pharm -Evo (Manufacturer)
conducted is dated as “2015-2016” while the date of
provided report concludes acceptable level of GMP

compliance.
 15% overage was included which; when
asked to justify, was justified for 5% overage
as:
“5% Cefixime excess is included to
compensate loss during granulation step of finished
pharmaceutical product, furthermore over initial
assay results are very close to standard limits.”
need verification.
 On justification of 15% applied overage, the
firm submitted the same for 5% which is not
on scientific grounds.
Asian Continental, D-32, S.I.T.E. II, Super
Highway, Karachi.
of challan and Board authorized its Chairman for the issuance of registration letter
501. Name and address of manufacturer / M/s Valor Pharmaceuticals, 124/A, Kahuta Road,
Applicant Industrial Triangle Zone, Islamabad.
Brand Name +Dosage Form + Strength Floxin Ear Drops 5ml
Composition Each ml of solution contains:
Ciprofloxacin (as Hydrochloride)…………3mg
Pharmacological Group Anti-infective
Type of Form Form-5
Finished product Specification Manufacturer‟s (non-pharmacopoeial)
Pack size & Demanded Price 5ml; as per SRO
Approval status of product in Ciloquin ear drops of Novartis (TGA Australia)
Me-too status Cipotic ear drops 5ml of M/s Barrett Hodgson,
(Reg.#032485)
the report concludes good compliance of GMP
guidelines.
Previous remarks of the Evaluator. i. Firm has submitted GMP certificate instead
of latest GMP inspection report which is
valid until 31st July, 2017 and was issued for
export purpose.
ii. The firm claims as the applied drug is non-
pharmacopoeial, so when it becomes the part
of official monograph (USP/BP/IP/EP/JP),
they will change the product specification
according to the official monograph.
Previous decision Deferred in 273rd meeting for following submissions:
 Last GMP inspection report conducted
within a period of last one year.
 USP specifications will be followed as the
proposed drug is present in USP monograph.
Evaluation by PEC  The firm has submitted the latest inspection
report dated 15-09-2017 which concludes
satisfactory level of GMP guidelines.
Brand Name +Dosage Form + Strength Quti Tablets 25mg
Quetiapine (as fumarate)…………25mg
Type of Form Form-5
Pack size & Demanded Price 1x10‟s; as per SRO
Me-too status Evokalm 25mg tablet of M/s PharmEvo
Pharmaceuticals (Reg.#139621)
guidelines.
Previous remarks of the Evaluator. i. The firm has applied manufacturer‟s
specifications while it is present in U.S.P.
ii. Firm has submitted GMP certificate instead
export purpose.
within a period of last one year
Decision:Approved with USP specification.
Type of Form Form-5
Me-too status Evokalm 100mg tablet of M/s PharmEvo
Pharmaceuicals (Reg.#042222)
guidelines.
ii. Firm has submitted GMP certificate instead of
latest GMP inspection report which is valid until
31st July, 2017 and was issued for export purpose.
Evaluation by PEC The firm has submitted the latest inspection report
dated 15-09-2017 which concludes satisfactory level
of GMP guidelines.
Type of Form Form-5
Me-too status Evokalm 200mg tablet of M/s Pharmevo
Pharmaceuicals (Reg.#053199)
guidelines.
ii. Firm has submitted GMP certificate instead
export purpose.
iii. The outline of method of manufacturing is
not revised by the firm as the coating process
is not mentioned.
Previous decision Deferred for following submissions:
 Outline of method of manufacturing, since
the submitted method do not contain step of
coating process.
 Firm claims coating process being involved
in the manufacturing of the proposed drug.
Brand Name +Dosage Form + Strength Valasin nasal spray 15ml
Flunisolide ………….0.025% w/v
Pharmacological Group Corticosteroids
Type of Form Form-5
Pack size & Demanded Price 1x15ml; as per SRO
Me-too status Tarisin nasal spray 0.025% of M/s Sante Pharma
(Reg.#025166)
guidelines.
Previous remarks of the Evaluator. Firm has submitted GMP certificate instead of latest
GMP inspection report which is valid until 31st July,
2017 and was issued for export purpose.
Previous decision Deferred in 273rd meeting for submission of last GMP
inspection report conducted within a period of last
one year.
Decision:Deferred for submission of evidence of manufacturing facility.
506. Name and address of manufacturer / M/s Mass Pharma (Pvt) Ltd, 17-Km, Ferozepur Road,
Applicant Lahore.
Brand Name +Dosage Form + Strength Renexa Tablet XR 500mg
Composition Each extended-release tablet contains:
Ranolazine XR……………..500mg
Pharmacological Group Anti–ischemic and antianginal
Type of Form Form-5
Pack size & Demanded Price 2x7‟s; Rs.400/-per pack
Me-too status Ranola 500mg tablet by M/s Highnoon Laboratories
the report concluded good level of GMP compliance.
Previous decision Deferred in 273rd meeting for last GMP inspection
report conducted within a period of last one year.
Evaluation by PEC Firm has submitted its latest inspection report dated
11-09-2017 which concludes a “fair” level of GMP
compliance.
Applicant Lahore.
Brand Name +Dosage Form + Strength Amodip V-Plus Tablet 10mg/160mg/12.5mg
Amlodipine besylate……..10mg
Valsartan ………………..160mg
Hydrochlorothiazide …..12.5mg
Pharmacological Group Angiotensin II antagonist/Ca antagonist (thiazide
diuretic)
Type of Form Form-5
Pack size & Demanded Price 2x7‟s; Rs.1015/pack
Me-too status Curo-Derm-H of M/s Epla laboratories
Previous remarks of the Evaluator.  Firm possesses tablet section.
 Firm has applied two drugs with same brand
names but different strengths.
 Last GMP inspection report conducted within
a period of last one year.
 Similarity of two applied brand names i.e.
Amodip-V Plus.
Evaluation by PEC  Firm has submitted its latest inspection report
dated 11-09-2017 which concludes a “fair”
 The firm claims the same proposed brand
name for two different strengths.
Applicant Lahore.
Brand Name +Dosage Form + Strength Amodip V-Plus Tablet 10mg/160mg/25mg
Amlodipine besylate……..10mg
Valsartan ………………..160mg
Hydrochlorothiazide …….25mg
Pharmacological Group Angiotensin II antagonist/Ca antagonist (thiazide
diuretic)
Type of Form Form-5
Pack size & Demanded Price 2x7‟s; Rs,1020/pack
Me-too status Curo-Derm-H of M/s Epla laboratories
 Last GMP inspection report conducted within
a period of last one year.
 Similarity of two applied brand names i.e.
Amodip-V Plus.
Evaluation by PEC  Firm has submitted its latest inspection report
dated 11-09-2017 which concludes a “fair”
 The firm claims the same proposed brand
name for two different strengths.
509. Name and address of manufacturer / M/s Biogen Pharma, 8km, Chakbeli Road, Rawat,
Brand Name +Dosage Form + Strength Vorizole Tablet 200mg
Voriconazole …..…………200mg
Pharmacological Group Triazole (anti-fungal)
Type of Form Form-5
Pack size & Demanded Price 10‟s,20‟s,30‟s; as per SRO
Approval status of product in V-fend tablet of M/s Pfizer Pharma(UK)
Me-too status Vorif tablets of M/s Ferozesons Laboratories
has no proper conclusion.
Previous remarks of the Evaluator. The firm was issued a letter on “11th May, 2017”
against which firm has failed to submit the reply for
the below mentioned deficiencies/ shortcomings:
 Latest GMP inspection report (which should
have been conducted within the period of
last one year).
 Approval of section /manufacturing facility
by the Central Licensing Board. However,
you may submit panel inspection report for
renewal of DML verifying the section
/manufacturing facility.
 Mention the type of drug everywhere in
form-5 as well as in every document of the
dossier (i.e. film-coated or enteric coated).
 The description of the product i.e.”Each
film-coated tablet contains” be mentioned in
Form -5 to recognize the information about
coating of the applied product/drug.
Previous decision Deferred in 273rd meeting due to paucity of time.
Evaluation by PEC  The firm has submitted its latest inspection
good GMP compliance.
 The relevant section is verified through
inspection report.
 Firm has clarified the proposed drug to be
film-coated and has revised the master
formulation including coating materials.
510. Name and address of manufacturer / M/s Glitz Pharma, Plot no.265, Industrial Triangle,
Applicant Kahuta Road, Islamabad.
Brand Name +Dosage Form + Strength G-Plot tablets 75mg
Clopidogrel (as bisulphate)……..75mg
Pharmacological Group Anti-coagulants/Platelet deaggregators
Type of Form Form-5
Pack size & Demanded Price 10‟s, 14‟s, 28‟s, 30‟s, 100‟s; as per policy of MOH
Approval status of product in Clopidogrel DRLA 75mg tablet (TGA)
Me-too status Clopid of M/s Ferozesons
the report concludes satisfactory level of GMP
compliance.
Previous remarks of the Evaluator. The firm was issued a letter on “25th July, 2017”
the below mentioned deficiencies/shortcomings:
i. Latest GMP inspection report (which should
last one year).
ii. Approval of section /manufacturing facility
Evaluation by PEC  The latest inspection report is dated as 19-09-
2017 which concludes “the panel
recommends grant of GMP certificate.”
 The tablet section is verified through GMP
inspection report.
Decision:Approved.
Brand Name +Dosage Form + Strength G-Sim Tablet 20mg
Simvastatin ……..………20mg
Pharmacological Group Lipid regulating drugs, Anti-atheromas
Type of Form Form-5
Pack size & Demanded Price 10‟s, 20‟s,30‟s, 50‟s, 100‟s; as per policy of MOH
Approval status of product in Meditab (simvastatin) 10mg tablet by
Reference Regulatory Authorities. Melbourne(Australia)
Me-too status Athenil Tablets 10mg by M/s Searle
compliance.
Previous remarks of the Evaluator. The firm was issued a letter on “12th May, 2017”
last one year).
inspection report.
Decision:Approved.
Brand Name +Dosage Form + Strength G-Car Tablet 6.25mg
Carvedilol ……..………6.25mg
Type of Form Form-5
Me-too status Carveda tablets 6.25mg tablets of M/s
Ferozesons‟Labs
compliance.
have been conducted within the period of last
one year).
ii. Approval of section /manufacturing facility by
the Central Licensing Board. However, you may
submit panel inspection report for renewal of
DML verifying the section /manufacturing
facility.
inspection report.
Decision:Approved.
Brand Name +Dosage Form + Strength G-Car Tablet 12.5mg
Carvedilol ……..………12.5mg
Diary No. Date of R& I & fee Dy. No.2708;16-04-2015; Rs.20,000/- (16-04-2015)
Type of Form Form-5
Me-too status Carveda tablet 12.5mg of M/s Ferozesons
compliance.
last one year).
ii. Approval of section /manufacturing facility
inspection report.
Decision:Approved.
Brand Name +Dosage Form + Strength G-Car Tablet 25mg

Carvedilol ……..………25mg
Type of Form Form-5
Me-too status Carveda tablet 25mg of M/s Ferozsons
(Reg.no.027548)
compliance.
last one year).
inspection report.
Decision:Approved.
515. Name and address of manufacturer / M/s Sigma Pharma International(Pvt) Ltd., Plot # E-
Applicant 50, North Western Industrial Zone, Bin Qasim
Karachi.
Brand Name +Dosage Form + Strength Doxy capsule 100mg
Doxycycline Hyclate eq. to
Doxycycline……..100mg
Pharmacological Group Antibiotic (Tetracyclines)
Type of Form Form-5
Pack size & Demanded Price 1x10‟s, 3x10‟s, 5x10‟s, 10x10‟s; as per Drap policy
Me-too status Megadox capsule 100mg of M/s Hilton Pharma (Pvt)
Ltd
GMP status Not provided
Previous remarks of the Evaluator.  Latest GMP inspection report is not provided.
Previous decision Deferred in 274th meeting as latest GMP inspection
report was not provided.
report dated 15-09-2017 which concludes an
acceptable level of cGMP compliance.
Decision:Approved.
516. Name and address of manufacturer / M/s Sigma Pharma International(Pvt) Ltd., Plot # E-
Karachi.
Brand Name +Dosage Form + Strength Easycol sachet
Mebeverine HCl……………..135mg
Ispaghula Husk……………..3500mg
Pharmacological Group Anti-spasmodic/ Laxative
Type of Form Form-5
Pack size & Demanded Price 1x10‟s; as per Drap policy
Me-too status Mebipas Sachet of M/s Hilton Pharma
Previous remarks of the Evaluator.  Latest GMP inspection report is not provided
by the firm.
517. Name and address of manufacturer / M/s Sigma Pharma International (Pvt) Ltd., Plot # E-
Karachi.
Brand Name +Dosage Form + Strength SMEC 3g sachet
Dioctahedral Smectite ……..………3g
Type of Form Form-5
Pack size & Demanded Price 1x30‟s; as per Drap policy
Approval status of product in ANSM (France) approved
Me-too status Diosecta 3g sachet by Woodwards Pakistan
Previous remarks of the Evaluator.  Latest GMP inspection report is not provided
by the firm.

b) Applications whose differential fee submitted upto 30th September, 2015
I. New cases
Evaluator PEC-VI
518. Name and address of manufacturer / M/s PharmEvo, Karachi
Applicant
Brand Name +Dosage Form + Strength Antimal 40/20mg tablet
Artemether……40mg
Lumefantrine……240mg
Diary No. Date of R& I & fee Dy. No.309; 4-3-2011; Rs. 8,000/- 4-03-2011,
Rs.12,000/- (19-11-2014)
Pharmacological Group Anti-malarial
Type of Form Form-5
Pack size & Demanded Price 4‟s. Rs.132/-6‟s, Rs.198/-
Me-too status Artem Plus by Hilton Pharma.
competing well within prevailing bracket of
acceptable compliance level.
Remarks of the Evaluator. Fee challan photocopies are attached.
Product Monograph is present in IP.
Decision: Approved with International Pharmacopoiea specifications
519. Name and address of manufacturer / M/s PharmEvo, Karachi
Applicant
Brand Name +Dosage Form + Strength Antimal 80/480mg tablet
Lumefantrine……480mg
Diary No. Date of R& I & fee Dy. No.309; 4-3-2011; Rs. 8,000/- 4-03-2011,
Rs.12,000/- (19-11-2014)
Type of Form Form-5
Pack size & Demanded Price 4‟s. Rs.250/-6‟s, Rs.375/-
Me-too status Artem by Hilton Pharma
competing well within prevailing bracket of
acceptable compliance level.
Remarks of the Evaluator. Fee challan photocopies are attached.
Product Monograph is present in IP.
520. Name and address of manufacturer / M/s Macquin‟s International, Karachi
Applicant
Brand Name +Dosage Form + Strength Euro DS dry suspension
Ciprofloxacin as HCl….250mg
Type of Form Form-5

Approval status of product in Ciproxin 250 mg/5 ml granules and solvent for oral
Reference Regulatory Authorities. suspension by M/s Bayer Healthcare, MHRA
approved.
Me-too status Hiflox Dry suspension 250mg/5ml by M/s Hilton
(Reg#067499)
GMP status Last inspection report 8-11-2016 firm is operating at
satisfactory level of compliance with GMP
guidelines.
Remarks of the Evaluator. Rs.8000/- fee challan is not attached.
 For deliberation in light of decision taken in 269th Registration Board meeting
regarding manufacturing facility of diluent for reconstitution of ciprofloxacin
suspension.
 Verificationof Fee challan of Rs. 8,000/-
Applicant
Brand Name +Dosage Form + Strength Nepax Eye Drops /ophthalmic Suspension
Nepafenac….1mg
Pharmacological Group Anti-inflammatory
Type of Form Form-5
Approval status of product in Nevanac 0.1% ophthalamic suspension/drops
Reference Regulatory Authorities. (USFDA approved)
Me-too status Barinep ophthalamic suspension of M/s Barrett
Hodgson Pakistan.
guidelines.
Remarks of the Evaluator. Rs.8000/- fee challan is not attached.
Decision: Deferred as Rs. 8000/- fee challan is not provided by the firm.
Applicant
Brand Name +Dosage Form + Strength Lutigan eye drops
Bimatoprost….0.3mg
Diary No. Date of R& I & fee Dy. No.403; 30-11-2011; Rs.8,000/- 28-11-2011,
Rs.12,000/- (18-6-2014)
Pharmacological Group Anti Glucoma, Prostaglandin analogue
Type of Form Form-5
Me-too status Lumigan Eye Drops by M/s Barrett Hodgson Pakistan
(Pvt) Ltd., Karachi. (Reg#033177)
guidelines.
Decision: Deferred for clarification of dosage form whether solution or suspension.

Applicant
Brand Name +Dosage Form + Strength Euro Suspension 125mg/5ml
Composition Each 5ml suspension contains:
Ciprofloxacin as HCl…..125mg
Type of Form Form-5
Approval status of product in Ciproxin® 250 mg/5 ml granules and solvent for
Reference Regulatory Authorities. oral Suspension
byM/sBayerHealthcare,MHRAapproved.
Me-too status Ciprin 125mg/5ml suspension of M/s Werrick
pharmaceuticals
guidelines.
Decision: Deferred for further deliberation regarding manufacturing facility of diluent for
reconstitution of ciprofloxacin suspension.

Applicant
Brand Name +Dosage Form + Strength Antimal Plus dry syrup
Lumifantrien……90mg
Diary No. Date of R& I & fee Dy. No.410; 30-11-2011; Rs.8,000/- 28-11-2011,
Rs.12,000/- (18-6-2014)
Type of Form Form-5
Approval status of product in WHO approved formulation
Me-too status Artem Plus Dry Suspension 15/90 mg of M/s Hilton
Pharmaceuticals (Reg#055015)
guidelines.
Remarks of the Evaluator. Product monograph is present in IP
Applicant
Brand Name +Dosage Form + Strength Patalol Eye Drops 5ml
Olopatadine…..2mg
Type of Form Form-5
Approval status of product in Olopatadine Hydrochloride 2mg/ml eye drops by M/s
Reference Regulatory Authorities. Barr Labs INC (USFDA Approved)
Me-too status Opat forte eye drops 0.2% by M/s Alza Pharma.
(Reg#081623)
guidelines.
Remarks of the Evaluator. Rs.8000/- fee challan is missing
 For clarification of dosage form whether solution or suspension.
 Verification o ffee challan of Rs. 8000/-
526. Name and address of manufacturer / M/s Weatherfold, Hattar
Applicant
Brand Name +Dosage Form + Strength Bizole 40mg/1100mg capsule
Omeprazole….40mg
Sodium Bicarbonate….1100mg
Diary No. Date of R& I & fee Dy. No.309; 29-12-2011;Rs. 12,000; 17-11-2014
Rs.8,000/- (29-10-2010)
Pharmacological Group Proton Pump Inhibitor, antacid
Type of Form Form-5
Me-too status Encid by Wilson
concluding GMP compliant status.
527. Name and address of manufacturer / M/s McOlson Research Laboratories
Applicant
Brand Name +Dosage Form + Strength Tramamac 50mg Capsule
Composition Diary No: 318, 25/11/2014, Rs: 12,000/- 18-11-2014,
Rs.8,000/- 18-1-2011
Diary No. Date of R& I & fee Each capsule contains:
Tramadol HCl….50mg
Pharmacological Group Analgesic
Type of Form Form 5
Pack size & Demanded Price 10‟s, As per SRO/-
Approval status of product in Tramadol Hydrochloride capsules 50mg approved by
Reference Regulatory Authorities. MHRA.
Me-too status Tramadol by Highnoon Laboratories,.
GMP status Last inspection report 10-4-2017 &24-04-2017
“Firm has fair compliance of GMP”
Decision: Approved
528. Name and address of manufacturer / M/s. Nawan Laboratories (Pvt) Ltd, 136 sector 15
Applicant Korangi Industrial Area Karachi.
Brand Name +Dosage Form + Strength Nolcer Capsule 20mg

Enteric coated pellets of Esomeprazole Magnesium
Trihydrate Eq.to Esomeprazole …………….. 20mg
Diary No. Date of R& I & fee Dy. No 719.; 28-03-2011 (Rs. 8,000) 025-03-2011
(Rs.12000) 6-03-2015
Type of Form Form-5
Pack size & Demanded Price 14 Capsules
Approval status of product in Nexium Capsule 20mg of Astra Zeneca
Reference Regulatory Authorities. Pharmaceuticals USAFDA Approved
Me-too status Esorid Capsule 20mg of M/s Hilton Pharmaceuticals
GMP status Last GMP inspection conducted on 26-09-2017 with
conclusive remarks of satisfactory level of cGMP
compliance.
Remarks of the Evaluator. Pellets are obtained from Vision Pharma.
Fee challan of Rs.8,000 photocopy is attached.
Decision: Approved. Reference will be sent to Budget & Accounts Division for verification
529. Name and address of manufacturer / M/s. Nawan Laboratories (Pvt) Ltd, 136 sector 15
Applicant Korangi Industrial Area Karachi.
Brand Name +Dosage Form + Strength Nolcer Capsule 40mg
Enteric coated pellets of
Esomeprazole Magnesium Trihydrate eq.to
Esomeprazole …………40mg
Diary No. Date of R& I & fee Dy. No 721.; 28-03-2011 (Rs. 8000) 025-03-2011
(Rs.12000) 6-03-2015
Type of Form Form-5
Pack size & Demanded Price 14 Capsules
Approval status of product in Nexium Capsule 40mg of Astra Zeneca
Reference Regulatory Authorities. Pharmaceuticals (
Me-too status Esorid Capsule 40mg of M/s Hilton Pharmaceuticals
GMP status Last GMP inspection conducted on 26-09-2017 with
conclusive remarks of satisfactory level of cGMP
compliance.
Remarks of the Evaluator. Pellets are obtained from vision Pharma.
Fee challan of Rs.8,000 photocopy is attached.
530. Name and address of manufacturer / M/s Helix Pharma, Karachi
Applicant
Brand Name +Dosage Form + Strength Cymanta capsule 60mg
Duloxetine HCl 67.3mg enteric coated pellets eq to
duloxetine …..60mg
Diary No. Date of R& I & fee Dy. No.309; 16-6-2011; Rs.8,000/- (16-6-2011),
Rs.12,000; 12-03-2015. Rs100,000; 28-09-2017
Type of Form Form-5
Pack size & Demanded Price 10‟s, 14‟s
Me-too status Dulan Capsules by Hilton
Remarks of the Evaluator. Pellets are imported from Pell Tech health care,
Mumbai, India.
GMP certificate of Pell TEch is valid up to 2018.
Stability data documents of pellets are attached.
Decision: Approved.
531. Name and address of manufacturer / M/ Welmark Pharmaceuticals, Hattar
Applicant
Brand Name +Dosage Form + Strength Omenate 40mg tablet
Omeprazole as magnesium salt….40mg
Diary No. Date of R& I & fee Dy. No.309; 18-12-2010; Rs.8,000/-
Rs.12,000/- (21-10-2014)
Pharmacological Group PPI
Type of Form Form-5
5x10‟s; As per SRO
Approval status of product in MHRA
Reference Regulatory Authorities. (Uses omeprazole enteric coated pellets)
Me-too status Omp Tablet by Genesis Pharma Reg No. 017807
GMP status Last inspection report 12-1-2017 Overall cGMP was
satisfactory as per Drap Guidelines.
Remarks of the Evaluator. Fee challan photocopy is attached.
Details of pellets are not provided.
MHRA, USFDA uses Multiple Unit Pellet System
(MUPS) in manufacturing process. The drug product
consists of a number of enteric coated pellets
compressed into a tablet.
otherwise.
Applicant
Brand Name +Dosage Form + Strength Clopix tablet
Clopidogril ….75mg
Aspirin……….75mg
Diary No. Date of R& I & fee Dy. No.30; 18-12-2010; Rs.8,000 Rs.12,000/-
(21-10-2014)
Pharmacological Group Anti-Platelets
Type of Form Form-5
Pack size & Demanded Price As per SRO, As per SRO
Approval status of product in DUOPALVIN by Sanofi
Reference Regulatory Authorities. (ANSM France Approved)
Me-too status Ascard Plus by Atco
Remarks of the Evaluator.  Fee challan photocopy is attached.

 Internationally available as film coated tablet
prepared by mixing granules of clopidogrel
(prepared by wet granulation) and
aspirin(prepared by dry granulation).
Decision: Deferred for deliberation on dosage form in comparison to refrence product.
Applicant
Brand Name +Dosage Form + Strength Penmark 40mg tablet
Pantoprazole as sodium sesquihydrate ……40mg
Diary No. Date of R& I & fee Dy. No.30; 18-12-2010; Rs.8,000; 1-09-2010
Rs.12,000/- (21-10-2014)
Type of Form Form-5
Me-too status Cantrofast by Candid
Decision: Deferred for clarification of applied dosage form as reference product is
available as enteric coated tablet whereas firm has applied for uncoated tablet
534. Name and address of manufacturer / M/s Himedic pharmaceuticals Lahore
Applicant
Brand Name +Dosage Form + Strength Cefactam injection 1.5gm IM/IV
Ceftriaxone Sodium eq to ceftriaxone…….1gm
Sulbactam Sodium eq to Sulbactam……..500mg
Diary No. Date of R& I & fee Dy. No.14; 4-08-2015 ; Rs.20,000/- (4-8-2015)
Type of Form Form-5
Me-too status Not Provided
to be operating at good level of compliance with
cGMP
Last inspection report does not fall within 1 year
International availability in RRA could not be
confirmed.
Application was received through (R-V)Letter
Decision: Registration Board rejected the application as applied formulation is not
approved by any reference regulatory authority and firm has not submitted safety and
efficacy data.
535. Name and address of manufacturer / M/s Linta Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Keston Cream 0.005%
Calcipotriol as Monohydrate…….0.05mg
Pharmacological Group Anti-psoriatic
Type of Form Form-5
Me-too status Calcipot by Valour
GMP status Last inspection report (8th june 2017)
Certificate of GMP that is valid until 7th june 2018
International availability in RRA is not confirmed.
Application was received through letter no F.6-
2/2016 (R-III)
Decision: Approved with innovator specifications. Fee challan shall be verified as per
procedure adopted in 264th meeting.
536. Name and address of manufacturer / M/s Dyson Research laboratories, sheikhupura
Applicant contract manufacturing by McOlson Research
Laboratories.
Brand Name +Dosage Form + Strength Pime 500mg dry powder injection
Sterile powder of cefepime HCl with L-Arginine eq
to Cefepime…500mg
Rs.8,000/- 18-5-2009
Type of Form Form-5
Approval status of product in Maxipime 500 mg of Hospira Inc., USA (USFDA)
Me-too status Nuxipim 500mg Injection of Bosch.
GMP status Last inspection report (McOlson Research
laboratories) 10-4-2017 &24-04-2017 “Firm has fair
compliance of GMP”
Last Inspection report (Dyson Research laboratories)
1.8.2017. “Panel recommended issuance of GMP
certificate”
Remarks of the Evaluator. Valid Contract agreement is attached.
Decision: Approved
537. Name and address of manufacturer / M/s Dyson Research laboratories, sheikhupura
Applicant contract manufacturing by McOlson Research
Laboratories.
Brand Name +Dosage Form + Strength Pime 1gm dry powder injection
Sterile powder of cefepime HCl with L-Arginine eq
to Cefepime…1gm
Rs.8,000/- 18-5-2009
Type of Form Form-5
Approval status of product in Maxipime 1 g of Hospira Inc., USA (USFDA)
Me-too status Nuxipim 1g Injection of Bosch
Last Inspection report (Dyson Research laboratories)
01-8-2017. “Panel recommended issuance of GMP
certificate”
Decision: Approved
538. Name and address of manufacturer / M/s Marvi Pharmaceuticals, Karachi
Applicant
Brand Name +Dosage Form + Strength Azicin 250mg Capsule
Composition Each capsule contains;
Azithromycin …………….....250mg
Diary No. Date of R& I & fee Diary No: 272, 29/04/2014, Rs: 20,000/-
Pharmacological Group Macrolide, Antibacterial
Type of Form Form 5
Pack size & Demanded Price 10‟s Rs.260/-
Approval status of product in Zithromax capsule by Pfizer
Me-too status Azomax by Novartis
GMP status Last Inspection report 29-11-2016 it is recommended
that firm may be allowed to start manufacturing in
compliance to the guidelines of current
manufacturing practices.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Fluvizole 150mg Capsule
Fluconazole ………....150mg
Pharmacological Group Anti-fungal
Type of Form Form 5
Pack size & Demanded Price 1‟s, Rs.400/-
Approval status of product in Azocan 150mg Capsule by FDC International
Me-too status Rexole by Biorex
Remarks of the Evaluator. Product monograph is present in JP
Decision: Approved with JP specifications
Applicant
Brand Name +Dosage Form + Strength Maripride tablet 3mg
Glimipride ………....3mg
Type of Form Form 5
Pack size & Demanded Price 20‟s Rs. 298/-
Me-too status Glimar by Asian Continental
Applicant
Type of Form Form 5
Decision: Approved with USP specifications.

Applicant
Type of Form Form 5
Decision: Approved with USP specifications.

Applicant
Brand Name +Dosage Form + Strength Maricam capsule 10mg
Piroxicam ………....10mg
Type of Form Form 5
Pack size & Demanded Price 14‟s, Rs.60/-
Approval status of product in Piroxicam Capsules 10mg by M/s Teva approved by
Reference Regulatory Authorities. USFDA
Me-too status Felden by Pfizer
GMP status Last Inspection report 29-11-2016; it is recommended
compliance to guidelines of current manufacturing
practices.
Decision: Approved
Applicant
Brand Name +Dosage Form + Strength Maripril tablets 25mg
Captopril ………....25mg
Pharmacological Group Anti-Hypertensive
Type of Form Form 5
Approval status of product in USFDA
Me-too status Eptril tablet ny Fynk
Applicant
Brand Name +Dosage Form + Strength Neutrofer-F chewable tablet
Iron III Hydroxide Polymaltose Complex. eq to
elemental iron…..100mg
Folic acid…..350mcg
Diary No. Date of R& I & fee Diary No: 536, 29/04/2014, Rs: 12,000/-,
Rs.8000/- 13-10-2013
Type of Form Form 5
Me-too status Bisleri-f Tablet by M/s. Sami, Karachi
Applicant
Brand Name +Dosage Form + Strength Martifin DS tablet
Artemether……..80mg
Lumefantrine….480mg
Rs.8000/- 13-10-2013
Type of Form Form 5
Approval status of product in WHO approved formulation
Me-too status A-Fantrine tablets (80/480) by M/s ATCO
Laboratories.
Applicant
Brand Name +Dosage Form + Strength Neutrofer Syrup
Iron III Hydroxide Polymaltose Complex. eq to
elemental iron…..50mg
Rs.8000/- 13-10-2013
Type of Form Form 5
Pack size & Demanded Price 120ml, As per SRO/-
Me-too status Luberon 50mg/5ml Liquid Syrup by M/s Ankaz
Applicant
Brand Name +Dosage Form + Strength Levozole 5mg tablet
Levocetirizine Dihydrochloride eq to
Levocetirizine…5mg
Diary No. Date of R& I & fee Diary No: 538, 29/04/2014, Rs: 12,000/-, Rs.8000/-
13-10-2013
Type of Form Form 5
Approval status of product in Levocetirizine tablets by Actavis
Me-too status Atiza by Asian Continental
549. Name and address of manufacturer / M/s McOlson Research Laboratories contract
Applicant manufactured by English Pharmaceuticals
Brand Name +Dosage Form + Strength Lornex 8mg Injection IM/IV
Lornoxicam……8mg
Type of Form Form 5
Approval status of product in Xefo 8 mg Filmtabletten by M/s Takeda Pharma
Reference Regulatory Authorities. AG,
(Swiss Medic approved)
(Reg No:061604)
Last inspection report (English Pharma) 24-11-2016
“Firm was operating under satisfactory compliance
of GMP.
 Deferred for submission of evidence of approval of section/manufacturing facility of
“Dry Powder Injection (Lyophilized) section” by the Central Licensing Board.
 Confirmation of generic / me too status
 Confirmation of already approved cases for contract manufacturing.
550. Name and address of manufacturer / M/s Unison Chemical Works, Lahore contract
Applicant manufactured by McOlson Research laboratories,
lahore
Brand Name +Dosage Form + Strength Zifi Suspension 200mg/5ml
Cefixime Trihydrate eq to cefixime……200mg
Type of Form Form 5
Pack size & Demanded Price 60ml, As per SRO
Me-too status Refspan Suspension 200mg of M/s Rasco Pharma
(Reg.# 038950)
Fee challan photocopy is attached

II. Deferred cases
Evaluator PEC-VI
551. Name and address of manufacturer / M/s Maple Pharma Karachi
Applicant
Brand Name +Dosage Form + Strength Menorest Tablet
Acetaminophen (USP)…….250mg
Magnesium Salicylate…..250mg
Pamabrom …….25 mg
Diary No. Date of R& I & fee Dy. No. 152, 20-10-2010Rs.8000/-
Rs.12,000/- 31-12-2014
Pharmacological Group NSAIDS & Diuretic
Type of Form Form 5
Pack size & Demanded Price 10„s As Per PRC
Approval status of product in Reference Pamprin tablet of M/s Chattem, Inc, USFDA
Regulatory Authorities. approved (as OTC product).
Me-too status Dolmi Extra Tablet of M/s Genix Pahrma (Reg.#
073561)
GMP status Inspection report dated 3-6-2016, conducted by Dr.
Ghulam Ali Lakho (Provincial Inspector of Drug)
showed GMP compliance.
Previous decision Decision of 271st meeting:
Deferred for submission of GMP inspection report
conducted within last 1 year by DRAP.
Evaluation by PEC Firm has now deposited Last inspection 24-07-2017
“acceptable level of GMP compliance.”
Decision of 275 meeting: Approved with innovator’s specifications and change of brand
th
name.
Applicant
Brand Name +Dosage Form + Strength Zeenate DS Syrup
Composition Each 5ml contains: Zinc sulphate monohydrate eq. to
elemental zinc … …20mg
Rs.12,000/- 16-3-2015
Pharmacological Group Minerals
Type of Form Form 5
Pack size & Demanded Price 60ml, As per PRC
Me-too status Diasul by Helix
th
Decision of 275 meeting: Approved with International pharmacopoeial specifications.

Applicant
Brand Name +Dosage Form + Strength Zeenate Syrup
Composition Each 5ml contains: Zinc sulphate monohydrate eq. to
elemental zinc … …10mg
Diary No. Date of R& I & fee Dy.No.543, 31-01-2011, Rs.8000/-
Rs.12,000/- 16-3-2015
Pharmacological Group Minerals
Type of Form Form 5
Pack size & Demanded Price 60ml As per PRC
Me-too status Zincasa by Macter
th
Decision of 275 meeting: Approved with International pharmacopoeial specifications.
554. Name and address of manufacturer / EG Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Iromalt-F tablets
Iron III hydroxide Polymaltose eq to elemental
iron…..…100mg
Folic acid USP…0.35mg
Diary No. Date of R& I & fee 654, 16-7-2012, Rs 8000, Rs 12,000, 12-6-2014
Type of Form Form-5
Finished product Specification Manufacturer‟s Specifications
Approval status of product in Reference N/A
Me-too status “ Irowan-F Tablet of Nawan Lab. Karachi
(Reg.#079685)
GMP status Last Inspection report 7-4-2016(Ampoule working area
was also small and due to space constrain, the laminar
flow hood in this room was not operative. The vial
working area is congested and need more space)
The pharmacists &other techni1qcal staff were advised
to be vigilant and follow the GMP
protocols/Guidelines. A compliance report was asked
to be submitted.
Previous remarks of the Evaluator. Last inspection report dated 7-4-2016 does not verify
the GMP status.
Previous decision Decision in 270th :
Deferred for submission of latest GMP inspection
report conducted within 1 year.
Evaluation by PEC Firm has submitted last inspection report 22-06-2017
Firm was considered to be operating at reasonable
level of compliance with GMP guidelines.
Applicant
Brand Name +Dosage Form + Strength Rifix 550mg tablet
Rifaximin…550mg
Diary No. Date of R& I & fee 8257, 7-8-2012, Rs 8,000, Rs 12,000
Pharmacological Group Non-Systemic antibiotic
Type of Form Form-5
Pack size & Demanded Price 10‟s As per SRO
Approval status of product in Reference Xifaxan By Salix Pharms (USFDA) `
Me-too status Nimixa By Getz Pharma
GMP status Last Inspection report 7-4-2016(Ampoule working
area was also small and due to space constrain, the
laminar flow hood in this room was not operative.
The vial working area is congested and need more
space)
The pharmacists &other technical staff were advised
to be submitted.
Previous remarks of the Evaluator.  Last inspection report does not verify the
GMP status.
The firm has claimed manufacturer‟s
specifications and has not submitted the data as
per requirement of the decision made in 267th
meeting of DRB.
Previous decision Decisionof 270th:
Decision of 275th meeting: Approved with innovator’s specifications.
Applicant
Brand Name +Dosage Form + Strength Rifix 200mg tablets
Rifaxamin….200mg
Diary No. Date of R& I & fee 812, 7-8-2012, Rs 8000, Rs 12,000
Pharmacological Group Non-Systemic antibiotic
Type of Form Form-5
Approval status of product in Reference Xifaxan By Salix Pharms (USFDA)
Me-too status Nimixa By Getz Pharma
space)
to be submitted.

Previous remarks of the Evaluator.  Last inspection report does not verify the GMP
status.
 The firm has claimed manufacturer‟s
specifications and has not submitted the data as
per requirement of the decision made in 267th
meeting of DRB.
Previous decision Decision of 270th:

Applicant
Brand Name +Dosage Form + Strength Fexidine 120mg tablet
Composition Each film coating tablet contains:
Fexofenadine HCL…120mg
Diary No. Date of R& I & fee 7305, 18-7-2012, Rs 8,000 Rs 12,000
Pharmacological Group Antihistamines
Type of Form Form-5
Pack size & Demanded Price 10‟s As per SRO
Me-too status Telfast by Sanofi
space)
to be submitted.
Previous remarks of the Evaluator.  Last inspection report does not verify the GMP status.
 Firm has claimed Manufacturing Specifications while
the product is present in available pharmacopoeia
(USP39,BP 2016)
Decision of 275th meeting: Approved.

Applicant
Brand Name +Dosage Form + Strength Diclonac 50mg tablet
Composition Each film coating tablet contains:
Diclofenac Potassium…….50mg
Diary No. Date of R& I & fee 7103, 13-7-2012, Rs 8000, Rs 12000
Type of Form Form-5

Pack size & Demanded Price 2*10‟s, As per SRO
Me-too status Diclorep by Sami
GMP status Last Inspection report 7-4-2016 (Ampoule working
space).
to be submitted.
Previous remarks of the Evaluator.  Last inspection report does not verify the
GMP status.
 Firm has claimed Manufacturing
Specifications while the product is present in
available pharmacopoeia (USP39,BP 2016)
Previous decision Decision of 270th: Deferred for submission of latest
GMP inspection report conducted within 1 year.
559. Name and address of manufacturer / M/S Dyson Research, Lahore
Applicant
Brand Name +Dosage Form + Strength Achedec- SR tablets 100mg
Composition Each slow release tablet contains:
Diclofenac sodium…100mg
Diary No. Date of R& I & fee 9639, 14-10-2010, Rs 8,000, Rs 12,000 24-7-2014
Type of Form Form-5
Me-too status Dicloran SR tablet by Sami
GMP status Last inspection report 14-10-2015, & 3-11-2015
The panel recommended the grant of renewal of DML.
Previous remarks of the Evaluator.  Last inspection report is older than 1 year.
 Available in USP
Evaluation by PEC Firm has submitted last inspection report 1-8-
2017with conclusion “panel recommended issuance
of GMP certificate to the firm.”
th
Decision of 275 meeting: Approved.
Applicant
Brand Name +Dosage Form + Strength Neurocap 500mg Capsules
Composition Each hard gelatin capsule contains:
Mecobalamin…..500mcg
Diary No. Date of R& I & fee 9643, 14-1-2010, Rs 8,000, Rs 12000, 24-7-2014
Pharmacological Group Vitamin B12
Type of Form Form-5
Approval status of product in Reference PMDA Approved
Me-too status Evemec capsule by Everest Pharma
GMP status Last inspection report 14-10-2015, & 3-11-2015
The panel recommended the grant of renewal of DML.
Previous remarks of the Evaluator. Last inspection report is of 14-10-2015, & 3-11-2015
Previous decision Decision of 270th: Deferred for submission of latest

Applicant
Brand Name +Dosage Form + Strength Neocetam Tablets 400mg
Piracetam BP….400mg
Diary No. Date of R& I & fee 9636, 14-10-2010, Rs 8,000, Rs 12,000, 24-7-2014
Pharmacological Group Nootropic and psychostimulant
Type of Form Form-5
Pack size & Demanded Price 20‟s, 30‟s As per SRO
Approval status of product in Reference Biogaran film-coated 400mg(ANSM_France)
Me-too status Ceremin tablet 400mg by Schazoo pharma
GMP status Last inspection report 14-10-2015, & 3-11-2015 The
panel recommended the grant of renewal of DML.
Previous remarks of the Evaluator. Last inspection report is of 14-10-2015, & 3-11-2015
Decision of 275 meeting: Approved with innovator’s specifications.
th
562. Name and address of manufacturer / M/s FYNK Pharmaceuticals, 19-Km G.T Road, Kala
Applicant Shah Kaku, Lahore
Brand Name +Dosage Form + Strength Ok-Zinc 20mg/5ml Syrup
Zinc Sulphate Monohydrate eq. to Elemental Zinc
…………..20mg
Diary No. Date of R& I & fee Dy. No. 3567, 23-05-2012 , Rs.8,000/- (23-05-2012),
18-03-2015 , Rs.12,000/- (17-03-2015)
Type of Form Form-5
Finished product Specification IP Specifications
Pack size & Demanded Price 60ml: Rs. As per SRO
120ml: Rs. As per SRO
Me-too status Diasul by Helix,
concludes that firm is complying most of the cGMP
Guidelines and exhibit positive approach towards
compliance. However short comings pointed out
should be rectified within 15 days.
Previous remarks of the Evaluator. Last inspection report is of 3-5-2016.
Applied formulation is approved by WHO and
International pharmacopoeia monograph is also
available
Previous decision Decision of 272nd:Deferred for submission of latest
with conclusion “Overall condition of the firm is
satisfactory”
Brand Name +Dosage Form + Strength Isodinit 10mg Tablet
Isosorbide As isosorbide Dinitrate ……… 10mg
Diary No. Date of R& I & fee Dy. No. 3552, 23-05-2012 , Rs.8,000/- (23-05-2012),
18-03-2015 , Rs.12,000/- (17-03-2015)
Pharmacological Group Cardiac Therapy(Nitrates)
Type of Form Form-5
Finished product Specification USP Specifications
Pack size & Demanded Price 10x10‟s: Rs. As per SRO
Me-too status ISor by CCL Reg No. 045970
satisfactory”
Brand Name +Dosage Form + Strength Enpril 10mg Tablet
Enalapril As Enalapril Maleate………..10mg
Diary No. Date of R& I & fee Dy. No. 3575 ,23-05-2012 , Rs.8,000/- (23-05-2012)
, Rs.12,000/- (17-03-2015)
Pharmacological Group ACE Inhibitor
Type of Form Form-5
Me-too status Entec by Alliance Reg No. 044737
satisfactory”
Brand Name +Dosage Form + Strength Rova 10mg Tablet
Composition Each Film Coated Tablet contains:
Rosuvastatin (as Calcium)……… 10mg
Diary No. Date of R& I & fee Dy. No.3581 ,23-05-2012 , Rs.8,000/- (23-05-2015),
Rs.12,000/- (17-03-2015)
Pharmacological Group Hypolipidaemics/Anti-atheroma
Type of Form Form-5
Finished product Specification FYNK Specifications
Pack size & Demanded Price 10‟s: Rs. As per SRO
Approval status of product in Reference Crestor 20mg Tablets by M/s AstraZeneca
Regulatory Authorities. Pharmaceuticals LP, USFDA approved.
Me-too status Rosut 20mg Tablet by M/s Genome Pharmaceuticals
(Reg No:042517)
satisfactory”
th
Brand Name +Dosage Form + Strength Lurk 750mg Tablet
Composition Each Film coated Tablet contains:-
Levofloxacin………. 750mg
Diary No. Date of R& I & fee Dy. No. 3569 ,23-05-2012 , Rs.8,000/- (23-05-2012),
Rs.12,000/- (17-03-2015)
Pharmacological Group Broad Spectrum Antibiotic
Type of Form Form-5
Approval status of product in Reference Levaquin 750 mg Tablet by M/s JANSSEN
Regulatory Authorities. PHARMS (USFDA approved)
Me-too status Aksolox 750mg Tablet by M/s Akson Pharmaceutical
(Reg No:073226)
satisfactory”
Brand Name +Dosage Form + Strength Zafin Tablet 8mg
Composition Each Tablets contains:
Ondansetron as Ondansetron HCl……… 8mg
Rs.12,000/- (17-03-2015)
Type of Form Form-5
Me-too status Onset by Pharmadic, Zofran by GSK
satisfactory”
Brand Name +Dosage Form + Strength Isomin 20mg Tablet
Isosorbide Mononitrate……. 20mg
Diary No. Date of R& I & fee Dy. No. 3571 ,23-05-2012 , Rs.8,000/- (23-05-2015,
Rs.12,000/- (17-03-2015)
Pharmacological Group Cardiac Therapy(Nitrates)
Type of Form Form-5
Me-too status Mnotab by Epla Reg No. 044199
satisfactory”
Brand Name +Dosage Form + Strength Carbam 200mg Tablet
Carbamazepine…………… 200mg
Rs.12,000/- (17-03-2015)
Pharmacological Group Anti Epileptics
Type of Form Form-5
Me-too status Carbawel by Welmark Reg No. 077462
satisfactory”
Brand Name +Dosage Form + Strength Rova 20mg Tablet
Rosuvastatin (as Calcium)……… 20mg
Diary No. Date of R& I & fee Dy. No.3581 ,23-05-2012 , Rs.8,000/- (23-05-2015),
Rs.12,000/- (17-03-2015)
Pharmacological Group Hypolipidaemics/Anti-atheroma
Type of Form Form-5
Finished product Specification FYNK Specifications
Approval status of product in Reference Crestor 20mg Tablets by M/s AstraZeneca
Regulatory Authorities. Pharmaceuticals LP, USFDA approved.
Me-too status Rosut 20mg Tablet by M/s Genome Pharmaceuticals
(Reg No:042517)
satisfactory”
Brand Name +Dosage Form + Strength Ethan 400 Tablet
Ethambutol HCl …………400mg
Rs.12,000/- (17-03-2015)
Pharmacological Group Anti-tuberculosis drugs
Type of Form Form-5
Me-too status Etham by Pacific Reg No. 057252
satisfactory”
Brand Name +Dosage Form + Strength Zafin Injection 8mg/4ml
Ondansetron (as Ondansetron HCl)…… 8mg
Diary No. Date of R& I & fee Dy. No.3579 ,23-05-2012 , Rs.8,000/- (23-05-2012)
Rs.12,000/- (17-03-2015)
Pharmacological Group 5HT3-Antagonist,
Type of Form Form-5
Approval status of product in Reference Ondansetron 2 mg/ml Solution for Injection by
Regulatory Authorities. Mhameln pharmaceuticals ltd, MHRA approved
Me-too status Zofran Injection 8mg/4ml by M/s Novartis
(Reg#084165)
satisfactory”
573. Name and address of manufacturer / M/s Titlis Pharma, Lahore

Applicant
Brand Name +Dosage Form + Strength Elert 20mg tablets
Ebastine…20mg
Type of Form Form-5
Finished product Specification JP
Approval status of product in Reference Not Provided
Me-too status Bestec 20mg Tablet by M/s Shrooq Pharmaceutical
(Reg No:068174)
GMP status Last inspection conducted for grant of GMP
certificate for export purpose on 22-11-2016 and
report concludes that the firm was GMP compliant
Previous remarks of the Evaluator. International availability in Reference Regulatory
Authority cannot be confirmed.
Previous decision Decision of 273rd:Deferred for evidence of approval
in reference regulatory authorities.
Evaluation by PEC The above product is approved in Netherland.
574. Name and address of manufacturer / M/s Novamed Pharmaceuticals, Lahore
Applicant
Brand Name +Dosage Form + Strength Pitava 4mg tablets
Pitavastatin as calcium………..4mg
Pharmacological Group Hypolipidemic agents
Type of Form Form-5
Me-too status Pitalo by Genix
GMP status Last inspection report 8-2-2017 Panel inspection for
the grant of additional section. The panel recommend
the grant of addition section
Previous remarks of the Evaluator. Inspection report is for the grant of additional section
Product monograph is present in Japanese
Pharmacopoeia
Deferred for submission of last GMP inspection
report conducted within a year
Evaluation by PEC Firm has submitted last GMP inspection report 8-2-
2017, Firm was considered to be operating at Good
th

Case No. 05: Registration applications of newly granted DML or New section (Human)
a. DML (Drug Manufacturing License(s))
b. New section(s)
c. Remaining products
d. Deferred Cases
____________________________________________________________________
a) DML (Drug Manufacturing License(s)
Evaluator PEC-XII
Case No. 1: M/s. Perk Pharma , Gadoon ( New License)
Following registration dossiers have been received vide letter No. F.16-4/2013 Reg-IV dated 14th
September, 2017stating that the firm has been granted approval of new DML by way of
formulation by Central Licensing Board in its 254th meeting for following sections
1. Tablet section (General)
2. Capsule section (General)
3. Dry powder suspension section (General)
4. Oral Liquid Section (General)
The following applications have been evaluated and presented before the Board
Sr. No Section No. of products No. of molecules
1 Tablet section (General) 8 8
2 Capsule section (General) 8 6
3 Dry powder suspension section (General) - -
4 Oral Liquid Section (General) - -
Tablet Section (General)
8 products / 8molecules
575. Name and address of manufacturer / M/s Perk Pharma,Plot No. 197/1-B, Industrial Estate,
Applicant Gadoon.
Brand Name +Dosage Form + Strength Noxi 4mg Tablet
Lornoxicam...4mg
Type of Form Form 5
Finished Product Specification Innovator‟s Specification
Pack size & Demanded Price 2x10‟s/As per SRO
Approval status of product in Reference Xefo 4 mg Filmtabletten by M/s Takeda Pharma AG,
Regulatory Authorities. (Swiss Medic approved)
(Reg No:061603)
GMP status 01/04/2017 / Inspection for grant of new DML
Panel recommends grant of DML
Decision:Approved with Innovator’s specifications.
576. Name and address of manufacturer / M/s Perk Pharma, Plot No. 197/1-B, Industrial Estate,
Applicant Gadoon.
Brand Name +Dosage Form + Strength Boxin 400mg Tablet
Composition Each film coated tablet contains;
Moxifloxacin (as hydrochloride)...400mg
Type of Form Form 5

Approval status of product in Reference Avelox 400 mg film-coated tablets by M/s Bayer plc,
Me-too status Metoxim 400mg Tablet by M/s Foray Pharmaceutical
(Reg No:056083)
Applicant Gadoon.
Brand Name +Dosage Form + Strength Percip 500mg Tablet
Ciprofloxacin(as hydrochloride)…500mg
Pharmacological Group Fluoroquinolone Antibiotic.
Type of Form Form 5
Approval status of product in Reference Ciprofloxacin 500 mg Film-Coated Tablets by M/s Teva
Regulatory Authorities. UK Limited
Me-too status Mercip 500mg Tablet by M/s Merck, (Reg#024602)
Decision:Approved.
Applicant Gadoon.
Brand Name +Dosage Form + Strength Perlev 500mg Tablet
Levofloxacin (as hemihydrate)…....500mg
Pharmacological Group Fluoroquinolone Antibiotic
Type of Form Form 5
Pack size & Demanded Price 1x10‟s/
As per SRO
Approval status of product in Reference Evoxil 500 mg film-coated tablets by M/s Beacon Pharm
Me-too status Lazer 500mg Tablet by M/s Foray Pharmaceutical
(Reg No:040614)
Decision:Approved
Applicant Gadoon.
Brand Name +Dosage Form + Strength Vaczid 600mg Tablet
Linezolid…600mg
Pharmacological Group Oxazolidinone
Type of Form Form-5
Pack size & Demanded Price 2x6‟s/
As per SRO.
Approval status of product in Reference Zyvox 600 mg film-coated tablets by M/s Pharmacia
Regulatory Authorities. Limited, MHRA approved.
Me-too status Ecasil 600mg tablet by M/s Sami (Reg#066904)
Applicant Gadoon.
Brand Name +Dosage Form + Strength Ipotep 50mg Tablet
Composition Each film coated tablet Contains:
Itopride hydrochloride….50 mg
Pharmacological Group Benzamides
Type of Form Form 5
Pack size & Demanded Price 30‟s/ As per SRO.
Approval status of product in Reference Confirmed from PMDA Japan
Me-too status Ganaton 50 mg Tablet by M/s Abbott. (Reg# 028429)
Applicant Gadoon.
Brand Name +Dosage Form + Strength Propin 40mg Tablet
Composition Each enteric Coated Tablet Contains:
Pantoprazole(as sodium)…40mg
Pharmacological Group Antipeptic Ulcerant /Proton Pump Inhibitor
Type of Form Form 5
Approval status of product in Reference Pantoprazole 40 mg gastro-resistant tablets by M/s
Regulatory Authorities. Generics [UK] Limited t/a Mylan (MHRA approved)
Me-too status Cantrofast 40mg enteric coated tablet by M/s Candid
pharmaceutical (Reg#082031)
GMP status 01/04/2017Inspection for grant of new DML
Decision:Approved.
Applicant Gadoon.
Brand Name +Dosage Form + Strength Depnor 10mg Tablet
Escitalopram(as oxalate)…10mg
Pharmacological Group Selective serotonin reuptake inhibitors (SSRI).
Type of Form Form 5

Pack size & Demanded Price 1x14‟s / As per SRO.
Approval status of product in Reference CIPRALEX 10 mg film-coated tablets by M/s H.
Regulatory Authorities. Lundbeck (MHRA approved)
Me-too status Citanew 10mg Tablet by M/s Hilton, (Reg#036426).
GMP status 01/04/2017; Inspection for grant of new DML
Decision:Approved.
Capsule section (General)
Applicant Gadoon.
Brand Name +Dosage Form + Strength Perjeb 75mg Capsule
Pregabalin.....75mg
Pharmacological Group Anti-epileptic /drug GABA analogue.
Type of Form Form 5
Approval status of product in Reference Lyrica 75mg Capsule by M/s PF Prism CV, (USFDA
Regulatory Authorities. approved)
Me-too status Lyrica 75mg Capsule by M/s Pfizer Pakistan Ltd.
(Reg#044817)
Applicant Gadoon.
Brand Name +Dosage Form + Strength Perkoten 12/25mg Capsule
Olanzapine…12mg
Fluoxetine(as hydrochloride)…25mg.
Pharmacological Group Antipsychotic, SSRI
Type of Form Form-5
Pack size & Demanded Price 2x10‟s/ As per SRO.
Approval status of product in Reference Symbyax 12mg/25mg capsule by Eli Lilly (USFDA
Me-too status Olanco 12/25mg Capsule by M/s Nabi Qasim
Pharmaceuticals Pvt.Ltd. (Reg#064014)
Decision:Approved.
Applicant Gadoon.
Brand Name +Dosage Form + Strength Esopep 20mg Capsule
Esomeprazole (as magnesium Trihydrate) enteric coated
pellets.....20mg
Pharmacological Group Proton Pump inhibitor
Type of Form Form 5
Ventra 20 mg gastro-resistant capsules by M/s
Regulatory Authorities. Ethypharm (MHRA approved)
Me-too status ESORID 20mg by M/s Hilton Pharma. Limited, (Reg#
032365 )
Remarks of the Evaluator. Source of pellets: Vision Pharmaceuticals, Islamabad.
Decision:Approved with change of brand name.
Applicant Gadoon.
Brand Name +Dosage Form + Strength Omeper 40mg Capsule
Omeprazole enteric coated pellets eq. to
Omeprazole....40mg
Type of Form Form 5
Losec 40 mg hard gastro-resistant capsules 20mg by
Regulatory Authorities. Astra Zeneca UK Ltd.(MHRA approved)
Me-too status Risek 40mg capsule by M/s Getz Pharma Pvt.Ltd.
(Reg#022109)
Applicant Gadoon.
Brand Name +Dosage Form + Strength Omeper 20mg Capsule
Omeprazole....20mg
Type of Form Form 5
Losec 20 mg hard gastro-resistant capsules 20mg by
Me-too status Losec 20mg capsule by M/s Barrett Hodgson Pakistan
Pvt. Limited, (Reg# 010800)
Remarks of the Evaluator.  Source of pellets: Vision Pharmaceuticals,
Islamabad.

Applicant Gadoon.
Brand Name +Dosage Form + Strength Esopep 40mg Capsule
pellets.....40mg
Type of Form Form 5
Approval status of product in Reference Ventra 40 mg gastro-resistant capsules by M/s
Me-too status ESORID 20mg by M/s Hilton Pharma Ltd(Reg#034227)
Applicant Gadoon.
Brand Name +Dosage Form + Strength Atezor 250mg Capsule
Azithromycin (as dihydrate).....250mg
Pharmacological Group Macrolide/Antibiotic.
Type of Form Form 5
Approval status of product in Reference Zithromax 250mg capsule by M/s Pfizer Ltd.(MHRA
Decision:Approved.
Applicant Gadoon.
Brand Name +Dosage Form + Strength Perzol 150mg Capsule
Fluconazole…150mg
Type of Form Form 5
Pack size & Demanded Price 1‟s/ As per SRO
Approval status of product in Reference Diflucan 150mg Capsule by M/s Pfizer (MHRA
Me-too status Diflucan 150mg Capsule by M/s Pfizer (Reg#011828)
Decision:Approved.
Case No. 2: M/s. N.S Pharma, Lahore ( New License)
Following registration dossiers have been received vide letter No. F.8-6/2013 Reg-IV dated
27th September, 2017stating that the firm has been granted approval of new DML by way of
formulation by Central Licensing Board in its 255th meeting for following sections
3. Sachet section (General)
4. Liquid injectable ampoule/ vial section (General)
3 Sachet section (General) 12 10
4 Liquid injectable ampoule/ vial section 15 10
(General)
Tablet (General) Section
18 products/ 10 molecules
591. Name and address of manufacturer / M/s N.S Pharma, Plot no. 576, 577 Sunder Industrial
Applicant Estate, Lahore.
Brand Name + Dosage Form + Strength Ciprosid 250mg Tablet
Diary No. Date of R& I & fee Diary No.16241; 26-09-2017; Rs.20,000/-
Ciprofloxacin (as hydrochloride)…250mg
Type of Form Form-5
Pack Size & Demand Price 10‟s/As Per SRO
Approval status of product in Reference Ciprofloxacin 250 mg Film-Coated Tablets by M/s
Regulatory Authorities Teva UK Limited (MHRA Approved)
Me-too Status Mercip 250mg tablet by M/s Merck, (Reg#024601)
GMP Status 08-06-2017; Grant of new DML
Panel recommends grant of new DML.
Remarks of Evaluator -
Decision: Approved
Diary No. Date of R& I & fee Diary No. 16242, 26/09/2017, Rs: 20,000/-
Type of Form Form-5
Approval status of product in Reference Ciprofloxacin 500 mg Film-Coated Tablets by M/s
Regulatory Authorities Teva UK Limited
Me-too Status Mercip 500mg Tablet by M/s Merck, (Reg#024602)
Decision: Approved

Type of Form Form-5
Approval status of product in Reference Ciprofloxacin 750 mg film-coated tablets by M/s
Regulatory Authorities Milpharm Limited (MHRA approved)
Me-too Status Cipropar Tablet 750mg by M/s Neomedix
GMP Status 08-06-2017
Grant of new DML
Decision: Approved
Brand Name + Dosage Form + Strength Dolphin 50mg E/C Tablet
Composition Each Enteric Coated Tablet Contains:
Diclofenac Sodium…50mg
Pharmacological Group Analgesics, Antipyretics, NSAIDs, & Antirheumatics
Type of Form Form-5
Pack Size & Demand Price 2x10‟s/As Per SRO
Approval status of product in Reference Diclofenac Sodium 50 mg Gastro-resistant Tablets by
Regulatory Authorities M/s Teva UK Limited (MHRA Approved)
Me-too Status Vorenac 50mg Tablet by M/s Mission Karachi
(Reg#080324)
Brand Name + Dosage Form + Strength Dolphin 100mg SR Tablet
Composition Each Film Coated SR Tablet Contains:
Diclofenac Sodium…100mg
Type of Form Form-5
Approval status of product in Reference Voltarol Retard Tablets 100mg by M/s Novartis
Regulatory Authorities Pharmaceuticals Limited (MHRA Approved)
Me-too Status Sintral SR Tablets 100mg by M/s Neomedix

Brand Name + Dosage Form + Strength Dolphin-K 50mg Tablet
Composition Each film coated Tablet Contains:
Diclofenac potassium…50mg
Type of Form Form-5
Approval status of product in Reference Diclofenac Potassium film coated 50 mg Tablets by
Regulatory Authorities M/s Focus Pharmaceuticals Ltd (MHRA approved)
Me-too Status Pngo Tablet 50mg by M/s Invotek Pharmaceuticals
(Reg#079985)
Grant of new DML
Brand Name + Dosage Form + Strength Iosid 100mg Tablet
Composition Each sugar Coated Tablet Contain:
Flurbiprofen…100mg
Pharmacological Group NSAIDs
Type of Form Form-5
Approval status of product in Reference Flurbiprofen 100 mg coated tablets by M/s Mylan
Regulatory Authorities Products Ltd. (MHRA Approved)
Me-too Status Neoflarbi 100mg Tablet by M/s Neomedix
Decision: Approved.
Brand Name + Dosage Form + Strength Levosid 250mg Tablet
Type of Form Form-5
Approval status of product in Reference Evoxil 250 mg film-coated tablets by M/s Beacon
Regulatory Authorities Pharm
(MHRA approved)
Me-too Status Lazer 250mg Tablet by M/s Foray Pharmaceutical
(Reg No:040615)
Decision: Approved.
599. Name and address of manufacturer / M/s N.S Pharma,Plot no. 576, 577 Sunder Industrial

Type of Form Form-5
Approval status of product in Reference Evoxil 500 mg film-coated tablets by M/s Beacon
Regulatory Authorities Pharm (MHRA approved)
Me-too Status Lazer 500mg Tablet by M/s Foray Pharmaceutical
(Reg No:040614)
Grant of new DML
Decision: Approved.
Composition Each Film Coated Tablet Contains:
Levofloxacin (as hemihydrate)…750mg
Type of Form Form-5
Approval status of product in Reference Levofloxacin Tablets 750mg by M/s Accord Health
Regulatory Authorities Care Limited approved by MHRA of UK
Me-too Status Leflox 750mg tablet by Getz Pharma, (Reg.#
047118)
Grant of new DML
Decision: Approved.
Brand Name + Dosage Form + Strength Moxisid 400mg Tablet
Moxifloxacin (as hydrochloride)...400mg
Type of Form Form-5
Approval status of product in Reference Avelox 400 mg film-coated tablets by M/s Bayer plc,
Regulatory Authorities (MHRA approved)
Me-too Status Metoxim 400mg Tablet by M/s Foray Pharmaceutical
(Reg No:056083)
Grant of new DML

Brand Name + Dosage Form + Strength Oflosid 200mg Tablet
Composition Each film-coated tablet contain:
Ofloxacin….200mg
Pharmacological Group Quinolone Antibacterial
Type of Form Form-5
Approval status of product in Reference Ofloxacin 200mg film-coated Tablets by M/s TEVA
Regulatory Authorities UK Limited (MHRA Approved)
Me-too Status Dyramid 200mg Tablet by M/s DonValley
(Reg#020291)
Grant of new DML
Brand Name + Dosage Form + Strength Parosid CR 25mg Tablet
Paroxetine (as hydrochloride)…25mg
Pharmacological Group Antidepressant-SSRI
Type of Form Form-5
Approval status of product in Reference Paxil CR 25mg Controlled-Release Tablets by M/s
Regulatory Authorities Apotex Technologies(USFDA Approved)
Me-too Status Seroxat CR 25mg by GSK (Reg#043058) but as
controlled release
Grant of new DML
Decision: Approved.
Brand Name + Dosage Form + Strength Parosid CR 37.5mg Tablet
Composition Each film coated controlled release tablet contains:
Paroxetine (as hydrochloride)…37.5mg
Type of Form Form-5
Approval status of product in Reference Paxil CR 37.5mg Controlled-Release Tablets by M/s
Regulatory Authorities Apotex Technologies(USFDA Approved)
Me-too Status Deroxat CR 37.5mg Tablet by M/s Global
(Reg#069948)
Decision: Approved.

Brand Name + Dosage Form + Strength Parosid 20mg Tablet
Paroxetine (as hydrochloride)…20 mg
Type of Form Form-5
Approval status of product in Reference Paxil 20mg film coated tablet by Apotex Corp.
Regulatory Authorities (USFDA Approved)
Me-too Status Seroxat 20mg Tablet by M/s GSK (Reg#019506)
Decision: Approved.
Brand Name + Dosage Form + Strength Sidamet 500-50 Tablet
Sitagliptin (as phosphate monohydrate)…50 mg
Metformin hydrochloride...500mg
Pharmacological Group Ant diabetic (dipeptidyl peptidase-4 inhibitor (DPP-4)
and biguanide)
Type of Form Form-5
Finished Product Specification Innovator‟s Specifications
Approval status of product in Reference Janumet 50mg/500mg Tablets by M/s Merck
Regulatory Authorities (USFDA approved)
Me-too Status Treviamet 50mg/500mg Tablets by M/s GETZ
Pharma Pakistan (Reg# 055443)
Decision: Approved with Innovator’s specifications and change of brand name.
Brand Name + Dosage Form + Strength Sidamet 1000-50 Tablet
Sitagliptin as phosphate monohydrate…50 mg
Metformin hydrochloride…1000mg
Pharmacological Group Ant diabetic (dipeptidyl peptidase-4 inhibitor (DPP-4)
and biguanide)
Type of Form Form 5
Pack Size & Demand Price 14‟s/ As per SRO
Approval status of product in Reference Janumet 50mg/1000mg Tablets by M/s Merck
Regulatory Authorities (USFDA approved)
Me-too Status Treviamet 50mg/1000mg Tablets by M/s GETZ
Pharma Pakistan. (Reg# 055444)
Decision: Approved with Innovator’s specifications and change of brand name.
Brand Name + Dosage Form + Strength Sidocam 20mg Tablet
Composition Each Tablet Contain:
Piroxicam (as Beta-Cyclodextrin) …..20mg
Type of Form Form-5
Approval status of product in Reference Brexin 20mg Tablet, ANSM approved.
Me-too Status Betacare 20 mg Tablet by M/s CSH Pharma
(Reg#047740)
Grant of new DML
Sachet (General) Section
12 products/ 10molecules
Brand Name + Dosage Form + Strength Dexid Plus Sachet
Polyethylene Glycol 3350….13.125g
Sodium chloride……0.3507g
Sodium Bicarbonate…0.1785g
Potassium Chloride…0.0466g
Pharmacological Group Laxative Electrolytes
Type of Form Form-5
Approval status of product in Reference Movicol 13.8g sachet, powder for oral solution by
Regulatory Authorities M/s Norgine Limited (MHRA Approved)
Me-too Status Movopeg Sachet by M/s Wns field Pharmaceutical
(Reg#078594)
Grant of new DML
610. Name and address of manufacturer / M/s N.S Pharma,
Applicant Plot no. 576, 577 Sunder Industrial Estate, Lahore.
Brand Name + Dosage Form + Strength Esosid 20mg Sachet
Esomeprazole (as magnesium trihydrate enteric
coated pellets)…20mg
Type of Form Form-5
Finished Product Specification Innovator‟s specifications
Approval status of product in Reference Nexium of Astra Zeneka (UK)
Me-too Status Nexum of Getz
Grant of new DML
Remarks of Evaluator Source of granules: Vision Pharmaceuticals,
Islamabad.
Brand Name + Dosage Form + Strength Esosid 40mg Sachet
Type of Form Form-5
Approval status of product in Reference Nexium 40mg packet by M/s AstraZeneca USFDA
Regulatory Authorities Approved)
Me-too Status Somezol 40mg Sachet by M/s Bosch (Reg#081612)
Remarks of Evaluator Source of granules: Vision Pharmaceuticals,
Islamabad.
Brand Name + Dosage Form + Strength Fosfosid 3g Sachet
Fosfomycin tromethamine…3gm
Type of Form Form 5
Approval status of product in Reference Monurol Sachet by M/s Zambon SPA, (USFDA
Me-too Status Monurol Sachet 3gm by M/s Scharper
Pharmaceuticals (Pvt) Ltd. Lahore. (Reg#022663)
Brand Name + Dosage Form + Strength Harsid 4g Sachet
Tartaric Acid…..0.215g
Sodium bicarbonate……0.429g
Citric acid…….0.176g
Sodium citrate……0.153g
Pharmacological Group Antacids & Antiflatulents
Type of Form Form-5

Approval status of product in Reference CitroSoda Granules of Adcock Ingram Limited
Regulatory Authorities (Bryanston, 2021)
Me-too Status Citrovel Sachet by M/s Well & Well pharma
(Reg#070071)
Grant of new DML
Remarks of Evaluator  Approval status of product in Reference
Decision: Deferred for evidence of approval of applied formulation in Reference
Brand Name + Dosage Form + Strength Harsid 5g Sachet
Tartaric Acid…0.215 g
Sodium bicarbonate…0.429g
Citric acid…0.176 g
Sodium citrate…0.153g
Type of Form Form-5
Approval status of product in Reference CitroSoda Granules of Adcock Ingram Limited
Me-too Status Citrovel Sachet by M/s Well & Well pharma
(Reg#070071)
Grant of new DML
Brand Name + Dosage Form + Strength Mebesid Plus (3.5g/135mg) Sachet
Mebeverine hydrochloride…135mg.
Ispaghula husk...3.5g.
Pharmacological Group Antispasmodic, Laxative
Type of Form Form-5
Approval status of product in Reference Fybogel Mebeverine effervescent granules by M/s
Regulatory Authorities Reckitt Benckiser Healthcare (UK) Ltd. (MHRA
approved)
Me-too Status Colospas Fibro 135mg/3.5g powder by M/s
Nabiqasim. (Reg# 058672)
Grant of new DML

Brand Name + Dosage Form + Strength Omesid Plus ( 20/1680 mg) Sachet
Omeprazole……….…20mg.
Sodium bicarbonate…1680mg.
Pharmacological Group Proton pump Inhibitor, antacid
Type of Form Form-5
Approval status of product in Reference Zegerid Sachet 20mg/1680mg powders by M/s
Regulatory Authorities SANTARUS INC (USFDA approved)
Me-too Status RULING+ 20mg/1680mg powders by M/s High-Q.
(Reg#070634)
Decision: Approved.
617. Name and address of manufacturer / M/s N.S Pharma,Plot no. 576, 577 Sunder Industrial
Brand Name + Dosage Form + Strength Orasid 20.80g Sachet
Composition Each Sachet contains
Anhydrous Glucose…13.5g
Tri sodium citrate Dihydrate…2.9g
Sodium Chloride…2.6g
Pharmacological Group Oral Rehydration Salts
Type of Form Form-5
Approval status of product in Reference Reduced Osmolarity Oral Rehydration Slat (WHO
Me-too Status Peditral of Searle
Brand Name + Dosage Form + Strength Sidecta 3g Sachet
Dioctahedral smectite…3gm
Pharmacological Group Anti-diarrheal
Type of Form Form-5
Finished Product Specification Innovator‟s specifications.
Approval status of product in Reference Smecta 3 g powder for oral suspension in sachet by
Regulatory Authorities M/s Ipsen Pharma (ANSM approved)
Me-too Status Diosecta 3g sachet by M/s Woodwards Pharma.
(Reg# 061111).

Brand Name + Dosage Form + Strength Sidkast 4mg Sachet
Montelukast sodium…4mg.
Pharmacological Group Leukotriene receptor antagonist.
Type of Form Form-5
Approval status of product in Reference Singulair Paediatric 4 Mg Granules by M/s Merck
Regulatory Authorities Sharp & Dohme Ltd.(MHRA approved)
Me-too Status Singulair 4mg powder by M/s OBS (Reg# 031377)
Decision: Approved.
Brand Name + Dosage Form + Strength Sidlate 2g Sachet
Strontium ranelate…2gm
Pharmacological Group Anti-osteoporotic drug
Type of Form Form-5
Approval status of product in Reference Strontium ranelate 2 g granules for oral suspension by
Regulatory Authorities M/s Rivopharm UK Ltd. (MHRA approved)
Me-too Status Onita 2g powder by M/s PharmEvo. (Reg# 057746)
Liquid Injectable Ampoule/ Vial (General) Section
12products/ 10 molecules
Brand Name + Dosage Form + Strength Dolphin 75mg/3ml Injection
Diclofenac Sodium…75 mg
Type of Form Form-5
Pack Size & Demand Price 5‟s x 3ml & 100‟s x 3ml/As Per SRO
Approval status of product in Reference Voltarol Ampoules by M/s Novartis
Regulatory Authorities Pharmaceuticals UK Ltd , MHRA approved.
Me-too Status Voltral Injection 75mg/3ml by M/s Novartis pharma
(Reg#004311)

Decision: Approved with Innovator’s specificationsand change of brand name.
Brand Name + Dosage Form + Strength Ciprosid 200mg/100ml Infusion
Composition Each 100ml vial contains:
Ciprofloxacin (as lactate)…200mg
Type of Form Form-5
Approval status of product in Reference CIPROXIN IV 200 ciprofloxacin 200mg/100mL (as
Regulatory Authorities lactate) injection vial by M/s Bayer Australia Ltd,
TGA approved.
Me-too Status Qilox 200mg/100ml Infusion by M/s Bosch
(Reg#073417)
Decision: Approved.
Brand Name + Dosage Form + Strength Gentasid 40mg/2ml Injection
Composition Each 2ml Ampoule contains:
Gentamicin (as sulphate)...20 mg
Pharmacological Group Aminoglycoside Antibacterial
Type of Form Form-5
Pack Size & Demand Price 2ml x 5‟s / 2ml x 25‟s
As Per SRO
Approval status of product in Reference Gentamicin Paediatric 20mg/2ml Solution for
Regulatory Authorities Injection by M/s Ennogen Pharma Limited, MHRA
approved.
Me-too Status Cidomycin 20mg/2ml Injection by M/s Sanofi
Aventis (Reg#006544)
Brand Name + Dosage Form + Strength Gentasid 80mg/2ml Injection
Composition Each 2ml Ampoule contains:
Gentamicin (as sulphate)...80 mg
Pharmacological Group Aminoglycoside Antibacterial
Type of Form Form-5
Pack Size & Demand Price 2ml x 5‟s / 2ml x 25‟s
As Per SRO
Approval status of product in Reference Cidomycin 80mg/2ml Solution for Injection by M/s
Regulatory Authorities Aventis Pharma Limited, MHRA Approved.
Me-too Status Gentic 80mg/2ml Injection by M/s Bosch
(Reg#015911)

Brand Name + Dosage Form + Strength Levosid 500mg/100ml Infusion
Levofloxacin (as hemihydrate)…500mg
Type of Form Form-5
Pack Size & Demand Price 100ml x 1‟s/As Per SRO
Approval status of product in Reference Evoxil 5 mg/ml solution for infusion by M/s Beacon
Regulatory Authorities Pharmaceuticals, MHRA approved
Me-too Status F-Oxacin Infusion 500mg/100ml by M/s Bio-Labs
(Reg#073086)
Grant of new DML
Brand Name + Dosage Form + Strength Sidazole 500mg/100ml Vial
Metronidazole…500mg
Pharmacological Group Imidazole derivatives/ Antibacterial
Type of Form Form-5
Pack Size & Demand Price 100ml x 1‟s/As Per SRO
Approval status of product in Reference Metronidazole 500mg/100ml Solution for Infusion by
Regulatory Authorities M/s Baxter Healthcare Ltd. (MHRA approved)
Me-too Status Metrida Infusion 500mg/100ml by M/s Zafa
(Reg#026232)
Grant of new DML
Decision: Approved.
Brand Name + Dosage Form + Strength NSbion 3ml Injection
Composition Each 3ml Ampoule Contains:
Thiamin (Vitamin B1)…100mg
Pyridoxin (Vitamin B6) ….100mg
Cyanocobalamin (Vitamin B12)….1000mcg
Pharmacological Group Vitamins
Type of Form Form-5
Pack Size & Demand Price 25‟s x 3ml/As Per SRO
Approval status of product in Reference Neurobion solution for Injection 3ml by M/s Merck
Regulatory Authorities Selbstmedikation GmbH (Germany Approved)

Me-too Status Neurolina Injection 3ml by M/s Alina Combine
(Reg#076143)
Grant of new DML
Decision: Approved with Innovator’s specifications and with shelf life of 18 months.
Brand Name + Dosage Form + Strength Ora-D 5mg (200,000IU) Injection 1ml
Cholecalciferol…5mg
Pharmacological Group Vitamin D analogue (Vitamin D3)
Type of Form Form-5
Pack Size & Demand Price 1‟s/
As Per SRO
Approval status of product in Reference VITAMIN D3 GOOD 200,000 IU / 1 ml IM solution
Regulatory Authorities for injection by M/s Bouchara-Recordati, ANSM
France approved
Me-too Status D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
Brand Name + Dosage Form + Strength Sidamin 500mcg/1ml Injection
Mecobalamin…500mcg
Pharmacological Group (Vitamin B12)Antianemic Preparations
Type of Form Form-5
Approval status of product in Reference COMESGEN Injection 500 μg by M/s Tatsumi
Regulatory Authorities Chemical Co, PMDA approved
Me-too Status Mecoborn Injection 500mcg/ml by M/s Wellborne
(Reg#054885)
Grant of new DML
Brand Name + Dosage Form + Strength Sidofer 100mg/5ml Injection
Iron (as Iron Sucrose Complex)…100mg
Pharmacological Group Antianemic Preparations
Type of Form Form-5
Approval status of product in Reference Venofer 20 mg iron / ml, solution for injection by M/s
Regulatory Authorities Vifor Pharma UK Limited , MHRA approved
Me-too Status Bisleri-S Injection 100mg/5ml by M/s Sami
(Reg#047252)
Grant of new DML
Remarks of Evaluator  Approved in MHRA with box warning. „This
medicinal product is subject to additional
monitoring.‟
Decision: Approved.
Brand Name + Dosage Form + Strength Sterile Water for Injection 5ml
Sterile Water for Injection….5ml
Pharmacological Group Diluent
Type of Form Form-5
As Per SRO
Approval status of product in Reference Sterile water for injection by M/s Pfizer Limited,
Regulatory Authorities MHRA approved .
Me-too Status Aqua R ampoule by M/s Regal Pharmaceuticals
(Reg#082010)
Grant of new DML
Decision: Approved.
Brand Name + Dosage Form + Strength Sterile Water for Injection 10ml
Sterile Water for Injection….10ml
Pharmacological Group Diluent
Type of Form Form-5
As Per SRO
Approval status of product in Reference Sterile water for injection by M/s Pfizer Limited,
Regulatory Authorities MHRA approved .
Me-too Status Water for injection 10ml by M/s Novamed
(Reg#076972)
Grant of new DML
Decision: Approved.

Capsule (General) Section
Brand Name + Dosage Form + Strength Esosid 20mg Capsule
Esomeprazole (as magnesium Trihydrate) enteric
coated pellets (22.5%)...20mg
Type of Form Form-5
Regulatory Authorities Ethypharm (MHRA approved)
Me-too Status ESORID 20mg by M/s Hilton Pharma. Limited,
(Reg# 032365 )
NEXUM 20mg by M/s Hilton Pharma. Limited
(Reg# 033890 )
Remarks of Evaluator  Source of pellets: Vision Pharmaceuticals
Decision: Approved.
Brand Name + Dosage Form + Strength Esosid 40mg Capsule
Esomeprazole (as magnesium Trihydrate) enteric
coated pellets (22.5%)...40mg
Type of Form Form-5
Regulatory Authorities Ethypharm (MHRA approved)
Me-too Status ESORID 40mg by M/s Hilton Pharma
Limited,(Reg#034227)
ESTONE 40mg by M/s Hilton Pharma Limited,
(Reg# 041394)
Decision: Approved.
Brand Name + Dosage Form + Strength Flucosid 150mg Capsule
Fluconazole.....150mg
Pharmacological Group Antifungal Drug
Type of Form Form-5
Approval status of product in Reference Diflucan 150 mg capsule by M/s Pfizer, MHRA
Regulatory Authorities Approved

Me-too Status Diflucan 150 mg capsule by M/s Pfizer
(Reg#011828)
Decision: Approved.
Brand Name + Dosage Form + Strength Itrasid 100mg Capsule
Itraconazole (IR pellets (22%))...100mg
Pharmacological Group Antifungal Drugs
Type of Form Form-5
Approval status of product in Reference Itraconazole 100 mg capsules, hard by M/s Sandoz
Regulatory Authorities Limited (MHRA Approved)
Me-too Status Itraneu of Neutro Pharma
Brand Name + Dosage Form + Strength Lincosid 500mg Capsule
Lincomycin (as hydrochloride)…500mg
Type of Form Form-5
Approval status of product in Reference Lincocine 500 mg Capsule by M/s Pfizer Holding
Regulatory Authorities France (ANSM approved)
Me-too Status Lincocin 500mg capsule by M/s Pfizer Reg#000602)
Decision: Approved.
Brand Name + Dosage Form + Strength Mebesid SR 200mg Capsule
Mebeverine as hydrochloride (SR pellets 50%)…200
mg
Pharmacological Group Muscular Antispasmodic
Type of Form Form-5
Approval status of product in Reference Colofac MR. Modified release capsule 200mg by M/s
Regulatory Authorities Mylan Products Limited (MHRA approved)
Me-too Status Mebever MR 200mg capsule by M/s Getz Pharma
Pvt. Ltd. (Reg#050754)

Remarks of Evaluator Source of pellets: Vision Pharmaceuticals
Brand Name + Dosage Form + Strength Omesid 20mg Capsule
Omeprazole (enteric coated pellets 8.5%)…20mg
Type of Form Form-5
Approval status of product in Reference Losec 20 mg hard gastro-resistant capsules 20mg by
Regulatory Authorities Astra Zeneca UK Ltd.(MHRA approved)
Me-too Status Losec 20mg capsule by M/s Barrett Hodgson
Pakistan Pvt. Limited, (Reg# 010800)
Remarks of Evaluator Source of pellets: Vision Pharmaceuticals, Islamabad.
Brand Name + Dosage Form + Strength Prelin 25mg Capsule
Pregabalin …..25mg
Pharmacological Group Anti-Epileptic
Type of Form Form-5
Approval status of product in Reference Lyrica 25mg Capsules M/s by PF Prism (USFDA
Me-too Status Dygab 25mg Capsules by M/s Dyson (Reg#079155)
Pregabalin....50mg
Type of Form Form-5
Me-too Status Gabica 50mg Capsule by M/s Getz Pharmaceuticals.
(Reg#048725)

Pregabalin.....75mg
Type of Form Form-5
Me-too Status Lyrica 75mg Capsule by M/s Pfizer Pakistan Ltd.
(Reg#044817)
Pregabalin.....100mg
Type of Form Form-5
Approval status of product in Reference Lyrica Capsules by PF Prism (USFDA Approved)
Me-too Status Zeegap 100mg Capsules by M/s Hilton
(Reg#047360)
Brand Name + Dosage Form + Strength Tamsid SR 0.4mg Capsule
Tamsulosin hydrochloride sustained release pellets
(0.2%) equivalent to Tamsulosin
hydrochloride...0.4mg
Pharmacological Group α1-Adrenergic blocking agent
Type of Form Form-5
Approval status of product in Reference Flomax 0.4mg capsule by M/s Boehringer Ingelheim
Regulatory Authorities Pharmaceuticals (USFDAApproved)
Me-too Status Tamflo 0.4mg SR Capsule by M/s Genome
Pharmaceutical (Reg#074562)
Remarks of Evaluator Source of Pellets: Vision Pharmaceuticals, Islamabad.
Decision: Approved.

Brand Name + Dosage Form + Strength Tramic 500mg Capsule
Tranexamic Acid.....500mg
Pharmacological Group Plasminogen activation inhibitor
Type of Form Form-5
Finished Product Specification Innovator‟s
Approval status of product in Reference Transamin of Daiichi Sanko (Japan) (Not confirmed)
Me-too Status Trasamin 500mg Capsule by M/s Hilton Pharma
(Reg#009730)
Brand Name + Dosage Form + Strength Tretisid 10mg Capsule
Acitretin…..10mg
Pharmacological Group Retinoid
Type of Form Form-5
Approval status of product in Reference Acitretin 10 mg Capsules by M/s Genus
Regulatory Authorities Pharmaceuticals (MHRA Approved)
Me-too Status Acetin 10 mg capsule of M/s Genome
Decision: Approved.
Brand Name + Dosage Form + Strength Tretisid 25mg Capsule
Acitretin…..25mg
Pharmacological Group Ratinoid
Type of Form Form-5
Approval status of product in Reference Acitretin 25 mg Capsules by M/s Genus
Regulatory Authorities Pharmaceuticals (MHRA Approved)
Me-too Status Acetin 25 mg capsule of M/s Genome
Decision: Approved.

Case no.3 M/s. AAA Health Pharmaceutical Laboratories, Rawat ( New License)
Following registration dossiers have been received vide letter No. F.6-2/2016 Reg-III dated 16th
October, 2017stating that the firm has been granted approval of new DML by way of formulation
by Central Licensing Board in its 255th meeting for following sections
3. Dry powder suspension section (General)
4. Capsule section (Cephalosporin)
5. Dry powder suspension section (Cephalosporin )
3 Dry powder suspension section (General) 00 00
4 Capsule section (Cephalosporin) 01 01
5 Dry powder suspension section 02 01
(Cephalosporin )
648. Name and address of manufacturer / M/s AAA Health Pharmaceutical Laboratories,Plot
Applicant No.9-A, Street No. N-5, RCCI, Rawat.
Brand Name +Dosage Form + Strength Ciprotab 500mg Tablet
Type of Form Form 5
Pack size & Demanded Price 10‟s/As per SRO
Me-too status Mercip 500mg Tablet by M/s Merck, (Reg#024602)
GMP status 13-06-2017; Grant of new DML
Decision:Approved.
649. Name and address of manufacturer / M/s AAA Health Pharmaceutical Laboratories,Plot
Brand Name +Dosage Form + Strength Ciprotab 250mg Tablet
Ciprofloxacin (as hydrochloride)…250mg
Type of Form Form 5
Me-too status Mercip 250mg tablet by M/s Merck, (Reg#024601)
Decision:Approved.
650. Name and address of manufacturer / M/s AAA Health Pharmaceutical Laboratories, Plot
Brand Name +Dosage Form + Strength Paragesic 450mg/35mg Tablet
Orphenadrine citrate…35mg
Paracetamol…450 mg
Pharmacological Group skeletal muscle relaxant + analgesic and antipyretic
Type of Form Form 5
Approval status of product in Reference NORGESIC paracetamol orphenadrine citrate
Regulatory Authorities. 450mg/35mg Tablet
Me-too status Barfim 450mg/35mg Tablet by M/s Wisdom
pharmaceuicals, (Reg#078572)
Decision:Approved with Innovator’s specifications and change of brand name.
Brand Name +Dosage Form + Strength Monte 5mg chewable Tablet
Montelukast (as sodium)…5mg
Type of Form Form 5
Approval status of product in Reference Singulair 5mg chewable tablet by M/s Merck Sharp &
Regulatory Authorities. Dohme Corp, USFDA approved
Me-too status NenKast 5mg chewable tablet by M/s Nenza
Brand Name +Dosage Form + Strength Monte 10mg Tablet
Montelukast (as sodium)…10mg
Type of Form Form 5
Approval status of product in Reference Montelukast 10 mg film-coated tablets by M/s Accord
Regulatory Authorities. Healthcare Limited (MHRA approved)
Me-too status Montiget 10 mg tablet by M/s Getz Pharma
(Reg#034838)

Brand Name +Dosage Form + Strength Levotab 250mg Tablet
Type of Form Form 5
Me-too status Lexa 250mg Tablet by M/s Reliance Pharma
Decision: Approved
Brand Name +Dosage Form + Strength Levotab 500mg Tablet
Type of Form Form 5
Me-too status Lexa 500mg Tablet by M/s Reliance Pharma
Decision: Approved
Brand Name +Dosage Form + Strength Fexonil 60mg Tablet
Fexofenadine hydrochloride....60mg
Type of Form Form 5
Approval status of product in Reference ALLEGRA- fexofenadine hydrochloride tablet, film
Regulatory Authorities. coated 60 mg by M/s Sano fi-Synthelabo Limited
(USFDA approved) (OTC product)
Me-too status Fecom 60mg Tablet by M/s Karachi Chemical Industries
(Reg#039097)
Decision: Approved
Brand Name +Dosage Form + Strength Fexonil 120mg Tablet
Fexofenadine hydrochloride....120mg
Type of Form Form 5
Approval status of product in Reference Fexofenadine Hydrochloride 120mg Film-Coated
Regulatory Authorities. Tablets by M/s Actavis UK Ltd (MHRA approved)
Me-too status Fexamed 120mg Tablet by M/s OBS (Reg#081065)
Decision: Approved
Brand Name +Dosage Form + Strength Diclo-P 50mg Tablet
Diclofenac potassium….50 mg
Type of Form Form 5
Approval status of product in Reference Diclofenac Potassium film coated 50 mg Tablets
Me-too status Pngo Tablet 50mg by M/s Invotek Pharmaceuticals
(Reg#079985)
Capsule Section (General)

Brand Name +Dosage Form + Strength Esomap 20mg Capsule
pellets.....20mg
Type of Form Form 5

032365 )
Brand Name +Dosage Form + Strength Gastrol 40mg Capsule
Omeprazole....40mg
Type of Form Form 5
Approval status of product in ReferenceLosec 40 mg hard gastro-resistant capsules 20mg by
Me-too status Risek 40mg capsule by M/s Getz Pharma Pvt.Ltd.
(Reg#022109)
Brand Name +Dosage Form + Strength Gastrol 20mg Capsule
Omeprazole....20mg
Type of Form Form 5
Pack size & Demanded Price 10‟s/
As per SRO
Approval status of product in Reference Losec 20 mg hard gastro-resistant capsules 20mg by
Me-too status Losec 20mg capsule by M/s Barrett Hodgson Pakistan
Pvt. Limited, (Reg# 010800)
Brand Name +Dosage Form + Strength Esomap 40mg Capsule
pellets.....40mg
Type of Form Form 5

Finished Product Specification Manufacturer‟s Specification
Ventra 40 mg gastro-resistant capsules by M/s
034227 )
Brand Name +Dosage Form + Strength Risen 60mg Capsule
Enteric coated Pellets of Duloxetine hydrochloride
equivalent to Duloxetine…60 mg
Pharmacological Group Heterocyclic antidepressants (serotonin–norepinephrine
reuptake inhibitors (SNRI).)
Type of Form Form 5
Approval status of product in Reference Cymbalta (Duloxetine 60 mg capsule) by M/s Eli Lilly,
Regulatory Authorities. USFDA
Me-too status Dulan (Duloxetine 60 mg capsule) by M/s Hilton
Pharma.(Reg#055448)
Remarks of the Evaluator. Source of Pellets: Vision Pharmaceuticals, Islamabad.
Decision: Deferred for clarification as submitted source of pellets is not of USP grade.
Brand Name +Dosage Form + Strength Risen 30mg Capsule
Pharmacological Group Heterocyclic antidepressants (serotonin–norepinephrine
reuptake inhibitors (SNRI).)
Type of Form Form 5
Approval status of product in Reference Cymbalta (Duloxetine 30 mg capsule) by M/s Eli Lilly,
Pharma.(Reg#055447)
Decision: Deferred for clarification as submitted source of pellets is not of USP grade.

Brand Name +Dosage Form + Strength Floxin 20mg Capsule
Fluoxetine as hydrochloride…20mg
Pharmacological Group Antidepressant ( SSRI)
Type of Form Form-5
Pack size & Demanded Price 10‟s/ As Per SRO
Approval status of product in Reference Prozac 20mg capsule by M/s Eli Lilly And Co, USFDA
Regulatory Authorities. approved
Me-too status Depex 20mg capsule by M/s Merck (Reg#020245)
Decision: Approved
Capsule section (Cephalosporin)
1 product / 1molecules
Brand Name +Dosage Form + Strength A-Cef 400mg Capsule
Cefixime (as trhydrate).....400mg
Type of Form Form 5
Approval status of product in Suprax 400 mg capsules by Lupin Pharma (USFDA
Me-too status Cefiget Capsule 400 mg by Getz Pharma (Reg#045118)
Dry powder suspension section (Cephalosporin )

2 products / 1molecule
Brand Name +Dosage Form + Strength A-Cef 100mg/5ml Dry Suspension
Composition Each 5ml after reconstitution contains:-
Cefixime (as trihydrate)…100mg
Type of Form Form 5
Pack size & Demanded Price 30ml/As per SRO
Approval status of product in Cefixime 100 mg/5 ml Powder for Oral Suspension by
Reference Regulatory Authorities. M/s Generics [UK] Ltd t/a Mylan (MHRA Approved)
Me-too status Stlicef dry suspension 100mg/5ml by M/s Treat Pharma
(Reg#073247)

Decision: Approved
Brand Name +Dosage Form + Strength A-Cef Dry Powder for Suspension 200mg/5ml
Composition Each 5 ml after reconstitution contains:
Type of Form Form 5
Pack size & Demanded Price 30ml /As per SRO
Approval status of product in Cefixime for oral suspension 200mg/5ml by M/s
Reference Regulatory Authorities. Aurobindo Pharma (USFDA approved)
Me-too status Biozil Dry Suspension 200mg/5ml by M/s Biolabs
(Reg#054770)
Decision: Approved

Evaluator PEC-VIII
Case No. 4: M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot #: 25 & 26, Street No. S-3,
RCCI, National Industrial Zone, Rawat, Islamabad.
Following registration dossiers have been received vide letter No. F.6-2/2016 (Reg-III) dated
11th September 2017stating that Central Licensing Board in its 254th meeting, granted
approval of following 11 sections to M/s Evolution Pharmaceuticals (Pvt) Ltd.
 Tablet (General)
 Capsule (General)
 Sachet (General)
 Dry suspension(general)
 Topical section (Cream/Ointment/Gel/Solution/Lotion) (General)
 Capsule(cephalosporin)
 Dry suspension(cephalosporin)
 Dry vial Injection(cephalosporin)
 Capsule(penicillin)
 Dry suspension(penicillin)
 Dry vial Injection(penicillin)
Now the firm has applied for following
1 Tablet (General) 34 10
2 Capsule (General) 32 10
3 Sachet (General) 10 09
4 Dry suspension(general) 13 09
5 Dry suspension(cephalosporin) 17 09
6 Capsule(penicillin) 07 04
7 Dry suspension(penicillin) 09 05
8 Dry vial Injection(penicillin) 17 09
Dry Suspension (Cephalosporin):
Products: 17 , Molecules: 09
668. Name and address of Manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot #: 25/26,
Applicant St.#S-3, RCCI, National Industrial Zone,
Rawat,Islamabad
Brand Name+DosageForm+Strength Zylocef Dry Suspension 125 mg
Composition Each 5 ml (after reconstitution) contains:
Cefprozil (as Monohydrate)........ 125 mg
Diary No. Date of R&I & fee DyNo.12839; 22-08-2017; Rs. 20000/-
Pharmacological Group Cephalosporins, Antibiotics
Type of Form Form-5
Finished Product Specification As per USP
Pack Size & Demanded Price 50 ml ; As per SRO
Me-too status Cerozil 125mg/5 ml by Fynk Pharmaceuticals
GMP status New License (Inspection Date: 07th June 2017)
Decision:Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Zylocef Dry Suspension 250 mg
Cefprozil (as monohydrate)........ 250 mg
Type of Form Form-5
Me-too status Cerozil250mg/5ml by Fynk Pharmaceuticals
Decision:Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Aroxil Dry Suspension 125 mg
Cefadroxil (as Monohydrate).......125 mg
Type of Form Form-5
Me-too status Evacef Suspension 125mg/5ml by M/s Highnoon
Laboratories, Lahore (Reg#011213)
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Aroxil Dry Suspension 250 mg
Cefadroxil (as Monohydrate).......250 mg
Diary No. Date of R&I & fee Dy.No.12828; 22-08-2017; Rs. 20000/-
Type of Form Form-5
Me-too status Evacef Suspension 250mg/5ml by M/s Highnoon
Laboratories, Lahore (Reg#011214)
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Avloxin Dry Suspension 250 mg
Cephalexin (as monohydrate).......250 mg
Type of Form Form-5

Me-too status Vegzin 250mg/5ml by M/s Vega Pharmaceuticals
(Reg#078700)
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Avloxin Dry Suspension 125 mg
Cephalexin (as monohydrate).......125 mg
Type of Form Form-5
Me-too status Vegzin 125mg/5ml by M/s Vega Pharmaceuticals
(Reg#078699)
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Xepran Dry Suspension 125 mg
Cephradine.......125 mg
Type of Form Form-5
Me-too status Licef Dry Powder suspension 125mg/5ml by M/s
Wisdom Pharmaceuticals (Reg#078532)
formulation in reference agencies in required.
Decision:Deferred for evidence of approval of applied formulation in reference regulatory
authorities/agencies which were declared/approved by the Registration Board.
Rawat,Islamabad
Brand Name+DosageForm+Strength Xepran Dry Suspension 250 mg
Cephradine.......250 mg
Type of Form Form-5
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Pixum Dry Suspension 40 mg
Cefpodoxime( as proxetil) …....40 mg
Type of Form Form-5
Approval status of product in CefpodoximeProxetil 40 mg/5 ml Powder for Oral
Reference Regulatory Authorities Suspension by M/s Sandoz GMBH, MHRA approved
Me-too status Apodox Dry Suspension by M/s Alliance (Reg#054697)
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Sefixim Dry Suspension 100 mg
Cefixime(as trihydrate)…....100 mg
Type of Form Form-5
Pack Size & Demanded Price 30 ml and 60ml ; As per SRO
Approval status of product in Cefixime 100 mg/5 ml Powder for Oral Suspension
(Reg#073247)
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Sefixim Dry Suspension 200 mg
Cefixime(as trihydrate) …....200 mg
Type of Form Form-5
Approval status of product in Cefixime for oral suspension 200mg/5ml (USFDA
Reference Regulatory Authorities approved)
(Reg#054770)
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Sefdin Dry Suspension 125 mg
Cefdinir.......125 mg
Type of Form Form-5
Approval status of product in Cefdinir 125mg/5ml of Lupin Ltd. USA (USFDA)
Me-too status Zefnir 125mg/5 ml by Genome pharmaceuticals
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Sefdin Dry Suspension 250mg
Cefdinir.......250 mg
Type of Form Form-5
Me-too status Zefnir250mg/5 ml by Genome pharmaceuticals
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Evoclor Dry Suspension 125 mg
Cefaclor (as monohydrate).......125 mg
Type of Form Form-5
Finished Product Specification As per BP
Approval status of product in Keftid 125mg/5ml of Strides Pharma Ltd. UK (MHRA)
Me-too status DuGen dry suspension125mg/5 ml by AGP (Pvt.) Ltd.
Remarks of Evaluator Firm has claimed BP specifications and the applied
formulation is also present in USP.
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Evoclor Dry Suspension 250 mg
Cefaclor (as Monohydrate).......250 mg
Type of Form Form-5
Approval status of product in Keftid 250mg/5ml of Strides Pharma Ltd. UK (MHRA)
Me-too status DuGen dry suspension250mg/5 ml by AGP (Pvt.) Ltd.
Remarks of Evaluator  Firm has claimed BP specifications and the
applied formulation is also present in USP.
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Cefurim Dry Suspension 125 mg
Cefuroxime (as axetil)……125 mg
Diary No. Date of R&I & fee Dy.No.12845; 22-08-2017; Rs. 20000/-
Type of Form Form-5
Reference Regulatory Authorities (Ceftin Suspension 250mg/5ml)
Me-too status Otim dry suspension125mg/5 ml by NeutroPharma
Decision: Approved.
Rawat,Islamabad
Brand Name+DosageForm+Strength Cefurim Dry Suspension 250 mg
Cefuroxime (as axetil) …250 mg
Type of Form Form-5
Reference Regulatory Authorities (Ceftin Suspension 250mg/5ml)
Me-too status Astaleximdry suspension 250mg/5ml of Astellas
Pharmaceuticals
Decision: Approved
Capsule (Penicillin):
Rawat,Islamabad
Brand Name+DosageForm+Strength Evomox Capsules 250 mg
Amoxicillin (as trihydrate).......250 mg
Pharmacological Group Penicillin, Antibiotics
Type of Form Form-5
Pack Size & Demanded Price 20‟s & 100‟s ; As per SRO
Approval status of product in Amoxil Capsules 250mg of GSK Ltd., UK (MHRA)
Me-too status Amoxilite Capsules 250mg by Elite Pharma
Remarks of Evaluator Overwriting on challan form?
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Evomox Capsules 500 mg
Amoxicillin (as trihydrate).......500 mg
Type of Form Form-5
Approval status of product in Amoxil Capsules 500mg of GSK Ltd., UK (MHRA)
Me-too status Amoxil Capsules 500mg by GSK
Remarks of Evaluator Overwriting on challan form?
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Fluamox Capsules 500 mg
Amoxicillin (as trihydrate) …….250 mg
Flucloxacillin (as Sodium) ……250 mg
Type of Form Form-5
Pack Size & Demanded Price 20‟s ; As per SRO
Approval status of product in Suprapen 500 capsules of SmithKline Beecham
Reference Regulatory Authorities Pharmaceuticals (Pty) Ltd., South Africa
Me-too status Flucomox500 capsules of Leama chemi pharma
Remarks of Evaluator Evidence of approval status of applied formulation in
reference agencies is required.
uthorities/agencies .
Rawat,Islamabad
Brand Name+DosageForm+Strength Amplex Capsules 250 mg
Ampicillin (as trihydrate).......250 mg
Type of Form Form-5
Approval status of product in (Approved in MHRA)
Reference Regulatory Authorities Penbritin Capsules 250mg of ChemidexPharma Ltd.,
UK
Me-too status Ampicillin trihydrate 250mg Capsules of Transclear
Karachi
Decision: Approved.

Rawat,Islamabad
Brand Name+DosageForm+Strength Amplex Capsules 500 mg
Ampicillin (as trihydrate).......500 mg
Type of Form Form-5
Reference Regulatory Authorities Penbritin Capsules 500mg of ChemidexPharma Ltd.,
UK
Me-too status Ampicillin trihydrate500mg Capsules of Transclear
Karachi
Decision: Approved.
Rawat,Islamabad
Brand Name+DosageForm+Strength Clobex Capsules 500 mg
Ampicillin (as trihydrate) …….250 mg
Cloxacillin (as sodium) …….. 250 mg
Type of Form Form-5
Approval status of product in Ampiclox 500 of SmithKline Beecham Pharmaceuticals
Reference Regulatory Authorities (Pvt) Ltd., South Africa
Me-too status PecloxCapsules 500mg of Lowitt Pharmaceuticals
 Firm has claimed manufacturer specifications
but has not submitted the data as required by the
decision of 267th meeting of registration board
and applied formulation is not present in
available USP and BP.
Rawat,Islamabad
Brand Name+DosageForm+Strength Clobex Capsules 250 mg
Ampicillin (as trihydrate)…….125 mg
Cloxacillin (as sodium) …….. 125 mg
Type of Form Form-5
Approval status of product in Ampicloxof SmithKline Beecham Pharmaceuticals (Pty)
Reference Regulatory Authorities Ltd., South Africa
Me-too status ZenoxilCapsules 250mg by GSK
Dry Vial Injection (Penicillin):

Rawat,Islamabad
Brand Name+DosageForm+Strength Amplex Injection IM/IV 250 mg
Ampicillin (as sodium)……250 mg
Type of Form Form-5
Reference Regulatory Authorities Ampicillin Sodium for Injection 250 mg of Generics
Ltd., UK
Me-too status Ampicillin Injection 250 mg of HydariInt Karachi
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Amplex Injection IM/IV 500 mg
Ampicillin (as sodium)……500 mg
Type of Form Form-5
Approval status of product in Ampicillin Sodium for Injection 500 mg of Generics
Reference Regulatory Authorities Ltd., UK (MHRA)
Me-too status ZyncillinInjection 500 mg by English Pharma
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Amplex Injection IV 1 g
Ampicillin (as sodium)…………1 g
Type of Form Form-5
Reference Regulatory Authorities Ampicillin Sodium for Injection 1 g of Generics Ltd.,
UK
Me-too status Ampicillin Injection 1 g of Martin dale Health care
Karachi.
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Amplex Injection IV 2 g
Ampicillin (as sodium)…2 g
Type of Form Form-5
Approval status of product in Ampicillin Sodium for Injection 2 g of Generics Ltd.,
Reference Regulatory Authorities UK (MHRA)
Me-too status Zampicillin Injection 2 g by Zafa Pharma.
Remarks of Evaluator Evidence of Me too of applied formulation is required.
Decision:Deferred for confirmation of generic / me-too status.
Rawat,Islamabad
Brand Name+DosageForm+Strength Ambact Injection IV 3 g
Ampicillin Sodium equivalent to Ampicillin ……….…2
g
Sulbactam Sodium equivalent to Sulbactam ……… 1 g
Pharmacological Group Penicillin / Betalactam Antibiotics
Type of Form Form-5
Approval status of product in Unasyn Injection 3 g of Pfizer Inc., USA (USFDA)
Me-too status Unasyn Injection 3 g by Pfizer Labs.
Remarks of Evaluator Evidence of Me too of applied formulation is required.
Rawat,Islamabad
Brand Name+DosageForm+Strength Avobact Injection IV 1.5 g
Ampicillin ( as sodium)……….…1 g

Sulbactam(as sodium) … 500 mg
Pharmacological Group Penicillin / Beta lactam Antibiotics
Type of Form Form-5
Approval status of product in Unasyn Injection 1.5 g of Pfizer Inc., USA (USFDA)
Me-too status Unasyn Injection 1.5 g by Pfizer Labs.
Remarks of Evaluator Evidence of Me too of applied formulation in this
strength is required.
Rawat,Islamabad
Brand Name+DosageForm+Strength Evomox Injection IM/IV 250 mg
Amoxicillin (as sodium)…250 mg
Type of Form Form-5
Approval status of product in Amoxil Vials for Injection 250 mg of GSK Ltd., UK
Reference Regulatory Authorities (MHRA)
Me-too status Enmox Injection 250mg Of English Pharma
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Evomox Injection IM/IV 500 mg
Amoxicillin Sodium equivalent to Amoxicillin…500 mg
Type of Form Form-5
Approval status of product in Amoxil Vials for Injection 500 mg of GSK Ltd., UK
Me-too status Enmox Injection 500mg Of English Pharma
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Evomox Injection IV 1 g
Amoxicillin Sodium equivalent to Amoxicillin ……1 g
Type of Form Form-5
Approval status of product in Amoxil Vials for Injection 1 g of GSK Ltd., UK
Me-too status Supramox Injection 1 g by Bosch Pharma.
Decision: Approved.

Rawat,Islamabad
Brand Name+DosageForm+Strength Fluamox Injection IM/IV 500 mg
Amoxicillin (as sodium) ….… 250 mg
Flucloxacillin (as sodium) …. 250 mg
Type of Form Form-5
Approval status of product in Macropenof Xixia Pharmaceuticals (Pvt)Ltd, South
Reference Regulatory Authorities Africa
Me-too status Biflocin Injection 500mg by Leo Pharma/ZamZam
Corp.
Remarks of Evaluator  Firm has claimed manufacturer specifications but has
not submitted data as required in decision of 267th
meeting and applied formulation is not present in
available USP.
 Evidence of approval status of applied formulation in
reference agencies.
 Evidence of me too.
regulatory authorities/agencies along with generic / me-too status.
Rawat,Islamabad
Brand Name+DosageForm+Strength Xenclav Injection IV 600 mg
Amoxicillin Sodium equivalent to Amoxicillin.....500 mg
Potassium Clavulanate eq. to Clavulanic Acid……100mg
Type of Form Form-5
Approval status of product in Augmentin IV 600 mg of GSK Ltd., UK (MHRA)
Me-too status Augmentin Injection 600 mg by GSK
Remarks of Evaluator Firm has claimed BP specifications and applied
formulation is not present in available USP and BP.
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Xenclav Injection IV 1.2 g
Amoxicillin Sodium equivalent to Amoxicillin.......1 g
Potassium Clavulanate eq. to Clavulanic Acid… 200 mg
Type of Form Form-5
Approval status of product in Augmentin IV 1.2 g of GSK Ltd., UK (MHRA)
Me-too status Augmentin Injection 1.2 g by GSK
Remarks of Evaluator Firm has claimed BP specifications and applied
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Teraclav Injection IV 3.2 g
Ticarcillin Disodium eq. to Ticarcillin …………..…...3
g
Clavulanate Potassium eq. to Clavulanic Acid… 200 mg
Type of Form Form-5
Approval status of product in Timentin 3.2 g of GSK Ltd., UK (MHRA)& (USFDA)
Me-too status Timentin Injection 3.2 g by GSK
Decision: Approved.
Rawat,Islamabad
Brand Name+DosageForm+Strength Piptaz Injection IV 2.25 g
Piperacillin Sodium equivalent to Piperacillin ……..2 g
Tazobactam Sodium equivalent to Tazobactam….250
mg
Type of Form Form-5
Approval status of product in Tazocin 2g/0.25g Powder for Solution for Infusion of
Reference Regulatory Authorities Pfizer Ltd., UK (MHRA)
Me-too status Tazop Injection 2.25 g by Global Pharma
Decision: Approved.
Rawat,Islamabad
Brand Name+DosageForm+Strength Piptaz Injection IV 4.5 g
Piperacillin Sodium equivalent to Piperacillin …..4 g
Tazobactam Sodium equivalent to Tazobactam….500
mg
Type of Form Form-5
Approval status of product in Tazocin 4g/0.5g Powder for Solution for Infusion of
Reference Regulatory Authorities Pfizer Ltd., UK (MHRA)
Me-too status Tazop Injection 4.5g by Global Pharma
Remarks of Evaluator Firm has mentioned 10ml of WFI (as diluent) for
reconstitution of applied formulation whereas reference
product uses 20ml WFI (as diluent ) for reconstitution.
Decision:Deferred for clarification of instructions for reconstitution of injection in
comparison to reference product.
Rawat,Islamabad
Brand Name+DosageForm+Strength Clobex Injection IM/IV 250 mg
Ampicillin (as sodium) ……..125 mg
Cloxacillin (as sodium) …….125 mg
Type of Form Form-5
Approval status of product in Ampicloxof SmithKline Beecham Pharmaceuticals (Pvt)
Reference Regulatory Authorities Ltd., South Africa
Me-too status Ampiclox Injection 250mg by GSK(drug infosis)
AMPICLOXACILLIN INJECTION 250MG of haji medicine
formulation in reference agencies in required.
Rawat,Islamabad
Brand Name+DosageForm+Strength Clobex Injection IM/IV 500 mg
Ampicillin (as sodium) ……..250 mg
Cloxacillin (as sodium) …….250 mg
Type of Form Form-5
Me-too status Ampiclox Injection 500mg by GSK
267th meeting of registration board and applied

Dry suspension(Penicillin):
Rawat,Islamabad
Brand Name+DosageForm+Strength Amplex Dry Suspension 125 mg
Ampicillin (as trihydrate)........ 125 mg
Type of Form Form-5
Me-too status Silpen125mg/5ml of lowit Pharma
Remarks of Evaluator  Firm has claimed BP specifications and the
applied formulation is also present in USP 2016.
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Amplex Dry Suspension 250 mg
Ampicillin (as trihydrate)........ 250 mg
Type of Form Form-5
Me-too status Zampicillin 250mg/5ml by Zafa Pharma Labs. Pvt. Ltd.
Decision: Approved.
Rawat,Islamabad
Brand Name+DosageForm+Strength Clobex Dry Suspension 250 mg
Ampicillin (as trihydrate) …125 mg
Cloxacillin (as sodium) ….. 125 mg
Type of Form Form-5
Finished Product Specification Manufacturer‟s specification
Approval status of product in Ampiclox S of SmithKline Beecham Pharmaceuticals
Reference Regulatory Authorities (Pty) Ltd., South Africa
Me-too status Ampiclox 250mg/5ml by GSK(drug infosis)
formulation in reference agencies.

Rawat,Islamabad
Brand Name+DosageForm+Strength Xenclav Dry Suspension 156.25 mg
Amoxicillin Trihydrate eq. to Amoxicillin ….…125 mg
Potassium Clavulanate eq.to Clavulanic
Acid…..31.25mg
Type of Form Form-5
Pack Size & Demanded Price 60 ml & 100 ml ; As per SRO
Approval status of product in Augmentin SF Suspension of GSK Ltd., UK (MHRA)
Me-too status Amclav of getz
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Xenclav Dry Suspension 312.50 mg
Amoxicillin Trihydrate eq. to Amoxicillin ….…250 mg
Potassium Clavulanate eq.to Clavulanic Acid..62.50 mg
Diary No. Date of R&I & fee Dy. No. 14234, 07-09-2017, Rs. 20000/-, 07-09-2017
Type of Form Form-5
Approval status of product in Augmentin 250/62 SF Suspension of GSK Ltd., UK
Me-too status Augmentin 312.5mg/5ml by GSK
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Xenclav Dry Suspension 457 mg
Amoxicillin Trihydrate eq. to Amoxicillin……..400 mg
Potassium Clavulanate eq. to Clavulanic Acid…. 57 mg
Diary No. Date of R&I & fee Dy. No. 14233, 07-09-2017, Rs. 20000/-, 07-09-2017
Type of Form Form-5
Approval status of product in Augmentin 400/57 Powder for Oral Suspension of GSK
Reference Regulatory Authorities Ltd., UK (MHRA)
Me-too status Amclav 457mg/5ml by Getz Pharma.
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Evomox Dry Suspension 125 mg
Amoxicillin (as trihydrate)........ 125 mg
Type of Form Form-5
Approval status of product in Respillin 125mg/5ml of Athlone Labs. Ltd. Ireland
Me-too status Lomoxy 125mg/5 ml of LowitPharma
Remarks of Evaluator  Firm has claimed BP specifications and applied
formulation is also present in USP 2016.
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Evomox Dry Suspension 250 mg
Amoxicillin (as trihydrate)........ 250 mg
Type of Form Form-5
Approval status of product in Respillin 250mg/5ml of Athlone Labs. Ltd. Ireland
Me-too status Lomoxy 250mg/5 ml of Lowitpharma
Remarks of Evaluator  Firm has claimed BP specifications and applied
formulation is also present in USP 2016.
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Fluamox Dry Suspension 250 mg
Amoxicillin (as trihydrate) BP …125 mg
Flucloxacillin (as sodium) BP … 125 mg
Type of Form Form-5
Approval status of product in Suprapen S of SmithKline Beecham Pharmaceuticals
Reference Regulatory Authorities (Pty) Ltd., South Africa
Me-too status Biflocin 250mg/5ml by Leo Pharma/ZamZam
Corp.(drug infosis syrup )

Remarks of Evaluator  Firm has claimed manufacturer‟s specifications
decision of 267thmeeting and the applied
formulation is not present in available USP.
 Evidence of approval status of applied
 Evidence of Me Too of applied formulation in
applied strength.
regulatory authorities/agencies and generic / me-too status.
Capsule(general):
Products: 32, Molecules:10
Rawat,Islamabad
Brand Name+DosageForm+Strength Zonex Capsules 20 mg
Composition Each Delayed-release Capsule contains
Esomeprazole Magnesium eq. to Esomeprazole….20 mg
Pharmacological Group Proton Pump Inhibitors
Type of Form Form-5
Me-too status Esoral 20 mg Capsule of City Pharma Karachi.
(Reg#070588)
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Zonex Capsules 40 mg
Esomeprazole (as magnesium)…….40 mg
(Enteric coated pellets 22.5%)
Source of pellets; Vision pharmaceuticals
Type of Form Form-5
Me-too status Esoral 40 mg Capsule by City Pharma Karachi.
(Reg#070589)
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Pregabin Capsules 25 mg
Pregabalin……..25 mg
Type of Form Form-5
Approval status of product in Lyrica 25 mg Capsules of PF Prism CV, USA (USFDA)
Me-too status Nergab 25 mg Capsules by AGP.
267th meeting & the applied formulation does not exist
in available USP & B.P.
Rawat,Islamabad
Type of Form Form-5
Me-too status Gabica 50 mg Capsules by Getz Pharma (Pvt.) Ltd.
Rawat,Islamabad
Type of Form Form-5
Rawat,Islamabad
Type of Form Form-5
Approval status of product in Lyrica 100 mg Capsules of PF Prism CV, USA
Reference Regulatory Authorities (USFDA)
Rawat,Islamabad
Type of Form Form-5
Rawat,Islamabad
Type of Form Form-5
Rawat,Islamabad
Brand Name+DosageForm+Strength Zerlox Capsules 20 mg
Duloxetine (as hydrochloride) …….20 mg
Pharmacological Group Selective Serotonin&Norepinephrine Reuptake
Inhibitors
Type of Form Form-5
Pack Size & Demanded Price 10‟s, 14‟s, 28‟s & 30‟s ; As per SRO
Me-too status Zenbar capsule 20mg by M/s Searle, Karachi
Remarks of Evaluator  GMP certificate of source of pellets.
Decision: Registration Board deferred for clarification as submitted source of pellets is not
of USP grade.
Rawat,Islamabad
Duloxetine (as hydrochloride)….30 mg
Pharmacological Group Selective Serotonin and Norepinephrine Reuptake
Inhibitors
Type of Form Form-5
Me-too status Zenbar capsule 30mg byM/s. Searle, Karachi
of USP grade.
Rawat,Islamabad
Pharmacological Group Selective Serotonin and Nor-epinephrine Reuptake
Inhibitors
Type of Form Form-5
Approval status of product in Approved inMHRA
Reference Regulatory Authorities Dutor 40 mg Capsules of Dr. Ebeling&Assoc GMBH,
Germany.
Me-too status Worth 40 mg Capsules of Werrick pharmaceuticals.
of USP grade.
Rawat,Islamabad
Enteric coated pellets 17%)
Pharmacological Group Selective Serotonin&Norepinephrine Reuptake
Inhibitors
Type of Form Form-5
Me-too status Zenbar capsule 60mg by Searle, Karachi
of USP grade.
Rawat,Islamabad
Pharmacological Group Selective Serotonin and Nor-epinephrine Reuptake
Inhibitors
Type of Form Form-5
Approval status of product in Cymbalta 90 mg Capsules of Eli Lilly and Company
Reference Regulatory Authorities Limited, USA. (USFDA) not verified
Me-too status Worth 90 mg Capsule of werrick Pharmaceuticals
Decision: Registration Board deferred the case as submitted source of pellets is not of USP
grade.Evidence of approval of applied formulation in reference regulatory
Rawat,Islamabad
Brand Name+DosageForm+Strength Fabzole Capsules 150 mg
Fluconazole…….150 mg
Pharmacological Group Triazol Antifungal
Type of Form Form-5
Finished Product Specification BP specifications
Me-too status Fiscon 150mg capsule of Fassgen
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Fabzole Capsules 200 mg
Fluconazole…….200 mg
Pharmacological Group Triazol Antifungal
Type of Form Form-5
Approval status of product in Diflucan 200 mg Hard Capsules of Pfizer Limited, UK
Me-too status Diflucan 200 mg Capsules by Pfizer Labs.
Ltd.(druginfosis)
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Venafex XR Capsules 75 mg
Composition Each Extended Release Capsule contains
Venlafaxine (as hydrochloride)...75 mg
(Extended release pellets 33%)
Pharmacological Group Antidepressant / SSNRIs
Type of Form Form-5
Approval status of product in Alventa XL 75mg Capsule by M/s Consilient Health
Reference Regulatory Authorities Ltd.(MHRA approved)
Me-too status VenflaxXR 75mg Capsule by M/s Regal Pharma.
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Venafex XR Capsules 150 mg
Composition Each Extended Release Capsule contains
Venlafaxine (as hydrochloride ) …..150 mg
Extended release pellets 33%)
Pharmacological Group Antidepressant / SSNRIs
Type of Form Form-5
Approval status of product in Xenalven XL 150 mg Prolonged release capsule(as
Reference Regulatory Authorities pellets)Approved in MHRA
Me-too status VEnofax SR 150 mg Capsules by Maple(Reg.#058494)
Decision: Approved.
Rawat,Islamabad
Brand Name+DosageForm+Strength Axeptra Capsules 18 mg
Atomoxetine (as hydrochloride)…….18 mg
Pharmacological Group Selective Nor-adrenaline Reuptake Inhibitors
Type of Form Form-5
Approval status of product in Strattera 18 mg Hard Capsules of Eli Lilly and Company
Reference Regulatory Authorities Limited, UK. (MHRA)
Me-too status Strattera 18 mg Capsules by Eli Lilly Pakistan (Pvt.)
Ltd.
Decision: Approved

Rawat,Islamabad
Type of Form Form-5
Ltd.
Decision: Approved
Rawat,Islamabad
Type of Form Form-5
Ltd.
Decision: Approved
Rawat,Islamabad
Type of Form Form-5
Ltd.
Decision: Approved

Applicant St.#S-3, RCCI, National Industrial Zone, Rawat,Islamabad
Type of Form Form-5
Me-too status Strattera 10 mg Capsules by Eli Lilly Pakistan (Pvt.) Ltd.
Decision: Approved
Brand Name+DosageForm+Strength Azirox Capsules 250 mg
Azithromycin (as dihydrate)…….250 mg
Pharmacological Group Macrolide (Antibiotics)
Type of Form Form-5
Me-too status Azofas of Fassgen Pharmaceuticals
Decision: Approved
Brand Name+DosageForm+Strength Azirox Capsules 500 mg
Azithromycin (as dihydrate)…….500 mg
Pharmacological Group Macrolide (Antibiotics)
Type of Form Form-5
Pack Size & Demanded Price 3‟s, 6‟s & 10‟s ; As per SRO
Approval status of product in Zithromax 500 mg Capsules of Pfizer Limited, UK.
Reference Regulatory Authorities (MHRA)()not confirmed
Me-too status Azrowin500mg capsule of WnsFeild
Remarks of Evaluator  Evidence of approval of applied formulation in
applied strength in reference agencies is required.
Brand Name+DosageForm+Strength Evotrin Capsules 10 mg
Acitretin……...…10 mg

Pharmacological Group Vitamin A Derivative
Type of Form Form-5
Approval status of product in Neotigason 10 mg Capsules of Actavis Group PTC EHF,
Reference Regulatory Authorities Iceland. (MHRA)
Me-too status Neotigason 10 mg Capsules by Roche Pakistan Ltd.
Decision: Approved
Brand Name+DosageForm+Strength Evotrin Capsules 25 mg
Acitretin……...…25 mg
Pharmacological Group Vitamin A Derivative
Type of Form Form-5
Approval status of product in Neotigason 25 mg Capsules of Actavis Group PTC EHF,
Reference Regulatory Authorities Iceland. (MHRA)
Me-too status Neotigason 25 mg Capsules by Roche Pakistan Ltd.
Decision: Approved
Brand Name+DosageForm+Strength Co-Olanza Capsules 12/50 mg
Olanzapine…………….12 mg
Fluoxetine (as HCl)...…50 mg
Pharmacological Group SSRIs / Antipsychotic
Type of Form Form-5
Finished Product Specification USPspecifications
Approval status of product in Symbyax 12 mg/50 mg Capsules of Eli Lilly , USA
Me-too status Olanco 12/50mg Capsules by Genome Pharma. (Pvt.) Ltd.
Remarks of Evaluator  Evidence of Me Too of applied formulation in
applied strength is required.
Olanzapine…………….12 mg
Fluoxetine (as hydrochloride)...…25 mg
Type of Form Form-5

Me-too status Olanzo-F12/25 mg Capsules of Regal Pharmaceuticals
Decision: Approved
Olanzapine……………...6 mg
Fluoxetine (as hyrochloride)...…25 mg
Type of Form Form-5
Me-too status Olanzo-F 6/25 mg Capsules of Regal pharmaceuticals
Decision: Approved
Olanzapine……………...3 mg
Fluoxetine (as hydrochloride)...…25 mg
Type of Form Form-5
Me-too status Olanzo-F 3/25 mg Capsules of Regal pharmaceuticals
Decision: Approved.
Brand Name+DosageForm+Strength Omig Capsules 20 mg
Omeprazole………20 mg
Pharmacological Group Proton Pump inhibitors
Type of Form Form-5
Approval status of product in Approved in MHRA.
Reference Regulatory Authorities (Losec Capsule 20mg by Astra Zaneca UK Ltd.)
Me-too status Aksozole Capsule 20mg of Akson Pharmaceuticals
Reg. # (023733)
Decision: Approved
Brand Name+DosageForm+Strength Omig Capsules 40 mg
Omeprazole………40 mg
Pharmacological Group Proton Pump inhibitors
Type of Form Form-5
Approval status of product in Approved in MHRA.
Reference Regulatory Authorities (Losec Capsule 40mg by Astra Zaneca UK Ltd.)
Me-too status Osprey Capsule 40mg of M/s Linta Pharmaceuticals.
Reg. # (081881)
Decision: Approved.
Tablet (general):
Products:21 , Molecules: 05
Brand Name+DosageForm+Strength Levepra Tablets 250 mg
Levetiracetam….…250 mg
Type of Form Form-5
Approval status of product in Keppra 250 mg Tablets of UCB Inc. USA (USFDA)
Me-too status Eppra250 mg Tablets of Global Pharmaceuticals
Decision: Approved.
Type of Form Form-5
Me-too status Eppra 500 mg Tablets of Global Pharmaceuticals
Decision: Approved

Rawat,Islamabad
Type of Form Form-5
Me-too status Levotam750 mg Tablets of Platinum pharmaceuticals
Decision: Approved
Rawat,Islamabad
Type of Form Form-5
Me-too status Levotam 1 g tablets of Platinum Pharmaceuticals
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Lexopram Tablets 5 mg
Escitalopram (as Oxalate)……5 mg
Pharmacological Group Selective Serotonin Reuptake Inhibitors (SSRIs)
Type of Form Form-5
Pack Size & Demanded Price 10‟s, 14‟s, 20‟s, 28‟s & 30‟s ; As per SRO
Me-too status Zavesca tablet 5mg of Getz Pharma
Decision: Approved
Rawat,Islamabad
Escitalopram (as Oxalate)……10 mg
Type of Form Form-5
Me-too status Citanew 10 mg tablet of Hilton Pharma
Decision: Approved.
Rawat,Islamabad
Escitalopram (as oxalate)……15 mg
Type of Form Form-5
Decision: Approved.
Rawat,Islamabad
Escitalopram (as oxalate)……20 mg
Type of Form Form-5
Decision: Approved
Rawat,Islamabad
Brand Name+DosageForm+Strength Leroxen Tablets 10 mg
Paroxetine (as HCl)….…10 mg
Type of Form Form-5
Approval status of product in Paxil 10 mg Tablets of Apotex Technologies Inc., USA
Me-too status Seroxat 10 mg Tablets by GSK ( not verified)
Remarks of Evaluator  Evidence of Me Too is required.
Decision:Deferred for confirmation of generic / me-too status
Rawat,Islamabad
Type of Form Form-5
Me-too status Hiprox tablet 20mg of Hygeia Pharmaceuticals
Decision: Approved
Rawat,Islamabad
Paroxetine (as hydrochloride)….…30 mg
Type of Form Form-5
Me-too status Plasare 30 mg Tablets by S.J & G Fazule Elahi
Decision: Approved
Rawat,Islamabad
Paroxetine (as hydrochloride)….…40 mg
Type of Form Form-5
Me-too status Seroxat 40 mg Tablets by GSK
Remarks of Evaluator Evidence of Me Too of applied formulation in applied
strength with registration number is required.

Decision:Deferred for confirmation of generic / me-too status
Rawat,Islamabad
Brand Name+DosageForm+Strength Leroxen CR Tablets 12.5 mg
Composition Each controlled release tablet contains
Paroxetine (as HCl)….…12.5 mg
Type of Form Form-5
Approval status of product in Paxil CR 12.5 mg Tablets of Apotex Technologies Inc.,
Reference Regulatory Authorities USA (USFDA)
Me-too status Seroxat CR 12.5 mg Tablets by GSK
Decision: Deferred for clarification whether applied dosage form is enteric coated
controlled release tablet or otherwise.
Rawat,Islamabad
Brand Name+DosageForm+Strength Leroxen CR Tablets 25 mg
Type of Form Form-5
Me-too status Deroxat CR tablet 25mg by Global Pharma
Rawat,Islamabad
Brand Name+DosageForm+Strength Leroxen CR Tablets 37.5 mg
Paroxetine (as HCl)….…37.5 mg
Type of Form Form-5
Approval status of product in Paxil CR 37.5 mg Tablets of Apotex Technologies Inc.,
Reference Regulatory Authorities USA (USFDA)
Me-too status Deroxat CR 37.5 mg Tablets by Global Pharma (Pvt.)
Ltd.
Rawat,Islamabad
Brand Name+DosageForm+Strength Sertil Tablets 50 mg
Sertraline (as hydrochloride)….…50 mg
Type of Form Form-5
Approval status of product in Lustral 50 mg Tablets of Pfizer Ltd., UK (MHRA)
Me-too status Ertalin50 mg Tablets of Genome Pharmaceuticals
Remarks of Evaluator Approved in US-FDA with box warning: suicidal
thoughts
Decision:Approved with Box warning.
Rawat,Islamabad
Brand Name+DosageForm+Strength Sertil Tablets 100 mg
Sertraline (as hydrochloride)….…100 mg
Type of Form Form-5
Approval status of product in Lustral 100 mg Tablets of Pfizer Ltd., UK (MHRA)
Me-too status Ertalin 100mg tablet of Genome Pharmaceuticals
Remarks of Evaluator Approved in US-FDA with box warning: suicidal
thoughts
Rawat,Islamabad
Brand Name+DosageForm+Strength Respril Tablets 4 mg
Risperidone….…4 mg
Pharmacological Group Antipsychotic / Benzisoxazole derivative
Type of Form Form-5
Approval status of product in Risperdal 4 mg Tablets of Janssen-Cilag Ltd., UK
Me-too status Resjun4 mg Tablets of Jupiter pharmaceuticals
Decision: Approved.
768. Name and address of Manufacturer / M/s Evolution Pharmaceuticals (Pvt.) Ltd. Plot #:25/26,
Rawat,Islamabad
Type of Form Form-5
Me-too status Resjun 3mg Tablets of Jupiter pharmaceuticals
Decision: Approved.
Rawat,Islamabad
Type of Form Form-5
Me-too status Becalm 2 mg tablets of Maple pharmaceuticals
Decision: Approved.
Rawat,Islamabad
Type of Form Form-5
Me-too status Becalm 1 mg tablets of Maple pharmaceuticals
Decision:Approved.

b) New section(s)
Evaluator PEC-XII
Case No.1. M/s Crest Pharmaceuticals (New section)
Following registration dossiers have been received vide letter No. F.6-2/2016 (R-III) dated
16th May 2016 stating that
Central Licensing Board in its 252nd meeting, granted approval of seven additional sections
to M/s Crest Pharmaceuticals, Islamabad
 Warehouse
 Dry powder injection (General)
 Capsule (General)
 QC Lab (II)
 Oral dry powder suspension(General)
 Liquid injection (General)
 Ear/Eye drops
Now the firm has applied for following:

1. Warehouse - -
2. Dry powder injection (General) 12 10
3. Capsule (General) 23 10
4. QC Lab (II) - -
5. Oral dry powder suspension(General) 06 04
6. Liquid injection (General) 14 10
7. Ear/Eye drops 11 10
Dry Powder Injection Vial (General)

Products:12 / Molecules:10
771. Name and address of manufacturer / M/s Crest PharmaceuticalsPlot No. 43, Industrial
Applicant Triangle Kahuta Road Islamabad.
Brand Name +Dosage Form + Lonex Injection 8 mg
Strength
Lornoxicam…8mg
Diary No. Date of R& I & fee Diary No.408; 25-04-2017; Rs.20,000/- (25-04-
2017)
Pharmacological Group NSAID‟s, Analgesic
Type of Form Form-5
Finished product Specifications Innovator‟s Specifications
Pack size & Demanded Price 1‟s vial/As per SRO
Approval status of product in Xefo 8 mg powder and solvent for solution for
Reference Regulatory Authorities injection by M/s Takeda Austria GmbH, (Austria
approved)
Me-too status (with strength and Viltaz Injection 8 mg/2ml by M/s Wilshire
dosage form) Laboratories Lahore. (Reg#077112)
Inspection of Additional Sections.
Panel recommends grant of additional sections.
Remarks of the Evaluator -
Decision:Deferred for submission of evidence of approval of section/manufacturing
facility of “Dry Powder Injection (Lyophilized) section” by the central licensing board.

Brand Name +Dosage Form + Hyzole Injection 20 mg
Strength
Omeprazole Sodium eq. to Omeprazole...20mg
Diary No. Date of R& I & fee Diary No.418; 25-4-2017; Rs.20,000/- (25-04-2017)
Type of Form Form-5
Approval status of product in Mepral Injection by Bracco S.p.A. Italy. (Not RRA)
Me-too status (with strength and Zolpro Injection 20mg by M/s Safe Karachi
dosage form) (Reg#070826)
GMP status 16-12-2016; Inspection of Additional Sections.
Remarks of the Evaluator  Approval status of product in Reference
 Firm has applied for omeprazole 40mg injection
with the name of „Brizole‟.
Brand Name +Dosage Form + Brizole Injection 40 mg
Strength
Omeprazole Sodium eq. to Omeprazole...40mg
Diary No. Date of R& I & fee Diary No.419; 25-4-2017; Rs.20,000/- (25-04-2017)
Type of Form Form-5
Approval status of product in Omeprazole 40 mg powder for solution for infusion
Reference Regulatory Authorities by M/s Mylan, ANSM approved
Me-too status (with strength/dosage Teph 40mg Injection by M/s Sami (Reg#057830)
form)
Decision: Approved with change of brand name & with Innovators specifications.
Brand Name +Dosage Form + Creszole Injection 40 mg
Strength
Pantoprazole (as sodium sesquihydrate)....40mg
2017)
Type of Form Form-5
Finished product Specifications Innovator‟s specifications
Approval status of product in Pantoprazole Sodium For Injection 40mg by M/s
Reference Regulatory Authorities Exela Pharma Sciences, LLC, USFDA approved
Me-too status (with strength and Protonix Injection 40mg by M/s Wilshire
dosage form) Laboratories Lahore. (Reg#071380)
Brand Name +Dosage Form + Sabizole Injection 40 mg
Strength
Esomeprazole Sodium eq. to Esomeprazole...40mg
2017)
Type of Form Form-5
Approval status of product in Nexium I.V.40 mg Powder for solution for
Reference Regulatory Authorities injection/infusion by M/s Astra Zeneca Ltd. UK,
MHRA approved
Me-too status (with strength and ES-Loprot 40mg Injection by M/s Nabiqasim
dosage form) Industries (Reg#070679)
Brand Name +Dosage Form + Claritec Injection 500 mg
Strength
Clarithromycin (as lactobionate)...500mg
2017)
Type of Form Form-5
Approval status of product in Clarithromycin 500 mg, Powder for Concentrate for
Reference Regulatory Authorities Solution for Infusion by M/s Concordia International
- formerly AMCo , MHRA approved
Me-too status (with strength and Klaricid IV 500mg Injection by M/s Abbott
Brand Name +Dosage Form + Nuzole Injection 20 mg
Strength
Esomeprazole Sodium eq. to Esomeprazole....20mg
2017)
Type of Form Form- 5
Approval status of product in Nexium Injection, Astra Zeneca Ltd. UK, MHRA
Reference Regulatory Authorities approved (not confirmed)
Me-too status (with strength and Pep-Ease Injection 20mg by M/s Safe Karachi.
Remarks of the Evaluator  Firm has applied for Esomeprazole 40mg
injection with the name of „Sabizole‟.
 Approval status of product in Reference
Brand Name +Dosage Form + Azi-Mac Injection 500 mg
Strength
Composition Each Vial contains:
Azithromycin dihydrate eq. to
Azithromycin…500mg
2017)
Type of Form Form-5
Approval status of product in Zedbac 500 mg powder for solution for infusion by
Reference Regulatory Authorities M/s Aspire Pharma Ltd , MHRA approved
Me-too status (with strength and Zezot Injection 500mg by M/s Bosch Karachi.
Decision: Approved
Brand Name +Dosage Form + Lansorest Injection 30 mg
Strength
Lansoprazole...30 mg
2017)
Type of Form Form-5
Approval status of product in Prevacid IV Injection, Takeda Pharmaceuticals USA,
Reference Regulatory Authorities (USFDA approved)
Me-too status (with strength and Belenz Injection 30mg by M/s Wellborn
dosage form) Pharmachem Hattar. (Reg#054894)
Brand Name +Dosage Form + Vancres Injection 500 mg
Strength
Vancomycin hydrochloride eq. to
Vancomycin…500mg
Diary No. Date of R& I & fee Diary .496; 25-04-2017; Rs.20,000/- (25-04-2017)
Pharmacological Group Glycopeptide antibacterial
Type of Form Form-5
Approval status of product in Vancomycin 500mg Powder for Concentrate for
Reference Regulatory Authorities Solution for Infusion by M/s Actavis UK Ltd,
MHRA approved.
Me-too status (with strength and Vancomycin 500mg Vial by M/s Abbott
Decision: Approved
Brand Name +Dosage Form + Tigicin Injection 50 mg
Strength
Tigecycline .... 50 mg
2017)
Pharmacological Group Glycylcycline Antibiotic (Tetracycline)
Type of Form Form-5
Approval status of product in Tygacil 50mg Injection, Pfizer UK, MHRA approved
Me-too status (with strength and Tygacil 50 mg Injection, Wyeth Karachi.
Decision: Approved
Brand Name +Dosage Form + Rabizole Injection 20 mg
Strength
Rabeprazole Sodium eq. to Rabeprazole .... 20 mg
2017)
Type of Form Form-5
Approval status of product in Akirab 20mg, So.Se. Pharm, Italy. EMA Approved.
Reference Regulatory Authorities (Not RRA)
Me-too status (with strength and Rabz Injection 20mg by M/s Wilshire Laboratory
dosage form) Lahore. (Reg#071379)
Remarks of the Evaluator  Approval status of product in Reference
Case No.2. M/s. Rotex Pharma (Pvt) Ltd , Islamabad ( New Sections)
Following registration dossiers have been received vide letter No. F.6-2/2016 (R-III), dated
15th Augus, 2017 stating that the firm has been granted approval of New Sections by way of
formulation by Central Licensing Board in its 253rd meeting for following sections
1.Capsule (Cephalosporin)
2.Dry Powder For Oral Suspension (Cephalosporin)
3.Dry Powder Vial SVP (Cephalosporin)
4.Capsule (Oncology)
5.Dry Powder Vial (Oncology)
6.Liquid Ampoule SVP (Oncology)
7.Liquid Vial SVP (Oncology)
8.Tablet (Oncology)
9.Dry Powder Vial (Carbapenem)
1 Capsule (Cephalosporin) 10 07
2 Dry Powder For Oral Suspension 20 10
(Cephalosporin)
3 Dry Powder Vial SVP (Cephalosporin) 22 06
4 Capsule (Oncology) 13 08
5 Dry Powder Vial (Oncology) 06 05
6 Liquid Ampoule SVP (Oncology) 06 04
7 Liquid Vial SVP (Oncology) 17 10
8 Tablet (Oncology) 15 10
9 Dry Powder Vial (Carbapenem) 05 03
Capsule (Oncology)
13 products / 08 molecules
783. Name and address of manufacturer / M/s Rotex Pharma (Pvt) Ltd. Plot No. 206 & 207,
Brand Name +Dosage Form + Strength TEMOVEX 20mg Capsule
Diary No. Date of R& I & fee Diary No:8023, 07/07/2017 , Rs: 20,000/-
Composition Each Capsule Contains:
Temozolomide …20mg
Pharmacological Group Alkylating agent
Type of Form Form-5
Pack size & Demanded Price 5‟s /
As per SRO
Approval status of product in Reference Temozolomide 20mg capsules by M/s Generics
Regulatory Authorities. [UK] Limited t/a Mylan (MHRA Approved)
Me-too status Temoside 20mg Capsule by M/s Cipla/A.J. Mirza,
(Reg#066112)
Grant of Additional Sections
Panel recommends grant of Additional Sections

Brand Name+Dosage Form+ Strength TEMOVEX 100mg Capsule
Temozolomide… 100mg
Type of Form Form-5
As per SRO
Approval status of product in Temozolomide 100mg capsules by M/s Generics [UK]
Reference Regulatory Authorities. Limited t/a Mylan (MHRA Approved)
(Reg#066113)
Brand Name+Dosage Form + Strength TEMOVEX 250mg Capsule
Temozolomide…250mg
Type of Form Form 5
Pack size & Demanded Price 5‟s /As per SRO
Approval status of product in Temozolomide 250mg capsules by M/s Generics [UK]
Reference Regulatory Authorities. Limited t/a Mylan (MHRA Approved)
(Reg#066114)
Brand Name+Dosage Form + Strength CANTEX 1mg Capsule
Topotecan (as hydrochloride)…1mg
Pharmacological Group Topoisomerase 1 inhibitor
Type of Form Form 5
Approval status of product in HYCAMTIN topotecan (as hydrochloride) 1 mg hard
Reference Regulatory Authorities. capsules by M/s Novartis Pharmaceuticals Australia Pty
Ltd(TGA Approved)
Me-too status Hycamtin 1mg Capsule by M/s GSK (Reg#066127)
GMP status 30-03-2017; Grant of Additional Sections
Remarks of the Evaluator.  Brand name resembles with the product already

approved by DRAP.
Decision:Deferred for confirmation/justification for manufacturing of the applied product
in Capsule (Oncology) section in the light of decision of Registration Board in its 271st
meeting regarding “Specific manufacturing requirements for certain classes of drugs.”
Brand Name+Dosage Form + Strength CANTEX 0.25mg Capsule
Topotecan (as hydrochloride)…0.25mg
Pharmacological Group Topoisomerase 1 inhibitor
Type of Form Form 5
As per SRO
Approval status of product in HYCAMTIN topotecan (as hydrochloride) 0.25 mg
Reference Regulatory Authorities. hard capsules by M/s Novartis Pharmaceuticals
Australia Pty Ltd(TGA Approved)
Me-too status Hycamtin 0.25mg Capsule by M/s GSK (Reg#066126)
approved by DRAP.
Brand Name+Dosage Form + Strength SUNTEX 50mg Capsule
Sunitinib (as Maleate)…50mg
Pharmacological Group Protein Kinase inhibitor
Type of Form Form 5
As per SRO
Approval status of product in Sutent 50 mg capsules (Sunitinib as Malate) by Pfizer
Reference Regulatory Authorities. Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United
Kingdom (USFDA Approved)
Me-too status Sutent 50mg Capsule by M/s Pfizer (Reg. No. 052227)
approved by DRAP.

Brand Name+Dosage Form + Strength HYDREX 500mg Capsule
Hydroxyurea…500mg
Pharmacological Group Antineoplastic agent that inhibits DNA synthesis
Type of Form Form 5
Pack size & Demanded Price 100s /
As per SRO
Approval status of product in HYDREA 500mg capsule by Bristol-Myers Squibb
Reference Regulatory Authorities. Australia Pty Ltd(TGA Approved)
Me-too status Hydra 500mg Capsule by M/s Medinet (Reg. No.
028484)
approved by DRAP.
Brand Name+Dosage Form + Strength TANIB 140mg Capsule
Ibrutinib…140mg
Pharmacological Group Protein kinase inhibitor
Type of Form Form 5
Pack size & Demanded Price 90‟s , 120‟s/
As per SRO
Approval status of product in IMBRUVICA ibrutinib 140mg capsule by Janssen-
Reference Regulatory Authorities. Cilag Pty Ltd(TGA Approved)
Me-too status Not confirmed.
Remarks of the Evaluator.  Me-too status not confirmed from available
database.
Decision:
 Deferred for confirmation/justification for manufacturing of the applied product in
Capsule (Oncology) section in the light of decision of Registration Board in its 271st
 Evidence of applied formulation/drug already approved by DRAP (generic / me-too
status) alongwith registration number, brand name and name of firm
Brand Name+Dosage Form + Strength LENALIDE 10mg Capsule
Lenalidomide…10mg
Pharmacological Group Thalidomide analogue (Immunomodulating agent)
Type of Form Form 5
Approval status of product in REVLIMID lenalidomide 10mg capsule blister pack by
Reference Regulatory Authorities. Celgene Pty Ltd (TGA Approved)
database.
Decision:
Capsule (Oncology) section in the light of decision of Registration Board in its 271st
 Confirmation of generic / me-too status.
Brand Name+Dosage Form+ Strength LENALIDE 25mg Capsule
Lenalidomide…25mg
Pharmacological Group Thalidomide analogue (Immunomodulating agent)
Type of Form Form 5
Approval status of product in REVLIMID lenalidomide 25mg capsule blister pack by
Reference Regulatory Authorities. Celgene Pty Ltd (TGA Approved)
Remarks of the Evaluator. Me-too status not confirmed from available database.
Brand Name+Dosage Form+ Strength IRITEC 100mg Capsule
Imatinib (as mesilate)…100mg
Pharmacological Group Protein-Tyrosine Kinase Inhibitor
Type of Form Form 5
Pack size & Demanded Price 10‟s, 60‟s, 120‟s, 180‟s, 96‟s, 24‟s & 48‟s/As per SRO
Approval status of product in IMATINIB GH imatinib (as mesilate) 100 mg capsules
Reference Regulatory Authorities. by Cipla Australia Pty Ltd(TGA Approved)
Me-too status Glivec 100mg Capsule by Novartis (Reg. No. 027364)
Brand Name+Dosage Form + Strength IRITEC 400mg Capsule

Imatinib (as mesilate)…400mg
Pharmacological Group Protein-Tyrosine Kinase Inhibitor
Type of Form Form 5
Pack size & Demanded Price 10‟s, 30‟s, 60‟s, 90‟s & 120‟s /
As per SRO
Approval status of product in IMATINIB -DRLA imatinib (as mesilate) 400 mg
Reference Regulatory Authorities. capsules by Cipla Australia Pty Ltd(TGA Approved)
Me-too status Glivec 400mg Capsule by Novartis (Reg. No. 033197)
Decision:
Deferred for confirmation/justification for manufacturing of the applied product in Capsule
(Oncology) section in the light of decision of Registration Board in its 271st meeting
regarding “Specific manufacturing requirements for certain classes of drugs.”
Brand Name+Dosage Form + Strength THALMED 100mg Capsule
Thalidomide…100mg
Pharmacological Group Immunosuppressant
Type of Form Form 5
As per SRO
Approval status of product in THALOMID thalidomide 100mg hard capsule capsules
Reference Regulatory Authorities. by Celgene Pty Ltd(TGA Approved)
Me-too status Thalido 100mg Capsule by Atco (Reg. No. 047188)
Decision:
Deferred for confirmation/justification for manufacturing of the applied product in Capsule
(Oncology) section in the light of decision of Registration Board in its 271st meeting
regarding “Specific manufacturing requirements for certain classes of drugs.”
Dry Powder Vial (Oncology)
Brand Name +Dosage Form + Strength ASP 10,000IU Powder for Injection
Composition Each Vail Contains:
L-Asparaginase…10,000IU
Pharmacological Group Protein Synthesis inhibitor
Type of Form Form 5
Pack size & Demanded Price 1‟s Vial/
As per SRO
Approval status of product in Reference Leunase 10,000KU injection vial by Sanofi-Aventis
Regulatory Authorities. Australia Pty Ltd (TGA Approved)
Me-too status Leunase 10,000KU injection by M/s S. Ejazuddin and
Co. (Reg no. 044896)
Decision:Deferred for confirmation/justification for manufacturing of the applied product in
Dry Powder Vial (Oncology) section in the light of decision of Registration Board in its 271st
Brand Name +Dosage Form + Strength DACA 200mg Powder for Injection
Dacarbazine…200mg
Pharmacological Group Antineoplastic agent
Type of Form Form 5
Pack size & Demanded Price 1‟s Vial/As per SRO
Approval status of product in Reference DBL DACARBAZINE 200mg Powder for Injection by
Regulatory Authorities. Hospira Australia Pty Ltd (TGA Approved)
Me-too status Dac 200mg injection by M/s Medinet Pharma (Reg no.
028482)
Decision:Approved
798.a.Name and address of manufacturer / M/s Rotex Pharma (Pvt) Ltd. Plot No. 206 & 207,
Brand Name +Dosage Form + Strength CYCLO 500mg Powder for Injection
Cyclophosphamide (as monohydrate)…500mg
Type of Form Form 5
Approval status of product in Reference Endoxan 500mg powder for injection vial by Baxter
Regulatory Authorities. Healthcare Pty Ltd (TGA Approved)
Me-too status Uniphos 500mg injection by M/s Revive Healthcare
(Reg no.081770)
Decision:Approved
Brand Name +Dosage Form + Strength CYCLO 1g Powder for Injection
Cyclophosphamide (as monohydrate)…1g
Type of Form Form 5
Approval status of product in Reference Endoxan 1g powder for injection vial by Baxter
Regulatory Authorities. Healthcare Pty Ltd (TGA Approved)
Me-too status Cyclomide 1gm injection by M/s Pharmedic
Decision:Approved
Brand Name +Dosage Form + Strength BLEO 15Units Powder for Injection
Bleomycin (as sulphate)…15 Units
Pharmacological Group Cytotoxic antibiotic
Type of Form Form 5
As per SRO
Approval status of product in Reference Hospira Bleomycin for Injection, USP 15 units vial by
Regulatory Authorities. Hospira Australia Pty Ltd (TGA Approved)
Me-too status Bemocin 15Units injection by Atco (Reg no. 045752)
Brand Name +Dosage Form + Strength DAUNO 20mg Powder for Injection
Daunorubicin (as hydrochloride)…20mg
Pharmacological Group Cytotoxic antibiotic
Type of Form Form 5
As per SRO
Approval status of product in Daunorubicin 20mg Powder for I.V. Injection by
Reference Regulatory Authorities Winthrop Pharmaceuticals UK (MHRA Approved)
Me-too status (with strength and Daunotec 20mg injection by M/s AJ Mirza (Reg no.
dosage form) 045601)

Liquid Ampoule (Oncology)
Brand Name +Dosage Form + Strength CESNA 400mg/4ml Injection
Mesna (Sodium 2-mercaptoethanesulfonate) …400mg
Pharmacological Group Detoxifying agent for antineoplastic treatment
Type of Form Form 5
Pack size & Demanded Price Pack of 15 Amp x 4ml, MRP. Rs. As per SRO
Approval status of product in UROMITEXAN 400mg/4mL injection ampoule by
Reference Regulatory Authorities Baxter Healthcare Pty Ltd (TGA Approved)
Me-too status (with strength and Uromes 400mg/4ml injection by Al Habib
dosage form) Pharmaceutical (Reg no.059256)
Panel recommends grant o[f Additional Sections
Decision:
Deferred for confirmation/justification for manufacturing of the applied product in Liquid
Ampoule (Oncology) section as applied product is not cytotoxic anti-cancer.
Brand Name +Dosage Form + Strength ONCOFU 250mg/5ml Injection
Fluorouracil…250mg
Pharmacological Group Antimetabolite (Pyrimidine analogue)
Type of Form Form 5
Approval status of product in Fluorouracil Injection, 50 mg/ml, solution for injection
Reference Regulatory Authorities by medac Gesellschaft für klinische Spezialpräparate
mbH Theaterstr. 6 22880 Wedel Germany (MHRA
Approved)
Me-too status (with strength and Fivuflu 250mg injection by Atco
dosage form)
Remarks of the Evaluator  Confirmed as vial in MHRA but firm has applied in
ampoule packaging.
 Evidence of vial from available me-too database
Decision:Deferred for clarification/justification on scientific basis for applied packaging
material as reference product approved by MHRA of UK is available in glass vial whereas
firm has applied for glass ampoule.
Brand Name +Dosage Form + Strength OCTERO 0.05mg/ml Injection
Octreotide (as acetate)…0.05mg
Pharmacological Group Somatostatin analogue (Cytostatics)
Type of Form Form 5
Approval status of product in SANDOSTATIN (octreotide acetate)50mcg injection,
Reference Regulatory Authorities solution by M/s Novartis Pharmaceuticals Corporation
(USFDA Approved)
Me-too status (with strength and Sandostatin 0.05mg injection by Novartis
dosage form) (Reg. No. 013473)
Liquid Ampoule (Oncology) section as applied product is not cytotoxic anti-cancer.
Moreover, source of Octreotide (synthetic or biological) shall be submitted by the applicant
along with relevant documents.
Brand Name +Dosage Form + Strength OCTERO 0.1mg/ml Injection
Octreotide (as acetate)…0.1mg
Pharmacological Group Somatostatin analogue (Cytostatics)
Type of Form Form 5
Approval status of product in SANDOSTATIN (octreotide acetate)100mcg injection,
Reference Regulatory Authorities solution by M/s Novartis Pharmaceuticals Corporation
(USFDA Approved)
Me-too status (with strength and Sandostatin 0.1mg injection by Novartis
Moreover, source of Octreotide (synthetic or biological) shall be submitted by the applicant
along with relevant documents.
Brand Name +Dosage Form + Strength ROTAFER 15mg/2ml Injection
Calcium Folinate eq. to folinic acid…15mg
Type of Form Form 5
Pack size & Demanded Price 5‟s x 2ml/As per SRO
Approval status of product in DBL LEUCOVORIN CALCIUM Folinic Acid
Reference Regulatory Authorities 15mg/2mL (as calcium folinate) Injection by Hospira
Australia Pty Ltd (TGA Approved)
Me-too status (with strength and Kunyrin 15mg/2ml injection by Al-Habib
Brand Name +Dosage Form + Strength ROTAFER 50mg/5ml Injection
Calcium Folinate eq. to folinic acid…50mg
Type of Form Form 5
Pack size & Demanded Price 5‟s x 5ml/
As per SRO
Approval status of product in DBL LEUCOVORIN CALCIUM Folinic Acid
Reference Regulatory Authorities 50mg/5mL (as calcium folinate) Injection by Hospira
Me-too status (with strength and Kunyrin 50mg/5ml injection by Al-Habib
Liquid Vial (Oncology)
Brand Name +Dosage Form + Strength CREST 1mg/ml Injection
Vincristine Sulphate…1mg
Pharmacological Group Vinca alkaloid (antineoplastic agent)
Type of Form Form 5
Pack size & Demanded Price 1 Vial x 1ml , 10 Vials x 1ml, /
As per SRO
Approval status of product in DBL Vincristine Sulphate 1 mg/1 mL Injection vial by
Reference Regulatory Authorities Hospira Australia Pty Ltd (TGA Approved)
Me-too status (with strength and Nevexitine 1mg/ml Injection by Novartis (Reg
dosage form) no.083092)
Remarks of the Evaluator  Brand name resembles with the product already
approved by DRAP.
Decision:Approved with change of brand name
Brand Name +Dosage Form + Strength CREST 2mg/2ml Injection
Vincristine Sulphate …2mg
Pharmacological Group Vinca alkaloid (antineoplastic agent)
Type of Form Form 5
Pack size & Demanded Price 1 Vial x 2ml , 10 Vials x 2ml /
As per SRO
Approval status of product in Pfizer (Perth) Vincristine Sulfate 2mg/2mL injection by
Reference Regulatory Authorities Pfizer Australia Pty Ltd (TGA Approved)
Me-too status (with strength and Nevexitine 2mg/2ml Injection by Novartis (Reg
approved by DRAP.
Decision:Approvedwith change of brand name
Brand Name +Dosage Form + Strength CISPLAT 10mg/10ml Injection
Cisplatin…10mg
Pharmacological Group Platinum compound (Antineoplastic Agent)
Type of Form Form 5
Pack size & Demanded Price 1 Vial x 10ml /
As per SRO
Approval status of product in Cisplatin Injection 10mg/10mL by Pfizer Australia Pty
Reference Regulatory Authorities Ltd (TGA Approved)
Me-too status (with strength and Sicatem 10mg Injection Vial by Haji Medicine (Reg
approved by DRAP.
Decision:Aproved with change of brand name
Brand Name +Dosage Form + Strength PEG-ASP 3750IU/5ml Injection
Pegylated – Asparaginase…3750IU
Pharmacological Group Antineoplastic Agent
Type of Form Form 5
Pack size & Demanded Price 1 Vial x 5ml/
As per SRO
Approval status of product in Oncaspar Injection 3750 International Units/5 mL
Reference Regulatory Authorities solution by Sigma-Tau Pharmaceuticals, Inc (USFDA
Approved)
Me-too status (with strength and Not confirmed
dosage form)
Remarks of the Evaluator  Me-too status not confirmed from available
database.
Decision:
Liquid Vial SVP (Oncology)as applied product is non-cytotoxic anti-cancer.

Brand Name +Dosage Form + Strength ROTANA 60mg/1.5ml Injection
Composition Each Injection Vial Contains:
Cabazitaxel (anhydrous) 60mg, Polysorbate 80 q.s.
1.5ml
Each Diluent Vial Contains:
Ethanol 13%(w/w) in Water for injection…4.5ml
Pharmacological Group Antineoplastic agent (Taxane)
Type of Form Form 5
Pack size & Demanded Price Combine Pack of
1 Vial x 1.5ml of injection & 1 Vial x 5.7ml Diluent/
As per SRO
Approval status of product in CABAZITAXEL SANOFI cabazitaxel 60mg/1.5mL
Reference Regulatory Authorities concentrated injection vial by Sanofi-Aventis Australia
Pty Ltd (TGA Approved)
Me-too status (with strength and Jevtana Injection 60mg/1.5ml by Sanofi-aventis
Decision: Deferred for deliberation on manufacturing of diluent
Brand Name +Dosage Form + Strength METOTREX 50mg/2ml Injection
Methotrexate…50mg
Pharmacological Group Folic acid analogue (Antimetabolite)
Type of Form Form 5
As per SRO
Approval status of product in DBL METHOTREXATE 50mg/2mL injection BP vial
Reference Regulatory Authorities by Hospira Australia Pty Ltd (TGA Approved)
Me-too status (with strength and Trexol 50mg/2ml Injection Vial by Helix Pharma (Reg
approved by DRAP.
in Liquid Vial SVP (Oncology) section as applied product is non-cytotoxic anti-cancer.
Methotrexate… 500mg
Type of Form Form 5
Pack size & Demanded Price 1 Vial x 5ml/As per SRO
Approval status of product in Methotrexate 100 mg/ml concentrate for solution for
Reference Regulatory Authorities infusion by M/s Accord Healthcare Limited Sage
House (MHRA Approved)
Me-too status (with strength and Metotrex 500mg Injection Vial by Haji Medicine
approved by DRAP.
Methotrexate …1000mg
Type of Form Form 5
As per SRO
Approval status of product in METHOTREXATE EBEWE methotrexate
Reference Regulatory Authorities concentrated injection 1000mg/5mL vial by Sandoz Pty
Ltd (TGA Approved)
Me-too status (with strength and Metotrex 1000mg Injection Vial by Haji Medicine
approved by DRAP.
Brand Name +Dosage Form + Strength RUBICIN 10mg/5ml Injection
Doxorubicin hydrochloride…10mg
Pharmacological Group Cytotoxic Anthracycline Antibiotic
Type of Form Form 5
Approval status of product in DOXORUBICIN ACC doxorubicin hydrochloride
Reference Regulatory Authorities 10mg/5ml concentrated solution for injection by
Accord Healthcare Pty Ltd (TGA Approved)
Me-too status (with strength and Nagun 10mg/5ml Injection Vial by Ghani Brothers
Decision: Approved

Brand Name +Dosage Form + Strength RUBICIN 50mg/25ml Injection
Doxorubicin hydrochloride…50mg
Type of Form Form 5
Pack size & Demanded Price Pack of 1 Vial x 25ml
MRP. Rs. As per SRO
Approval status of product in Doxorubicin hydrochloride solution for infusion
Reference Regulatory Authorities 50mg/25mL by medac Gesellschaft für klinische
Spezialpräparate mbH (TGA Approved)
Me-too status (with strength and Robol 50mg/25ml Injection Vial by Helix Pharma
Decision: Approved
Brand Name +Dosage Form + Strength TEXADA 120mg/6ml Injection
Docetaxel (anhydrous) 120mg
Type of Form Form 5
Pack size & Demanded Price Combine Pack of 1 Vial x 6ml of injection & 1 Vial x
9ml Diluent / MRP. Rs. As per SRO
Approval status of product in HOSPIRA DOCETAXEL docetaxel 120mg/6mL
Reference Regulatory Authorities concentrated injection vialby Pfizer Australia Pty Ltd
(TGA Approved)
Me-too status (with strength and Docetax 120mg Injection by Cipla A.J. Mirza
Decision:Approved
Brand Name +Dosage Form + Strength TEXADA 160mg/8ml Injection
Docetaxel (anhydrous) 160mg
Type of Form Form 5
Pack size & Demanded Price Combine Pack of 1 Vial x 8ml of injection & 1 Vial x
12ml Diluent
MRP. Rs. As per SRO
Approval status of product in DOCETAXEL KABI docetaxel anhydrous 160 mg/8
Reference Regulatory Authorities mL concentrated injection vial by Fresenius
Kabi Australia Pty Ltd (TGA Approved)
Me-too status (with strength and Not confirmed
dosage form)
Remarks of the Evaluator  Me-too status not confirmed from available
database.
Decision: deferred for confirmation of generic / me too status.
Brand Name +Dosage Form + Strength IRIS 40mg/2ml Injection
Irinotecan hydrochloride trihydrate…40mg
Type of Form Form 5
As per SRO
Approval status of product in DBL IRINOTECAN irinotecan 40mg/2mL (as
Reference Regulatory Authorities hydrochloride) concentrated injection vial by Hospira
Me-too status (with strength and Irinotecan 40mg/2ml Injection Vial by Novartis (Reg.
dosage form) No. 066186)
approved by DRAP.
in Liquid Vial SVP (Oncology) section as applied product is non-cytotoxic anti- cancer
drug.
Brand Name +Dosage Form + Strength IRIS 100mg/5ml Injection
Irinotecan hydrochloride trihydrate…100mg
Type of Form Form 5
As per SRO
Approval status of product in DBL IRINOTECAN irinotecan 100mg/5mL (as
Reference Regulatory Authorities hydrochloride) concentrated injection vial by Hospira
Me-too status (with strength and Irinotecan 100mg/5ml Injection Vial by Novartis (Reg.
dosage form) No. 066187)
approved by DRAP.
in Liquid Vial SVP (Oncology) section as applied product is non-cytotoxic anti- cancer
drug.
Brand Name +Dosage Form + Strength EPITEX 10mg/5ml Injection
Epirubicin hydrochloride…10mg
Pharmacological Group Anthracycline cytotoxic antibiotics
Type of Form Form 5
As per SRO
Approval status of product in DBL EPIRUBICIN HYDROCHLORIDE INJECTION
Reference Regulatory Authorities epirubicin hydrochloride 10mg/5mL injection vial by
Hospira Australia Pty Ltd (TGA Approved)
Me-too status (with strength and Ciazil 10mg/5ml Injection Vial by Rotexmedica (Reg
Decision: Approved.
Brand Name +Dosage Form + Strength EPITEX 50mg/25ml Injection
Epirubicin hydrochloride…50mg
Pharmacological Group Anthracycline cytotoxic antibiotics
Type of Form Form 5
As per SRO
Approval status of product in DBL EPIRUBICIN HYDROCHLORIDE INJECTION
Reference Regulatory Authorities epirubicin hydrochloride 50mg/25mL injection vial by
Hospira Australia Pty Ltd (TGA Approved)
Me-too status (with strength and Ciazil 50mg/25ml Injection Vial by Rotexmedica (Reg
Decision: Approved.
Brand Name +Dosage Form + Strength RUBICIN LIPOSOM 20mg/10ml Injection
Doxorubicin hydrochloride (as pegylated Liposomal)
…20mg
Type of Form Form 5
Approval status of product in LIPOSOMAL DOXORUBICIN SUN Doxorubicin
Reference Regulatory Authorities Hydrochloride 20mg/10mL Liposome Injection
concentrate glass vial vial by Sun Pharma ANZ Pty Ltd
(TGA Approved)
Me-too status (with strength and Doxopeg 20mg Injection by Ferozsons
Decision: Approved.
Tablet (Oncology)
Brand Name +Dosage Form + Strength IRITEC 100mg Tablet
Imatinib (as mesylate)…100mg
Pharmacological Group Protein kinase inhibitor (antineoplastic agent)
Type of Form Form 5
Pack size & Demanded Price 60‟s, 180‟s/
As per SRO
Approval status of product in IMATINIB SANDOZ imatinib (as mesilate) 100mg
Reference Regulatory Authorities tablet blister pack by Novartis Pharmaceuticals
Me-too status (with strength and Glivec 100mg Tablet by Novartis (Reg. No. 033196)
dosage form)
in Tablet (Oncology) section in the light of decision of Registration Board in its 271st
Brand Name +Dosage Form + Strength IRITEC 400mg Tablet
Imatinib (as mesylate)…400mg
Pharmacological Group Protein kinase inhibitor (antineoplastic agent)
Type of Form Form 5
As per SRO
Approval status of product in IMATINIB SANDOZ imatinib (as mesilate) 400mg
Reference Regulatory Authorities tablet blister pack by Novartis Pharmaceuticals
Me-too status (with strength and Glivec 400mg Tablet by Novartis (Reg. No. 033197)
dosage form)

Brand Name +Dosage Form + Strength METOTREX 2.5mg Tablet
Composition Each Tablet Contains:
Methotrexate…2.5mg
Pharmacological Group folic acid analogue (antineoplastic agent)
Type of Form Form 5
As per SRO
Approval status of product in Maxtrex uncoated Tablets 2.5 mg by Pharmacia
Me-too status (with strength and Methotrexate 2.5mg Tablet by Phak-China
dosage form) International (Reg#066007)
approved by DRAP.
Brand Name +Dosage Form + Strength METOTREX 10mg Tablet
Composition Each Tablet Contains:
Methotrexate …..10mg
Pharmacological Group folic acid antagonist (antineoplastic agent)
Type of Form Form 5
Pack size & Demanded Price 10‟s, 100‟s & 10x5‟s/
As per SRO
Approval status of product in Maxtrex uncoated Tablets 10mg by Pfizer Limited
Me-too status (with strength and Methotrexate 2.5mg Tablet by Phak-China
dosage form) International (Reg#066009)
Remarks of the Evaluator  Brand name resembles with the product
already approved by DRAP.
Brand Name +Dosage Form + Strength ESTROX 50mg Tablet
Bicalutamide…50mg
Pharmacological Group Anti-androgen
Type of Form Form 5
Pack size & Demanded Price 10‟s, 28‟s /
As per SRO
Approval status of product in COSUDEX bicalutamide 50mg tablet film coated by
Reference Regulatory Authorities AstraZeneca Pty Ltd (TGA Approved)
Me-too status (with strength and Casodex 50mg Tablet by ICI (Reg. No. 027380)
dosage form)
Brand Name +Dosage Form + Strength ESTROX 150mg Tablet
Bicalutamide…150mg
Pharmacological Group Anti-androgen
Type of Form Form 5
Pack size & Demanded Price 10‟s, 28‟s /
As per SRO
Approval status of product in COSUDEX bicalutamide 150mg tablet blister pack by
Reference Regulatory Authorities AstraZeneca Pty Ltd (TGA Approved)
Me-too status (with strength and Geperprostin 150mg Tablet by Novartis Pharma (Reg
Brand Name +Dosage Form + Strength ERIS 100mg Tablet
Erlotinib (as hydrochloride)…100mg
Type of Form Form 5
As per SRO
Approval status of product in TARCEVA erlotinib 100mg film-coated tablet by
Reference Regulatory Authorities Roche Products Pty Ltd (TGA Approved)
Me-too status (with strength and Tarceva 100mg Tablet by Roche (Reg. No. 043002)
dosage form)
Brand Name +Dosage Form + Strength ERIS 150mg Tablet
Erlotinib (as hydrochloride)…150mg
Type of Form Form 5
As per SRO
Approval status of product in TARCEVA erlotinib 150mg film-coated tablet by
Reference Regulatory Authorities Roche Products Pty Ltd (TGA Approved)
Me-too status (with strength and Tarceva 150mg Tablet by Roche (Reg. No. 043003)
dosage form)
Brand Name +Dosage Form + Strength OVILET 2.5mg Tablet
Letrozole…2.5mg
Pharmacological Group Non Steroidal aromatase inhibitor
Type of Form Form 5
Pack size & Demanded Price 10‟s, 30‟s/
As per SRO
Approval status of product in FEMARA letrozole 2.5mg coated tablet by Novartis
Reference Regulatory Authorities Pharmaceuticals Australia Pty Ltd (TGA Approved)
Me-too status (with strength and Femara 2.5mg Tablet by Novartis (Reg. No. 021129)
dosage form)
Brand Name +Dosage Form + Strength SORANIB 200mg Tablet
Sorafenib (as tosylate)…200mg
Type of Form Form 5
Pack size & Demanded Price 60‟s, 112‟s, 120‟s/
As per SRO
Approval status of product in NEXAVAR sorafenib 200 mg (as tosilate)film coated
Reference Regulatory Authorities tablet by Bayer Australia Ltd (TGA Approved)
Me-too status (with strength and Nexvar 200mg Tablet by Bayer Health Care
Brand Name +Dosage Form + Strength TOXIFEN 10mg Tablet
Tamoxifen (as citrate)…10mg
Pharmacological Group Anti-oestrogen
Type of Form Form 5
Pack size & Demanded Price 20‟s, 30‟s, 60‟s, 2x10‟s, 3x10‟s, 6x10‟s, 10x10‟s/
As per SRO
Approval status of product in TAMOXIFEN SANDOZ tamoxifen 10mg (as citrate)
Reference Regulatory Authorities film coated tablet by Sandoz Pty Ltd (TGA Approved)
Me-too status (with strength and Tamoxifen Sandoz 10mg Tablet by Novartis Pharma
dosage form) (Reg no.047670)
Brand Name +Dosage Form + Strength TOXIFEN 20mg Tablet
Tamoxifen (as citrate)…20mg
Pharmacological Group Nonsteroidal Anti-oestrogen
Type of Form Form 5
Pack size & Demanded Price Pack of 30‟s, 3x10‟s, MRP. Rs. As per SRO
Approval status of product in TAMOXIFEN SANDOZ tamoxifen 20mg (as citrate)
Reference Regulatory Authorities film coated tablet by Sandoz Pty Ltd (TGA Approved)
Me-too status (with strength and Tamoxifen Sandoz 20mg Tablet by Novartis Pharma
dosage form) (Reg no.047671)

Brand Name +Dosage Form + Strength NASTRO 1mg Tablet
Anastrozole…1mg
Type of Form Form 5
Pack size & Demanded Price 10‟s & 30‟s/
As per SRO
Approval status of product in ANASTROZOLE FBM anastrozole 1mg film coated
Reference Regulatory Authorities tablet by Southern Cross Pharma Pty Ltd (TGA
Approved)
Me-too status (with strength and Anastrozole 1mg Tablet by Novartis (Reg. No. 066179)
dosage form)
Brand Name +Dosage Form + Strength MESTA 25mg Tablet
Exemestane…25mg
Type of Form Form 5
As per SRO
Approval status of product in Aromasin 25mg Tablet (Exemestane) by Pharmacia
Reference Regulatory Authorities And Upjohn (USFDA Approved)
Me-too status (with strength and PH&T Exemestane 25mg Tablet by M/s Mehran
dosage form) International (Reg no.078122)
Brand Name +Dosage Form + Strength CAPECIT 500mg Tablet
Capecitabine…500mg
Pharmacological Group Pyrimidine analogue
Type of Form Form 5
Approval status of product in Capecitabine Sandoz 500mg film coated tablet by
Reference Regulatory Authorities Sandoz Pty Ltd (TGA Approved)
Me-too status (with strength and Xelocel 500mg Tablet by Hakimsons (Reg. No.
dosage form) 078107)

Dry Powder Vial (Carbapenem)
Brand Name +Dosage Form + Strength DEMOPENEM 250mg Powder for Injection
Imipenem (as monohydrate)…250mg
Cilastatin (as sodium)………..250mg
Pharmacological Group Antibiotic; Carbapenem
Type of Form Form 5
As per SRO
Approval status of product in Imipenem/Cilastatin 250mg/250mg Powder for
Reference Regulatory Authorities Solution for Infusion by M/s Actavis Group PTC ehf
(MHRA Approved)
Me-too status (with strength and Cilapen 250mg Injection by Bosch (Reg. No. 048490)
dosage form)
Decision:Approved
Brand Name +Dosage Form + Strength DEMOPENEM 500mg Powder for Injection
Imipenem (as monohydrate) ………………500mg
Cilastatin (as sodium) ………………. 500mg
Type of Form Form 5
As per SRO
Approval status of product in Imipenem/Cilastatin 500 mg/500 mg, powder for
Reference Regulatory Authorities solution for infusion b M/s Fresenius Kabi Ltd (MHRA
Approved)
Me-too status (with strength and Cilapen 500mg Injection by Bosch (Reg. No. 048491)
dosage form)
Decision:Approved

Brand Name +Dosage Form + Strength Europenem 1gm Powder for Injection
Ertapenem (as sodium)…1gm
Type of Form Form 5
As per SRO
Approval status of product in Ertapenem 1g Powder for Concentrate for Solution
Reference Regulatory Authorities for Infusion by M/s Fresenius Kabi Limited (MHRA
Approved)
Me-too status (with strength and Invanz 1gm Injection by OBS (Reg. No. 043051)
dosage form)
Decision:Approved with change of brand name & with Innovators specifications.
Brand Name +Dosage Form + Strength MEROMAX 500mg Powder for Injection
Meropenem (as mixture of sodium carbonate) eq. to
Meropenem …500mg
Type of Form Form 5
As per SRO
Approval status of product in Meropenem 500 mg Powder for Solution for Injection
Reference Regulatory Authorities or Infusion by M/s Hospira UK Limited (MHRA
Approved)
Me-too status (with strength and Meronem 500mg Injection by ICI (Reg. No. 018543)
dosage form)
Brand Name +Dosage Form + Strength MEROMAX 1g Powder for Injection
Meropenem (as mixture of sodium carbonate) eq. to
Meropenem….1gm
Type of Form Form 5

As per SRO
Approval status of product in Meronem IV 1g by M/s Pfizer Limited (MHRA
Reference Regulatory Authorities Approved)
Me-too status (with strength and Meronem 1g Injection by ICI (Reg. No. 018548)
dosage form)
Case No.3. M/s. Weather Folds Pharmaceuticals, Hattar (New Section)
25th September, 2017 & 12th October, 2017 stating that the firm has been granted additional
section by Central Licensing Board in its 255th meeting for following section:
Tablet Section (Hormone)
The following applications have been evaluated and presented before the Board;
Tablet Section (Hormone)

845. Name and address of the M/s Weather Folds Pharmaceuticals
manufacturer/Applicant Plot No. 69/2, Phase-II, Industrial Area, Hattar
Brand Name +Dosage Form + Dyfogest 10mg Tablet
Strength
Dydrogesterone …10mg
Diary No. Date of R&I & Fees Dy No.14499; 11-09-2017; Rs.20,000/-
Pharmacological Group Progestogen
Finish Product Specification USP
Pack size & Demanded price As per SRO
Approval Status of product in Duphaston 10 mg film-coated tablet by M/s Mylan
Reference Regulatory Authorities Medical SAS , ANSM approved
Me – too Status Duphaston 10 mg tablet by M/s Abbott(Reg#006654)
Inspection for grant of additional sections
Decision:Deferred for further deliberation regarding cis and trans isomer.
846. Name and address of the M/s Weather Folds PharmaceuticalsPlot No. 69/2,
manufacturer/Applicant Phase-II, Industrial Area, Hattar
Brand Name +Dosage Form + Tibogen 2.5mg Tablet
Strength
Tibolone…2.5mg
Pharmacological Group Estrogen
Finish Product Specification BP
Pack size & Demanded price 3x10‟s/As per SRO
Approval Status of product in Tibelia 2.5 mg uncoated tablets by M/s Mithra
Reference Regulatory Authorities Pharmaceuticals S.A, (MHRA approved )
Me – too Status Tibol 2.5mg Tablet by M/s OBS
GMP Status 17-06-2017; Inspection for grant of additional
sections
Decision: Approved
Brand Name +Dosage Form + Dyotra 10mg/2mg Tablet
Strength
Oestradiol (as hemihydrate)…2mg
Dydrogesterone…10mg
Pharmacological Group Progestogen & Estrogen
Finish Product Specification Innovator‟s specifications
Pack size & Demanded price 28‟s/As per SRO
Approval Status of product in Femoston 2/10mg film-coated tablets by M/s Mylan
Reference Regulatory Authorities Products Ltd. (MHRA Approved)
Me – too Status Femoston 2/10mg tablets by M/s Abbott
(Reg#019420)
848. Name and address of M/s Weather Folds Pharmaceuticals
Brand Name +Dosage Form + Lynest BP 500mcg Tablet
Strength
Lynestrenol…500mcg
Pack size & Demanded price 3x10‟s/As per SRO
Approval Status of product in Exluton, 0.5 mg tablet by M/s N.V. Organon
Reference Regulatory Authorities (Netherland approved)
Me – too Status Minipyl 500mcg Tablet by M/s Zafa Karachi (Reg#
081463)
Brand Name +Dosage Form + Norcet 5mg Tablet
Strength
Norethisterone…5mg
Approval Status of product in Norethisterone 5mg Tablets by M/s Wockhardt UK
Reference Regulatory Authorities Ltd , MHRA approved
Me – too Status Primolut-N tablet by M/s Bayer Health Care
(Reg#000677)
sections
Decision: Approved
Brand Name +Dosage Form + Etges 0.02mg/0.075mg Tablet
Strength
Ethinylestradiol…0.02mg
Gestodene…0.075mg
Pharmacological Group Progestogen and estrogen
Pack size & Demanded price 21‟s/
As per SRO
Approval Status of product in Millinette 20/75 microgram coated tablets (MHRA
Me – too Status Meliane tablet by M/s Bayer (Reg#024076)

Brand Name +Dosage Form + Mesto 25mg Tablet
Strength
Mesterolone…25mg
Pharmacological Group Androgen (5-androstanon (3) derivative)
Pack size & Demanded price 2x10‟s/
As per SRO
Approval Status of product in Pro-Viron 25 Tablet by M/s Bayer plc, MHRA
Reference Regulatory Authorities approved
Me – too Status Proviron 25mg Tablet by M/s Bayer Health Care
(Reg#000697)

Brand Name +Dosage Form + Cypo-E Tablet
Strength
Cyproterone acetate…2mg
Ethinylestradiol…35mcg
Pharmacological Group Anti-androgen/ Oestrogen (Anti-Acne Preps)
Pack size & Demanded price 3x7‟s/
As per SRO
Approval Status of product in Co-cyprindiol 2000/35 Tablets by M/s Fannin (UK)
Reference Regulatory Authorities Ltd, MHRA approved
Me – too Status Eva-35 tablet by M/s Hansel (Reg#064796)
Case No.4. M/s. Welmed Pharmaceuticals Industries (Pvt.) Ltd., Lahore (New Section)
21st July, 2017 & 21st August, 2017stating that the firm has been granted additional sections
by Central Licensing Board in its 252nd meeting for following sections:
1.Oral Liquid Section
2.Cream/ ointment section
3.Sachet section
4.Dry powder suspension (General)
Sr. Section Total no. of Total no. of

No molecules products
1 Cream/ ointment section 10 13
2 Sachet section 10 12
Cream/ ointment section
853. Name and address of the M/s Welmed Pharmaceutical Industries (Pvt.) Ltd.
manufacturer/Applicant 108-R-2, Industrial Estate, Gadoon, Swabi.
Brand Name +Dosage Form + Strength Isowel 0.05% Cream
Isotretinoin …0.5mg (0.05% w/w)
Pharmacological Group Retinoid for treatment of acne
Finish Product Specification Manufacturer‟s specifications
Pack size & Demanded price 10g/
As per SRO
Approval Status of product in Isotrex 0.05% Cream by M/s GlaxoSmithKline UK
Me – too Status Accunate Cream by M/s Safe Karachi (Reg
no.070833)
Brand Name +Dosage Form + Strength Diofen 1% Cream
Composition Each gram of cream contains;
Terbinafine hydrochloride…10mg (1.0% w/w)
Pharmacological Group Antifungal for topical use
Finish Product Specification JP
Pack size & Demanded price 10 gm/
As per SRO
Approval Status of product in LAMISIL 1% w/w Cream by M/s Novartis
Reference Regulatory Authorities Consumer Health, USFDA Approved.
Me – too Status Terbiderm Cream 1% by M/s Atco Laboratories
Limited (Reg#032004)
Decision: Approved
Brand Name +Dosage Form + Strength Metagen 0.1% Cream
Mometasone furoate…1mg (0.1% w/w)
As per SRO
Approval Status of product in Elocon Cream 0.1% w/w by M/s Merck Sharp &
Reference Regulatory Authorities Dohme Limited (MHRA Approved)
Me – too Status Momevate Cream 0.1% by M/s Pearl
Pharmaceuticals (Reg no.066606)
Decision: Approved
Brand Name +Dosage Form + Strength Clobimed 0.05% Ointment
Composition Each gram of ointment contains;
Clobetasol Propionate…0.5mg (0.05% w/w)
As per SRO
Approval Status of product in ClobaDerm 0.05% w/w Cream by M/s Auden
Reference Regulatory Authorities Mckenzie (Pharma Division) Ltd (MHRA Approved)
Me – too Status Fari-Derm Ointment 0.05% by M/s Fresh
Pharmaceuticals (Reg no.080459)
Decision: Approved
Brand Name +Dosage Form + Strength Micovel-V Cream
Miconazole nitrate…20mg (2% w/w)
Pharmacological Group Imidazole and triazole derivative (Antifungal)
Pack size & Demanded price 20 gm/ As per SRO
Approval Status of product in Gyno-Daktarin 20mg/g vaginal cream by M/s
Reference Regulatory Authorities Janssen-Cilag Limited (MHRA Approved)
Me – too Status Macnaz-V Cream 2% by M/s Opal Labs (Reg
no.075803)
Decision: Approved
Brand Name +Dosage Form + Strength Fumed 2% Cream
Fusidic Acid…20mg (2% w/w)
Pharmacological Group Antibiotic for topical use
Pack size & Demanded price 20gm/
As per SRO
Approval Status of product in Fucidin 20 mg/g Cream by M/s LEO Laboratories
Me – too Status Ucid 2% Cream by M/s Ciba Pharmaceuticals (Reg
no. 081566)
Decision: Approved
Brand Name +Dosage Form + Strength Fumed –H Cream
Hydrocortisone acetate…10mg (1%w/w)
Pharmacological Group Antibiotic in combination with corticosteroid
Pack size & Demanded price 15gm /As per SRO
Approval Status of product in Fucidin H Cream by M/s LEO Laboratories Limited
Me – too Status Fosic-H Cream by M/s Metro Pharmaceuticals (Reg
no. 082039)
Brand Name +Dosage Form + Strength Fumed –B Cream
Betamethasone (as valerate)…1mg (0.1%w/w)
Pharmacological Group Antibiotic in combination with corticosteroid
Pack size & Demanded price 15gm /
As per SRO
Approval Status of product in Fusidic acid/Betamethasone 20 mg/g + 1 mg/g cream
Reference Regulatory Authorities by M/s Goapharma, (MHRA Approve)
Me – too Status Fusirum B Cream by M/s Fynk Pharmaceuticals (Reg
no. 080079)
Brand Name +Dosage Form + Strength Clicip-V 2% Cream
Clindamycin (as phosphate)…20mg (2% w/w)
As per SRO
Approval Status of product in Dalacin Cream 2%. By M/s Pfizer Limited (MHRA
Me – too Status Glucin-V Cream 2% by M/s Gulf Pharmaceuticals
(Reg no. 077948)
Decision: Approved
Brand Name +Dosage Form + Strength Micowel-T 2% Cream
Miconazole nitrate…20mg (2% w/w)
As per SRO
Approval Status of product in Daktarin 2% Cream. By M/s McNeil Products
th
Me – too Status Miazaol Cream 2% by M/s Gulf Pharmaceuticals
(Reg no. 075117)
Decision: Approved
Brand Name +Dosage Form + Strength Micowel 2% Gel
Composition Each gram of gel contains;
Miconazole …20mg (2% w/w)
As per SRO
Approval Status of product in Reference DAKTARINTM Oral Gel 20mg/gm by M/s
Regulatory Authorities Janssen-Cilag Limited (MHRA Approved)
Me – too Status Mogel 20mg/g Oral Gel by M/s Sigma Pharma
(Reg no. 079910)
Decision: Approved
Brand Name +Dosage Form + Strength Isowel-E Cream
Isotretinoin…0.5mg (0.05% w/w)
Erythromycin…20mg (2% w/w)
Pharmacological Group anti-acne preparation for topical use
Pack size & Demanded price 10gm /
As per SRO
Approval Status of product in Reference Isotrexin Gel by M/s Stiefel Laboratories Ltd.
Regulatory Authorities (MHRA Approved)
Me – too Status Not confirmed.
Remarks of Evaluator  Confirmed as gel in MHRA.
 Me-too Status of applied formulation as
cream not confirmed from available database.
 Firm has claimed USP specifications;
however, product monograph was not confirmed in
available pharmacopeias.
Decision: Deferred for clarificationof dosage form as reference product is availablel as gel
whereas firm has applied for cream.
Brand Name +Dosage Form + Strength Clicip 1% oral gel
Composition Each gram of gel contains;
Clindamycin Phosphate…10mg (1% w/w)
Pharmacological Group Antiinfective
As per SRO
Approval Status of product in Reference Not confirmed
Me – too Status Sixil 10mg/g Gel by M/s Sigma Pharma (Reg no.
079912)
Remarks of Evaluator  Evidence of applied formulation as oral gel
not confirmed from Reference Regulatory
Authorities.
 Evidence of formulation approved by
DRAP as oral gel not confirmed from available
database.
Sachet section
Brand Name +Dosage Form + Strength Movi-Col Sachet
Polyethylene Glycol 3350….13.125g
Sodium chloride……0.3507g
Sodium Bicarbonate…0.1785g
Pharmacological Group Laxative Electrolytes
Approval Status of product in Reference Movicol 13.8g sachet, powder for oral solution by
Regulatory Authorities M/s Norgine Limited (MHRA Approved)
Me – too Status Movopeg Sachet by M/s Wns field Pharmaceutical
(Reg#078594)
Decision: Approved with change of brand name & with Innovator’s specifications.
Brand Name +Dosage Form + Strength Foscim 3gm Sachet
Fosfomycin tromethamine…3gm

Approval Status of product in Reference Monurol Sachet by M/s Zambon SPA, (USFDA
Me – too Status Monurol Sachet 3gm by M/s Scharper
Pharmaceuticals (Pvt) Ltd. Lahore. (Reg#022663)
sections
Brand Name +Dosage Form + Strength Di-smeca 3gm Sachet
Dioctahedral smectite…3gm
Pharmacological Group Anti-diarrheal
As per SRO
Approval Status of product in Reference Smecta 3 g powder for oral suspension in sachet by
Regulatory Authorities M/s Ipsen Pharma (ANSM approved)
Me – too Status Diosecta 3g sachet by M/s Woodwards Pharma.
(Reg# 061111)
Brand Name +Dosage Form + Strength Strontim 2gm Sachet
Strontium ranelate…2gm
Pharmacological Group Anti-osteoporotic drug
As per SRO
Approval Status of product in Reference Strontium ranelate 2 g granules for oral suspension
Regulatory Authorities by M/s Rivopharm UK Ltd. (MHRA approved)
Me – too Status Onita 2g powder by M/s PharmEvo. (Reg# 057746)
Brand Name +Dosage Form + Strength Citrowel 4gm Sachet
Tartaric Acid…..0.215g
Sodium bicarbonate……0.429g
Citric acid…….0.176g
Sodium citrate……0.153g
Approval Status of product in ReferenceCitroSoda Granules of Adcock Ingram Limited
Me – too Status Citrovel Sachet by M/s Well & Well pharma
(Reg#070071)
Decision: Deferred for evidence of approval of applied formulation in reference
regulatory authorities/agencies.
Brand Name +Dosage Form + Strength Babywel Sachet
Sodium chloride…3.5
Trisodium citrate…2.9
Potassium chloride…1.5
Dextrose…20
Pharmacological Group Electrolytes
Finish Product Specification International pharmacopeia
Approval Status of product in Reference WHO Approved standard ORS formulation
Me – too Status P-Dart (ORS) Sachet by M/s Pride Pharma (Reg
no. 039335)
Decision: Approved
Brand Name +Dosage Form + Strength Ozimed Plus 40mg Sachet
Pharmacological Group Proton pump inhibitor/ Antacid.
Approval Status of product in Reference Zegerid Sachet 40mg/1680mg powders by M/s
Me – too Status RULING+ 40mg/1680mg powders by M/s High-Q.
(Reg#070633)
sections

Decision: Approved
Brand Name +Dosage Form + Strength Ozimed 20mg Sachet
Pharmacological Group Proton pump Inhibitor, antacid
As per SRO
Approval Status of product in Reference Zegerid Sachet 20mg/1680mg powders by M/s
Me – too Status RULING+ 20mg/1680mg powders by M/s High-Q.
(Reg#070634)
Decision: Approved
Brand Name +Dosage Form + Strength Esowel Plus 40mg Sachet
As per SRO
Approval Status of product in Reference Nexium 40mg packet by M/s AstraZeneca (USFDA
Me – too Status Somezol 40mg Sachet by M/s Bosch (Reg#081612)
Remarks of Evaluator Source of pellets M/s Visison Pharma
Brand Name +Dosage Form + Strength Esowel 20mg Sachet
As per SRO

Approval Status of product in ReferenceNexium 20mg packet by M/s AstraZeneca (USFDA
Me – too Status Somezol 20mg Sachet by M/s Bosch (Reg#081611)
Remarks of Evaluator Source of pellets M/s Visison Pharma

Brand Name +Dosage Form + Strength Meb-hus Sachet
Mebeverine hydrochloride…135mg.
Ispaghula husk...3.5g.
Pharmacological Group Antispasmodic, laxative
As per SRO
Approval Status of product in Fybogel Mebeverine effervescent granules by M/s
Reference Regulatory Authorities Reckitt Benckiser Healthcare (UK) Ltd. (MHRA
approved)
Me – too Status Colospas Fibro 135mg/3.5g powder by M/s
Nabiqasim. (Reg# 058672)
Brand Name +Dosage Form + Strength Montimed 4mg Sachet
Montelukast sodium…4mg.
Pharmacological Group Leukotriene receptor antagonist.
As per SRO
Approval Status of product in Singulair Paediatric 4 Mg Granules by M/s Merck
Reference Regulatory Authorities Sharp & Dohme Ltd.(MHRA approved)
Me – too Status Singulair 4mg powder by M/s OBS (Reg# 031377)
Decision: Approved

Evaluator PEC-VIII
Case No. 5 M/s MKB Pharmaceuticals (Pvt) Ltd. 66–Hayatabad Industrial Estate,
Peshawar.
Following registration dossiers have been received vide letter No. F.16-4/2013 (Reg-IV)
dated 15th August 2017 stating that Dry Powder Suspension(cephalosporin) and capsule
(cephalosporin) of M/s MKB Pharmaceuticals were approved vide Secretary Licensing
Board‟s letter # F.3-8/2006-Lic dated 21st June 2017
Sr. No Section No. of No. of

products molecules
1 Dry suspension(cephalosporin) 12 05
2 Capsule(cephalosporin) 07 04
Capsule (cephalosporin):
Products: 07, Molecules: 04
878. Name and address of manufacturer / M/s MKB Pharmaceuticals (Pvt) Ltd.
Applicant 66 – Hayatabad Industrial Estate, Peshawar, KPK.
Brand Name +Dosage Form + Strength CEFAPRIM Capsules 250 mg
Diary No. Date of R& I & fee Dy No.11460;09-08-2017; Rs.20,000/-
Cefaclor (as monohydrate) …..250 mg
Pharmacological Group 2nd Generation Cephalosporin
Type of Form Form 5
Approval status of product in Keftid 250 mg of Strides Pharma, UK (MHRA)
Me-too status Efaclor capsules 250mg of legacy Pharma
GMP status Inspection report dated 30-03-2017; the panel
recommends the additional sections Cephalosporin
Capsule & Cephalosporin Dry powder suspension.
Decision:Approved
Brand Name +Dosage Form + Strength CEFAPRIM Capsules 500 mg
Cefaclor (as monohydrate) …..500 mg
Type of Form Form 5
Approval status of product in Keftid 500 mg of Strides Pharma, UK (MHRA)
Me-too status Efaclor capsules 500mg of legacy Pharma
Decision:Approved

Brand Name +Dosage Form + Strength PURACEF Capsules 250 mg
Cefadroxil (as monohydrate) ----- 250 mg
Pharmacological Group 1st Generation Cephalosporin
Type of Form Form 5
Approval status of product in DURICEF 250 mg Capsules
Reference Regulatory Authorities. WARNER CHILCOTT, USA.
NDA # 050512(USFDA Approved Drug.)
Me-too status ULTROXIL 250 mg Capsules of Schazoo
Pharmaceuticals Laboratories (Pvt) Ltd.Reg. No
069411
Remarks of the Evaluator.  Evidence of approval status of product in
reference agencies is required as the provided
evidence is of Cefadroxil as hemihydrate.
Decision: deferred for clarification regarding discontinuation of 250mg capsule by
USFDA.
Brand Name +Dosage Form + Strength PURACEF Capsules 500 mg
Cefadroxil (as monohydrate) …..500 mg
Type of Form Form 5
Approval status of product in Cefadroxil 500 mg of Sandoz Ltd. UK (MHRA)
Me-too status Roxif capsules 500mg of legacy Pharma
Decision:Approved
Brand Name +Dosage Form + Strength CEFITEC Capsules 400 mg
Cefixime(as trihydrate) ...400 mg
Pharmacological Group 3rd Generation Cephalosporin
Type of Form Form 5
Finished Product Specification JP Specs
Pack size & Demanded Price 5‟s ;As per SRO
Approval status of product in Suprax 400 mg of Lupin Ltd. USA (USFDA)
Me-too status Obpan 400mg capsules of Obsonspharma
Brand Name +Dosage Form + Strength CEFADIN Capsules 250 mg
Cephradine …..250 mg
Type of Form Form 5
Pack size & Demanded Price 10‟s & 12‟s ; As per SRO
Me-too status Legaceph 250mg capsules of Legacy Pharma
Decision:Approved
Brand Name +Dosage Form + Strength CEFADIN Capsules 500 mg
Cephradine ----- 500 mg
Type of Form Form 5
Pack size & Demanded Price 10‟s & 12‟s ; As per SRO
Me-too status Legaceph 500mg capsules of Legacy Pharma
Decision: Approved
Dry suspension(cephalosporin)
11 products/5 molecules
Brand Name +Dosage Form + Strength CEFAPRIM Dry Suspension 50 mg / mL
Composition Each mL reconstituted suspension contains:
Cefaclor(as monohydrate)-------- 50 mg
Type of Form Form 5
Pack size & Demanded Price 15mL; As per SRO
Approval status of product in Cefaclor Oral Suspension 250 mg / 5 mL
Reference Regulatory Authorities. YUNG SHIN PHARM , USA
NDA # 065412(USFDA Approved Drug.)
Me-too status CEFALOR 50mg / ml Drops 15 mL

th
(Reg # 034368)Bosch pharmaceuticals (Pvt) Ltd.
Trinkle drops 50mg/ml of Wilshire Pharma.
Decision: Approved
Brand Name +Dosage Form + Strength CEFAPRIM Dry Suspension 125 mg / 5 mL
Composition Each 5mL reconstituted suspension contains:
Cefaclor(as monohydrate)---- 125 mg
Type of Form Form 5
Pack size & Demanded Price 60 mL; As per SRO
Me-too status Riclor Suspension 125mg / 5mL of Nenza
Pharmaceuticals
Decision: Approved
Brand Name +Dosage Form + Strength CEFAPRIM Dry Suspension 250 mg / 5 mL
Cefaclor(as monohydrate)--------- 250 mg
Type of Form Form 5
Pack size & Demanded Price 60 mL ; As per SRO
Me-too status Riclor Suspension 250mg / 5mL of Nenza
Pharmaceuticals
Remarks of the Evaluator. In MHRA primary packaging material is Type III
glass bottle while firm is using HDPE bottle.
Decision: Approved
Brand Name +Dosage Form + Strength PURACEF Dry Suspension 100 mg / mL
Composition Each mL reconstituted suspension contains:
Cefadroxil(as monohydrate)------ 100 mg
Type of Form Form 5
Reference Regulatory Authorities. CEFADROXIL 500 mg / 5 ml - ORACEFAL 500 mg
/ 5 ml, powder for oral suspension.
Me-too status DROMAX 100 mg / mL dry suspension drops
(Reg # 039441)
Bosch pharmaceuticals (Pvt) Ltd.
Decision: Approved
Brand Name +Dosage Form + Strength PURACEF Dry Suspension 125 mg / 5 mL
Cefadroxil (as monohydrate))--------- 125 mg
Type of Form Form 5
Me-too status Baxef 125mg/5ml powder for suspension of Baxter
Pharma

Decision: Approved
Brand Name +Dosage Form + Strength PURACEF Dry Suspension 250 mg / 5 mL
Cefadroxil (as monohydrate))----------- 250 mg
Type of Form Form 5
Approval status of product in Approved in MHRA (as granules for oral suspension)
Reference Regulatory Authorities. Approved in ANSM (as powder for oral suspension)
CEFADROXIL 250 mg / 5 ml - ORACEFAL 250 mg
/ 5 ml, powder for oral suspension
Me-too status Oxibac250 mg/5ml dry suspension of UDL Karachi
Decision: Approved
Brand Name +Dosage Form + Strength CEFITEC Dry Suspension 100 mg / 5 mL
Composition Each 5 mL reconstituted suspension contains:
Cefixime(as trihydrate)----------- 100 mg
Type of Form Form 5
Pack size & Demanded Price 30mL & 60 mL ; As per SRO
Approval status of product in Cefixime 100 mg/5 ml Powder for Oral Suspension
Me-too status Stlicef dry suspension 100mg/5ml by M/s Treat
Pharma (Reg#073247)
Decision: Approved
Brand Name +Dosage Form + Strength CEFITEC Dry Suspension 200 mg / 5 mL
Composition Each 5 mL reconstituted suspension contains:
Cefixime(as trihydrate)-------- 200 mg
Type of Form Form 5
Approval status of product in Cefixime for oral suspension 200mg/5ml (USFDA
Reference Regulatory Authorities. approved)
(Reg#054770)
Decision: Approved
Brand Name +Dosage Form + Strength CEFPODOX Dry Suspension 40 mg / 5 mL
Cefpodoxime(as proxetil)---------- 40 mg
Type of Form Form 5
Me-too status Xipodox 40mg /5mL Oral Suspension(Reg. No.
078766), Vega Pharmaceuticals, Lahore
Capsule &Cephalosporin Dry powder suspension.
Decision: Approved
Brand Name +Dosage Form + Strength CEFADIN Dry Suspension 125 mg / 5 mL
Cephradine -------------- 125 mg
Type of Form Form 5
Approval status of product in Not verified.
Me-too status CEFRINEX 125mg/5ml dry suspension (Reg #
015125)
Bosch pharmaceuticals (Pvt) Ltd.
Remarks of the Evaluator.  Evidence of approval status of applied
formulation in applied strength is required.
Brand Name +Dosage Form + Strength CEFADIN Dry Suspension 250 mg / 5 mL
Cephradine----------- 250 mg
Type of Form Form 5
Decision: Approved

Case No. 6 M/s. Farm Aid Group, Plot No. 3/2, Phase I & II, Hattar Industrial Estate,
Haripur.
Following registration dossiers have been received vide letter No. F.16-4/2013 (Reg-IV) dated
28th July 2017 stating that and capsule (general) of M/s Farm Aid Group were approved vide
Secretary Licensing Board‟s letter # F.3-9/91-Lic-(Vol-I) dated 21st June 2017.
Sr. No Section No. of No. of

products molecules
1 Capsule(General) 22 10
896. Name and address of manufacturer / M/s. Farm Aid Group, Plot No. 3/2, Phase I & II, Hattar
Applicant Industrial Estate, Haripur.
Brand Name +Dosage Form + Strength Tamosin0.4mg Capsule
Tamsulosin HCl (as SR Pellets 0.2%)……. 0.4mg
(USP Specs)
Diary No. Date of R& I & fee DiaryNo:10065; 26-07-2017, 20,000/-
Pharmacological Group Anti- benign prostatic hyperplasia (BPH)
Type of Form Form-5
Pack size & Demanded Price 10‟s, 20‟s, 30‟s;As Per SRO
Approval status of product in Reference Approved in MHRA
Me-too status M-Sol 0.4mg cap of M/s Regal Parma
GMP status The Panel Inspection conducted on 20-03-2017
recommended the grant of additional section of
Capsule General Section and renewal of DML-
formulation.
Remarks of the Evaluator. COA and GMP of pellet's manufacturer and stability
studies both real time and accelerated of three batches
of pellets conducted in accordance with zone IV-A
conditions.
Decision:Deferred for submission of source of pellets, along with stability studies data, GMP
certificate of supplier and differential fee in case of import of pellets
Brand Name +Dosage Form + Strength Pregofarm 50mg Capsule
Pregabalin …………………. 50mg
Pharmacological Group Analgesic and Anticonvulsant:
An analogue of the neurotransmitter Gamma Amino
Butyric Acid (GABA)
Type of Form Form-5
Pack size & Demanded Price 10‟s, 14‟s;As Per SRO
Me-too status Regab of Caraway pharmaceuticals
GMP status On recommendation of panel of experts, The CLB in
its 253rd meeting held on May 15-16th , 2017 has
considered and approved the grant of following two
additional sections to M/s. Farm Aid group:
 Dry Penicillin Powder section(vet)
 Capsule Section(general)
Remarks of the Evaluator. Firm has claimed manufacturer specifications but has
Pregabalin ……………. 75mg
Pharmacological Group Analgesic and Anticonvulsant
Butyric Acid (GABA)
Type of Form Form-5
Pregabalin…………. 100mg
Butyric Acid (GABA)
Type of Form Form-5
Remarks of the Evaluator.  Firm has claimed manufacturer specifications but has
267th meeting & the applied formulation does not
exist in available USP & B.P.
Pregabalin ……………. 150mg
Butyric Acid (GABA)
Type of Form Form-5
Pack size & Demanded Price 2×7‟s;As Per SRO
its 253rd meeting held on May 15th-16th , 2017 has
Pregabalin …………. 300mg
Butyric Acid (GABA)
Type of Form Form-5
Me-too status Gabica capsules 300mg of Getz Pharma


Brand Name +Dosage Form + Strength Tramol 50mg Capsule
Tramadol HCl………..50mg
Pharmacological Group Centrally acting synthetic opioid analgesic
Type of Form Form-5
Pack size & Demanded Price 3‟s, 10‟s, 20‟s, 30‟s, 50‟s; As Per SRO
Approval status of product in Reference Approved in USFDA
Me-too status Trauma-Nil 50mg Capsule of Global Pharma

Remarks of the Evaluator. Firm has claimed Innovator‟s specifications& the

applied formulation is present in available B.P.
Decision: Approved with BP specification

Brand Name +Dosage Form + Strength Tramol 100mg Capsule
Tramadol HCl………..100mg
Pharmacological Group Centrally acting synthetic opioid analgesic
Type of Form Form-5
Pack size & Demanded Price 10‟s, 20‟s, 30‟s ; As Per SRO
Approval status of product in Reference Not provided
Me-too status Not provided
Remarks of the Evaluator.  Evidence of Me Too of applied formulation.
 Evidence of approval status of applied
 It is present in reference agencies as SR cap
Brand Name +Dosage Form + Strength Diclofarm 50mg Capsule
Composition Each Hard Gelatin Capsule Contains:
Diclofenac Sodium (as SR Pellets) ……………. 50mg
Pharmacological Group Non-steroidalanti-inflammatory drug (NSAID) with
analgesic, antipyretic and anti-inflammatory activity.
Type of Form Form-5
Finished Product Specification As per Innovator‟s Specifications
Approval status of product in Reference Not provided.
Regulatory Authorities. Not found in usfda, mhra and ansm.
Me-too status Lotofenac 50mg SR capsules of Lotus
pharmaceuticals(drug infosis)


Brand Name +Dosage Form + Strength Diclofarm 100mg Capsule
Diclofenac Sodium (as SR Pellets)………. 100mg
Pharmacological Group Non-steroidalanti-inflammatory drug (NSAID) with
analgesic, antipyretic and anti-inflammatory activity.
Type of Form Form-5
Finished Product Specification As per Innovator‟s Specifications
Approval status of product in Reference Rhumalgan XL 100 mg modified-release capsules
Regulatory Authorities. approved by MHRA of UK
Me-too status Durum 100mg SR capsules of M/s Pride
Pharmaceutricals (Reg.0.39543)
 Justification on scientific basis for addition of
3% overage in master formulation.
 Mistake in stability studies in dissolution test.
Decision: Deferred for calrification of following observation:
COA of Diclofenac sodium pellets state time limit of 8 hrs in dissolution test for buffer stage
whereas in stability data sheet time limit of 7 hrs is mentioned for the same test.
Brand Name +Dosage Form + Strength Esofag 20mg Capsule
Esomeprazole (as magnesium trihydrate) …. 20 mg
Pharmacological Group Anti-Ulcerant
Type of Form Form-5
Pack size & Demanded Price 10‟s, 20‟s, 14‟s, 15‟s, 28‟s 56‟s, 100‟s ;14‟s/ Rs:168.0
Me-too status Esoral 20 mg Capsule of City Pharma Karachi.
(Reg#070588)

907. Name and address of manufacturer / M/s. Farm Aid Group, Plot No. 3/2, Phase I & II,
Applicant Hattar Industrial Estate, Haripur.
Brand Name +Dosage Form + Strength Esofag 40mg Capsule
Esomeprazole (as magnesium trihydrate) …. 40 mg
Pharmacological Group Anti-Ulcerant
Type of Form Form-5
Pack size & Demanded Price 10‟s, 20‟s, 14‟s, 15‟s, 100‟s ;14‟s/ Rs:320.0
Me-too status Esoral 40 mg Capsule by City Pharma Karachi.
(Reg#070589)

Brand Name +Dosage Form + Strength Falko 50mg Capsule
Fluconazole………..50mg
Diary No. Date of R& I & fee DiaryNo:10070; 26-07-2017; 20,000/-
Type of Form Form-5
Finished Product Specification As per innovator‟s Specification
Pack size & Demanded Price 1‟s, 6‟s, 7‟s, 10‟s; As Per SRO
Me-too status Fiscon capsule 50mg of Fassgen

Type of Form Form-5
Finished Product Specification As per Innovator‟s specifications.
Pack size & Demanded Price 1‟s, 2‟s, 4‟s, 10‟s; As Per SRO
Me-too status Fiscon 150mg capsule of Fassgen
Remarks of the Evaluator.  Firm has claimed Innovator‟s specifications &
the applied formulation is available in B.P.
Type of Form Form-5
Pack size & Demanded Price 1×4‟s; As Per SRO
Me-too status Diflucan 200mg capsule of Pfizer Laboratories(drug
infosis)
Remarks of the Evaluator.  Firm has claimed Innovator‟s specifications &
the applied formulation is available in B.P.
Brand Name +Dosage Form + Strength Apitant 40mg Capsule
Aprepitant……………. 40mg
Type of Form Form-5
Pack size & Demanded Price 2‟s ;As Per SRO
Approval status of product in Reference Approved in US-FDA
Me-too status Apreon 40mg Capsule of Ferozsons Laboratories
Remarks of the Evaluator.  Applied formulation is present in USP
Decision: Approved with USP specification
Type of Form Form-5
Remarks of the Evaluator.  Applied formulation is present in USP.
Type of Form Form-5
Remarks of the Evaluator.  Applied formulation is present in USP.
Brand Name +Dosage Form + Strength Zirow Capsule 250mg
Azithromycin (as dihydrate)………..250mg
(USP Specs)
Type of Form Form-5
Pack size & Demanded Price 3‟s, 6‟s, 10‟s, 12‟s ;As Per SRO
Me-too status Azofas of Fassgen Pharmaceuticals
Brand Name +Dosage Form + Strength Faprazole 20mg Capsule
Omeprazole…. 20 mg
Type of Form Form-5
Pack size & Demanded Price 10‟s, 14‟s, 20‟s, 28‟s, 30‟s, and 100‟s ;14‟s/ Rs:224.0
Regulatory Authorities. (Losec Capsule 20mg by Astra Zaneca UK Ltd.)
Me-too status Aksozole Capsule 20mg of Akson Pharmaceuticals
Reg. # (023733)
Decision: Approved
Brand Name +Dosage Form + Strength Faprazole 40mg Capsule

Omeprazole…. 40 mg
Type of Form Form-5
Pack size & Demanded Price 10‟s, 14‟s, 20‟s, 100‟s;14‟s/ Rs:320.0
Regulatory Authorities. (Losec Capsule 40mg by Astra Zaneca UK Ltd.)
Me-too status Osprey Capsule 40mg of M/s Linta Pharmaceuticals
Reg. # (081881)

Decision: Approved
Brand Name +Dosage Form + Strength FLUXPINE 6/25mg CAPSULE
Composition Each Capsule contains;
Olanzapine……………...6mg
Fluoxetine(as HCl)…....25mg
Pharmacological Group AtypicalantipsychoticSelective Serotonin Reuptake
Inhibitor
Type of Form Form-5
Finished Product Specification USP specifications.
Pack size & Demanded Price 14‟s;As Per SRO
Me-too status Co-depricap capsule of Nabiqasim industries
Remarks of Evaluator.
Decision: Approved

c) Remaining Products
Evaluator PEC-XII
Case No.1.M/s Demont Research Laboratories (Pvt) Ltd, Lahore. (Remaining products)
Following registration dossiers have been received vide letter No. F.8-6/2013 (Reg-V) dated 18th
August, 2017 stating that
The CLB in its 248th meeting the grant of DML by way of formulation with following four sections:
Sections (04)
1. Tablet Section (General)
2. Capsule Section (General)
3. Dry Suspension (General)
4. Sachet Section (General)
Sr. no Section No. of products/ Balance

molecules already
approved
1 Sachet Section 8 2
(General)
The following applications have been evaluated and presented before the Board:
Sachet Section (General)
2 products/ 1molecule
918. Name and address of manufacturer / M/s Demont Research Laboratories (Pvt) Ltd,
Applicant 20-km, Lahore-Shariqpur Road, Shikhupura.
Brand Name +Dosage Form + Strength Omnic Plus Sachet 40mg/1680mg
Diary No. Date of R& I & fee Diary No: 8937, 17/07/2017, Rs. 20,000/-
Type of Form Form-5
Pack size & Demanded Price 30 sachets/ As per SRO.
Regulatory Authorities. SANTARUS INC (USFDA approved)
Me-too status RULING+ 40mg/1680mg powders by M/s High-
Q. (Reg#070633)
GMP status 25-05-2016; Good Compliance; New DML
Remarks of the Evaluator.  Inspection report is older than 1 year.
Decision: Deferred for submission of latest GMP inspection report conducted within a
period of last 1 year by DRAP
919. Name and address of manufacturer / M/s Demont Research Laboratories (Pvt) Ltd,
Applicant 20-km, Lahore-Shariqpur Road, Shikhupura.
Brand Name +Dosage Form + Strength Omnic Plus Sachet 20mg/1680mg
Type of Form Form-5
Pack size & Demanded Price 30 sachets/ As per SRO.
Regulatory Authorities. SANTARUS INC (USFDA approved)
Me-too status RULING+ 20mg/1680mg powders by M/s High-
Q. (Reg#070634)
Good Compliance.
New DML
Remarks of the Evaluator.  Inspection report is older than 1 year.
Decision:Deferred for submission of latest GMP inspection report conducted within a
period of last 1 year by DRAP
Case. No.2. M/s. MTI Medical (Pvt) Ltd. ( Remaining products)
Files received vide letter No. F.8-6/2013-Reg-V, Dated 10th August, 2017 and 16th August , 2017, stating
following details:
Section Tablet (General) was granted by CLB on 23rd September,2014
Section Products considered Balance Applied product

by RB
Tablet Section (General) 09 (M-246) 1 1
New Section Lyophilized Vials Injectable (General) was granted on 11th April, 2017 by CLB.
Section Applied Already Total no. of

molecules considered molecules
molecules
Lyophilized Vials Injectable 4 3 7
(General)
Lyophilized Vials Injectable (General)

920. Name and address of manufacturer / M/s. MTI Medical (Pvt) Ltd.586-587 Sundar Industrial
Brand Name+Dosage Form + Strength Tycon 200mg Lyophilized Injection
Composition Each lyophilized Vial contains:
Teicoplanin…200mg
Pharmacological Group Glycopeptide Antibiotic
Type of Form Form-5
Pack size & Demanded Price 1‟s Vial /
As per SRO
Approval status of product in Targocid 200mg powder for solution for
Reference Regulatory Authorities. injection/infusion or oral solution by M/s Aventis
Pharma Limited (MHRA Approved)
Me-too status Planin 200mg Injection by M/s S.J &G. Fazul Ellahie
(Reg# 055188)
GMP status 22-11-16
Grant of new section
Grant of Additional section Recommended
Remarks of the Evaluator.  Approved in MHRA with warning: This medicinal
product is subject to additional monitoring.

921. Name and address of manufacturer / M/s. MTI Medical (Pvt) Ltd.
Applicant 586-587 Sundar Industrial Estate, Lahore.
Brand Name+Dosage Form + Strength Tycon 400mg Lyophilized Injection
Teicoplanin…400mg
Pharmacological Group Glycopeptide Antibiotic
Type of Form Form-5
Pack size & Demanded Price 1‟s Vial / As per SRO
Approval status of product in Targocid 400mg powder for solution for
Reference Regulatory Authorities. injection/infusion or oral solution by M/s Aventis
Pharma Limited (MHRA Approved)
Me-too status Teicon Injection 400mg by M/s Al Habib
Pharmacueticals (Reg# 069536)
GMP status 22-11-16; Grant of new section
Remarks of the Evaluator.  Approved in MHRA with warning: This medicinal
product is subject to additional monitoring.
Brand Name+Dosage Form + Strength Esto 40mg Lyophilized Injection
Esomeprazole (as sodium)…40mg
Type of Form Form-5
Approval status of product in Esomeprazole 40 mg powder for solution for infusion
Reference Regulatory Authorities. or injection by M/s IBIGEN S. r. l. (MHRA approved)
Me-too status Esasia 40mg injection by M/s Med Asia
Pharmaceuticals (Pvt) Ltd (Reg# 080977)
Remarks of the Evaluator. -
Brand Name+Dosage Form + Strength Panto 40mg Lyophilized Injection
Pantoprazole (as sodium)…40mg
Type of Form Form-5
Approval status of product in Pantoprazole 40mg Powder for Solution for Injection
Reference Regulatory Authorities. or Infusion. By M/s TEVA UK Limited (MHRA
Approved)
Me-too status Pazole Dry Powder Injection IV 40mg by M/s Fynk

Brand Name+Dosage Form + Strength Vindop 500mg Lyophilized Injection
Daptomycin…500mg
Pharmacological Group Cyclic lipopeptide antibiotic
Type of Form Form-5
Approval status of product in Daptomycin 500 mg powder for solution for
Reference Regulatory Authorities. injection/infusion by M/s Medichem, S.A. (MHRA
Approved)
Me-too status -
Remarks of the Evaluator.  Applied formulation was approved by RB in its
257th meeting but registration number is not
confirmed from available database.
Decision: Deferred for confirmation of generic / me-too status.

1 product
Brand Name+Dosage Form + Strength Aminose Tablet
Histidine …………….…45 mg
Isoleucine……….………60 mg
Leucine……………….…90 mg
Lysine (as acetate)………65 mg
Methionine…………..….90 mg
Phenyl alanine…………..70 mg
Threonine……………….65 mg
Tryptophan….....……..…25 mg
Tyrosine……………....…75 mg
Valine……………...…….135mg
Pharmacological Group Essential amino acids
Type of Form Form-5
Approval status of product in Aminess N film-coated tablets by M/s Meda AB
Reference Regulatory Authorities. (Sweden approved)
Me-too status Not confirmed
database.

Case No.3. M/s. Novamed Pharmaceuticals (Pvt.) Ltd., Lahore (Remaining Products)
Following registration dossiers have been received vide letter No. F.8-6/2013 Reg-V dated
24th July, 2017stating that the firm has been granted additional sections by Central Licensing
Board in its 252nd meeting for following sections:
1. Cream/ ointment/ gel (General)
2. Eye Drops (General)
3. Tulle Dressing
Sr. Section Total no. of Total no. of Balance of
No molecules already products molecules
considered by RB
1 Eye Drops (General) 5 (M-270) 5 (M-270) 05
Eye Drops (General)
926. Name and address of the M/s Novamed Pharmaceuticals (Pvt.) Ltd.
manufacturer/Applicant 28-km, Ferozepur Road, Lahore.
Brand Name +Dosage Form + Strength Travost Eye drops
Travoprost ….. 40mcg
Diary No. Date of R&I & Fees Dy No. 8934; 17-07-2017; Rs.20,000/- (17-7-2017)
Pack size & Demanded price 1 x 2.5ml/
As per SRO
Approval Status of product in Bondulc 40micrograms/ml Eye Drops, Solution by
Reference Regulatory Authorities M/s Actavis UK Ltd (MHRA approved)
Me – too Status Travop ophthalmic solution of M/s M/s Alza
Pharmaceuticals, Rawalpindi (Reg.#081621)
Decision: Approved
Brand Name +Dosage Form + Strength Opdine Eye drops
Olopatadine (as hydrochloride) ….. 1mg
Diary No. Date of R&I & Fees Dy No. 8931; 17-07-2017; Rs.20,000/- (17-07-
2017)
Pack size & Demanded price 1 x 5ml/
As per SRO
Approval Status of product in Patanol ophthalmic solution 0.1 % by M/s Alcon
Reference Regulatory Authorities Laboratories, Inc (USFDA Approved)
Me – too Status Patlerg ophthalmic solution 0.1% by M/s
Medicaids. (Reg.#061089)

Decision: Approved
Brand Name +Dosage Form + Strength Gentil Eye drops
Carboxy methyl cellulose ….. 2.5mg
Hypermellose …. 3mg
2017)
Pharmacological Group Ocular Lubricant
Finish Product Specification
As per SRO
Approval Status of product in Genteal eye drops by M/s Alcon (USA)
Reference Regulatory Authorities (Not same as applied formulation).
Me – too Status Genteal eye drops by M/s Alcon
(Not same as applied formulation).
Remarks of Evaluator  Approval Status of product in Reference
 Me – too Status not confirmed.
regulatory authorities/agenciesand generic / me-too status.
Brand Name +Dosage Form + Strength Opoflox Eye drops
Moxifloxacin (as hydrochloride) ……0.5%
2017)
Pharmacological Group Flouroquinolones
As per SRO
Approval Status of product in Moxivig 0.5%w/v eye drops, solution by M/s
Reference Regulatory Authorities Novartis Pharmaceuticals UK Limited. (MHRA
Approved)
Me – too Status Opmox Eye Drops, Moxifloxacin 5mg/ml by M/s
Opth-Pharma Karachi. (Reg#058367)
Brand Name +Dosage Form + Strength Nefnac Eye drops
Nepafenac ……0.1%
2017)
Pack size & Demanded price 1 x 5ml; As per SRO
Approval Status of product in NEVANAC ophthalmic suspension 1 mg/ml by
Reference Regulatory Authorities M/s Novartis Pharmaceuticals. (USFDA Approved)
Me – too Status Neplo ophthalmic solution by M/s Alza
Pharmaceuticals, Rawalpindi (Reg#081620)
Decision: Approved with change of brand name & with Innovator’s specifications.
Case No.4. M/s. Pharma Lord (Pvt.) Ltd, Layyah ( Remaining Products)
Following registration dossiers have been received vide letter No. F.8-6/2013-(R-V) dated 8th August,
2017 stating that the firm has been granted approval of new section on 21st February, 2013 by Central
Licensing Board for following sections
 Capsule Section (General)
 Oral Dry Powder Suspension section (General)
Sr. Approved Sections Approved Newly submitted Balance

No products products
1 Capsule Section (General) 4 (M-237) 6 0
2 Oral Dry Powder Suspension 4 (M-237) 6 0
section (General)

6 products
931. Name and address of manufacturer / M/s. Pharma Lord (Pvt.) Ltd
Applicant 12-km, Lahore Road, Layyah.
Brand Name +Dosage Form + Strength Piro 20mg Capsule
Piroxicam…20mg
Type of Form Form-5
Pack size & Demanded Price 1x10‟s, 2x10‟s, 10x10‟s/
As per SRO.
Approval status of product in Reference Feldene 20mg Capsules by M/s Pfizer Limited,
Me-too status Jucam Capsule 20mg by M/s Juniper Pharma
(Reg#081940)
Firm is GMP compliant.
Decision: Deferred for clarification and details of already approved/deferred applications
since grant of approval of “Capsule Section (General)”
Brand Name +Dosage Form + Strength Feramax 150mg Capsule

Iron Polysaccharide complex…150mg.
Pharmacological Group Iron Supplement/Hematinic.
Type of Form Form-5
Pack size & Demanded Price 1x10‟s, 3x10‟s, 10x10‟s/ As per SRO.
Approval status of product in Reference IFEREX 150 - polysaccharide-iron complex capsule
Regulatory Authorities. by M/s Nnodum Pharmaceuticals (DailyMED)
Me-too status Ferricure 150mg Capsule by M/s Continental
Brand Name +Dosage Form + Strength Azin 250mg Capsule
Azithromycin (as dihydrate).....250mg
Pharmacological Group Macrolide/Antibiotic.
Type of Form Form 5
As per SRO.
Approval status of product in Reference Zithromax 250mg capsule by M/s Pfizer Ltd.(MHRA
Pharmaceuticals. (Reg#022200)
Brand Name +Dosage Form + Strength Fcon 150mg Capsule
Fluconazole.....150mg
Pharmacological Group Anti-Fungal
Type of Form Form 5
Pack size & Demanded Price 1‟s, 1x10‟s, 10x10‟s/
As per SRO.
Approval status of product in Reference Diflucan 150 mg capsule by M/s Pfizer, MHRA
Regulatory Authorities. Approved
Me-too status Diflucan 150 mg capsule by M/s Pfizer (Reg#011828)


Brand Name +Dosage Form + Strength Flutin 20mg Capsule
Fluoxetine as hydrochloride…20mg
Pharmacological Group Antidepressant ( SSRI)
Type of Form Form-5
As per SRO.
Approval status of product in Reference Prozac 20mg capsule by M/s Eli Lilly And Co,
Regulatory Authorities. USFDA approved
Me-too status Depex 20mg capsule by M/s Merck (Reg#020245)
Brand Name +Dosage Form + Strength Duetin 30mg Capsule
Pharmacological Group Heterocyclic antidepressants (serotonin–
norepinephrine reuptake inhibitors (SNRI).)
Type of Form Form 5
Pack size & Demanded Price 1x10‟s, 3x10‟s, 10x10‟s/ As per SRO.
Approval status of product in Reference Cymbalta (Duloxetine 30 mg capsule) by M/s Eli
Regulatory Authorities. Lilly, USFDA
Pharma.(Reg#055447)
Remarks of the Evaluator. Source of Pellets: Vision Pharmaceuticals, Islamabad.
Oral Dry Powder Suspension section (General)
6 products
Brand Name +Dosage Form + Strength Azin 200mg/5ml Dry Powder Suspension
Azithromycin (as dihydrate)…200mg
Type of Form Form 5

Pack size & Demanded Price 15 ml /
As per SRO
Approval status of product in Reference Zithromax Powder for Oral Suspension 200mg/5ml by
Regulatory Authorities. M/s Pfizer Limited, MHRA approved.
Me-too status Azomax Dry Suspension by M/s Novartis
(Reg#022201)
since grant of approval of “ Oral Dry Powder Suspension section (General)”
Brand Name +Dosage Form + Strength Fcon 50mg/5ml Dry Powder Suspension
Fluconazole…50mg
Type of Form Form 5
As per SRO
Approval status of product in Reference Diflucan 10 mg/ml powder for oral suspension by M/s
Regulatory Authorities. Pfizer Limited, MHRA approved.
Me-too status Derocon Dry Suspension50mg/5ml by M/s Raazee
(Reg#027219)
Brand Name +Dosage Form + Strength Nitz 100mg/5ml Dry Powder Suspension
Nitazoxanide…100mg
Type of Form Form 5
As per SRO
Approval status of product in Reference Alinia powder for Suspension 100mg/5ml by M/s
Regulatory Authorities. Romark Pharma Inc., (USFDA Approved)
Me-too status Izato Dry Suspension 100 mg/ 5ml Sami

Brand Name +Dosage Form + Strength Fine 40mg/5ml Dry Powder Suspension
Famotidine…40mg
Pharmacological Group Histamine H2-antagonists
Type of Form Form 5
As per SRO
Approval status of product in Reference Pepcid for oral suspension 40mg/5ml by M/s Salix
Regulatory Authorities. Pharma, USFDA
Me-too status Zepcin Dry Suspension by M/s Cirin Pharmaceuticals
(Reg#064330)
Brand Name +Dosage Form + Strength Clar 250mg/5ml Dry Powder Suspension
Composition Each 5ml of suspension contains:
Clarithromycin (as EC taste masked granules
27.5%)…250mg
Type of Form Form 5
As per SRO
Approval status of product in Reference Biaxin granules for oral suspension 250mg/5ml by M/s
Regulatory Authorities. Abbvie, USFDA approved.
Me-too status Claritek Dry Suspension 250mg/5ml by M/s Getz
Pharma (Reg#061347)
Remarks of the Evaluator.  Source of granules:
Surge Laboratories (Pvt.) Ltd,
10-km Faisalabad Road, Bikhi District,
Sheikhupura.
Brand Name +Dosage Form + Strength Clar 125mg/5ml Dry Powder Suspension
Clarithromycin (as EC taste masked granules
27.5%)…125mg

Type of Form Form 5
As per SRO
Approval status of product in Reference Biaxin granules for oral suspension 125mg/5ml by M/s
Regulatory Authorities. Abbvie, USFDA approved.
Me-too status Claritek Dry Suspension 125mg/5ml by M/s Getz
Pharma (Reg#009846)
Remarks of the Evaluator.  Source of granules:
Surge Laboratories (Pvt.) Ltd,
10-km Faisalabad Road, Bikhi District,
Sheikhupura.
Case No.5. M/s. Seraph Pharmaceuticals, Islamabad( Remaining product)
Following registration dossiers have been received vide letter No. F.6-2/2016 (R-III) dated 23rd
August, 2017.
Sections No. of products No. of molecules Total products Total molecules

freshly freshly submitted per section after per section after
submitted by the by the firm adding fresh adding fresh
firm application(s) application(s)
Dry powder for oral 01 01 09 05
suspension
(Cephalosporin)
Dry powder for oral suspension (Cephalosporin)

1 product/ 1molecule
943. Name and address of manufacturer / M/s Seraph Pharmaceutical Plot No. 210, Industrial
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form +Strength Serdoxime DS 40mg/5ml Dry suspension
Cefpodoxime (as proxetil)…40mg
Type of Form Form 5
Pack size & Demanded Price 50ml / As per SRO
Approval status of product in Reference Cefpodoxime Proxetil 40 mg/5 ml Powder for Oral
Regulatory Authorities. Suspension by M/s Sandoz GMBH, MHRA approved
Me-too status Apodox 40mg/5ml Dry Suspension by M/s Alliance
(Reg#054697)
GMP status New License (Inspection Date: 8th May 2017)
Decision: Approved

Case No.6. M/s. Titlis Pharma, Lahore( Remaining product)
Following registration dossier has been received vide letter No. F.8-6/2013 (R-V) dated 8th
August, 2017.
Approved No of products already considered by Newly Submitted product

Section RB
Capsule 5 approved (M-245) 1
(General) 1 Deferred (M-245)
Capsule (General Section)
2 product
944. Name and address of manufacturer / M/s. Titlis Pharma
Applicant 528-A, Sundar Indusrial Estate, Raiwind Road, Lahore.
Brand Name +Dosage Form + Strength Tamsulis 0.4mg Capsule
Tamsulosin hydrochloride sustained release pellets
(0.2%) eq. to Tamsulosin hydrochloride…0.4 mg.
Pharmacological Group α1-Adrenergic blocking agent
Type of Form Form 5
Pack size & Demanded Price 2x10‟s /
As per SRO
Approval status of product in Flomax 0.4mg capsule by M/s Boehringer Ingelheim
Reference Regulatory Authorities. Pharmaceuticals (USFDAApproved)
Me-too status Tamflo 0.4mg SR Capsule by M/s Genome
Pharmaceutical (Reg#074562)
GMP was compliant on the day of inspection
Remarks of the Evaluator.  Source of pellets: Precise Chemipharma Pvt Ltd,
India.
Gut No. 215/1 & 215/2, Khatwad Phata at Post
Talegaon, Taluka Dindori, Nashik 422202,
Maharashtra State.
 Certificate of GMP of pellet source valid till
22-01-19
 Proof of approval of pellets from Relevant
Regulatory Authority is provided.
 Real time stability data: 12 months
Accelerated stability data: 6 months
Decision: Approved

Case No.7. M/s. Well & well Pharma (Pvt) Ltd, Islamabad( Remaining product)
The Central licencing Board in its 254th meeting has granted approval of following additional
sections to M/s Well & well Pharma (Pvt) Ltd, Islamabad.
1. Dry powder for oral suspension (Cephalosporin)
2. Capsule (Cephalosporin)
Following registration dossiers have been received vide letter No. F.6-2/2016 (R-III) dated 20th
July, 2017.
The current status of products/ molecules per section is as under:
Sr. no Sections No. of products No. of molecules

already sent to PEC already sent to PEC
1 Dry powder for oral 02 01
suspension (Cephalosporin)
2 Capsule (Cephalosporin) 02 01
Dry powder for oral suspension (Cephalosporin)
945. Name and address of manufacturer / M/s Well & well Pharma (Pvt) Ltd
Applicant Plot No. 7, Street no. S-8, RCCI, Rawat, Rawalpindi.
Brand Name +Dosage Form + Strength Cefzime 200mg/5ml Dry suspension
Type of Form Form 5
Pack size & Demanded Price 30ml / Rs.250/-
Approval status of product in Cefixime for oral suspension 200mg/5ml by M/s
Reference Regulatory Authorities. Aurobindo Pharma (USFDA approved)
(Reg#054770)
GMP status 8th May 2017
Brand Name +Dosage Form + Strength Cefzime 100mg/5ml Dry suspension
Type of Form Form 5
Pack size & Demanded Price 30ml / Rs.180/-
Approval status of product in Cefixime 100 mg/5 ml Powder for Oral Suspension by
Reference Regulatory Authorities. M/s Generics [UK] Ltd t/a Mylan (MHRA Approved)
(Reg#073247)
GMP status 8thMay 2017
Capsule (Cephalosporin)

2 products/ 1 molecule
Brand Name +Dosage Form + Strength Cefzime 400mg Capsule
Cefixime (as trihydrate).....400mg
Type of Form Form 5
Rs.325/-
Approval status of product in Suprax 400 mg capsules by Lupin Pharma (USFDA
Me-too status Cefiget Capsule 400 mg by Getz Pharma (Reg#045118)
Brand Name +Dosage Form + Strength Cefzime 200mg Capsule
Cefixime (as trihydrate).....200mg
Type of Form Form 5
Rs.300/-
Approval status of product in Not confirmed
Me-too status Soxime Capsule 200 mg by Swat Pharmaceuticals
(Reg#060127)
Remarks of the Evaluator.  Approval status of applied formulation in reference
regulatory authorities could not be verified.

Case No.8.M/s WinBrains Research Laboratories, Hattar. (Remaining products)
Following registration dossiers have been received vide letter No. F.16-4/2013 (Reg-IV) dated
15th August, 2017 stating thatCentral Licensing Board in its 252nd meeting held on 15th March
2017, granted approval of four new sections to M/s WinBrains Research Laboratories, Hattar
1.Eye Drop (General)

2.Liquid Injection (General)
3.Dry powder Injection (General)
3.Cream/Ointmen/Gel (General)

Sr. no Section No. of products/ Deferred products/ Balance Applied
molecules already molecules products/
approved molecules
1 Liquid Injection 5 {M-270) Nil 2 1
(General) 3 {M-271)
Liquid Injection (General)

949. Name and address of manufacturer / M/s WinBrains Research Laboratories,
Applicant Plot # 69/1, Phase I-II, Industrial Estate, Hattar.
Brand Name +Dosage Form + Strength Bin-D3 Injection 1ml
Cholecalciferol…5mg (200,000 I.U)
Pharmacological Group Vitamin D analogue (Vitamin D3)
Type of Form Form-5
Pack size & Demanded Price 1ml x 1‟s, 1ml x 5‟s /
As per SRO
Approval status of product in VITAMIN D3 GOOD 200,000 IU / 1 ml IM solution for
Reference Regulatory Authorities. injection by M/s Bouchara-Recordati, ANSM France
approved
Me-too status D-Tres 5mg/ml Injection by M/s Sami (Reg#076115)
GMP status Panel Inspection conducted on 03-02-2017 recommends
renewal of DML and grant of four additional sections.
Decision:
Approved with innovator’s specification

Case. No.9. M/s. Tayyab Laboratories, Islamabad (Remaining products)
Following registration dossiers have been received vide letter No. F.6-2/2016 (Reg-III) dated
24th August, 2017 stating thatCLB has granted in its 249th meeting DML by way of formulation
for following sections:
1. Tablet (General) Section.
2. Tablet (Psychotropic) Section.
3. Capsule (General) Section.
4. Oral Liquid (General) Section.
APPROVED APPROVED DEFFERED TOTAL

SECTIONS (Products / Molecules) (Products+ Molecules) (MOLECULES)
Tablet (Psychotropic) 7-P/ 4-M (M-263)
2-P/ 2-M (M-270) 06
Section. 1-P (M-267)
Now firm has applied for following products detailed as under

Tablet (Psychotropic) Section
950. Name and address of manufacturer / M/s. Tayyab Laboratories (Pvt) Ltd.
Applicant Plot # 13-A, Street i # N-5, RCCI Rawat, Islamabad.
Brand Name +Dosage Form + Strength Clonze 0.5mg Tablet
Clonazepam…0.5mg
Pharmacological Group Benzodiazepine derivative
Type of Form Form-5

As per SRO
Approval status of product in Reference Rivotril 0.5mg Tablets by M/s Roche Farma, S.A
Me-too status Clonazep 2 mg Tablet by M/s Roryan Pharmaceutical
Industries (Pvt) Ltd (Reg#078588)
GMP status Routine GMP inspection.
Last GMP inspection: 23-10-2017
Good GMP compliance
Decision:Approved
Brand Name +Dosage Form + Strength Clonze 2mg Tablet
Clonazepam…2mg
Pharmacological Group Benzodiazepine derivative
Type of Form Form-5
Pack size & Demanded Price 10‟s, 30‟s, 50‟s/As per SRO
Approval status of product in Reference Rivotril 2mg Tablets by M/s Roche Farma, S.A
Me-too status Clonazep 2 mg Tablet by M/s Roryan Pharmaceutical
Industries (Pvt) Ltd (Reg#078589)
Good GMP compliance
Decision:Approved
Brand Name +Dosage Form + Strength Zolim 10mg Tablet
Zolpidem tartrate…10mg
Pharmacological Group Benzodiazepine related drugs
Type of Form Form-5
Pack size & Demanded Price 14‟s, 20‟s/As per SRO
Approval status of product in Reference Zolpidem 10 mg Film-Coated Tablets by M/s Generics
Regulatory Authorities. [UK] Limited t/a Mylan (MHRA Approved)
Me-too status Somnia 10mg Tablets by M/s Wilshire Laboratories
(Pvt) Ltd (Reg#067737)
Good GMP compliance
Decision:Approved
d) Deferred Cases
Evaluator PEC-XII
953. Name and address of manufacturer / M/s. MTI Medical (Pvt) Ltd.586-587 Sundar Industrial
Brand Name +Dosage Form + Strength Sulproz Injection 2gm
Sulbactum (as sodium) ….. 1gm
Cefoperazone (as sodium) …1gm
Type of Form Form 5
Pack size & Demanded Price 1„s Vial with WFI 2x5ml / As per SRO
Approval status of product in Bfarm Injection 2gm,Germany ( not confirmed)
Me-too status Cebac Injection 2gm by M/s Bosch (Reg#037631)
GMP status Inspection report conducted on 22-11-16 grant of
Additional section Recommended grant of New
Section Dry Powder Injectable (Cephalosporin) and
Lyophilized Vials Injectable (General)
Previous remarks of the Evaluator. Firm has claimed USP specifications but the product is
not found in available pharmacopeias (BP 2013 & USP
39- NF 34)
 Approval status of product in Reference
 Source of WFI (Medistil 5ml) by M/s Medisave
evidence of approval of applied formulation in reference
regulatory authorities.
Evaluation by PEC  Applied formulation has been approved by 3 EMA
member countries i.e. Poland, Slovakia,Czech
Republic.
Decision: Approved
954. Name and address of manufacturer / M/s Astellas Pharmaceutical (Pvt) Ltd.
Applicant Industrial Estate, Hayatabad, Peshawar.
Brand Name +Dosage Form + Strength Moxilox 400mg tablet
Moxifloxacin (as hydrochloride)…....400mg
Type of Form Form 5
Approval status of product in Avelox 400 mg film-coated tablets by M/s Bayer plc,
Reference Regulatory Authorities. (MHRA approved)
Me-too status Metoxim 400mg Tablet by M/s Foray Pharmaceutical
(Reg No:056083)
GMP status Last inspection conducted on 31-03-17 recommended
grant of additional sections including Tablet (general)
section.
Previous remarks of the Evaluator.  Firm has not specified whether tablet is plain or
coated.
 Use of methylene chloride in formulation.
Previous decision Deferred in 272nd meeting of Registration Board for
confirmation whether applied formulation is plain or
coated and use of banned excipient in formulation.
Evaluation by PEC Firm has submitted master formulation for film coated
tablet excluding methylene chloride
Decision of 275th meeting:Approved with Innovator’s specifications
Brand Name +Dosage Form + Strength Tlagyl 30mg Tablet

Phenobarbitone…30mg
Pharmacological Group Barbiturate
Type of Form Form-5
Finished product Specification USP Specs
Pack size & Demanded Price As per SRO / 30‟s, 60‟s, 100‟s
Approval status of product in PHENOBARBITAL ACTAVIS TABLETS BP 30mg
Reference Regulatory Authorities. by Actavis UK Limited, (MHRA)
Me-too status Debritone 30mg by M/s. Xenon Pharma, Lahore.
Good GMP compliance
Previous remarks of the Evaluator.  Tlagyl 30mg Suspension mentioned on Fee challan
instead of Tablet.
 STO stamp is available.
submission of fee for applied product.
Evaluation by PEC  Firm has submitted Rs 20,000 stating Tlagyl 30mg
Tablet .
Decision of 275th meeting:Approved with change of brand name

Brand Name +Dosage Form + Strength Mudom 7.5mg Tablet
Midazolam…7.5mg
Pharmacological Group Benzodiazepine
Type of Form Form-5
Approval status of product in Hypnovel Tablet by M/s Roche Produts, New
Reference Regulatory Authorities. Zealand.
Me-too status Dormicum Tablet by M/s. Roche Pharma, Karachi.
Good GMP compliance
Previous remarks of the Evaluator.  Mudom 7.5mg Suspension mentioned on Fee
challan instead of Tablet.
 International availability for 7.5mg Tablets was
not confirmed.
Previous decision Deferred in 270th meeting of Registration Board for for
submission of fee for applied product and
confirmation of approval status in reference
regulstaory authorities.
Evaluation by PEC  Firm has submitted Rs 20,000 stating Mudom 7.5
mg Tablet.
 Inspection report is older than 1 year.
 International availability for 7.5mg Tablets was
not confirmed.
Decision of 275th meeting:Approved with innovator’s specification
Evaluator PEC-III
957. Name and address of manufacturer / M/s Seraph Pharmaceutical Plot No. 210, Industrial
Applicant Triangle, Kahuta Road, Islamabad
Brand Name +Dosage Form + Serbica 20mg capsule
Strength
Diary No. Date of R& I & fee 08-06-2017 / Dy No. 5155 / Rs.20,000/-
Isotretinoin…....20mg
Pharmacological Group AntiAcne
Type of Form Form 5
Pack size & Demanded Price 30‟s, 20‟s, 10‟s, 5‟s / As per SRO
Approval status of product in Absorica 20mg capsule by Ranbaxy Laboratories Inc.
Me-too status Atractin by Genome
GMP status New License (Inspection Date: 8th May 2017)
Decision of previous meeting Deferred for confirmation of manufacturing
process/facility for applied formulation/dosage form
as decided by Registration Board for this product(M-
271)

Evaluation by PEC Firm has submitted that as per the decision of 249th
meeting of RB isotretinoin can be formulated as hard
gelatin capsule. Isotretinoin is highly prone to
oxidation and contains narrow dissolution profile
that‟s why their formulation is according to the
innovator reference product i.e. Absorbica capsule
USFDA, to avoid the risk of incompatibility via
selecting innovator excipient and ehnancement of
dissolution via addition of emulsifiers and to
overcome the oxidation via adding suitable
antioxidants.
They have further submitted that they have facility of
semi automatic capsule filling machine with the help
of which capsule shells can be conveniently opened
and filled manually. The filling and mixing process
will be carried out under nitrogen purged
environment to protect materila from environemnt.
Firm has further submitted master formulation, and
method of manufacturing.
Decision:Deferred for clarification of submitted manufacturing method for applied
formulation particularly how nitrogen purging will be carried out during manufacturing
of hard gelatin capsules and justification in light of decision of 250th meeting.
958. Name and address of manufacturer / M/S Walt Danzay Pharmaceuticals, Plot No 35-A,
Applicant Small Industrial Estate, Taxila, Pakistan
Brand Name +Dosage Form + Pridwalt 50 mg tablet
Strength
Diary No. Date of R& I & fee Dy No: 1402 (3-05-2017 )PKR 20,000/- : 03-05-
2017
Itopride as hydrochloride ………………50mg
Pharmacological Group Gastroprokinetic
Type of Form Form-5
Finished product Specifications -
Pack size & Demanded Price 10‟s: As Per SRO
Approval status of product in (PMDA JAPAN Approved)
Me-too status Ganaton tablet by Abbott
GMP status Inspection report dated 15-02-2017, the panel
recommended the grant of drug manufacturing
license
Remarks of the Evaluator Firm has claimed in house specifications without
providing data as per requirement of 267th RB
meeting
 The formulation applied is of uncoated tablet while
the reference product is available as film coated
Decision of previous meeting Deferred for clarification of dosage form since the
reference product is available as film coated tablet.
(M-271)
Evaluation by PEC Firm has submitted master formulation and method
of manufacturing for film coated tablets.
Brand Name +Dosage Form + PAROZE 12.5 mg Tablet
Strength
Diary No. Date of R& I & fee Dy No: 1411 (03-05-2017)PKR 20,000/- : 03-05-
2017

Composition Each enteric, film coated controlled release tablet
contains:
Paroxetine as hydrochloride ………..12.5 mg
Type of Form Form-5
Pack size & Demanded Price 1 x 10‟s, 3 x 10‟s : As Per SRO
Approval status of product in Paxil CR by Apotex Technologies
Reference Regulatory Authorities (USFDA Approved) but as controlled release
Me-too status SEROXAT CR by GSK but as controlled release
license
Remarks of the Evaluator  Firm has applied for simple film coated tablets while
the formulation is available as controlled release
tablets in USFDA
product approved by the reference regulatory
authority is as enteric film coated controlled release
tablet. (M-271)
Evaluation by PEC Firm has provided master formulation for enteric,
film coated controlled release tablet.
Decision:Approved
Brand Name +Dosage Form + WALTOP 40 mg Tablet
Strength
2017
Composition Each eneteric coated tablet contains:
Pantoprazole (as sodium sesquihydrate)….40mg
Type of Form Form-5
Approval status of product in Pantoprazole tablets by Rakeda
Me-too status APTIZOLE by Global Pharma
license
Remarks of the Evaluator Firm has claimed in house specifications while the
 Internationally available as enteric coated tablets
while the firm has applied for film coated tablet
product approved in reference regulatory authorities
is as enteric coated tablet. (M-271)
Evaluation by PEC Firm has provided formulation and method of
manufacturing of enteric coated tablet
Decision:Approved with USP specification
961. Name and address of manufacturer / M/s Walt Danzay Pharmaceuticals, Plot No 35-A,
Brand Name +Dosage Form + Walgestron 10mg Tablet
Strength
Diary No. Date of R& I & fee Dy No:1397 (03-05-2017) PKR 20,000/- : 03-05-
2017
Dydrogesterone … ……………..10 mg
Pharmacological Group Progestogens
Type of Form Form-5
Finished product Specifications USP Specification
Pack size & Demanded Price As Per SRO
Approval status of product in Duphaston by BGP Products
Reference Regulatory Authorities (Swissmedic Approved)
Me-too status Duphaston by Abbott
license
Remarks of the Evaluator Clarification regarding cis or trans isomer is required.
Decision of previous meeting Registration Board deferred all the applications
applied for Tablet (Hormone) section for clarification
from the firm whether it specifies/retains the section
for steroidal preparations or for non-steroidal
preparations. Registration Board Further deferred this
application for clarification of formulation whether it
contains “cis” or “trans” isomer. (M-271)
Evaluation by PEC  Firm has stated that they want to specify the tablet
hormone section for steroidal hormonal
preparations
 Firm has stated that they will use “Cis” isomer of
Dydrogesterone
Brand Name +Dosage Form + Walgesdiol Tablet
Strength
Diary No. Date of R& I & fee Dy No: 1393 : 03-05-2017
PKR 20,000/- : 03-05-2017
Dydrogesterone … ……………..10mg
Estradiol valerate………….. 2mg
Pharmacological Group Progestogen and synthetic steroid
Type of Form Form-5
Approval status of product in Femoston by BGP products
Reference Regulatory Authorities (MHRA approved)
Me-too status Femoston by Abbott
license
Remarks of the Evaluator i. Clarification regarding cis or trans isomer is
required.
ii. Firm has claimed USP specifications while the
formulation is not present in BP and USP
iii. Firm has applied for estradiol valerate tablets
while internationally the salt is available as
estradiol as hemihydrate
preparations. Registration Board further deferred this

case for following clarifications:
 Whether applied formulation contains “cis” or
“trans” isomer.
 Product approved in reference regulatory
authorities as “estradiol as hemihydrate” while
the applied product is “Estradiol valerate”
 Submission of finished product specification.
(M-271)
preparations
 Firm has stated that they will use “Cis” isomer of
Dydrogesterone
 Firm has submitted that they will use “estradiol as
hemihydrate” instead of “estradiol valerate”
 The Firm has submitted finished product
specification claiming in house specification
Brand Name +Dosage Form + WALSTONE 5mg Tablet
Strength
PKR 20,000/- : 03-05-2017
Norethindrone………………….…..5 mg
Pharmacological Group Progestin
Type of Form Form-5
Approval status of product in Aygestin by Duramed Pharmaceuticals, Inc
Reference Regulatory Authorities (USFDA Approved) available as acetate
Me-too status Noregyn by Zafa
license
formulation is present in USP
 Firm has applied for film coated tablet, while
internationally available as uncoated tablet
 Firm has applied for norethindrone base while the
USFDA approved formulation contains
norethindrone acetate
case for clarification of formulation since the product
approved in reference regulatory authorities is
“norethindrone acetate” uncoated tablet while applied
formulation is without salt and as film coated tablet.
(M-271)
preparations
 Firm has submitted revised formulation of uncoated
tablet with norethindrone acetate
Decision: Registration Board deliberated that applied formulation is steroidal hormone
whereas CLB has approved section as "TabletHormone" only. Thus the Board deferred
products and advised to get approval from Licensing Division for Steroidal hormone
tablets for further processing by Registration Board
Brand Name +Dosage Form + Walstone 3mg Tablet
Strength
PKR 20,000/- : 03-05-2017
Composition Each vaginal tablet contains:
Dinoprostone ……………..3mg
Pharmacological Group Naturally occurring prostaglandin E2 (PGE2)
Type of Form Form 5
Pack size & Demanded Price 1 ×4‟s: As Per SRO
Me-too status Gynaid by Wilson
license
providing documents required as per 267th RB
meeting
confirmed
 Firm has applied the same brand name for
norethindrone tablets as well
case for evidence of approval in reference regulatory
authorities. (M-271)
preparations
 Firm has provided reference of Prostin E2 tablets
Vaginal tablet by Pfizer (MHRA Approved)
Decision:Deferred for clarification as applied product is steroid and section is hormone.
Brand Name +Dosage Form + ETHIDROS Tablet
Strength
PKR 20,000/- : 11-05-2017
Ethinyl estradiol …………0.02 mg
Drospirenone ……….…..3.00mg
Pharmacological Group Hormonal contraceptive
Type of Form Form 5
Pack size & Demanded Price 1×`28‟s
As Per SRO
Yaz tablets by Bayer
Me-too status Yaz tablets by Bayer
license
Remarks of the Evaluator Firm has claimed in house specification while the
formulation is present in USP
preparations.(M-271)
preparations

Brand Name +Dosage Form + ETHITERONE Tablet
Strength
Diary No. Date of R& I & fee Dy No: 2366 (11-5-20172017)PKR 20,000/-11-5-
2017
Ethinyl estradiol …………0.035 mg
Cyproterone acetate ……..2.00mg
Type of Form Form-5
Approval status of product in Alisma tablets by Gynial
Reference Regulatory Authorities (Austria Approved)
Me-too status Diane-35 by Bayer
license
meeting
 EMA has issued an assessment report along with
final decision of European commission after serious
adverse reactions i.e. thromboembolism was
reported by ANSM france. According to the final
decision various changes in SmPC were made
including changes in
o clinical indications: 1. for moderate to severe
acne only after topical and systemic antibiotic
therapy has been failed 2. It should not be used
with other hormonal contraceptives
o Posology
o Contraindications
o Adverse reactions
o Patient information leaflet etc.
preparations. (M-271)
preparations
Brand Name +Dosage Form + WALTEROLON 25mg tablet
Strength
PKR 20,000/- : 11-05-2017
Mesterolone ……….…25mg
Pharmacological Group Androgen

Type of Form Form 5
Pack size & Demanded Price 1×`10‟s; 3×`10‟s/ As Per SRO
Approval status of product in Proviron by Bayer
Me-too status Proviron by Bayer
license
meeting
preparations. (M-271)
preparations
Brand Name +Dosage Form + WALPAUSE 2.5mg tablet
Strength
PKR 20,000/- : 11-05-2017
Tibolone ……….…2.5mg
Pharmacological Group Other estrogens
Type of Form Form-5
Approval status of product in Livial 2.5mg tablets by MSD
Me-too status Tibopause by Zafa
license
Remarks of the Evaluator  Firm has applied for film coated tablet, while the
formulation is available as uncoated tablet in MHRA
preparations. Registration Board further deferred the
case for clarification of formulation since the
reference product is available as uncoated tablet
while the applied product is film coated tablet. (M-
271)
preparations
 Firm has submitted revised formulation for
uncoated tablet
Brand Name +Dosage Form + Waltdul Capsule 30 mg
Strength
Diary No. Date of R& I & fee Dy No: 1396 (3-5-2017)PKR 20,000/- : 03-05-2017
(17.5%) equivalent to Duloxetine……………30mg
Pharmacological Group Selective Serotonin Reuptake Inhibitor (SSRI)
Type of Form Form 5
Pack size & Demanded Price 14‟s/ As Per SRO
Approval status of product in Cymbalta by Lilly
Me-too status Dulan by Hilton Pharma
license
 Firm has not provided source, GMP, COA and
stability data of pellets
 Source of pellets
 GMP of manufacturer of pellets
 Certificate of analysis of pellets
 Real time and accelerated stability study data
of 3 batches of pellets
 Differential fee (if pellets are imported)
 Submission of same brand name for all
strengths (M-271)
Evaluation by PEC Firm has submitted COA, GMP certificate and
stability study data of 3 batches of 17% pellets of
M/s Vision Pharmaceuticals Islamabad
Firm has not submitted same brand name for both
strengths
Decision: Registration Board deferred for clarification as submitted source of pellets is
not of USP grade.
Brand Name +Dosage Form + DULAXWALT 60 mg Capsule
Strength
2017
Composition Each capsule contains
(22.5%) equivalent to Duloxetine……………60mg
Pharmacological Group Selective Serotonin Reuptake Inhibitor (SSRI)
Type of Form Form-5
Pack size & Demanded Price 1 x 10‟s: As Per SRO
Approval status of product in Cymbalta by Lilly
Me-too status Dulan by Hilton Pharma
license
Firm has not provided source, GMP, COA and
stability data of pellets
Firm has applied for different brand name for 30mg
strength of same drug
 Source of pellets
 GMP of manufacturer of pellets
 Certificate of analysis of pellets
 Real time and accelerated stability study data
of 3 batches of pellets
 Differential fee (if pellets are imported)
 Submission of same brand name for all
strengths (M-271)
Evaluation by PEC Firm has submitted COA, GMP certificate and
stability study data of 3 batches of 17% pellets of
M/s Vision Pharmaceuticals Islamabad
Firm has not submitted same brand name for both
strengths
Decision: Registration Board deferred for clarification as submitted source of pellets is
not of USP grade.
Brand Name +Dosage Form + Ometa 0.1% Cream
Strength
PKR 20,000/- : 03-05-2017
Composition Each tube contains:
Mometasone ……….0.1% (1 mg/gm)
Type of Form Form-5
Pack size & Demanded Price 5g, 15g: As Per SRO
Approval status of product in ELOCON by MSD
Me-too status MOMEVATE by Pearle
license
Remarks of the Evaluator  Firm has applied for mometasone base while the
reference product approved by FDA contains
mometasone furoate salt.
Decision of previous meeting Deferred for change in brand name and clarification
of formulation since the product approved in
reference regulatory authority as mometasone furoate
instead of base. (M-271)
Evaluation by PEC  Firm has provided master formulation for
mometasone furoate 0.1% w/w cream
 Firm has not provided same brand name for all
strengths
Decision: Approved with change of Brand name
Brand Name +Dosage Form + Dexawal Eye Drops
Strength
PKR 20,000/- : 03-05-2017
Composition Each ml of solution contains:
Dextran 70…….... 0.1% (1mg/g)
Hydroxypropyl methyl cellulose…….. 0.3%
(0.3mg/g)
Pharmacological Group Artificial tears
Type of Form Form-5
Pack size & Demanded Price 15ml: As Per SRO
Me-too status TEARS NATURAL II by Novartis Pharma
license
Remarks of the Evaluator Firm has claimed in house specification without
providing documents as per 267th RB meeting
 The master formulation provided is of tobramycin
and it does not specify whether the formulation
applied is solution or suspension
 Evidence of approval status in reference
regulatory authorities
 Clarification of formulation whether it is
ophthalmic solution or suspension. (M-271)
 Evidence of Tears Naturale of Novartis
Pharmaceuticals (MHRA Approved)
 Firm has submitted that the applied formulation is
ophthalmic solution
Decision: Approved withinnovator’s specifications.
Brand Name +Dosage Form + BETA-WALT 0.1 % Eye Drops. (solution)
Strength
PKR 20,000/- : 22-05-2017
Composition Each drop tainer dispenser contains:
Betamethasone sodium phosphate…….0.1%
(1mg/ml)
Pharmacological Group Glucocorticoid
Type of Form Form-5
Pack size & Demanded Price 7.5ml
As Per SRO
Me-too status Betnesol Drops by GSK
license
confirmed
 The master formulation provided is of
ciprofloxacin and it does not specify whether the
applied formulation is solution or suspension.
 Evidence of approval status of applied formulation
in reference regulatory authorities
ophthalmic solution or suspension. (M-271)
 Evidence of Vistamethasone drops by
Martindale Pharma (MHRA Approved)
 Firm has submitted that the applied
formulation is sterile ophthalmic solution
 Finished product specification is present in
BP.
Decision: Approved with BP specifications
Brand Name +Dosage Form + CIPRO-DEX Eye Drops
Strength
PKR 20,000/- : 22-05-2017
Composition Each Drop Tainer Dispenser Contains:
Ciprofloxacin as hydrochloride….. 0.3%
Dexamethasone……….. 0.1%
Pharmacological Group Quinolone Antibiotic and Corticosteroid
Type of Form Form-5
Pack size & Demanded Price 7.5ml per pack / As Per SRO
Approval status of product in CIPRODEX by Novartis
Me-too status Metadex by Optx Pharma
license
Firm has provided formulation of ophthalmic
solution while the FDA approved product is available
as ophthalmic suspension
Decision of previous meeting Deferred for following:
ophthalmic solution or suspension.
 Clarification of drop tainer dispenser. (M-271)
Evaluation by PEC Firm has submitted that the applied formulation is
ophthalmic suspension, the previously submitted
formulation was ophthalmic solution and the firm
has not submitted fee for change in formulation.
Firm has submitted that drop tainer dispenser is
potentially compatible with dispensed formulations
containing benzalkonium chloride and other
excipients. The composition of drop tainer dispenser
is
o Low density polyethylene bottle
o Dropper nozzle
o Tamper evident high density polyethylene cap
Decision:Deferred for submission of fee of Rs. 20,000/- for change of formulation.
Brand Name +Dosage Form + TOP-PRED Eye Drops
Strength
PKR 20,000/- : 22-05-2017
Loteprednol etabonate……….. 0.5 %
Tobramycin………… 0.3 %
Pharmacological Group Corticosteroid and aminoglycoside antibiotic
Type of Form Form-5
Pack size & Demanded Price 5ml × 1‟s
As Per SRO
Approval status of product in ZYLET by bausch & lomb
Me-too status LOTEPRED-T by Sante
license
Firm has provided formulation of ophthalmic
solution while the FDA approved product is
available as ophthalmic suspension
is
o Dropper nozzle
Brand Name +Dosage Form + TOP-DEX Eye Drops
Strength
PKR 20,000/- : 26-05-2017
Dexamethasone………… 0.1%
Tobramycin ………………0.3%
Pharmacological Group Corticosteroids and Aminoglycoside antibiotic
Type of Form Form-5
Pack size & Demanded Price 1 ×`1‟s(5 ml Drop Tainer Dispenser)
As Per SRO
Approval status of product in TOBRADEX by Novartis
Me-too status TOBRADEX by Novartis
license
 Firm has provided formulation of ophthalmic
solution while the FDA approved product is
available as ophthalmic suspension
is
o Dropper nozzle
Brand Name +Dosage Form + PIROSUN 20 mg Injection
Strength
Diary No. Date of R& I & fee Dy. 1436 : 03-05-2017PKR 20,000/- : 03-05-2017
Composition Each 1ml Injection Contains
Piroxicam ……….20 mg
Pharmacological Group Oxicam- NSAID
Type of Form Form-5
Pack size & Demanded Price 1ml: As Per SRO
Approval status of product in Feldene Injection by Pfizer
Reference Regulatory Authorities (ANSM France Approved)
Me-too status Pirowrd Injection by Welwrd pharma
license
 Method of manufacturing do not specify the
method of sterilization, filtration or aseptic filling
Decision of previous meeting Deferred for clarification of method of sterilization.
(M-271)
Evaluation by PEC Firm has submitted complete method of
manufacturing including autoclave as method of
sterilization.
Brand Name +Dosage Form + WALTAMIN 500 mcg Injection
Strength
PKR 20,000/- : 03-05-2017
Composition Each ml Contains
Mecobalamin…………… 500mcg
Pharmacological Group Coenzyme-type vitamin B12
Type of Form Form 5
Pack size & Demanded Price 1ml x 10‟s: As Per SRO
Approval status of product in (PMDA Japan Approved)
Me-too status Anacobin Injection by EPharm
license
 Method of manufacturing do not specify the method
of sterilization, filtration or aseptic filling
(M-271)
sterilization.
Brand Name +Dosage Form + Rolac 30 mg/ ml Injection
Strength
PKR 20,000/- : 03-05-2017
Composition Each Injection contains
Ketorolac tromethamol ………. 30 mg/ml
Type of Form Form-5
Pack size & Demanded Price 1ml x 5‟s: As Per SRO
Approval status of product in KETOROLAC by Hospira
Me-too status Torapan Injection by Valor Pharma
license
product monograph is present in USP
(M-271)
sterilization.
Decision:Approved with USP specifications
Brand Name +Dosage Form + MEDOL 100mg Injection
Strength
PKR 20,000/- : 03-05-2017
Composition Each (2ml) Injection Contains
Tramadol as hydrochloride………..100mg
Type of Form Form-5
Approval status of product in Tramal Injection 100mg/2ml by Seqirus Pvt Ltd
Reference Regulatory Authorities (TGA Australia Approved)
Me-too status Tramal (50mg/ml) injection by Searle
license
(M-271)
sterilization.
Brand Name +Dosage Form + WALTFENAC Injection 75mg/3ml
Strength
PKR 20,000/- : 11-05-2017
Diclofenac sodium……………… 75 mg
Pharmacological Group Nonsteroidal anti-inflammatory drug (NSAID).
Type of Form Injection
Approval status of product in Akis 75 mg/ml Injection by IBSA Farmaceutici
Econac 75 mg/3 ml Injection by Mercury Pharma
(MHRA Approved)
Me-too status Dicloran Injection (3ml) by Sami
license
(M-271)
sterilization.
Brand Name +Dosage Form + THIOWALT Injection
Strength
PKR 20,000/- : 18-05-2017
Composition Each 2ml Injection Contains
Thiocolchicoside …………. 4 mg
Pharmacological Group Skeletal Muscle relaxants
Type of Form Form 5
Pack size & Demanded Price 1 × 5‟s
As Per SRO
Approval status of product in Thiocolchicoside injection by Laboratories Pharmy
Reference Regulatory Authorities (ANSM France Approved)
Me-too status MUSCORIL injection by Sanofi
license
(M-271)
sterilization.
Brand Name +Dosage Form + Hydrogest 250mg /ml Injection
Strength
PKR 20,000/- : 03-05-2017
Hydroxyprogesterone caproate….…..250mg
Pharmacological Group steroidalprogestin
Type of Form Form-5
Approval status of product in Makena 250mg/ml Injection by Amag Pharma
Me-too status Hydroxyprogesterone Injection By Zafa
Pharmaceuticals
license
Remarks of the Evaluator  Method of manufacturing do not specify the method
applied for Liquid injection ampuole (Hormone)
section for clarification from the firm whether it
specifies/retains the section for steroidal preparations
or for non-steroidal preparations. Registration Board
further deferred the case for clarification of method
of sterilization. (M-271)
Evaluation by PEC Firm has submitted complete method of
sterilization.
Firm stated that they want to retain this section for
steroidal hormonal preparation
whereas CLB has approved section as "injectionHormone" only. Thus the Board
deferred products and advised to get approval from Licensing Division for Steroidal
hormone injection for further processing by Registration Board
Brand Name +Dosage Form + WALT-NOR Injection 1mg/ml
Strength
PKR 20,000/- : 22-05-2017
Norepinephrine bitartrate equivalent to
Norepinephrine Base ……………..1 mg
Pharmacological Group Naturally occurring catecholamine
Type of Form Form-5
Approval status of product in LEVOPHED INJECTION by Hospira
license
Remarks of the Evaluator  Evidence of me-too status in applied strength could
not be confirmed
sterilization.
Decision:Deferred for clarification as applied formulation is not steroid
Brand Name +Dosage Form + WALT-O-GEN 200mg/ml Injection
Strength
PKR 20,000/- : 22-05-2017
Norethisterone Enantate……………..200 mg
Type of Form Form-5
Noristerat 200mg by Bayer Health
Me-too status Norigest by Bayer Health Care
license
meeting
sterilization.
whereas CLB has approved section as "injectionHormone" only. Thus the Board
deferred products and advised to get approval from Licensing Division for Steroidal
hormone injection for further processing by Registration Board
Brand Name +Dosage Form + OCTREO-WALT 0.05mg/ml Injection
Strength
PKR 20,000/- : 22-05-2017
Octreotide as acetate……………..0.05 mg
Pharmacological Group Somatostatin analogue
Type of Form Form-5
Approval status of product in Sandostatin Injection by Novartis Pharma
Me-too status Sandostatin Injection by Novartis Pharma
license
meeting

sterilization.
Decision:Deferred for confirmation/justification for manufacturing of the applied
product in Liquid Ampoule (steroidal hormone) section. Moreover, source of Octreotide
(synthetic or biological) shall be submitted by the applicant along with relevant
documents
Brand Name +Dosage Form + OCTREO-WALT Injection
Strength
PKR 20,000/- : 22-05-2017
Octreotide as acetate……………..0.1 mg
Pharmacological Group Somatostatin analogue
Type of Form Form-5
Approval status of product in Sandostatin Injection by Novartis Pharma
Me-too status Sandostatin Injection by Novartis Pharma
license
meeting
sterilization.
product in Liquid Ampoule (steroidal hormone) section. Moreover, source of Octreotide
(synthetic or biological) shall be submitted by the applicant along with relevant
documents
Brand Name +Dosage Form + WALT-TONIN Injection.
Strength
PKR 20,000/- : 22-05-2017
Calcitonin salmon….….. 100 IU
Pharmacological Group Anti parathyroid agent
Type of Form Form-5
Approval status of product in Miacalcin by Mylan
Me-too status Miacalcic by Novartis
license
Remarks of the Evaluator  Method of manufacturing do not specify the method
sterilization.
product in Liquid Ampoule (steroidal hormone) section as applied product is polypeptide
hormone.
Brand Name +Dosage Form + WALTVIR 250mg Injection
Strength
PKR 20,000/- : 05-06-2017
Composition Each vial Contains
Acyclovir Sodiumequivalent to Acyclovir….. 250mg
(Lyophilized Powder)
Type of Form Form-5
Approval status of product in Zovirax Injection by GSK
Reference Regulatory Authorities (USFDA Approved) but discontinued for reasons
other than safety and efficacy
Me-too status Cycloz by Highnoon
license
Decision of previous meeting Deferred for clarification of formulation since the
reference product is available as lyophilized
injection. (M-271)
Evaluation by PEC Firm has provided master formulation of acyclovir in
which lyophilized powder of acyclovir is used. Firm
has not provided any clarification regarding the use
of lyophilized powder and that the reference product
is available as lyophilized injection.
Decision: Deferred as firm has not provided reply to last query as reference product is
available as lyophilized injection
Case No. 04: Registration applications for local manufacturing of (veterinary) drugs
a) Applications of New DML/section
a) Applications of New DML/section

Evaluator PEC-XIV
Case No.01 M/s. ICI Pakistan Limited, Life Sciences, 45-Km, Multan Road, Lahore
Files received against letter No. F.8-11/2013-Reg-I.
Registration applications of 20 dossiers for one additional section i.e., Liquid
injectable (SVP) Veterinary section, approved by the Central Licensing Board vide letter
No.F.1-41/2007-Lic (Vol-I) dated 10th July, 2017, were submitted by M/s.ICI Pakistan
Limited, Life Sciences, 45-Km, Multan Road, Lahore. Accordingly, dossiers of 20 products
related to these sections were as follows:
Liquid injectable (SVP) Veterinary section: 8 molecules/20 products
The firm has submitted NOC from M/s. Breeze Pharma, Kahuta Road, Islamabad having no
objection in giving her brand names of registered veterinary prodcuts to ICI Pakistan Ltd,
Life sciences, Lahore. Moreover, stated that the request for change in brand names for these
products has already been submitted by M/s. Breeze Pharma.
990. Name and address of manufacturer / M/s. ICI Pakistan Ltd, Life Sciences, 45-KM, Multan
Applicant Road, Lahore
Brand Name +Dosage Form + Strength Dayfos Liquid Injection
Toldimfos Sodium……………….100mg
Diary No. Date of R& I & fee 10046, 26-07-2017, 20,000/-25-07-2017
Pharmacological Group Alimentary tract Mineral supplements
Type of Form Form 5
Finished Product Specification Innovator‟s specification
Pack size & Demanded Price 50ml; Decontrolled
Approval status of product in Reference Vetophos® Injection; Bela-pharm GmbH & Co. KG,
Regulatory Authorities. Lohner Str. 19, 49377 Vechta Germany
Me-too status Metafos Injection of Star Laboratories, Lahore.
GMP status  CLB in its 254th meeting held on 15th June,2017
has considered and approved the grant of one
additional section i.e., Liquid injectable (SVP)
Vet.
Remarks of the Evaluator.  The firm has submitted revised Form-5 stating
correct salt form Toldimfos sodium
Trihydrate……100mg Eq. to Toldimfos
sodium…..80.36mg which has been verified from
database of Germany. However, me-too reference
is registered in Toldimfos sodium …..100mg.
 Indicated species:
Cattle, horse, Calf, Foal, Sheep
Decision:Deferred for verification of salt form of API as reference product is available as
Toldimfos sodium trihydrate whereas firm has applied for Toldimfos sodium.
Brand Name +Dosage Form + Strength Dayfos Liquid Injection
Toldimfos Sodium……………….100mg
Diary No. Date of R& I & fee 10047, 26-07-2017, 20,000/-, 25-07-2017
Pharmacological Group Alimentary tract Mineral supplements
Type of Form Form 5
Approval status of product in Reference Vetophos® Injection; Bela-pharm GmbH & Co. KG,
Regulatory Authorities. Lohner Str. 19, 49377 Vechta Germany
Me-too status Metafos Injection of Star Laboratories, Lahore,
Pakistan.
GMP status CLB in its 254th meeting held on 15th June,2017 has
considered and approved the grant of one additional
section i.e., Liquid injectable (SVP) Vet.
correct salt form Toldimfos sodium
Trihydrate……100mg Eq. to Toldimfos
sodium…..80.36mg which has been verified from
database of Germany. However, me-too reference
is registered in Toldimfos sodium …..100mg.
Cattle, horse, Calf, Foal, Sheep
Decision:Deferred for verification of salt form of API as reference product is available as
Toldimfos sodium trihydrate whereas firm has applied for Toldimfos sodium.
Brand Name +Dosage Form + Strength Dectron Liquid Injection
Doramectin-----------------10mg
Pharmacological Group Anthelmintic
Type of Form Form 5
Approval status of product in Reference Dectomax® Injection of Zoetis, USFDA
Me-too status Doramec Injection of Selmore Pharmaceuticals
Remarks of the Evaluator.  Indicated species
Cattle, Sheep
Decision:Approved
Doramectin-----------------10mg
Type of Form Form 5
Cattle, Sheep
Decision:Approved
Doramectin----------------- 10mg
Type of Form Form 5
Vet.
Cattle, Sheep
Decision:Approved
Doramectin----------------- 10mg
Type of Form Form 5
Vet.
Cattle, Sheep
Decision: Approved
Brand Name +Dosage Form + Strength Disulf Liquid Injection

Sulphadimidine Sodium -------------- 333mg
Pharmacological Group Antimicrobials (Sulphonamides)
Type of Form Form 5
Approval status of product in Reference Intradine of Norbrook laboratories, UK
Regulatory Authority

Me-too status Diaadin injection of Nawan lab (Reg # 025384)
GMP status CLB in its 254th meeting held on 15th June, 2017 has
Remarks of the Evaluator.  Product is not present in USP or BP.
 Indicated species
Sheep, Cow, Horse, Dog, Cat, Rabbit, Poultry and
birds
Decision:Approved with innovator’s specifications
Brand Name +Dosage Form + Strength Genton 5% Liquid Injection
Gentamycin Sulphate equal to 50mg Gentamycin
base.
Pharmacological Group Aminoglycoside antibiotic
Type of Form Form 5
Approval status of product in Reference Garasol® Injection of Intervet Inc. USFDA
Me-too status Genta care 5% Injection of Leads Pharma (Reg #
025319)
Remarks of the Evaluator.  The product monograph is present in USP but the
monograph does not specify for veterinary use
only.
Cattle, horse, Camel, Calf, Sheep, Goat, Pets,
Poultry
Decision: Approved
Brand Name +Dosage Form + Strength Genton 5% Liquid Injection
base.
Type of Form Form 5
025319)
only.
Poultry
Decision: Approved
Brand Name +Dosage Form + Strength Genton 10% Injection
base.
Type of Form Form 5
025320)
only.
Poultry
Decision:Approved
Brand Name +Dosage Form + Strength Genton 10% Injection
base.
Type of Form Form 5
025320)
only.
Poultry
Decision: Approved
Brand Name +Dosage Form + Strength Melonac Injection
Meloxicam………….…….7.5mg
Pharmacological Group Non-Steroidal anti-inflammatory agent
Type of Form Form 5
Approval status of product in Reference Could not be verified.
Me-too status Melox 7.5mg Injection of Alina Combine Pharma
(Reg # 053995)
GMP status  CLB in its 254th meeting held on 15th June, 2017
Vet.
Remarks of the Evaluator.  Indicated species:
Cattle, Buffalo, horse, Camel, Sheep, Goat, Dogs
Decision:Approved with BP specifications
Brand Name +Dosage Form + Strength Melonac Injection
Meloxicam……………….7.5mg
Pharmacological Group Non-Steroidal anti-inflammatory agent
Type of Form Form 5
Me-too status Melox 7.5mg Injection of Alina Combine Pharma
(Reg # 053995)
Vet.
Cattle, Buffalo, horse, Camel, Sheep, Goat, Dogs
Brand Name +Dosage Form + Strength Tryton Injection
Sulphadiazine (as sodium) ……. 400mg
Trimethoprim ………………...…. 80mg
Type of Form Form 5
Approval status of product in Reference Tribrissen 48%® Intervet/schering-plough animal
Regulatory Authorities. health, 19966-0318, USFDA
Me-too status Santrim-50 Injection of Sanna laboratories (Reg #
027421)
Vet.
Cattle, Horses
Trimethoprim ………………...….80mg
Type of Form Form 5
027421)
Vet.
Cattle, Horses
Trimethoprim ………………...…. 80mg
Type of Form Form 5
027421)
Vet.
Cattle, Horses
Brand Name +Dosage Form + Strength V Sel Liquid Injection
Vitamin E ………. 100mg
Sodium Selenite … 0.5mg
Pharmacological Group Vitamin / Restorative
Type of Form Form 5
Approval status of product in ReferenceVitamine E50 + SE Pro Injection of Eurovet Animal
Regulatory Authorities. Health BV, Netherland
Me-too status Pri-Tolevit + SE injection of Prix Pharmaceutica
(Reg#080760)
Vet.
50mg of Vitamin E. The new formulation has
been confirmed from Netherland and me-too
reference has been verified.
Calves, Lamb, Goat, Sheep
Decision:Deferred for submission of fee of Rs. 20,000/- for revision of applied formulation.
Brand Name +Dosage Form + Strength V Sel Injection
Vitamin E ………. 100mg
Sodium Selenite … 0.5mg
Type of Form Form 5
Approval status of product in Reference Vitamine E50 + SE Pro Injection of Eurovet Animal
Regulatory Authorities. Health BV, Netherland
Me-too status Pri-Tolevit + SE injection of Prix Pharmaceutica
(Reg#080760)
50mg of Vitamin E. The new formulation has
been confirmed from Netherland and me-too
reference has been verified.
Calves, Lamb, Goat, Sheep
Brand Name +Dosage Form + Strength VAD3 Liquid Injection
Vitamin A ……………. 40,000IU
Vitamin D3 …… ….…. 80,000IU
Vitamin E ……………. 20mg
Type of Form Form 5
Approval status of product in Reference Vita. AD3E Solution for Injection; The Netherlands
Me-too status Vitamin ADE Injection of Alina combine
pharmaceuticals
(Reg # 052346)
Vet.
80,000IU of vitamin A and 40,000IU of Vitamin
D3. The new formulation has been confirmed
from Netherland and me-too reference has been
verified.
Horse, Cow, Calf, Foal, Goat, Sheep, Dog, Cat
Brand Name +Dosage Form + Strength VAD3 Liquid Injection
Vitamin A ……………. 40,000IU
Vitamin D3 …… ….…. 80,000IU
Vitamin E ……………. 20mg
Type of Form Form 5
Approval status of product in Reference Vita. AD3E Solution for Injection; The Netherlands
Me-too status Vitamin ADE Injection of Alina combine
pharmaceuticals
(Reg # 052346)
Vet.
80,000IU of vitamin A and 40,000IU of Vitamin
D3. The new formulation has been confirmed
from Netherland and me-too reference has been
verified.
Horse, Cow, Calf, Foal, Goat, Sheep, Dog, Cat

Case No 2. M/s. Baariq Pharmaceuticals, Plot # 600, Sundar Industrial Estate, Sundar
Raiwind Road, Lahore
The CLB in its 255th meeting held on 16th& 17th August, 2017 has considered and approved the
expansion of additional section/ amendment to M/s. Baariq Pharmaceuticals,Plot # 600, Sundar
Industrial Estate, Sundar Raiwind Road, Lahore, under Drug Manufacturing License No.
000715 (Formulation) as under;
i. Liquid Injection (General) Veterinary (10 Molecules/36 Files)
ii. Oral Powder II (General) Veterinary (10 Molecules/20 Files)
iii. Liquid Injection (Penicillin) Veterinary (10 Molecules/24 Files)
iv. Oral Powder (Penicillin) Veterinary (09 Molecules/13 Files)
Liquid Injection (General) Veterinary (10 Molecules/36 Files)
1010. Name and address of manufacturer / M/s. Baariq Pharmaceuticals, Plot # 600, Sundar
Applicant Industrial Estate, Sundar Raiwind Road, Lahore
Brand Name +Dosage Form + Strength Meloxibar-5 Injection
Meloxicam….................5 mg
Diary No. Date of R& I & fee 10723, 01-08-2017 Rs 20,000/-, 28-07-2017
Pharmacological Group (Analgesic & Anti-inflammatory)
Type of Form Form-5
Pack size & Demanded Price 100 ml; Decontrolled
Approval status of product in Metacam® Injection; Boehringer Ingelheim
Reference Regulatory Authorities. Vetmedica, Inc.
USFDA
Me-too status Melocsym Injection of Symans (Reg # 059000)
GMP status  The Panel inspection conducted on 09-06-2017/22-
06-2017 recommended for the renewal of Drug
Manufacturing License and for the grant of
additional sections of Veterinary Liquid Injection
(General), Veterinary Oral Powder-II, Veterinary
Liquid Injection (Penicillin) and Veterinary Oral
Powder (Penicillin).
Decision: Approved
Meloxicam….................10 mg
Type of Form Form-5
Me-too status Loxibak 10 % injection of Attabak (Reg # 062155)
Decision: Approved
Meloxicam….....................10 mg
Pharmacological Group Analgesic & Anti-inflammatory
Type of Form Form-5
Pack size & Demanded Price 100 ml ; Decontrolled
Me-too status Loxibak 10 % injection of Attabak (Reg # 062155)
Decision: Approved
Meloxicam….….................20 mg
Type of Form Form-5
Approval status of product in Meloxidyl of Ceva Sante (Sweden)
Me-too status Diclocam Injection of Manhattan Pharma (Reg #
052367)
Decision: Approved

Meloxicam….…..................20 mg
Pharmacological Group Analgesic & Anti-inflammatory
Type of Form Form-5
Approval status of product in Meloxidyl of Ceva Sante (Sweden)
Me-too status Diclocam Injection of Manhattan Pharma (Reg #
052367)
Decision: Approved
Brand Name +Dosage Form + Strength Iverbar-1% Injection
Ivermectin……………….10 mg
Pharmacological Group (Dewormer / Anthelmintic)
Type of Form Form-5
Approval status of product in Ivomec 1% injection of Merial Inc. USFDA
Me-too status Actimec injection of Selmore pharmaceuticals (Reg #
034595)
Remarks of the Evaluator.  Indicated species:Cattle, Calves
Decision: Approved
Type of Form Form-5
Finished Product Specification BP specification

034595)
06-2017 for the renewal of Drug Manufacturing
License and for the grant of additional sections of
Veterinary Liquid Injection (General), Veterinary
Oral Powder-II, Veterinary Liquid Injection
(Penicillin) and Veterinary Oral Powder
(Penicillin).
Cattle, Calves
Decision: Approved
Type of Form Form-5
034595)
(Penicillin).
Cattle, Calves
Decision: Approved
Type of Form Form-5
Approval status of product in Eqvalan Injection of Merial Inc. USFDA
Me-too status Elvomec D/S. Injection of Elko organization (Reg #
052312)

Remarks of the Evaluator.  Do not use intravenously. Not for use in horses
intended for food. Effects of this drug on pregnant
mares have not been determined.
 Withdrawal Period:
N/A
Decision: Approved
Type of Form Form-5
052312)
 Withdrawal Period:
N/A
Decision: Approved.
Type of Form Form-5
052312)

 Withdrawal Period:N/A
Decision: Approved
Brand Name +Dosage Form+ Strength Amicoc Injection
Novaminsulfon…………...4.0 gm
Etilefrin……………….....0.02 gm
Calcium Gluconate…….....10.0gm
Magnesium Gluconate…….1.0 gm
Sodium Salicylate…….…0.700gm
Nicotinamide……………0.030gm
Caffeine…………..………..1.0gm
Boric Acid……….…….…1.0gm
Pharmacological Group (Analgesic/Antipyretic, cardiac stimulant, /Electrolyte)
Type of Form Form-5
Me-too status Aminox Injection of Selmore (Reg # 029663)
Remarks of the Evaluator.  Evidence of approval of applied formulation in
Reference regulatory authority could not be
confirmed.
 The Registration Board in 273rd meeting deferred
the case as the product contains Novaminsulfon
(Metamizole), which is a banned drug.
Decision:Registration Board rejected the case as the product contains Novaminsulfon
Brand Name +Dosage Form + Strength Amicoc Injection
Novaminsulfon…………...4.0 gm
Etilefrin……………….....0.02 gm
Calcium Gluconate…….....10.0gm
Magnesium Gluconate…….1.0 gm
Sodium Salicylate…….…0.700gm
Nicotinamide……………0.030gm
Caffeine…………..………..1.0gm
Boric Acid……….…….…1.0gm
Pharmacological Group (Analgesic/Antipyretic, ,cardiac stimulant,
/Electrolyte)
Type of Form Form-5
Me-too status Aminox Injection of Selmore (Reg # 029663)
Reference regulatory authority could not be
confirmed.
 The Registration Board in 273rd meeting deferred
the case as the product contains Novaminsulfon
Decision:
Registration Board rejected the case as the product contains Novaminsulfon (Metamizole),
which is a banned drug.
Brand Name +Dosage Form + Strength Lincos Injection
Composition Each ml Contains:
Lincomycin HCl equival to lincomycin base…...50 mg
Spectinomycin HCl equival to Spectinomycin
base…..100 mg
Pharmacological Group (Antibiotic / Antibacterial)
Type of Form Form-5
Approval status of product in Linspec 50/100 mg/ml Solution for injection of
Reference Regulatory Authorities. Chanelle Pharmaceuticals- Ireland
Me-too status Lincospec injectable solution of Avicenna laboratories
(Reg # 043167)
Remarks of the Evaluator.  The applied formulation has been confirmed in
drug database of Ireland. However, Ireland is not
our Reference country.
 The salt form of me-too reference is spectinomycin
sulphate while that of the applied product is
spectinomycin HCl. Moreover, the salt form in the
database of Ireland is spectinomycin sulphate

tetrahydrate.
Decision:Deferred for clarification of salt form of Spectinomycin in comparison to
reference product and submission of correct me-too reference accordingly
Brand Name +Dosage Form + Strength Lincos Injection
Lincomycin HCl equivalent to lincomycin
base…………...50 mg
Spectinomycin HCl equivalent to Spectinomycin
base…..100 mg
Type of Form Form-5
Approval status of product in Linspec 50/100 mg/ml Solution for injection of
Reference Regulatory Authorities. Chanelle Pharmaceuticals- Ireland
Me-too status Lincospec injectable solution of Avicenna laboratories
(Reg # 043167)
Remarks of the Evaluator.  The applied formulation has been confirmed in
drug database of Ireland. However, Ireland is not
our Reference country.
 The salt form of me-too reference is spectinomycin
sulphate while that of the applied product is
spectinomycin HCl. Moreover, the salt form in the
database of Ireland is spectinomycin sulphate
tetrahydrate.
Decision:Deferred for clarification of salt form of Spectinomycin in comparison to
reference product and submission of correct me-too reference accordingly
Brand Name +Dosage Form + Strength Gentabar-5 Injection
Gentamicin as Sulphate…50 mg
Pharmacological Group (Antibiotic/antimicrobial)
Type of Form Form-5
Finished Product Specification As per innovator‟s specifications
Approval status of product in Garasol® Injection of Intervet Inc. USFDA
025319)

only.
Decision: Approved
Composition Each ml contains :
Gentamicin as Sulphate….100 mg
Type of Form Form-5
Approval status of product in Garasol® Injection of Intervet Inc. USFDA
025320)
Remarks of the Evaluator. The product monograph is present in USP but the
monograph does not specify for veterinary use only.
Decision: Approved

Gentamicin as Sulphate….100 mg
Type of Form Form-5
025320)
GMP status The Panel inspection conducted on 09-06-2017/22-06-
2017 for the renewal of Drug Manufacturing License
and for the grant of additional sections of Veterinary
Liquid Injection (General), Veterinary Oral Powder-II,
Veterinary Liquid Injection (Penicillin) and Veterinary
Oral Powder (Penicillin).
Decision: Approved
Gentamicin as Sulphate…200 mg
Type of Form Form-5
Me-too status Gentamisan-200 Injection of Sanna laboratories (Reg #
078364)
(Penicillin).
only.
Decision: Approved
Gentamicin as Sulphate……………200 mg
Type of Form Form-5
Approval status of product in Reference Could not be confirmed.
Me-too status Gentamisan-200 Injection of Sanna laboratories (Reg #
078364)
Decision: Approved
Brand Name +Dosage Form + Strength Coliriq-20 Injection
Colistin Sulphate….... 20 M.I.U
Type of Form Form-5
Me-too status Colt Injection of S.J & G Fazul Ellahie (Reg # 026509)
2017 recommended for the renewal of Drug
Manufacturing License and for the grant of additional
sections of Veterinary Liquid Injection (General),
Veterinary Oral Powder-II, Veterinary Liquid Injection
(Penicillin) and Veterinary Oral Powder (Penicillin).
Remarks of the Evaluator. 
Decision: Approved
Composition Each 100 ml contains :
Colistin Sulphate………….……..50 MIU
Type of Form Form-5
Approval status of product in Reference Colivet injection solution of Prodivet Pharmaceuticals,
Regulatory Authorities. Belgium
Me-too status Colisym-50 injection of Symans pharmaceuticals (Reg
# 062109)
Decision: Approved
Colistin Sulphate………50 M.I.U
Type of Form Form-5
Me-too status Colisym-50 injection of Symans pharmaceuticals (Reg
# 062109)
Decision: Approved.
Colistin Sulphate…..……….60 MIU
Type of Form Form-5
Me-too status Colistan Forte injection of Leads pharma (Reg #
043514)
Decision: Approved.

Colistin Sulphate………60 MIU
Type of Form Form-5
Me-too status Colistan Forte injection of Leads pharma (Reg #
043514)
Decision: Approved
Brand Name +Dosage Form + Strength Oxyriq-5 Injection
Oxytetracycline as HCl…………..50 mg
Type of Form Form-5
Approval status of product in Reference Liquamycin Injectable solution of Zoetis inc. USFDA
Me-too status Emivet-5 injection of Zakfas Pharma (Reg # 046543)
Cattle, Chicken and Turkey
Decision: Approved
Composition Each ml Contains :
Oxytetracycline as HCl……...100 mg
Type of Form Form-5

Approval status of product in Reference Alamycin 10 of Norbrook Laboratories, Netherland
Me-too status Santracycline PVC-100 Injection of Sanna
laboratories (Reg # 027418)
Decision: Approved
Oxytetracycline as HCl…………100 mg
Type of Form Form-5
Approval status of product in Reference Alamycin 10 of Norbrook Laboratories, Netherland
Me-too status Santracycline PVC-100 Injection of Sanna
laboratories (Reg # 027418)
Decision: Approved
Oxytetracycline as HCl…………...200 mg
Type of Form Form-5
Approval status of product in Reference Oxycare 20 %w/v LA Solution for Injection of
Regulatory Authorities. Norbrook laboratories-UK
Me-too status Rimoxyn 20% LA injection of PDH Laboratories (Reg
# 028534)
Remarks of the Evaluator.  The salt form in reference country is
Oxytetracycline Dihydrate which is different from
applied salt form.
Decision:
Deferred for clarification of salt form of API in comparison to reference product.
Composition Oxytetracycline as HCl………200 mg
Type of Form Form-5
Approval status of product in Reference Oxycare 20 %w/v LA Solution for Injection of
Regulatory Authorities. Norbrook laboratories-UK
Me-too status Rimoxyn 20% LA injection of PDH Laboratories (Reg
# 028534)
Remarks of the Evaluator.  The salt form in reference country is
Oxytetracycline Dihydrate which is different from
applied salt form.
Decision:
Deferred for clarification of salt form of Oxytetracycline in comparison to reference product.
Brand Name +Dosage Form + Strength Kill Crd Injection
Tylosin Tartrate……...….50 mg
Colistin Sulphate……..…10 mg
Streptomycin (base)……100 mg
Type of Form Form-5
Approval status of product in Reference Tyson Injection of Impect Labs – India
Me-too status Target CRD injection of Leads Pharma (Reg #
046577)
Remarks of the Evaluator.  Evidence of approval of applied in reference
regulatory authority could not be confirmed.
Brand Name +Dosage Form + Strength Kill Crd Injection
Tylosin Tartrate……...….50 mg
Colistin Sulphate……..…10 mg
Streptomycin (base)..……100 mg
Type of Form Form-5
Approval status of product in Reference Tyson Injection of Impect Labs – India
Me-too status Target CRD injection of Leads Pharma (Reg #
046577)
Remarks of the Evaluator.  Evidence of approval of applied in reference
regulatory authority could not be confirmed.
Decision:
Approved with change of brand name.
Brand Name +Dosage Form + Strength Sulphabar-33 Injection
Sulphadimidine Sodium………333 mg
Type of Form Form-5
Me-too status Sulpha-S injection of Star Laboratories (Reg # 033269)
Sheep & Cattle
Decision: Approved

Brand Name +Dosage Form + Strength Sulphabar-33 Injection
Sulphadimidine Sodium…333 mg
Type of Form Form-5
Me-too status Sulpha-S injection of Star Laboratories (Reg # 033269)
Sheep & Cattle
Decision: Approved.
Brand Name +Dosage Form + Strength Oxyflun Injection
Oxytetracycline………...…300mg
Flunixin meglumine…….....20mg
Pharmacological Group (Antibiotic/antimicrobial, NSAID )
Type of Form Form-5
Approval status of product in Reference Hexasol Injection of Norbrook Laboratories Ltd –
Me-too status Oxy-flu injection of Leads pharma (Reg # 057048)
Sheep & Cattle
Decision: Approved
Brand Name +Dosage Form + Strength Oxyflun Injection
Oxytetracycline…………300 mg
Flunixin meglumine……...20 mg
Pharmacological Group (Antibiotic/antimicrobial, NSAID )

Type of Form Form-5
Approval status of product in Reference Hexasol Injection of Norbrook Laboratories Ltd –
Me-too status Oxy-flu injection of Leads pharma (Reg # 057048)
Sheep & Cattle
Decision: Approved
Oral Powder-II Veterinary
(10 Molecules/20 Files)
Brand Name +Dosage Form + Strength Tyloriq Premix 10%
Composition Each gm powder contains:
Tylosin phosphate……….100 mg
Diary No. Date of R& I & fee 10780, 01-08-2017Rs 20,000/-, 28-07-2017
Pharmacological Group (Antibiotic/Antibacterial)
Type of Form Form-5
Pack size & Demanded Price 100g,250g, 500g,1000g,2.5Kg,5Kg,10Kg,25Kg ;
Decontrolled
Approval status of product in Reference Tylosin Phasphate Premix 10% of Jiangxibolai
Regulatory Authorities. Pharmacy Company - China
Me-too status Sanna Tylosin Premix of Sanna Laboratories (Reg #
026505)
(Penicillin).
Remarks of the Evaluator. The product is present in USFDA in following
strengths :
Tylan premix No.10
Type A medicated levels of tylosin: 10, 40, 100grams
per pound.
Decision: Approved
Brand Name +Dosage Form + Strength Doxybar-50 Water soluble powder
Doxycycline.....................500 mg.
Type of Form Form-5
Pack size & Demanded Price 100g,250g, 500g,1000g,2.5Kg,5Kg,10Kg,25Kg;
Decontrolled
Approval status of product in Reference Altidox 500mg/g powder of Eurovet Animal Health-
Regulatory Authorities. TheNetherland
Me-too status Doxybak powder of Attabak Pharma (Reg # 053918)
Remarks of the Evaluator.  Salt form of applied product is Doxycycline
Hyclate in Reference country while me-too
reference is available in Doxycycline HCl.
Decision:Deferred for clarification of salt form of Doxycycline in comparison to reference
product and submission of correct me-too reference accordingly.
Brand Name +Dosage Form + Strength Doxybar-20 Water soluble powder
Doxycycline.....................200 mg
Diary No. Date of R& I & fee 10778, 01-08-2017, Rs 20,000/-, 28-07-2017
Type of Form Form-5
Decontrolled
Approval status of product in Reference Doxycycline 20% W.O.powder of Feramed BV-
Regulatory Authorities. Netherland
Me-too status Sandox-20 powder of Sanna Lab (Reg # 026507)
(Penicillin).
Remarks of the Evaluator.  Salt form of applied product is Doxycycline
Hyclate in Reference country while me-too
reference is registered as Doxycycline HCl.
Decision:
Deferred for clarification of salt form of Doxycycline in comparison to reference product and
submission of correct me-too reference accordingly
Brand Name +Dosage Form + Strength Lincol Water Soluble Powder
Lincomycin HCl……….……100 mg
Colistin Sulphate…………….800,000 IU
Type of Form Form-5
Decontrolled
Me-too status Lincocol W/S powder of International Champharma,
Lahore (Imported from Ireland, Reg # 016204)
(Penicillin).
Decision: Approved
Brand Name +Dosage Form + Strength Premixbar Powder
Composition Each 1000 gm powder contains:
Vitamin A…………..……4,000,000 IU
DL-Methionine……..……50,500mg
Vitamin D3……………….820,000 IU
Choline Chloride……...….125,500 mg
Vitamin E……………………6,200 mg
Manganese………………30,000 mg
Vitamin K3…………………….800 mg
Iron………………………….15,100 mg
Vitamin B2………………….2500 mg
Zinc………………………….17,555 mg
Vitamin B6………………….3100 mg
Copper……………………….1000 mg
Vitamin B12……………..1000 mcg
Cobalt…………………………….50 mg
Vitamin PP………………10,500 mg
Iodine………………………..…300 mg
L. Lysine…………………..10,500 mg
Selenium………………………..80 mg
Pharmacological Group (Vitamins, Amino acids and Minerals)
Type of Form Form-5
Pack size & Demanded Price 100g,250g, 500g,1000g,2.5Kg,5Kg,10Kg,25Kg;
Decontrolled
Approval status of product in Reference VMD Oligovit Plus
Regulatory Authorities. VMD Belgium
Me-too status Sanna Premix (B) of Sanna Lab
Reference Regulatory Authority and me-too
reference could not be confirmed.
Brand Name +Dosage Form + Strength Acevit Powder
Composition Each 100gm powder contains:
Acetylsalicylic acid……..……6.7gm
Vitamin C (Ascorbic Acid)…...20gm
Pharmacological Group NSAID with Vitamin C
Type of Form Form-5
Decontrolled
Approval status of product in Reference Nobi Asper-C
Regulatory Authorities. Santel Pharma-Korea
Me-too status Aspersym-C WSP of M/s. Symans (Reg # 079109)
(Penicillin).
Reference Regulatory Authority could not be
confirmed.
Decision:
Deferred for evidence of compatibility of vitamin C with other ingredients of applied
formulation and submission of intended use.
Brand Name +Dosage Form + Strength Quindox Powder
Composition Each 1000 gm contains:
Olaquindox…………………...100gm
Type of Form Form-5
Decontrolled
Me-too status Olandox Powder of Nawan Labs (Reg # 022150)
(Penicillin).
confirmed.
Decision: Approved

Brand Name +Dosage Form + Strength Neoxflor Oral Powder
Neomycin Sulphate……….150 mg
Florfenicol…………………....100 mg
Oxytetracycline HCl……….300 mg
Type of Form Form-5
Decontrolled
Me-too status E-Col Oral Powder of Evergreen Pharma
(Penicillin).
Remarks of the Evaluator.  Evidence of already approved formulation could
not be confirmed.
Brand Name +Dosage Form + Strength Lincobar-11 Premix

Lincomycin HCl...…………..11 gm
Type of Form Form-5
Decontrolled
Approval status of product in Reference Uni-Linco P11
Regulatory Authorities. Unipharma Malaysia
Me-too status Lincofeed oral powder of Mediexcel pharma (Reg #
031403)
Remarks of the Evaluator. Evidence of approval of applied formulation in
confirmed.
Decision: Deferred for clarification of pharmacological group " Anticoccidal"
Brand Name +Dosage Form + Strength Lincobar-44 Premix
Lincomycin HCl...…………..44 gm
Pharmacological Group (Antibiotic/Antibacterial/)
Type of Form Form-5
Decontrolled
Approval status of product in Reference Uni-Linco P44
Regulatory Authorities. Unipharma Malaysia
Me-too status Lincos-P Powder of A & K Pharmaceutical (Reg #
049667)
(Penicillin).
confirmed.
Brand Name +Dosage Form + Strength Lincobar-Forte Premix
Lincomycin HCl...…………110 gm
Pharmacological Group (Antibiotic/Antibacterial/)
Type of Form Form-5
Decontrolled
Approval status of product in Reference Lincomycin 11% Premix
Regulatory Authorities. China
Me-too status Lincowan-Forte Powder of Nawan Lab (Reg #
022149)
confirmed.
Brand Name +Dosage Form + Strength Para-C+ Powder
Paracetamol……………………….20 gm
Vitamin C…………….………..…5 gm
Potassium carbonate…………...5 gm
Sodium bicarbonate………..12.5 gm
Vitamin E………………………….12.5 gm
Pharmacological Group Analgesic, Antipyretic with Vitamin C, E &
Electrolytes
Type of Form Form-5
Decontrolled
Me-too status Paracet Water Soluble Powder of Decent Pharma
(Penicillin).
Brand Name +Dosage Form + Strength Parascorbic Powder
Paracetamol………………………….20 gm
Vitamin C…………………………..…5 gm
Potassium carbonate……………….12.5 gm
Sodium bicarbonate…………….…..12.5 gm
Vitamin E……………………....….12.5 gm
Pharmacological Group (Analgesic, Antipyretic with Vitamin C, E &
Electrolytes)
Type of Form Form-5
Decontrolled
Me-too status Para CE Oral Powder of Biogen Pharma (Reg #
063812)
Decision: Approved
Brand Name +Dosage Form + Strength Respicure Water soluble powder
Tylosin Tartrate………….…100 gm
Doxycycline HCl…………….200 gm
Colistin Sulphate……………..50MIU
Bromhexine HCl………………2 gm
Pharmacological Group (Antibiotic/Antibacterial,mucolytic)
Type of Form Form-5
Decontrolled
Approval status of product in Reference Microresp WSP
Regulatory Authorities. Zoo Pharma International China
Me-too status Doximax Powder of Nawan Lab (Reg # 074019)
(Penicillin).
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Respixine Water soluble powder
Tylosin Tartrate…………….…10 gm
Doxycycline HCl……………….20 gm
Colistin Sulphate……………...5 gm
Bromhexine HCl……………0.5 gm
Pharmacological Group (Antibiotic / Antibacterial, mucolytic)
Type of Form Form-5
Decontrolled
Me-too status Hirra Doxi T Plus Water Soluble Powder
(Penicillin).
Brand Name +Dosage Form + Strength Respicline Water soluble powder
Tylosin Tartrate………..….112.5 gm
Doxycycline HCl………….…225 gm
Colistin Sulphate………......400 MIU
Bromhexine HCl………….……4 gm
Pharmacological Group (Antibiotic/antimicrobial, mucolytic)
Type of Form Form-5
Decontrolled
Me-too status Hirra Doxi T Plus Water Soluble Powder of Hirra Lab
(Penicillin).
Brand Name +Dosage Form + Strength Fighter-CRD Water soluble powder
Tylosin Tartrate…………….200 gm
Colistin Sulphate…….…1000 MIU
Bromhexine HCl……….……10 gm
Pharmacological Group (Antibiotic/Antibacterial, mucolytic)
Type of Form Form-5
Decontrolled
Me-too status Mexin Plus Water Soluble Powder of Medicure Lab
(Reg # 058956)
(Penicillin).
confirmed.
Brand Name +Dosage Form + Strength Maxin Water soluble powder
Tylosin Tartrate…………….…20 gm
Doxycycline HCl……………….40 gm
Colistin Sulphate……………...6 gm
Bromhexine HCl………………2 gm
Type of Form Form-5
Decontrolled
Me-too status Nobi TDC680 Water Soluble Powder of Noble
Pharma (Reg # 062127)
(Penicillin).
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Colidox Plus Water soluble powder

Tylosin Tartrate…………….100 gm
Colistin Sulphate…………480 MIU
Bromhexine HCl………..………5 gm
Type of Form Form-5
Decontrolled
Me-too status Pulmotin Water Soluble Powder of Attabak Pharma
(Reg # 058878)
(Penicillin).
confirmed.
Decision: Approved

Brand Name +Dosage Form + Strength Respicol Water soluble powder
Tylosin Tartrate………..…….170 gm
Colistin Sulphate………….…30 gm
Bromhexine HCl………..……5 gm
Type of Form Form-5
Decontrolled
Me-too status Tylodox+BC Water Soluble Powder of Intervac
Pharma (Reg # 071036)
confirmed.
Decision: Approved
Liquid injection (Penicillin)
Veterinary (10 Molecules/24 Files)
Brand Name +Dosage Form + Strength Amoxibar- LA Injection
Amoxicillin as Amoxicillin trihydrate……....150 mg
Pharmacological Group (Antibiotic)
Type of Form Form-5
Approval status of product in Reference Amoxycare LA suspension for injection of Norbrook
Regulatory Authorities. laboratories- UK
Me-too status Amovet LA injection of Nawan labs (Reg # 021305)
(Penicillin).
Decision: Approved

Brand Name +Dosage Form + Strength Amoxibar- LA Injection
Amoxicillin as Amoxicllin Trihydrate…….150 mg
Type of Form Form-5
Approval status of product in Amoxycare LA suspension for injection of Norbrook
Reference Regulatory Authorities. laboratories- UK
Me-too status Amovet LA injection of Nawan labs (Reg # 021305)
Decision: Approved
Brand Name +Dosage Form + Strength Ampicloxa Injection
Ampicillin (as trihydrate)…………………...125 mg
Cloxacillin (as sodium) ……………….…….125 mg
Pharmacological Group (Penicillin Antibiotic)
Type of Form Form-5
Approval status of product in 2-Pen Injection
Reference Regulatory Authorities. Shreya India
Me-too status Ampicox injection of Nawan lab. (Reg # 035061)
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Ampicloxa Injection
Ampicillin (as trihydrate) B.P……..125 mg
Cloxacillin (as sodium) B.P………..125 mg
Type of Form Form-5

Approval status of product in Amporcin Injection
Reference Regulatory Authorities. Urichem India
Me-too status Ampicox injection of Nawan lab. (Reg # 035061)
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Colimoxbar Injection

Amoxicillin (as Trihydrate)...100 mg
Colistin Sulphate……….250,000 IU
Diary No. Date of R& I & fee 10719, 01-08-2017. Rs 20,000/-, 27-07-2017
Type of Form Form-5
Approval status of product in Amoxycol Injection
Reference Regulatory Authorities. Neocell Pharmaceuticals Germany
Me-too status Colimoxin injection of Selmore pharma (Reg # 034576)
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Colimoxbar Injection
Amoxicillin (as Trihydrate)……100mg
Colistin Sulphate……………….250,000 IU
Diary No. Date of R& I & fee 10718, 01-08-2017 .Rs 20,000/-, 27-07-2017
Type of Form Form-5
Approval status of product in Bacolam Injection
Reference Regulatory Authorities. Azinda Therapeutics Italy.
Me-too status Colimoxin injection of Selmore pharma (Reg # 034576)
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Colicillin L.A Injection

Amoxicillin (As Trihydrate)……….120 mg
Colistin Sulphate………..................300,000 I.U
Type of Form Form-5
Approval status of product in Bacolam Injection of Azinda Therapeutics, Italy.
Me-too status Colimox injection of Alina combine (Reg # 049675)
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Colicillin L.A Injection
Amoxicillin (As Trihydrate)...120 mg
Colistin Sulphate……..…300,000 I.U
Type of Form Form-5
Approval status of product in Bacolam Injection
Reference Regulatory Authorities. Azinda Therapeutics Italy.
Me-too status Colimox injection of Alina combine (Reg # 049675)

confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Penibar Injection
Procaine Penicillin……….300 mg
Type of Form Form-5
Approval status of product in Depocillin 300mg/ml of Intervet BV, UK
Me-too status Nawapen-30 injection of Nawan lab (Reg # 053996)
Brand Name +Dosage Form + Strength Penibar Injection
Procaine Penicillin……….300 mg
Type of Form Form-5
Approval status of product in Depocillin 300mg/ml of Intervet BV, UK
Me-too status Nawapen-30 injection of Nawan lab (Reg # 053996)
Brand Name +Dosage Form + Strength Benzcilllin Injection
Procaine Penicillin……………...3,000,000 I.U
Benzyl Penicillin……..…………1,000,000 I.U
Type of Form Form-5
Approval status of product in Fortified Procaine Penicillin Injection
Reference Regulatory Authorities. Intracin pharmaceuticals india
Me-too status Penicill-40 injection of Star lab
Reference Regulatory Authority and me–too
Brand Name +Dosage Form + Strength Strepcillin Injection
Procaine Penicillin……...200 mg
Streptomycin Sulphate ….160 mg
Type of Form Form-5
Approval status of product in Kepro Penstrep 20/16 injection
Reference Regulatory Authorities. Pharma Vet
Me-too status NEO Strep-pen injection of Nawan labs (Reg # 053997)
Reference Regulatory Authority could not be confirmed.
Decision: Approved

Brand Name +Dosage Form + Strength Strepcillin Injection
Procaine Penicillin …………...200 mg
Streptomycin Sulphate……….160 mg
Diary No. Date of R& I & fee 10752, 01-08-2017.Rs 20,000/-, 27-07-2017
Pharmacological Group (Antibiotics)
Type of Form Form-5
Reference Regulatory Authorities. Pharma Vet.
Me-too status NEO Strep-pen injection of Nawan labs (Reg #
053997)
(Penicillin).
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength PPS Injection
Procaine Penicillin…………………...200 mg
Streptomycin Sulphate…...………….250 mg
Type of Form Form-5
Reference Regulatory Authorities. Pharma Vet.
Me-too status Strep-pen injection of Nawan labs (Reg # 022716)
(Penicillin).
confirmed.
Decision: Approved

Brand Name +Dosage Form + Strength PPS Injection
Procaine Penicillin…………………200 mg
Streptomycin Sulphate……………..250 mg
Diary No. Date of R& I & fee 10748, 01-08-2017Rs 20,000/-, 27-07-2017
Type of Form Form-5
Reference Regulatory Authorities. Pharma Vet Westindies.
Me-too status Strep-pen injection of Nawan labs (Reg # 022716)
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Cloxacillin Injection
Cloxacillin 50mg as Cloxacillin Sodium
Amoxicillin 100mg as Amoxicillin Trihydrate
Type of Form Form-5
Approval status of product in Veterinary Amoxicil
Reference Regulatory Authorities. Zuche Pharmaceuticals India
Me-too status Clomix injection of Alina Combine (Reg # 049680)
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Cloxacillin Injection
Cloxacillin…………….50mg as Cloxacillin Sodium
Amoxicillin……………100mg as Amoxicillin
Trihydrate
Type of Form Form-5
Approval status of product in Veterinary Amoxicil of Zuche Pharmaceuticals, India
Me-too status Clomix injection of Alina Combine (Reg # 049680)
(Penicillin).
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Amoxigent Injection
Amoxicillin (as Trihydrate)………..100 mg
Gentamicin (as Sulfate)……………..25 mg
Type of Form Form-5
Approval status of product in Amoxigentin injection of Agrovet; Spain
Me-too status Genmoxtic injection of International pharma lab
(Penicillin).
Brand Name +Dosage Form + Strength Amoxigent Injection
Amoxicillin (as Amoxicillin Trihydrate)……....100 mg
Gentamicin (as Sulfate)…………….25 mg
Type of Form Form-5
Approval status of product in Amoxigentin injection
Reference Regulatory Authorities. Agrovet Spain
Me-too status Genmoxtic injection of International pharma lab
(Penicillin).
Brand Name +Dosage Form + Strength Gentacillin Injection
Gentamicin sulphate Eq. to Gentamicin …..…..25mg
Amoxicillin Trihydrate Eq. to Amoxicillin …..50mg
Pharmacological Group (Penicillin/ Antibiotic)
Type of Form Form-5
Me-too status Genta-AC injection of Alina combine (Reg # 048290)
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Gentacillin Injection
Gentamicin sulphate Eq. to Gentamicin ……..25mg
Amoxicillin Trihydrate Eq. to Amoxicillin..50mg
Type of Form Form-5
Me-too status Genta-AC injection of Alina combine (Reg # 048290)
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Amoxicla Injection
Composition Each ml contains.
Amoxicillin (as Amoxicillin Trihydrate).....140 mg
Clavulanic Acid (as Potassium Clavulanate)…35 mg
Type of Form Form-5
Approval status of product in Synolox RTU Injection of Pfizer Ltd, UK
Me-too status Nugmentan injection of Nawan lab (Reg # 072675)
Decision: Approved
Brand Name +Dosage Form + Strength Amoxicla Injection
Amoxicillin (as Amoxicillin Trihydrate)BP....140 mg
Clavulanic Acid (as Potassium Clavulanate)
USP…35mg
Type of Form Form-5
Approval status of product in Synolox RTU Injection of Pfizer Ltd, UK
Me-too status Nugmentan injection of Nawan lab (Reg # 072675)
Decision: Approved
Brand Name +Dosage Form + Strength PBD L.A Injection
Procaine Penicillin G……150,000IU
Benzathine Penicillin G ….…..100,000IU
Dihydrostreptomycin Sulphate....200mg
Type of Form Form-5
Approval status of product in PPS Injection
Reference Regulatory Authorities. DAE Sung South Korea.
Me-too status Pencin-LA injection of Star lab (Reg # 063626)
confirmed.
Sheeps, Goats, Calves, Cattle
Decision: Approved
Oral powder (Penicillin) Veterinary (09 Molecules/13 Files)

Brand Name +Dosage Form + Strength Amoxiriq-50 Oral Powder
Amoxicillin as Amoxicillin Trihydrate……500 mg
Type of Form Form-5
Pack size & Demanded Price 100g,250g, 500g,1Kg,2.5Kg,5Kg,10Kg,25Kg ;
Decontrolled
Approval status of product in Amoxicillin 500mg/g of Global vet health, UK
Me-too status Primox 50% of Prix Pharmaceutica (Reg # 063899)
(Penicillin).
Cows, Sheeps, Goats, Dogs, Horses
Decision: Approved

Brand Name +Dosage Form + Strength Trimox-20 Oral Powder
Amoxicillin as amoxicillin trihydrate……200 mg
Diary No. Date of R& I & fee 10712 , 01-08-2017, Rs 20,000/-, 27-07-2017
Type of Form Form-5
Decontrolled
Approval status of product in Amoxicillin 20% pro Injection of Alfasan, The
Reference Regulatory Authorities. Netherlands
Me-too status Amoxicin-20 Oral Powder of Nawan Lab
(Penicillin).
Decision: Approved
Brand Name +Dosage Form + Strength Amoxilvet Oral Powder
Composition Each 100gm contains:
Amoxicillin Trihydrate……..… 80 gm
Equivalent to 70 gm of Amoxicillin
Type of Form Form-5
Decontrolled
Approval status of product in Amatib 800 mg/g oral powder of KRKA, d.d., Novo
Reference Regulatory Authorities. mesto, UK

(Penicillin).
Cows, Sheeps, Goats, Dogs, Horses
Decision: Approved

Brand Name +Dosage Form + Strength BPS-100 Powder
Procaine Penicillin………………12 gm
Streptomycin Sulphate……….....36 gm
Zinc Bacitracin………….…..…..52 gm
Type of Form Form-5
Decontrolled
Approval status of product in PSB Shong Shanian Pharma China
Me-too status Pribiotic Oral Powder of Prix (Reg # 063898)
Decision: Approved
Brand Name +Dosage Form + Strength BPS-Plus Powder
Composition Each 1000 gm powder contains:
Procaine Penicillin…………........12 gm
Streptomycin Sulphate….…........36 gm
Colistin Sulphate……………..…60MIU
Zinc Bacitracin…………………...52 gm
Type of Form Form-5
Decontrolled
Approval status of product in PSB
Reference Regulatory Authorities. Shong Shanian Pharma China
Me-too status Ultra Grow Powder of Intervac (Reg # 071034)
(Penicillin).
Decision: Approved

Brand Name +Dosage Form + Strength Lincomox-S Oral Powder
Amoxicillin Trihydrate….. 200mg
Lincomycin HCl…………... 88mg
Spectinomycin Sulphate……….88mg
Vitamin-E Acetate………... .30mg
Pharmacological Group Antibiotic, vitamin
Type of Form Form-5
Pack size & Demanded Price 100g,250g, 500g,1Kg,2.5Kg,5Kg,10Kg,25Kg;
Decontrolled
Approval status of product in Speclink-50 WSP
Reference Regulatory Authorities. Biomeda Irland
Me-too status Lincomoxel Plus oral Powder of Selmore
Pharmaceuticals
 Clarification of salt form is required.
Brand Name +Dosage Form + Strength Moxabect Water soluble powder
Amoxycillin Trihydrate…….……200 gm
Colistin Sulphate…………….. 800 M.I.U
Type of Form Form-5
Decontrolled
Approval status of product in Vet Colis 200WSP
Reference Regulatory Authorities. Shandong Uxovet Pharma, China
Me-too status Ascot WSP of Decent Pharma (Reg # 079841)
(Penicillin).
confirmed.
Decision:Deferred for clarification of strength of applied formulation in terms of
amoxicillin base.
Brand Name +Dosage Form + Strength ColiMox-10 Water soluble powder
Amoxycillin Trihydrate…….....…100 mg
Colistin Sulphate…………………500,000.I.U
Type of Form Form-5
Decontrolled
Approval status of product in Bacolam powder
Reference Regulatory Authorities. Fatro Pharma Italy.
Me-too status Colimoxin WSP of Selmore Pharmaceuticals (Reg #
034583)
(Penicillin).
confirmed.
Decision:
Deferred for clarification of strength of applied formulation in terms of amoxicillin base.
Brand Name +Dosage Form + Strength Cillin-23 Water soluble powder
Amoxycillin Trihydrate………….....230 gm
Colistin Sulphate………………….1000 MIU
Type of Form Form-5
Decontrolled
Approval status of product in Vet Colis 200WSP
Reference Regulatory Authorities. Shandong Uxovet Pharma China
Me-too status Senacilin WSP of Decent Pharma (Reg # 079845)
(Penicillin).
confirmed.
Decision:
Deferred for clarification of strength of applied formulation in terms of amoxicillin base.
Brand Name +Dosage Form + Strength Spectocillin Oral Powder
Amoxycillin Trihydrate…….......…10 gm
Lincomycin …………………...……5 gm
Spectinomycin sulphate………....…5 gm
Type of Form Form-5
Decontrolled
Approval status of product in Lincomycin-Spectinomycin Powder
Reference Regulatory Authorities. Agri Laboratories Joseph
Me-too status Moxapect oral Powder of Biogen Pharma (Reg #
048241)
confirmed.
 Clarification of salt form is required
amoxicillin base and spectinomycin base.
Brand Name +Dosage Form + Strength Moxacol-N Water soluble powder
Neomycin Sulphate………...….200 gm
Amoxycillin Trihydrate…..…...100 gm
Colistin Sulphate……………….50 gm
Type of Form Form-5
Decontrolled
Approval status of product in Amoxycol WS
Reference Regulatory Authorities. Avivet Pharma India
Me-too status NEO AC Water Soluble Powder of Decent Pharma
Reg # 079844)
confirmed.
 Clarfication of salt form is required.
amoxicillin base.
Brand Name +Dosage Form + Strength Clavexine Oral Powder
Amoxycillin as Amoxycillin Trihydrate……16 gm
Clavulanic Acid as potassium clavulanate….…..4 gm
Bromhexine HCl……………......0.5 gm
Pharmacological Group (Penicillin Antibiotic, mucolytic)
Type of Form Form-5
Decontrolled
Approval status of product in Clamox Powder
Reference Regulatory Authorities. Haupt Pharma Italy
Me-too status Clavmox-Forte Powder of Sana Lab (Reg # 081697)
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Moxalinco-B Water soluble powder
Amoxycillin Trihydrate……….…10 gm
Lincomycin HCl…………...……5 gm
Colistin Sulphate………………50 MIU
Bromhexine HCl…………….......0.5gm
Type of Form Form-5
Decontrolled
Approval status of product in Amoxycoli WSP of Mercator Pharmaceutical Solution
Reference Regulatory Authorities. China.
Me-too status Moxin-L Water Soluble Powder of Attabak Pharma
(Reg # 071053)
confirmed.
Decision: Approved

Case No.03. M/s. Intervac (Pvt) Ltd, 18km, Lahore sheikhupura Road, Sheikhupura.
Registration applications for two additional sections viz Veterinary Oral Dry powder
Suspension (Penicillin) & Veterinary liquid vial injection (Hormone), approved by the
Central Licensing Board vide letter No.F.1-37-2004-Lic (Vol-I) dated 11th April, 2017, were
submitted by M/s. Intervac (Pvt) Limited, 18km, Lahore sheikhupura Road, Sheikhupura.
Accordingly, the dossiers of 17 products related to these sections were as follows:
No. of No. of Deferred
S. No. Name of sections
products molecules cases
1. Hormone Liquid vial injection
7 9 2
(Veterinary)
2. Penicillin Oral Dry powder
8 8 -
Suspension (Veterinary)
Veterinary liquid vial injection (Hormone):

Products-9, Molecules-9
1103. Name and address of manufacturer M/s. Intervac (Pvt) Limited, 18km, Lahore
/Applicant sheikhupura Road, Sheikhupura.
Brand Name +Dosage Form + Strength Heatafas Injection
Dinoprost tromethamine responding to
Dinoprost………………….5mg
Type of Form Form-5
Finished Product Specification Firm has claimed in-house specifications
Approval status of product in Reference Lutalyse® Injection of Zoetic Inc. USFDA
Me-too status Lutalyse Injection of Upjohn, Islamabad (Reg #
015481)
GMP status  The CLB recommended the grant of Veterinary
Oral Dry Powder Suspension (Penicillin),
Veterinary Liquid vials injection (Hormone).
Remarks of the Evaluator.  The pharmacological group of the applied product
is “Prostaglandin F2α”. Clarification is required
whether the applied can be manufactured in the
hormone section.
Decision: Approved
1104. Name and address of M/s. Intervac (Pvt) Limited, 18km, Lahore
manufacturer/Applicant sheikhupura Road, Sheikhupura.
Brand Name +Dosage Form +Strength Progefas Injection
Progesterone ………………….25mg
Pharmacological Group Hormones
Type of Form Form-5
Reference RegulatoryAuthorities.
Me-too status I-Proges Injection of International pharma Labs (Reg #
074758)
Remarks of the Evaluator.  The applied product is present in USP but the
monograph does not specify for veterinary use only
Decision: Approved
manufacturer/Applicant sheikhupuraRoad, Sheikhupura.
Brand Name +Dosage Form +Strength Prednidex injection
Composition Each ml contain
Prednisolone……………. 9mg.
Dexamethasone ……………3mg
Pharmacological Group corticostroids
Type of Form Form-5
Approval status of product in Could not be verified
Me-too status LA-Dexpred Injection of International Pharma Labs
Remarks of the Evaluator.  The submitted me-too reference is of different
strength/composition.
 Confirmation of steroidal hormone section is
required.
Decision: Deferred for followings:
 Confirmation of generic / me-too status
 Submission of evidence of approval of section/manufacturing facility of “Liquid Injectable
(Steroidal Hormone) section” by the Central Licensing Board.
Brand Name +Dosage Form +Strength Lecirfas Injection
Lecirelin ………………….25mcg.
Type of Form Form-5
Pack size & Demanded Price 10×2 ml; Decontrolled
Approval status of product in Dalmarelin 25mcg/ml of Fatro S.P.A, Italy, Ireland
Me-too status Serilin Injection of Selmore pharma (Reg # 071092)
Remarks of the Evaluator.  The applied product has been confirmed from drug
database of Ireland. However, Ireland is not our
reference country.
 The description of applied product in reference
country is as follows:
Lecirelin acetate equivalent to lecirelin………25
micrograms
Decision: Deferred for clarification as reference product approved by Ireland, which is
available as Lecirelin acetate equivalent to lecirelin.25 micrograms, the firm has applied for
Lecirelin.25 microgram.
Brand Name +Dosage Form +Strength Bestrol Injection
Stilboestrol Dipropionate ……………….10mg
Type of Form Form-5
Me-too status Stilboestrol Injection of P.D.H Lahore (Reg # 002151)
reference regulatory authority is required.
Decision: Approved
Brand Name +Dosage Form + Strength Busefas Injection
Composition Each ml contains: -
Buserelin acetate…0.0042mg eq to 0.004mg Buserelin
Type of Form Form-5
Approval status of product in Reference Busol – 0.004 mg/ml solution for injection aniMedica
Regulatory Authorities. GmbH, UK
Me-too status Conceptal Injection of Star Laboratories (Pvt) Ltd,
Lahore (Reg # 058939)
Decision: Approved
Brand Name +Dosage Form +Strength Proge+AE Injection
Progesterone ………………….50mg
Vitamin A …………………….5000 IU
Vitamin E ……………………..15 IU
Pharmacological Group Hormones, vitamin
Type of Form Form-5
Approval status of product in Could not be verified.
Me-too status Progest-AE Injection of Alina combine Pharma (Reg #
063699)

Decision: Approved
Brand Name +Dosage Form +Strength Dexafas Injection
Dexamethasone Sodium Phosphate eq.to
Dexamethasone ……1mg
Diary No. Date of R& I & fee 211, 28-04-2011
Pharmacological Group Steroid
Type of Form Form-5
Finished Product Specification
Pack size & Demanded Price 100ml,; Decontrolled
Me-too status Dexavet Injection of Star lab
Previous Decision Deferred in 254th Drug Registration Board meeting
for following reasons:
 Finished product specifications are not provided.
 Segregated vial section approval is required.
 The firm do not have distillation unit for the
manufacturing ofWFI.
 Differential fee of 12000 is not provided.
 Last inspection report conducted within period of 1
year is notprovided.
 Commitment as per the decision of Board is not
provided.
 Outline method of manufacture is not provided.
 As per policy of Board only one registration be
granted for one application.
Evaluation of Firm‟s reply Following documents were provided
 The firm has submitted commitment as per the
decision of Board
 The firm has submitted me-too “Dexavet injection”
of Star labs which is of different strength in DRAP
database.
 The firm has submitted fee-challan of 12000/-
(photocopy attached.
 Volume of 100ml was specified for registration
application.
 Confirmation of generic / me-too status
 Reference of finished product specifications

Brand Name +Dosage Form +Strength Penafas Injection

Prednisolone (as acetate)………………..……7.5mg
Dexamethasone (as sodium phosphate)……… 2.5mg
Diary No. Date of R& I & fee 278, 13-11-2012, 20,000/-
Pharmacological Group Steroids
Type of Form Form-5
Finished Product Specification In-house specifications
Pack size & Demanded Price 10ml, 30ml, 50ml, 100ml & 200ml; Decontrolled
Reference RegulatoryAuthorities.
Me-too status Pronil injection of Selmore Pharma
Previous Decision  Deferred for confirmation from Licensing Division,
DRAP, for segregated section for steroid injection
manufacturing.
Evaluation of Firm‟s reply  Now the firm has been granted “Veterinary liquid
vial injection (Hormone)” section.
 The me-too reference could not be verified from
available database of DRAP.

Veterinary Oral Dry powder Suspension (Penicillin):
Products-8, Molecules-8
1112. Name and address of manufacturer / M/s. Intervac (Pvt) Limited, 18km, Lahore
Applicant sheikhupura Road, Sheikhupura.
Brand Name +Dosage Form + Strength Super Grow Powder (Feed premix)
Composition Each 1000 gm powder Contain
Procaine Penicillin………….. 12 gm.
Streptomycin Sulphate………. 36 gm.
Zinc Bacitracin ………………. 52 gm.
Pharmacological Group Anti-biotics (Veterinary preparation)
Type of Form Form-5
Pack size & Demanded Price 1Kg , 5kg, 10kg, 20kg, 25kg; Decontrolled
Me-too status PSB-100 Powder of EPLA Labs, Karachi (Reg #
013257)
Brand Name +Dosage Form + Intermox-500 Oral Powder
Strength
Amoxicillin as Amoxicilin Trihydrate ….. 500mg
Pharmacological Group Penicillin (Veterinary preparation)
Type of Form Form-5
Pack size & Demanded Price 100gm, 150gm, 250gm,5Kg, 1Kg, 5Kg, 25Kg;
Decontrolled
Approval status of product in Amoxicillin 500mg/g of Global vet health, UK
Me-too status Amoxi-50 WSP of Symans Pharmaceuticals (Reg #
063484)
Decision: Approved
1114. Name and address of M/s. Intervac (Pvt) Ltd, 18km, Lahore sheikhupura
manufacturer/Applicant Road, Sheikhupura.
Brand Name +Dosage Form +Strength - Lincospect-C powder
Composition - Each 150gm contains:
Lincomycin as HCl ……………6.66gm
Spectinomycin as HCl ………..13.34 gm
Colistin sulphate ………………5gm
Type of Form Form-5
Pack size & Demanded Price 100gm, 150gm,250gm, 500gm,1000gm,
5000gm;Decontrolled
Me-too status LINCO-S Powder of Attabak Pharma
Remarks of the Evaluator.  The submitted me-too reference is of different
Decision:
Deferred for confirmation of generic / me-too status.
Brand Name +Dosage Form +Strength - Lincospect+A Powder

Spectinomycin HCl….. ………………..5gm
Lincomycin HCl……………………..…5gm
Amoxicillin (Amoxicillin Trihydrate)……. 10gm
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm,1000gm; Decontrolled
Me-too status Limox-P of Biolabs Islamabad (Reg # 043174)
Decision: Approved
Brand Name +Dosage Form +Strength - Lincospectomix WSP
Composition - Each gm contains
Lincomycin HCl (as base) ……….… 88mg
Spectinomycin sulfate tetrahydrate (as base)….88mg.
Amoxicillin as trihydrate……………………... 200mg
Vitamin E acetate………..……….. 30mg
Diary No. Date of R& I & fee 326, 25-04-2017, 20,000/-,25-04-2017
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1kg; Decontrolled
Me-too status Lincamox-S WSP of Breeze pharma (Reg # 063788)
Decision: Approved

Brand Name +Dosage Form + Strength Enromox+C Powder
Composition Each Kg contains
Enrofloxacin HCl……………………….. 100gm
Amoxicillin Trihydrate ………………….. 100gm
Colistin sulphate ………………………….. 50gm
Type of Form Form-5
Pack size & Demanded Price 100gm, 200gm, 500gm, 1 Kg, 2 Kg; Decontrolled
Me-too status Not provided by the firm.
Remarks of the Evaluator.  The firm did not submit evidence of already
approved formulation (me-too/generic) with DRAP.
Brand Name +Dosage Form +Strength - Clavomox Powder
Composition - Each gm contains:
Amoxicillin (As Amoxicillin Trihydrate)….. 160mg.
Clavulanic Acid (As Potassium Clavulanate)… 40mg.
Pharmacological Group Penicillin/β-lactamase inhibitor
Type of Form Form-5
Pack size & Demanded Price 100gm, 150gm, 250gm, 500gm,1000gm, 5000gm;
Decontrolled
Approval status of product in Could not be verified.
Me-too status CLAVET WSP of Selmore Pharmaceuticals (Reg #
034582)
Decision: Approved
Brand Name +Dosage Form +Strength Amoxycol Powder
Amoxicilin Trihydrate…………….….. 230gm
Colistin Sulphate ………………..…….. 50gm
Pharmacological Group Penicillin/Antibiotic
Type of Form Form-5
Pack size & Demanded Price 100gm, 150gm, 250gm, 500gm,1000gm, 5000gm;
Decontrolled
Me-too status AMOX-C Water Soluble Powder of Hirra
Pharmaceuticals
Remarks of the Evaluator.  The submitted me-too reference could not be
confirmed from available database of DRAP.
Case No.04: M/s. Farm Aid Group pharmaceuticals, Haripur

The CLB in its 253rd meeting held on 15th-16th May, 2017 has considered and
approved the grant of additional sections to M/s. Farm Aid Group, Plot No. 2/3, Phase I & II,
Hattar Industrial Estate, Haripur (Drug Manufacturing License No. 000298-formulation) as
under:
 Penicillin Dry Powder Section (Veterinary)
Now, the firm has applied for registration of 19 products in Penicillin Dry powder section
(Veterinary).
Penicillin Dry Powder Section (Veterinary):
10 molecules/19 products
Brand Name +Dosage Form + Strength Moxifarm 50 Oral Powder
Composition Each 100g contain :
Amoxicillin as Amoxicillin trihydrate…… 50gm
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm, 1kg, 2.5Kg, 5Kg;
Decontrolled
Approval status of product in Reference Amoxicillin 500mg/g of Global vet health, UK
GMP status The Panel inspection conducted on 20-03-2017
Penicillin Dry Powder section and renewal of DML.
Decision: Approved
Brand Name +Dosage Form + Strength Moxyfag 60% Oral Powder
Composition Each gm powder contains.
Amoxicillin Trihydrate equivalent to Amoxicillin
……600mg
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm, 500gm,1Kg, 2.5Kg; Decontrolled
Me-too status Triger Dry Powder of Selmore Pharmaceutical (Reg #
080958)
GMP status  The Panel inspection conducted on 20-03-2017
Penicillin Dry Powder and renewal of DML.
reference regulatory authority could not be
confirmed.
Decision: Approved
Brand Name +Dosage Form + Strength Pure Mox Oral Powder
Composition Each 100gm Powder contain:
Amoxicillin trihydrate……… 80 gm eq. to amoxicillin
base…….70gm
Type of Form Form-5
Approval status of product in Reference Amoxicillin Trihydrate 800mg/g of Krka d.d., Novo
Regulatory Authorities. Mesto-Netherland
Decision: Approved
Brand Name +Dosage Form + Strength Moxywell Oral Powder
Composition Each 100gm contains:-
Amoxicillin as Amoxicillin Trihydrate………...50gm
Colistin Sulphate……………………....50MIU
Type of Form Form-5
Pack size & Demanded Price 100gm, 250gm 500gm, 1kg, 2.5Kg, 5Kg; Decontrolled
Me-too status ATC-Forte W/S Powder Sanna Labs (Reg # 081695)
Decision: Approved
Brand Name +Dosage Form + Strength Mox-23 Oral Powder
Amoxicillin as AmoxicillinTrihydrate………..23gm
Colistin Sulphate………………100MIU
Type of Form Form-5
Decontrolled
Me-too status Pentamox W/S powder of Biogen Pharma (Reg #
071018)
Penicillin Dry Powder section and renewal of
DML.
Decision: Approved
Brand Name +Dosage Form + Strength Fagomox Oral Powder
Composition Each 100gm powder contains:-
Amoxicillin as amoxicillin trihydrate ………....20g
Colistin sulphate……………………………..…50MIU
Type of Form Form-5
Decontrolled
Me-too status  Pri-Bacstin WSP of Prix Pharmaceutica (Reg #
074033)
DML.
Decision: Approved
Brand Name +Dosage Form + Strength Micro Mox Oral Powder
Composition Each 100gm Powder contain :
Amoxicillin as Amoxicillin Trihydrate ……….. 15gm
Colistin Sulphate……………………….. 50MIU
Type of Form Form-5
Pack size & Demanded Price 100g, 250g, 500g, 1kg, 5kg, 10kg, 25kg; Decontrolled
Me-too status Extin-P Powder of M/s. Eros Pharmaceutical (Reg #
071024)
recommended the grant of additional section of Dry
Penicillin Powder and renewal of DML.
Remarks of the Evaluator.  The applied product is present in the list of
demanded veterinary products approved by
Government of KPK in 2017- 2018.
Decision: Approved
Brand Name +Dosage Form + Strength Moxel C Oral Powder
Composition Each 100 g powder contains.
Amoxicillin as Amoxicillin Trihydrate ……20gm
Colistin Sulphate ………………………….80MIU
Type of Form Form-5
Me-too status  Colimoxin Forte Powder of Selmore Pharma (Reg #
080961)
DML.
Decision: Approved
Brand Name +Dosage Form + Strength Fullmox Oral Powder
Amoxicillin as Amoxicillin Trihydrate ……15%
Colistin Sulphate ……………………….….550MIU
Type of Form Form-5
Me-too status  Am col water soluble powder of Inshal Pharmaceutical
(Reg # 073944)
Penicillin Dry Powder section (Veterinary) and
renewal of DML.
Decision: Approved
Brand Name +Dosage Form + Strength Skymox Oral Powder
Amoxicillin as Trihydrate …….…20%
Colistin Sulphate ………………..500MIU
Type of Form Form-5
Me-too status Amoxypep WSP of M/s. Inshal Pharma (Reg #
073945)
Decision: Approved
Brand Name +Dosage Form + Strength Lyzomoxy Oral Powder
Composition Each 1000g Contain :

Amoxycillin as trihydrate ……………..50gm
Lysozyme Chloride………………10gm
Guaifenesin………..……………. 35gm
Pharmacological Group Antibacterial, enzyme and expectorant
Type of Form Form-5
Me-too status Amoxy Add Powder of Hassan Brothers (Imported
from Korea; Reg # 069649)
DML.
Decision: Approved
Brand Name +Dosage Form + Strength NC Mox Oral Powder
Composition Each 1000gm contain :
Amoxicillin As trihydrate……………..100gm
Colistin Sulphate……………………… 50gm
Neomycin sulphate ……………………..200gm
Type of Form Form-5
Me-too status Neo AC Powder of Decent Pharma (Reg # 079844)
Decision: Approved

Brand Name +Dosage Form + Strength Cal Mox Oral Powder
Amoxicillin as Amoxicillin Trihydrate…… 16gm,
Calvulanic Acid as potassium…………………4gm
Bromhexine HCl……………………………….0.5gm
Type of Form Form-5
Me-too status Wealmox of Prix Pharmaceutica (Reg # 074034)
DML.
Decision: Approved
Brand Name +Dosage Form + Strength Moxi Line Oral Powder
Composition Each 100gm Powder contain
Lincomycin as HCl……………… 5gm
Spectinomycin as HCl…………… 5gm
Amoxicillin as Amoxicillin Trihydrate …10gm
Type of Form Form-5
Me-too status Salinobak WSP of Attabak Pharma (Reg # 063822)
recommended the grant of additional section of Dry
Penicillin Powder and renewal of DML
Remarks of the Evaluator.  The applied product is included in the demanded
list of Government of Punjab in 2016-2017.
Decision: Approved
Brand Name +Dosage Form + Strength T-Moxin Oral Powder
Composition Each 100gm powder contains
Amoxicillin Trihydrate ……………….20g
Lincomycin HCl………….….................8.8g
Spectinomycin 2HCl……...……………8.8g
Type of Form Form-5

Me-too status Lincomox Plus of Prix Pharmaceutica (Reg # 074035)
GMP status  The Panel Inspection conducted on 20-03-2017
Dry Penicillin Powder and renewal of DML.
Remarks of the Evaluator.  The applied product is included in the approved list
of Government of Punjab and demanded in 2016-
2017 (Total quantity 15000Kg).
Decision: Approved
Brand Name +Dosage Form + Strength Moxin S Oral Powder
Composition Each 1000gm contain
Amoxicillin as Amoxicillin Trihydrate ………. 100g,
Lincomycin as HCl …………….... 50g
Streptomycin 2HCl ………………. 50g
Type of Form Form-5
Me-too status Linkomox of Decent Pharmaceutical
Remarks of the Evaluator. The submitted me-too reference is of different
Brand Name +Dosage Form + Strength PBS FARM Oral Powder
Composition Streptomycin Sulphate………………..36gm
Procaine Penicillin ……………………12gm
Colistin Sulphate ………………………60MIU
Zinc Bacitracin…………………………52gm
Type of Form Form-5
Me-too status  Pen BS+C Powder of Epla Laboratories (Reg #
058723)
Decision: Approved

Brand Name +Dosage Form + Strength Lavomoxy Oral Powder
Amoxicillin as Amoxicillin Trihydrate……16gm
Clavulanic Acid as potassium …….…………….. 4gm
Type of Form Form-5
Me-too status Primox-Plus WS Powder Prix Pharmaceutica (Reg #
074026)
DML.
Decision: Approved
Brand Name +Dosage Form + Strength E-Mox Oral Powder
Composition Each gm Powder contains:
Amoxicillin Trihydrate eq. to base…………200mg
Lincomycin HCl as base…………….….88mg
Spectinomycin Sulphate as base……..…88mg
Vitamin E Acetat.………………………30mg
Pharmacological Group Antibacterial, vitamin
Type of Form Form-5
Me-too status Lincomoxel Plus oral Powder of Selmore Pharma (Reg
# 080960)
DML.
Decision: Approved

Case No. 07: Registration applications of drugs for which stability studies data is
required to be verified
a) New cases of stability studies for consideration

b) Deferred cases of stability studies
c) Verification Of Genuineness / Authenticity Of Stability Data And Associated
Documents
a) New cases of stability studies for consideration
Evaluator PEC-I
Sr. Name & Brand Name Type of International Previous DRB
No. Address of (Proprietary Name + Form, Availability / Local Decision /
Manufacturer / Dosage Form + Initial Diary Availability Remarks
Applicant Strength), & Date, Fee (if any)
Composition, (including GMP Inspection
Pharmacological differential Report Date &
Group, fee), Remarks
Finished Product Demanded
Specification Price / Pack
size
1139.M/s ATCO VELSOVIR Tablet Form 5-D EPCLUSA by M/s The Firm has
Laboratories 100mg / 400mg Gilead Sciences Inc. claimed
Limited, Dairy No. USA. Manufacturer‟s
B-18 SITE. Each film coated tablet 3916 Specifications.
contains:- 27-12-2016 Not applicable.
Karachi.
Velpatasvir…100mg Rs.50,000/- GMP compliant dated
Sofosbuvir…400mg Rs. 5,000/- 20-06-2016.
per tablet for
(Anti-Viral) 1‟s, 7‟s, 10‟s,
14‟s, 20‟s,
21‟s, 28‟s,
30‟s, 35‟s,
42‟s, 56‟s,
60‟s, 63‟s,
70‟s, 77‟s,
84‟s, 90‟s,
100‟s.
STABILITY STUDY DATA
Drug VELSOVIR Tablet 100mg / 400mg (Velpatasvir Co-povidone + Sofosbuvir)
Name of
M/s ATCO Laboratories Limited, Karachi.
Manufacturer
Manufacturer of API Velpatasvir Co-Povidone: M/s Xi‟an Reyphon Pharmaceutical Co., Ltd. China.
Sofosbuvir: M/s Pharmagen Limited Lahore.
API Lot No. Velpatasvir Co-Povidone: 161203
Sofosbuvir: 00511211/001/2017
Description of Pack Alu-Alu Blister Pack.
(Container closure
system)
Stability Storage Accelerated: 40°C ± 2°C & 75±5%RH
Condition Real Time: 30°C ± 2°C & 75±5%RH
Time Period Accelerated: 06 Months

Real Time: 06 Months
Frequency Accelerated: 0,1,3,6 (Month)
Real Time: 0,3,6 (Month)
Batch No. 15B17 16B17 17B17
Batch Size 2,500 Tablets 2,500 Tablets 2,500 Tablets
Manufacturing Date 08-02-2017 08-02-2017 08-02-2017
Date of Initiation 20-02-2017 20-02-2017 20-02-2017
No. of Batches 03
Date of Submission 18-08-2017 (Dy. No. 12428)
DOCUMENTS / DATA PROVIDED BY THE APPLICANT
Sr. Documents To Be Provided Status
No.
1. COA of API Sofosbuvir: Copy of COA from M/s Pharmagen
Limited Lahore is submitted.
Velpatasvir Co-Povidone: Copy of COA from M/s
Xi‟an Reyphon Pharmaceutical Co., Ltd. China is
submitted.
2. Approval of API by regulatory authority M/s Pharmagen Limited Lahore: Copy of GMP
of country of origin or GMP certificate of Certificate issued by DDG (Lahore) is submitted.
API manufacturer issued by regulatory M/s Xi‟an Reyphon Pharmaceutical Co., Ltd. China:
authority of country of origin. Copy of GMP Certificate for Pharmaceutical Products
in Xian issued by Gaoling Food and Drug
Administration China is submitted. Certificate Number
is not mentioned on GMP Certificate.
3. Protocols followed for conduction of Yes
stability study and details of tests.
4. Data of 03 batches will be supported by Yes
attested respective documents like
chromatograms, laboratory reports, data
sheets etc.
5. Documents confirming import of API etc. Sofosbuvir: Not applicable; since the API is from local
source (M/s Pharmagen Limited Lahore).
Velpatasvir Co-Povidone: Copy of ADC (Karachi)
attested invoice by M/s Xiamen Halosyntec Co., Ltd.
China is submitted.
6. All provided documents will be attested Yes
(name, sign and stamp) for ensuring
7. Commitment to continue real time Yes
stability study till assigned shelf life of
the product.
8. Commitment to follow Drug Yes
Specification Rules, 1978.
REMARKS OF EVALUATOR1
 The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03 Lab
Scale Batches).
 The firm has clarified that the description mentioned in the specifications mentioned in initial dossier
as “White to off-white film coated tablet” is proposed specification while the description mentioned
in the specifications submitted with the stability studies as “Reddish brown colored, oblong shape,

film coated tablet is established during development of product.
 Dissolution Parameters as mentioned in dossier are different from that mentioned in Stability Study
Data; however Dissolution Parameters as mentioned in Stability Data are as per US FDA Dissolution
Database.
 M/s Xi‟an Reyphon Pharmaceutical Co., Ltd. China: Copy of GMP Certificate for Pharmaceutical
Products in Xian issued by Gaoling Food and Drug Administration China is submitted. Certificate
Number is not mentioned on GMP Certificate.
 The firm has submitted following “Statement of Contract manufacturing”:
M/s Xi‟an Reyphon Pharmaceutical Co., Ltd. China (referred as “Reyphon Pharma”), current GMP
holder agree to sign as contract manufacturer of M/s Xiamen Halosyntec Co., Ltd (referred as
“Halosyntec”) to produce the following APIs and its intermediates:
o Sofosbuvir, Ledipasvir, Daclatasvir, Obeticholic Acid, Sacubatril + Valsartan, Asunaprevir,

Osimertinib, Grazoprevir, Velpatasvir.
Halosyntec, as technology holder, will be in full charge of the technical guidance and quality control
and have full distribution right of above products.
Registration Board was apprised that although GMP certificate was not provided by the firm but
GMP certificate No. SN20160193 was verified from SFDA’s website. The certificate is also
availableon M/s XI’AN Reyphon Pharmaceutical Co., Ltd., China’s website..
Decision: Registration Board deliberated that it has been decided that onsite inspection for
verification of data will be exempted as decided in instant meeting. Thus the Board decided as
follows:
Onsite inspectionby following panel to confirm genuineness/ authenticity of stability data and
associated documents, import of API, quality, specification, test analysis, facilities etc.
 Prof. Dr. Rafeeq Alam Khan, Merotorious Professor / Member Registration Board.
 Prof. Dr. Ghulam Sarwar, The Dean , Faculty of Pharmacy, Jinnah Universityfor Women
Karachi.
 Dr. Saif ur Rehman Khattak, Director/FGA, CDL, Karachi.
OR
Firm can submit requisite documents as decided in instant meeting in Case No. 02 (On site
investigation of submitted data).
Manufacturer Dosage Form + Initial Diary Availability Remarks
/ Applicant Strength), & Date, Fee (if any)
size
1140.M/s Sami TONOFLEX-P FORTE Form 5-D Tramadol/Paracetamol
Pharmaceuticals Tablets 75 mg / 650 mg
(Pvt.) Ltd. 75mg / 650mg Dairy No. Tablets by M/s Aspire
9791 dated Pharma Ltd. UK.
F-95, S.I.T.E. Each film coated tablet 24-07-2017
contains:- Not applicable.
Karachi. Tramadol HCl…75mg Rs.50,000/-
Paracetamol…650mg GMP compliant dated
As per DPC. 04-05-2017.
(Opioids in combination
with non-opioid
analgesics)

USP Specs
Drug TONOFLEX-P FORTE Tablets 75mg / 650mg (Tramadol HCl + Paracetamol)
Name of
M/s Sami Pharmaceuticals (Pvt.) Ltd. Karachi.
Manufacturer
Manufacturer of API Tramadol HCl: M/s Supriya Lifesciences Ltd. India.
Paracetamol: M/s Citi Pharma (Pvt.) Ltd. Kasur.
API Lot No. Tramadol HCl: SLL/TDM/0216007-A
Paracetamol: PGS16-083
(Container closure
system)
Batch No. Lab-01 Lab-02 Lab-03
Manufacturing Date January 2017 January 2017 January 2017
Date of Initiation January 2017 January 2017 January 2017
No. of Batches 03
No.
1. COA of API Paracetamol: Yes
Tramadol HCl: Yes
2. Approval of API by regulatory authority M/s Citi Pharma (Pvt.) Ltd. Kasur: Copy of GMP
of country of origin or GMP certificate of Certificate issued by DDG (Lahore) is submitted.
API manufacturer issued by regulatory M/s Supriya Lifesciences Ltd. India: Copy of GMP
authority of country of origin. Certificate issued by Food and Drug Administration
(Maharashtra) India is submitted.
sheets etc.
5. Documents confirming import of API etc. Paracetamol: Not applicable, since the API is
purchased from local source; M/s Citi Pharma
(Pvt.) Ltd. Kasur.
Tramadol HCl: Copy of ADC (Karachi) attested
Commercial Invoice is submitted.

the product.
Scale Batches.
follows:
 Director DTL, Karachi.
OR
Manufacturer Dosage Form + Initial Diary Availability Remarks
/ Applicant Strength), & Date, Fee (if any)
size
1141.M/s Global CORDIN Gel 4% Form 5
Not available in
Pharmaceuticals reference SRAs,
(Pvt.) Ltd. Each gram contains:- Dairy No. However available in
17440 dated WHO Model List of
Plot # 204-205, Chlorhexidine 09-10-2017 Essential Medicines
Industrial Gluconate 7.1% eq. to for Children and
Triangle Kahuta Chlorhexidine…4%w/w Rs.50,000/- Nepal, Nigeria.
Road.
(Bisbiguanide As per DRAP GMP compliant dated
Islamabad. Disinfectant) Policy. 12-07-2017.
BP Specs.
Drug CORDIN Gel 4% (Chlorhexidine Gluconate)
Name of
M/s Global Pharmaceuticals (Pvt.) Ltd. Islamabad.
Manufacturer
Manufacturer of API M/s Unilab Chemicals & Pharmaceuticals (Pvt.) Ltd. India
API Lot No. F/006/16
Description of Pack Aluminum Tubes
(Container closure
system)
Time Period Accelerated: 26 Weeks
Real Time: 26 Weeks
Frequency Accelerated: 0,6,8,12,16,20,24,26 (Weeks)
Real Time: 0,6,8,12,16,20,24,26 (Weeks)
Batch No. T-006(Q) T-007(Q) T-008(Q)
Batch Size 100 Tubes 100 Tubes 100 Tubes
Manufacturing Date 02-2017 02-2017 02-2017
No. of Batches 03
No.
1. COA of API
Yes
2. Approval of API by regulatory authority Copy of Certificate of a Pharmaceutical Product

of country of origin or GMP certificate of (Chlorhexidine Gluconate Solution BP) marked YES at
API manufacturer issued by regulatory 3.3,issued by Food and Drug Administration
authority of country of origin. (Maharashtra) India is submitted. Importing Country is
mentioned „As per Annexure‟; however the annexure is
not enclosed.
sheets etc.
5. Documents confirming import of API etc. Copy of ADC (Islamabad) attested Commercial Invoice
is submitted.
the product.
 The firm has provided 26 Weeks Accelerated and 26 Weeks Real Time Stability Data for 03 Lab
Scale Batches.
 Copy of Certificate of a Pharmaceutical Product (Chlorhexidine Gluconate Solution BP) marked
YES at 3.3,issued by Food and Drug Administration (Maharashtra) India is submitted. Importing
Country is mentioned „As per Annexure‟; however the annexure is not enclosed.
The Registration Board was apprised that the firm has submitted copy of GMP certificate No.
6077690 issued by FDA, Maharashtra, India for M/s Unilab Chemicals & Pharmaceuticals (Pvt.)
Ltd. India.

follows:
 Additional Director (E&M), DRAP Islamabad
 Director DTL Rawalpindi
 Area FID, DRAP, Islamanbad
OR
Sr. Name & Brand Name Type of Form, International Previous DRB
No. Address of (Proprietary Name + Initial Diary & Date, Availability / Decision /
Manufacturer Dosage Form + Fee (including Local Remarks
/ Applicant Strength), differential fee), Availability (if any)
Composition, Demanded Price /
Pharmacological Pack size GMP
Group, Inspection
Finished Product Report Date
Specification & Remarks
1142.M/s Dyson SOVIR Tablets 400mg Form 5D SOVALDI by The firm had
Research M/s Gilead claimed
Laboratories Each film coated tablet Diary No. 1628 dated Sciences Inc. Manufacturer‟s
contains: 17/07/2014 USA. Specifications.
(Pvt.) Ltd., 28
Km, Ferozpur Sofosbuvir…. 400mg Rs. 50,000/- Not applicable. Decision 253rd
Road, RB Meeting:
(Direct acting antiviral) As per SRO for 28‟s. GMP Board decided
Lahore. Compliant to defer all the
dated 01-08- cases till
2017. provision of
scientifically
rationale lab
scale stability
data in
accordance
with the
guidelines
approved by
the Board in
251st meeting.
Drug SOVIR Tablets 400mg (Sofosbuvir)
Name of Manufacturer M/s Dyson Research Laboratories, Lahore.
Manufacturer of API M/s Ruyuan HEC Pharm Co., Ltd. China.
API Lot No. YAK-RD201608202
(Container closure
system)

Real Time: 24 Weeks
Frequency Accelerated: 0,1,2,3,4,6,8,12,16,20,26 (Week)
Real Time (Week)
0,12,16,20,24,26 0,4,6,8,12,16,20,24,26 0,2,4,6,8,12,16,20,24,26
Batch No. T1/16 BF002/16 BF003/17
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority Copy of GMP Certificate for Pharmaceutical Products
of country of origin or GMP certificate of issued by Shaoguan Food and Drug Administration,
API manufacturer issued by regulatory China is submitted. Certificate Number is not mentioned
authority of country of origin. on GMP Certificate.
Copy of GMP Certificate for Pharmaceutical Products
(No. 2015001) issued by Center for Certification &
Evaluation, Guangdong Food and Drug Administration ,
China is submitted.
sheets etc.
5. Documents confirming import of API etc.
Copy of ADC (Lahore) attested commercial invoice is
submitted.

stability study till assigned shelf life of the
product.
8. Commitment to follow Drug Specification Yes
Rules, 1978.
Scale Batches.
 Dissolution Parameters as submitted with the dossier are not as per US FDA Dissolution Database.
Whereas Dissolution Parameters as submitted with Stability Data are as recommended by US FDA
Dissolution Database.
Decision: Registration Board decided that the following panel may be constituted for onsite
investigation to confirm genuineness/ authenticity of stability data and associated documents,
import of API, quality, specification, test analysis, facilities etc.
 Dr. Rafeeq Alam Khan, Meritorius Professor / Member Registration Board.
 Dr. Obaidullah, Additional Director (PE&R), DRAP, Islamabad.
 Additional Director, DRAP, Lahore.
Group, Inspection
1143.M/s Ferozsons LEDISA Tablets 400/90 Form 5D HARVONI by The firm has
Laboratories mg M/s Gilead claimed
Ltd. Diary No. 4192 dated Sciences Inc. Manufacturer‟s
Each film coated tablet 21/10/2016 USA. Specifications.
Amangarh, contains:
Nowshera, Rs. 50,000/- Not applicable.
Sofosbuvir…. 400mg
Khyber Ledipasvir…90mg As per DRAP Policy. GMP
PakhtunKhwa. Compliant
(Anti-viral) dated 25-08-
2016.
Drug LEDISA Tablets 400/90 mg (Sofosbuvir + Ledipasvir)
Name of Manufacturer M/s Ferozsons Laboratories Ltd. Khyber PakhtunKhwa.
Manufacturer of API Sofosbuvir: M/s Sequent Scientific Limited, India.
Ledipasvir Spray Dried Dispersion: M/s Sequent Scientific Limited, India.
API Lot No. Sofosbuvir: PS066990
Ledipasvir Spray Dried Dispersion: LPR1506001
Description of Pack HDPE Bottle
(Container closure
system)
Real Time: 26 Weeks
Frequency Accelerated: 0,1,2,3,4,6,8,12,16,20,24,26 (Week)
Real Time: 0,1,2,3,4,6,8,12,16,20,24,26 (Week)
Batch No. PD16N007 PD16N008 PD16N009
No. of Batches 03
Date of Submission 26/09/2017 (Dy. No. 16162)

No.
1. COA of API Yes
2. Approval of API by regulatory authority M/s Sequent Scientific Limited, India: Copy of GMP
of country of origin or GMP certificate of Certificate issued by Drugs Control Department
API manufacturer issued by regulatory (Karnataka), India is submitted.
authority of country of origin.
sheets etc.
5. Documents confirming import of API etc. Copy of License to import API (Sofosbuvir) issued by
ADC (Peshawar) is submitted.
Copy of License to import API (Ledipasvir spray dried
dispersion) issued by ADC (Peshawar) is submitted.
product.
Rules, 1978.
 The firm has provided 26 Weeks Accelerated and 26 Weeks Real Time Stability Data for 03 Batches.
Registration Board deliberated that it has been decided that onsite inspection for verification of
data will be exempted as decided in instant meeting. Thus the Board decided as follows:

 Additional Director, DRAP, Peshawar.
Or

Group, Inspection
1144.M/s Saffron SAFALDI Tablets Form 5D SOVALDI by The firm has
Pharmaceuticals 400mg M/s Gilead claimed
(Pvt.) Ltd. Diary No. 11027 Sciences Inc. Manufacturer‟s
Each film coated tablet dated 03-08-2017 USA. Specifications.
19 km, contains:
Sheikhupura Rs. 20,000/- dated 12- Not applicable. Verification
Road, Sofosbuvir…. 400mg 09-2014 (Photocopy) of fee is
GMP required.
Faisalabad. (Anti-viral) Rs. 30,000/- dated 18- Compliant
09-2014 dated 28-11-
(Photocopy) 2016.
Rs. 12,000/- for 28‟s

Drug SAFALDI Tablets 400mg (Sofosbuvir)
Name of Manufacturer M/s Saffron Pharmaceuticals (Pvt.) Ltd. Faisalabad.
Manufacturer of API M/s Ruyuan HEC Pharm Co., Ltd. China.
API Lot No. YAK-201603002
Description of Pack Alu- Alu Blister Pack
(Container closure
system)
Frequency Accelerated: 0,3,6 (Month)
Real Time: 0,1,3,6 (Month)
Batch No. T-002 T-003 T-004
No. of Batches 03
Date of Submission 21/09/2017 (Dy. No. 15793)
1. COA of API Yes
2. Approval of API by regulatory authority Copy of GMP Certificate (No. 2016002) issued by
of country of origin or GMP certificate of Shaoguan Food and Drug Administration, China is
API manufacturer issued by regulatory submitted.
authority of country of origin. Copy of GMP Certificate for Pharmaceutical Products
(No. 2015001) issued by Center for Certification and

Evaluation, Guangdong Food and Drug Administration,
China is submitted.
sheets etc.
5. Documents confirming import of API etc. Copy of ADC (Lahore) attested Commercial Invoice is
submitted.
product.
Rules, 1978.
Scale Batches.
Decision: The Registration Board decided to constitute following panel for onsite investigation to
confirm genuineness/ authenticity of stability data and associated documents, import of API,
quality, specification, test analysis, facilities etc.
 Dr. Obaidullah, Additional Director (Reg-I), DRAP, Islamabad.
 Additional Director, DRAP, Lahore.
Group, Inspection
1145.M/s Getz SILOGET Capsules Form 5D RAPAFLO by The firm has
Pharma (Pvt.) 8mg M/s Allergan claimed
Limited. Diary No. 2089 dated Sales LLC, Manufacturer‟s
Each capsules contains: 28/10/2016 USA. Specifications.
29-30-Sector For
27, Korangi, Silodosin….8mg Rs. 50,000/- Not applicable. Dissolution
Industrial Area. FDA
(Alpha adrenoreceptor Rs. 100/- per capsule. GMP recommends:
Karachi. antagonist) Compliant II (Paddle)
Rs. 1,000/- for 10‟s. dated 31-05- with sinker, 50
2016. RPM, 0.1 N
HCl, 900ml
Whereas firm
has submitted:
I (Basket), 100
RPM,
Methanol,

900ml.

Drug SILOGET Capsules 8mg (Silodosin)
Name of Manufacturer M/s Getz Pharma (Pvt.) Limited. Karachi.
Manufacturer of API M/s Zhejiang Tianyu Pharmaceutical Co., Ltd. China.
API Lot No. L20160909
Description of Pack Hard Gelatin Capsules,
(Container closure Alu-Alu Blister Pack.
system)
Real Time: 24 Weeks
Batch No. 402DS03 402DS04 402DS05
Batch Size 4,500 Capsules 4,500 Capsules 4,500 Capsules
Manufacturing Date 01 – 2017 02 – 2017 02 – 2017
Date of Initiation 02 - 2017 02 – 2017 03 – 2017
No. of Batches 03
No.
1. COA of API Yes
of country of origin or GMP certificate of (No. ZJ20130111). Issuing authority is not mentioned
API manufacturer issued by regulatory whereas Printed by State Food and Drug Administration,
authority of country of origin. China is mentioned.
sheets etc.
5. Documents confirming import of API etc. Copy of ADC (Karachi) attested commercial invoice is
submitted.
product.
Rules, 1978.
 The firm has provided 06 Months Accelerated and 06 Months Real Time Stability Data for 03
Batches.
 Dissolution Parameters as submitted with the dossier (I (Basket), 100 RPM, Methanol, 900ml) are not
as per US FDA Dissolution Database(II (Paddle) with sinker, 50 RPM, 0.1 N HCl, 900ml).
 Whereas Dissolution Parameters as submitted with Stability Data are as recommended by US FDA
Dissolution Database.
 Copy of GMP Certificate for Pharmaceutical Products (No. ZJ20130111). Issuing authority is not
mentioned whereas Printed by State Food and Drug Administration, China is mentioned.
follows:
 Prof. Dr. Rafeeq Alam Khan, Merotorious professor / Member Registration Board.
 Director DTL, Karachi.
OR
Group, Inspection
1146.M/s Aspin DASAVIR Tablets Form 5D DAKLINZA The firm has
Pharma (Pvt.) 30mg by M/s Bristol claimed
Ltd. Diary No. 387 dated - Myers Manufacturer‟s
Each film coated tablet 23/05/2016 Squibb USA. Specifications.
Plot No. 10 & contains:
25, Sector 20, Rs. 50,000/- Not applicable.
Korangi Daclatasvir
Industrial Area dihydrochloride eq. to As per SRO GMP
– 74900, Daclatasvir…30mg Compliant
dated 18-08-
Karachi. (Anti-viral) 2017.
Drug DASAVIR Tablets 30mg (Daclatasvir).
Name of Manufacturer M/s Aspin Pharma (Pvt.) Ltd. Karachi.
Manufacturer of API M/s Ruyuan HEC Pharm, China.
API Lot No. DSV-RD201604201B
Description of Pack HDPE Bottle.
(Container closure
system)

Batch No. 023/2017 024/2017 025/2017
No. of Batches 03
No.
1. COA of API Yes
of country of origin or GMP certificate of (No. 2016012) issued by Shaoguan Food and Drug
API manufacturer issued by regulatory Administration, China is submitted.
sheets etc.
submitted.
product.
Rules, 1978.
Batches.
Decision:Registration Board decided to constitute following panel for onsite investigation to confirm
genuineness/ authenticity of stability data and associated documents, import of API, quality,
specification, test analysis, facilities etc.
Karachi.

Group, Inspection
Korangi Daclatasvir
dated 18-08-
(Container closure
system)
Batch No. 020/2017 021/2017 022/2017
No. of Batches 03
No.
1. COA of API Yes
sheets etc.
submitted.
product.
Rules, 1978.
Batches.
Karachi.
Group, Inspection
Korangi Daclatasvir
dated 18-08-

(Container closure
system)
Batch No. 017/2017 018/2017 019/2017
No. of Batches 03
No.
1. COA of API Yes
sheets etc.
submitted.
product.
Rules, 1978.
Batches.
 Prof. Dr. Ghulam Sarwar, Dean , Faculty of Pharmacy, Jinnah Universityfor Women Karachi.

Group, Inspection
1149.M/s CCL GLUKANA Tablets Form 5D INVOKANA Verification
Pharmaceuticals 100mg by M/s Janssen of fee is
(Pvt.) Ltd. Diary No. 888 (PEC) Pharms, USA. required.
Each film coated tablet dated 19-10-2017.
62-Industrial contains: Not applicable. Duplicate
Estate, Kot Rs. 20,000/- dated 25- dossier was
Lakhpat, Canagliflozin (as 05-2015 (Photocopy) GMP presented for
hemihydrate)..100mg Compliant evaluation.
Lahore. Rs. 30,000/- dated 08- dated 21-03-
(Anti-diabetic) 09-2016 2016 (DML The firm has
(Photocopy) Renewal). claimed
Manufacturer‟s
As per brand leader Specifications.
for 10‟s, 14‟s, 30‟s.

Drug GLUKANA Tablets 100mg (Canagliflozin)
Name of Manufacturer M/s CCL Pharmaceuticals (Pvt.) Ltd. Lahore.
Manufacturer of API M/s Nantong Chanyoo Pharmatech Co., Ltd. China.
API Lot No. RD-CLF(hemihydrate)-201511081
Description of Pack Alu- PVC Blister Pack
(Container closure
system)
Real Time: 0,3,6,9,12,18 (Month)
Batch No. T2/15 T3/15 T4/15
Batch Size 1,000 Tabs 1,000 Tabs 1,000 Tablets
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority Copy of GMP Certificate issued by Nantong Chemical
of country of origin or GMP certificate of & Medical Industry Association China is submitted.

API manufacturer issued by regulatory
sheets etc.
5. Documents confirming import of API etc. Copy of Commercial Invoice No. CYI16395 dated
JUL.07, 2015 issued by M/s Changzhou Pharmaceutical
Factory is submitted.
The Firm has submitted a statement from M/s

Changzhou Pharmaceutical Factory stating that M/s
Nantong Chanyo Pharmatech Co. Ltd China is their
wholly owned-subsidiary.
product.
Rules, 1978.
Scale Batches.
 24th Month Stability Study Results to be conducted on 06-10-2017 are not included in submission.
 Copy of GMP Certificate issued by Nantong Chemical & Medical Industry Association China is
submitted.
follows:
associated documents, import of API, quality, specification, test analysis, facilities etc
 Director, Drug Testing Laboratory Government of Punjab, Lahore.

 Additional Director, Drug Regulatory Authority of Pakistan, Lahore.
 Area FID, DRAP, Lahore.
OR

Group, Inspection
1150.M/s CCL GLUKANA Tablets Form 5D INVOKANA Verification
Pharmaceuticals 300mg by M/s Janssen of fee is
(Pvt.) Ltd. Diary No. 887 (PEC) Pharms, USA. required.
Each film coated tablet dated 19-10-2017.
62-Industrial contains: Not applicable. The firm has
Estate, Kot Rs. 20,000/- dated 25- claimed
Lakhpat, Canagliflozin (as 05-2015 (Photocopy) GMP Manufacturer‟s
hemihydrate)..300mg Compliant Specifications.
Lahore. Rs. 30,000/- dated 08- dated 21-03-
(Anti-diabetic) 09-2016 2016 (DML
(Photocopy) Renewal).
As per brand leader

for 10‟s, 14‟s, 30‟s.
Drug GLUKANA Tablets 300mg (Canagliflozin)
Name of Manufacturer M/s CCL Pharmaceuticals (Pvt.) Ltd. Lahore.
API Lot No. RD-CLF(hemihydrate)-201511081
Description of Pack Alu- PVC Blister Pack
(Container closure
system)
Real Time: 0,3,6,9,12,18 (Month)
Batch No. T2/15 T3/15 T4/15
Batch Size 1,000 Tabs 1,000 Tabs 1,000 Tablets
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority Copy of GMP Certificate issued by Nantong Chemical
of country of origin or GMP certificate of & Medical Industry Association China is submitted.

sheets etc.
5. Documents confirming import of API etc. Copy of Commercial Invoice No. CYI16395 dated
JUL.07, 2015 issued by M/s Changzhou Pharmaceutical
Factory is submitted.
The Firm has submitted a statement from M/s

Changzhou Pharmaceutical Factory stating that M/s
Nantong Chanyo Pharmatech Co. Ltd China is their
wholly owned-subsidiary.
product.
Rules, 1978.
Scale Batches.
 24th Month Stability Study Results to be conducted on 06-10-2017 are not included in submission.
 Copy of GMP Certificate issued by Nantong Chemical & Medical Industry Association China is
submitted.
follows:
 Director, Drug Testing Laboratory Government of Punjab, Lahore.

 Additional Director, Drug Regulatory Authority of Pakistan, Lahore.
 Area FID, DRAP, Lahore.
OR

Group, Inspection
1151.M/s Scilife SOWAITA Tablets Form 5D EPCLUSA by The firm has
Pharma (Pvt.) 400/100mg M/s Gilead claimed
Ltd. Diary No. 1263 dated Sciences Inc. Manufacturer‟s
Each film coated tablet 21-09-2016. USA. Specifications.
Plot # FD- contains:
57/58-A2, Rs. 50,000/- Not applicable. The firm has
Korangi Creek Sofosbuvir...400mg requested to
Industrial Park. Velpatasvir...100mg As per DPC for 30‟s GMP change the
Compliant name to
Karachi. (Anti-viral) dated 29-03- SOFO-VEL
2016 (DML 400/100 mg
Renewal). Tablet.

Drug SOFO-VEL Tablets 400/100mg (Sofosbuvir + Velpatasvir)
Name of Manufacturer M/s Scilife Pharma (Pvt.) Ltd. Karachi.
Manufacturer of API Sofosbuvir: M/s Nantong Chanyoo Pharmatech Co., Ltd. China.
Velpatasvir and Copovidone Solid Dispersion: M/s Ruyuan HEC Pharm China.
API Lot No. Sofosbuvir: RD-SFB (Form VI) - 201609161
Velpatasvir and Copovidone Solid Dispersion: VEPII-201702001
Description of Pack Alu-Alu Blister Pack
(Container closure
system)
Batch No. SF001 SF002 SF003
Batch Size 800 Tablets 500 Tablets 500 Tablets
No. of Batches 03
No.
1. COA of API Sofosbuvir: Yes
Velpatasvir and Copovidone Solid Dispersion: Yes
th
2. Approval of API by regulatory authority M/s Nantong Chanyoo Pharmatech Co., Ltd. China:
of country of origin or GMP certificate of Copy of GMP Certificate (No. 2017006) issued by
API manufacturer issued by regulatory Nantong Food and Drug Administration, China is
authority of country of origin. submitted.
M/s Ruyuan HEC Pharm China: Copy of GMP
Certificate for Pharmaceutical Products (No. 2016009)
issued by Shaoguan Food and Drug Administration,
China is submitted.
sheets etc.
5. Documents confirming import of API etc. Sofosbuvir: Copy of ADC (Karachi) attested
Commercial Invoice is submitted.
Velpatasvir and Copovidone Solid Dispersion: Copy of
ADC (Karachi) attested Commercial Invoice is
submitted.
product.
Rules, 1978.
Scale Batches.
follows:
Karachi.
 Dr. Saif ur Rehman Khattak, Director/FGA, CDL, Karachi
OR
investigation of submitted data)

Sr. Dexlansoprazole - M/s OBS Pakistan, Karachi
No. Registration Board in its 235th meeting deferred following products of M/s OBS Pakistan,
Karachi for reason mentioned in last column.
1152.
Name of Drug & Pack Demanded Decision
Composition MRP
Kapdex 30mg Capsule 14‟s Rs.840.00 Deferred.
Not me- too product.
Each capsule contains:- May be referred to
Dexlansoprazole..30mg expert committee for
new molecule
(Anti ulcerants)
Registration Board in 245th meeting discussed same formulation and agreed to expert
opinions and advised the firms to provide data for stability studies conducted under zone IV-
A conditions as per ICH / WHO guidelines for consideration of Registration Board.
M/s OBS Pakistan, Karachi has deposited remaining fee (Rs.50,000/-) and requested to
consider their above formulations.
Decision 246th RB Meeting (Registration-II): Keeping in view decision of 245th meeting

of registration board regarding same formulation, the advised firm to provide data for
stability studies conducted under zone IV-A conditions as per ICH / WHO guidelines for
consideration of Registration Board.
Drug Kapdex Capsule 30mg (Dexlansoprazole DDR Pellets 22.5%)
Name of Manufacturer M/s OBS Pakistan, Karachi.
Manufacturer of API M/s Vision Pharmaceuticals, Islamabad.
API Lot No. DLP162T
Description of Pack Hard Gelatin Capsule Size #3,
system)
Time Period Accelerated: 06 MonthsReal Time: 06 Months
Batch No. EXP-C-06 EXP-C-07 EXP-C-08
Manufacturing Date October 2016 October 2016 October 2016
Date of Initiation December 2016 December 2016 December 2016
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of GMP Certificate issued by DDG (E&M),
country of origin or GMP certificate of Islamabad is submitted.

sheets etc.
5. Documents confirming import of API etc. Not Applicable, as the API is purchased from a local
source; M/s Vision Pharmaceuticals, Islamabad.
7. Commitment to continue real time stability Yes
study till assigned shelf life of the product.
Rules, 1978.
Scale Batches.
Decision: Deferred for further deliberation in the light of decision taken in 273rd meeting of
Registration Board regarding “Innovator‟s Formulation of Dexlansoprazole”.
Sr. Dexlansoprazole - M/s OBS Pakistan, Karachi

No. Registration Board in its 235th meeting deferred following products of M/s OBS Pakistan,
Karachi for reason mentioned in last column.
1153.
Name of Drug & Pack Demanded Decision
Composition MRP
Kapdex 60mg Capsule 14‟s Rs.1,260.00 Deferred.
Not me- too product.
Each capsule contains:- May be referred to
Dexlansoprazole..60mg expert committee for
new molecule
(Anti ulcerants)
Registration Board in 245th meeting discussed same formulation and agreed to expert
opinions and advised the firms to provide data for stability studies conducted under zone IV-
A conditions as per ICH / WHO guidelines for consideration of Registration Board.
M/s OBS Pakistan, Karachi has deposited remaining fee (Rs.50,000/-) and requested to
consider their above formulations.
Decision 246th RB Meeting (Registration-II): Keeping in view decision of 245th meeting

of registration board regarding same formulation, the advised firm to provide data for
stability studies conducted under zone IV-A conditions as per ICH / WHO guidelines for
Drug Kapdex Capsule 60mg (Dexlansoprazole DDR Pellets 22.5%)
Name of Manufacturer M/s OBS Pakistan, Karachi.

Manufacturer of API M/s Vision Pharmaceuticals, Islamabad.
API Lot No. DLP162T
Description of Pack Hard Gelatin Capsule Size #2,
system)
Batch No. EXP-C-09 006DS01 006DS02
Manufacturing Date October 2016 October 2016 October 2016
Date of Initiation December 2016 December 2016 December 2016
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of GMP Certificate issued by DDG (E&M),
country of origin or GMP certificate of Islamabad is submitted.
sheets etc.
5. Documents confirming import of API etc. Not Applicable, as the API is purchased from a local
source; M/s Vision Pharmaceuticals, Islamabad.
Rules, 1978.
Scale Batches.
 Significant Change (6.4%) was observed between initial (100.8%) and 6th Month (94.4%) Assay
Results for Accelerated Stability Study of Dexlansoprazole (Batch No. EXP-C-09).
Results for Accelerated Stability Study of Dexlansoprazole (Batch No. 006DS01).
Results for Accelerated Stability Study of Dexlansoprazole (Batch No. 006DS02).
 Limits specified for Assay Results are 90%-110%.
Registration Board regarding “Innovator‟s Formulation of Dexlansoprazole”
Manufacturer / Dosage Form + Fee (including Local Remarks
Applicant Strength), differential fee), Availability (if any)
Group, Inspection
1154. M/s Scotmann DASCOT Tablets 30mg Form 5 DAKLINZA The firm has
Pharmaceuticals by M/s Bristol claimed
Each film coated tablet Dairy No. 15006 Myers Manufacturer‟s
I-10/3 contains:- dated 14-09-2017 Squibb, USA. Specifications.
Islamabad. Daclatasvir as Rs.20,000/- CLAVIR by

Dihydrochloride…30mg M/s Hilton
As per SRO. Pharma,
(Anti-viral) Karachi.
GMP
compliant
dated 21-03-
2017.
Drug DASCOT Tablets 30mg (Daclatasvir)
Name of Manufacturer M/s Scotmann Pharmaceuticals, Islamabad.
Manufacturer of API M/s Virupaksha Organics Ltd. India.
API Lot No. ADLTC0517001
(Container closure
system)
Real Time: 12 Weeks
Frequency Accelerated: 0,1,2,3,4,6,8,12 (Week)
Real Time: 0,1,2,3,4,6,8,12 (Week)
Batch No. Trial#01 Trial#02 Trial#03
Date of Initiation 29/06/2017 29/06/2017 29/06/2017
No. of Batches 03
Date of Submission 08 Weeks Data 19-09-2017 (Dy. No. 15553)
th
12 Week Data 02-10-2017 (Dy. No. 16677)
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of Cover Letter for Issuance of GMP Certificate
country of origin or GMP certificate of by Joint Director & Licensing Authority, Drug Control
API manufacturer issued by regulatory Administration (Telangana) India is submitted.
authority of country of origin. However the Joint Inspection Report is not enclosed.
4. Data of 03 batches will be supported by The firm has provided supporting documents for 12
attested respective documents like Weeks Accelerated and 12 Weeks Real Time Stability
chromatograms, laboratory reports, data Data for 03 Lab Scale Batches.
sheets etc.
5. Documents confirming import of API etc. Copy of License to Import (Daclatasvir
Dihydrochloride) issued by ADC (Islamabad) is
submitted.
Rules, 1978.
 The firm has provided 12 Weeks Accelerated and 12 Weeks Real Time Stability Data for 03
Lab Scale Batches.
 Copy of Cover Letter for Issuance of GMP Certificate by Joint Director & Licensing
Authority, Drug Control Administration (Telangana) India is submitted. However the Joint
Inspection Report is not enclosed.
i. Submission of GMP certificate of API manufacturer issued by relevant regulatory
ii. Submission of complete 6 months data of both Accelerated and Real Time Stability
studies.
Manufacturer / Dosage Form + Fee (including Local Remarks
Applicant Strength), differential fee), Availability (if any)
Group, Inspection
1155. M/s Scotmann DASCOT Tablets 60mg Form 5 DAKLINZA The firm has
Pharmaceuticals by M/s Bristol claimed
Each film coated tablet Dairy No. 15005 Myers Manufacturer‟s
I-10/3 contains:- dated 14-09-2017 Squibb, USA. Specifications.
CLAVIR by
Islamabad. Daclatasvir as Rs.20,000/- M/s Hilton
Dihydrochloride…60mg Pharma,
As per SRO. Karachi.
(Anti-viral) GMP
compliant dt:
21-3-2017

Drug DASCOT Tablets 60mg (Daclatasvir)
Name of Manufacturer M/s Scotmann Pharmaceuticals, Islamabad.
Manufacturer of API M/s Virupaksha Organics Ltd. India.
API Lot No. ADLTC0517001
(Container closure
system)
Real Time: 12 Weeks
Frequency Accelerated: 0,1,2,3,4,6,8,12 (Week)
Real Time: 0,1,2,3,4,6,8,12 (Week)
Batch No. Trial#01 Trial#02 Trial#03
Date of Initiation 03/07/2017 03/07/2017 03/07/2017
No. of Batches 03
Date of Submission 08 Weeks Data 19-09-2017 (Dy. No. 15552)
th
12 Week Data 02-10-2017 (Dy. No. 16679)
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of Cover Letter for Issuance of GMP Certificate
country of origin or GMP certificate of by Joint Director & Licensing Authority, Drug Control
API manufacturer issued by regulatory Administration (Telangana) India is submitted.
authority of country of origin. However the Joint Inspection Report is not enclosed.
4. Data of 03 batches will be supported by The firm has provided supporting documents for 08
attested respective documents like Weeks Accelerated and 08 Weeks Real Time Stability
chromatograms, laboratory reports, data Data for 03 Lab Scale Batches.
sheets etc.
5. Documents confirming import of API etc.
Rules, 1978.
 The firm has provided 12 Weeks Accelerated and 12 Weeks Real Time Stability Data for 03 Lab Scale
Batches.
 Copy of Cover Letter for Issuance of GMP Certificate by Joint Director & Licensing Authority, Drug
Control Administration (Telangana) India is submitted. However the Joint Inspection Report is not
enclosed.
i. Submission of GMP certificate of API manufacturer issued by relevant regulatory authority
of country of origin.
ii. Submission of complete 6 months data of both Accelerated and Real Time Stability studies.
Evaluator PEC-II
1156. Name and address of manufacturer / M/s PharmEvo (Pvt.) Ltd, Karachi
Applicant
Brand Name +Dosage Form + Strength Empal 10 mg tablet
Empagliflozin….. 10mg
Diary No. Date of R& I & fee Dy No. 637; 19-10-2015, Rs.50,000/- (19-10-2015)
Type of Form Form 5-D
Approval status of product in Jardiance tablet of M/s Boehringer Ingelheim
Me-too status Not applicable
compliance level.
Previous Remarks of the Evaluator.
Drug Empal 10 mg tablet
Name of Manufacturer M/s PharmEvo (Pvt.) Ltd, Karachi
Manufacturer of API/pellets M/s Beijing Huikang Boyuan Chemical Tech Co., Ltd, China
API Lot No. 160120
Description of Pack
Alu-Alu foil blister packed in unit carton
(Container closure system)
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Time Period Real time: 6 months
Accelerated: 24 weeks
Frequency Real time: 0,1,2,3,4,6 (months)
Accelerated: 0,1,2,3,4,6,8,1012,1416,18,20,22,24 (weeks
Batch No. 16PD-1817- 16PD-1818-03-T 16PD-1819-04-T
02-T
Batch Size 2500 tablets 2500 tablets 2500 tablets
Manufacturing Date May-2016 May-2016 May-2016
No. of Batches 03
th
No.
1. COAs of API Yes
2. Approval of API by regulatory authority Copy of GMP certificate issued by Liaoning Fuxin
of country of origin or GMP certificate Management Committee for Fluoride Industrial
of API manufacturer issued by Development Zone has been submitted. The certificate
regulatory authority of country of origin. is valid upto 05-01-2019
3. Protocols followed for conduction of
Yes
4. Data of 03 batches will be supported by
Yes
sheets etc.
5. Documents confirming import of API Copy of invoice attested by ADC, DRAP Karachi has
etc. been submitted.
6. All provided documents will be attested
(name, sign and stamp) for ensuring Yes
7. Commitment to continue real time
stability study till assigned shelf life of Yes
the product.
8. Commitment to follow Drug
Yes
Remarks Of Evaluator2
 The firm has submitted 24 weeks Accelerated and 6 months of Real time Stability Study Data for 03
Batches.
 GMP certificate of supplier of API is not from any pharmaceutical regulatory authority.
Decision: Registration Board deferred the case for submission / clarification of GMP Certificate
issued by provincial / state drug administration.
Applicant
Brand Name +Dosage Form + Strength Locaserin 10mg Tablet
Lorcaserin hydrochloride ……. 10 mg
Diary No. Date of R& I & fee Dy No. 735, 14-05-2014, Rs.50,000/- (13-05-2014)
Pharmacological Group Anti-obesity
Finished Product Specification Pharmevo Specs.
Pack size & Demanded Price Rs. 72 per tabletRs. 720 per 10 tablets
Rs. 1008 per 14‟s tabletsRs. 2016 per 30‟s tablets
Approval status of product in Belviq tablet of Eiasi Inc. approved by USFDA
GMP status Last GMP Inspection of M/s PharmEvo (Pvt.) Ltd,
Karachi conducted on 01-04-2014 with conclusive
remarks of good level of cGMP compliance.
Previous Remarks of the Evaluator.

Drug Locaserin 10mg Tablet
Name of Manufacturer M/s PharmEvo (Pvt.) Ltd, Karachi
Manufacturer of API/pellets M/s Symed Labs Ltd, Jeedimetla, Hyderbad, India
API Lot No. ARK0020136
Description of Pack
Stability Storage Condition Real time : 30°C ± 2°C / 75% ± 5%RH
Accelerated: 40°C ± 2°C / 75% ± 5%RH
Batch No. 16PD-1792- 16PD-1793-03-T 16PD-1794-04-T
02-T
Manufacturing Date Apr-2016 Apr-2016 Apr-2016
No. of Batches 03
No.
1. COAs of API Yes
2. Approval of API by regulatory authority
Copy of GMP Certificate for M/s Symed Labs Ltd,
of country of origin or GMP certificate
Jeedimetla, Hyderbad, India issued by DCA,
of API manufacturer issued by
Government of Telangana valid upto 08-11-2018.
regulatory authority of country of origin.
Yes
Yes
sheets etc.
the product.
Yes
Remarks Of Evaluator2
Batches.

follows:
 Director DTL Karachi.
OR
b) Deferred cases of stability studies

Evaluator PEC-II
No. Address of (Proprietary Name + Initial Diary & Availability / Decision /
Manufacturer Dosage Form + Date, Fee Local Remarks
/ Applicant Strength), Composition, (including Availability (if any)
Pharmacological Group, differential fee),
Finished Product Demanded Price / GMP Inspection
Specification Pack size Report Date &
Remarks
1158. M/s Carveda XR Form-5 Coreg CR 20 The case was
Ferozsons 20mg Capsule 21-06-2011 mg capsules of deferred in
Laboratories Each capsule contains:- Diary No 222. M/s Smithkline 265th meeting
limited, P.O Carvedilol Phosphate Beecham of Registration
Ferozsons, SR Form-5D approved by Board for
USFDA submission of
Amangarh, pellets (20% w/w) eq. (20-06-2016)
stability data as
Nowshera, to Copy of challan
per guidelines
KPK Carvedilol 20mg. of Rs. 15000/-
of 251st DRB
Beta-adrenergic dated 21-06-2011
meeting and
blocking drug Copy of challan verification of
of Rs. 85000/- fee challan.
Source of dated 27-2-2014
pellets:- M/s
Alphamed
formulations (Pvt.)
Ltd. India
Drug Carveda XR 20mg Capsule
Name of M/s Ferozsons Laboratories limited,Nowshera, KPK
Manufacturer
Manufacturer of M/s Alphamed formulations (Pvt.) Ltd. India
API/pellets
API Lot No. AF050-011
Description of Pack Extended release Carvedilol Phosphate (pellets 20% w/w) are filled in empty
(Container closure hard gelatin capsules soize#2 and such 7 capsules are packed in a blister made
system) up of unprinted aluminium foil & alu-silver film. Such two blisters packed in
unit carton

Time Period Accelerated: 26 weeks
Real Time: 26 weeks
Frequency Accelerated: 0,1st,2nd, 3rd,4th,6th,8th, 12th,16th,20th,24th,26th (Week)
Real Time: 0,1st,2nd, 3rd,4th,6th,8th, 12th,16th,20th,24th,26th (Week)
Batch No. PD16-73A PD16-73B PD16-73C
Batch Size 2,500 capsules 2,500 capsules 2,500 capsules
No. of Batches 03
No.
1. COAs of API Copy of COA for Carvedilol phosphate ER pellets
(20% w/w) from M/s Alphamed Formulations Pvt.
Ltd has been submitted.
2. Approval of API by regulatory authority Copy of GMP Certificate for M/s Alphamed
of country of origin or GMP certificate of formulations (Pvt.) Ltd. India issued by DCA,
API manufacturer issued by regulatory Government of Telangana valid upto 13-12-2018.
3. Protocols followed for conduction of Finished product testing method has not been
stability study and details of tests. submitted.
sheets etc.
5. Documents confirming import of API Copy of Form 6 for Carvediolol Phosphate Extended
etc. release pellets 20% w/w attested by ADC (Peshawar)
has been submitted.
the product.
batches.
 Firm has also submitted data of analytical method validation & Comparative dissolution profile for
applied formulation.
 Label of reference product Coreg CR capsules states as under:
“COREG CR is available for once-a-day administration as controlled-release oral capsules
containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled
with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-
layered and then coated with methacrylic acid copolymers. Inactive ingredients include
crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic

acid copolymers, microcrystalline cellulose, and povidone.”
 No such details have been provided along with stability studies data which declares that applied
formulation consists of immediate-release and controlled-release microparticles.
Decision: Registeration Board deferred the case for clarification of description of product in
comparison to reference product in light of above cited observation.
Remarks
1159. M/s CarvedaXR Form-5 Coreg CR 40 The case was
Ferozsons 40mg Capsule 21-06-2011 mg capsules of deferred in
Laboratories Each capsule contains:- diary No 220. M/s Smithkline 265th meeting
limited, P.O Carvedilol Phosphate Form 5-D (20- Beecham of Registration
Ferozsons, SR 06-2016) approved by Board for
USFDA submission of
Amangarh, pellets (20% w/w ) eq. Copy of challan
stability data as
Nowshera, to of Rs. 15000/-
per guidelines
KPK Carvedilol ….40mg. dated 21-06-2011
of 251st DRB
Beta-adrenergic Copy of challan
meeting and
blocking drug of Rs. 85000/-
verification of
dated 26-2-2014
Source of fee challan.
pellets:- M/s
Rs.40 per
Alphamed
capsule
formulations (Pvt.)
Ltd. India.
Manufacturer
API/pellets
Description of Pack Extended release Carvedilol Phosphate (pellets 20% w/w) are filled in empty
(Container closure hard gelatin capsules soize#2 and such 7 capsules are packed in a blister made
system) up of unprinted aluminium foil & alu-silver film. Such two blisters packed in
unit carton
Real Time: 26 weeks

No. of Batches 03

No.
1. COAs of API Copy of COA for Carvedilol phosphate ER pellets
(20% w/w) from M/s Alphamed Formulations Pvt.
Ltd has been submitted.
3. Protocols followed for conduction of Finished product testing method has not been
stability study and details of tests. submitted.
sheets etc.
has been submitted.
the product.
batches.
“COREG CR is available for once-a-day administration as controlled-release oral capsules
containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled
with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-
layered and then coated with methacrylic acid copolymers. Inactive ingredients include
crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic
acid copolymers, microcrystalline cellulose, and povidone.”

Remarks
Ferozsons 80mg Capsule 21-06-2011 mg capsules of deferred in 265th
Laboratories Each capsule diary No 219. M/s Smithkline meeting of
limited, P.O contains:- Form 5-D (20-06- Beecham Registration
Ferozsons, Carvedilol 2016) approved by Board for
Amangarh, Phosphate SR pellets Copy of challan USFDA submission of
Nowshera, (20% w/w) eq. to of Rs. 15000/- stability data as
KPK Carvedilol 80mg. dated 21-06-2011 per guidelines of
Beta-adrenergic blocking Copy of challan 251st DRB
drug of Rs. 85000/- meeting and
dated 27-2-2014 verification of fee
Source ofpellets:- M/s challan.
Alphamed formulations Rs.79 per
(Pvt.) Ltd. India. capsule
Manufacturer
API/pellets
Description of Pack Extended release Carvedilol Phosphate (pellets 20% w/w) are filled in empty hard
(Container closure gelatin capsules soize#2 and such 7 capsules are packed in a blister made up of
system) unprinted aluminium foil & alu-silver film. Such two blisters packed in unit carton
Real Time: 26 weeks
No. of Batches 03
No.
1. COAs of API Copy of COA for Carvedilol phosphate ER pellets (20%
w/w) from M/s Alphamed Formulations Pvt. Ltd has
been submitted.
3. Protocols followed for conduction of Finished product testing method has not been submitted.
sheets etc.
has been submitted.
the product.
 The firm has provided 26 Weeks Accelerated and 26 Weeks Real Time Stability Data for 03 batches.
“COREG CR is available for once-a-day administration as controlled-release oral capsules containing
10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol
phosphate immediate-release and controlled-release microparticles that are drug-layered and then
coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated
castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers,
microcrystalline cellulose, and povidone.”
Remarks
Ferozsons 10mg Capsule 21-06-2011 mg capsules of deferred in 265th
Laboratories Each capsule diary No 221. M/s Smithkline meeting of
limited, P.O contains:- Form 5-D (20-06- Beecham Registration
Ferozsons, Carvedilol 2016) approved by Board for
Amangarh, Phosphate SR pellets Copy of challan USFDA submission of
Nowshera, (20% w/w) eq. to of Rs. 15000/- stability data as
KPK Carvedilol 10mg. dated 21-06-2011 per guidelines of
Beta-adrenergic Copy of challan 251st DRB
blocking drug of Rs. 85000/- meeting and
dated 27-2-2014 verification of fee
Source of pellets:- M/s challan.
Alphamed formulations Rs.79 per
(Pvt.) Ltd. India capsule
Manufacturer
API/pellets
Description of Pack Extended release Carvedilol Phosphate (pellets 20% w/w) are filled in empty hard
(Container closure gelatin capsules soize#2 and such 7 capsules are packed in a blister made up of
system) unprinted aluminium foil & alu-silver film. Such two blisters packed in unit carton
Real Time: 26 weeks
No. of Batches 03
No.
1. COAs of API Copy of COA for Carvedilol phosphate ER pellets (20%
w/w) from M/s Alphamed Formulations Pvt. Ltd has
been submitted.
3. Protocols followed for conduction of Finished product testing method has not been submitted.
sheets etc.
has been submitted.

the product.
 The firm has provided 26 Weeks Accelerated and 26 Weeks Real Time Stability Data for 03 batches.
“COREG CR is available for once-a-day administration as controlled-release oral capsules containing
10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol
phosphate immediate-release and controlled-release microparticles that are drug-layered and then
coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated
castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers,
microcrystalline cellulose, and povidone.”
Applicant
Brand Name +Dosage Form + Strength Daplos 10 mg tablet
Dapagliflozin (as propanediol monohydrate)….. 10mg
Pack size & Demanded Price 30‟s As per PRC
Approval status of product in Reference Farxiga tablet-USFDA approved
Previous Remarks of the Evaluator. Outer carton label design shall be submitted.
Labeling & prescribing Information (to be submitted on
the pack/leaflet) specimen or draft shall be submitted.
Drug Daplos 10 mg tablet
Name of
M/s PharmEvo (Pvt.) Ltd, Karachi
Manufacturer
Manufacturer of
M/s Beijing Huikang Boyuan Chemical Tech Co., Ltd, China
API/pellets
API Lot No. 160310
Description of Pack
(Container closure

system)
Stability Storage Real time : 30°C ± 2°C / 75% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Batch No. 16PD-1856-02-T 16PD-1857-03-T 16PD-1858-04-T
Manufacturing Date Jun-2016 Jun-2016 Jun-2016
No. of Batches 03
No.
1. COAs of API Yes
of country of origin or GMP certificate of Management Committee for Fluoride Industrial
API manufacturer issued by regulatory Development Zone has been submitted. The certificate
authority of country of origin. is valid upto 05-01-2019
Yes
Yes
sheets etc.
the product.
Yes
Previous Remarks Of Evaluator2
Batches.
 Revised master formulation & finished product testing method has been submitted along with stability
studies data.
 Master formulation for each tablet submitted along with stability studies data states use of 12.74 mg of
Dapagliflozin propanediol monohydrate equivalent to 10 mg of Dapagliflozin whereas reference
product has used 12.3 mg of Dapagliflozin propanediol monohydrate equivalent to 10 mg of
Dapagliflozin.
Previous Decision:
Deferred in 272nd meeting of registration Board for clarification/justification of following observations:
Dapagliflozin propanediol monohydrate equivalent to 10 mg of Dapagliflozin whereas reference
product has used 12.3 mg of Dapagliflozin propanediol monohydrate equivalent to 10 mg of
Dapagliflozin.
 Outer carton label design has not been submitted.
 Labeling & prescribing Information has not been submitted.
Evaluation by PEC:
 Firm has stated that there was a typographical error in master formulation submitted along with
stability studies data and now has submitted correct composition as under:
“Each tablet contains 12.3 mg of Dapagliflozin propanediol monohydrate equivalent to 10 mg of
Dapagliflozin”
 Outer carton label design has been submitted.
 Labeling & prescribing Information has been submitted.
 Firm has submitted a declaration from supplier of Dapagliflozin i.e. M/s Beijing Huikang Boyuan
Chemical Tech Co., Ltd, China, stating as under:
“We Beijing Huikang hereby declare that we are manufacturing Dapagliflozin Propanediol
Monohydrate at our manufacturing iste address Flouride Industrial Park, Fuxin city, Liaoning
Province-123000, China. We have provincial GMP and manufacturing License but we don‟t have
SFDA GMP at the moment & it will take time to get SFDA GMP.
 Submitted GMP certificate of supplier is issued by Food & Drug of Peoples Republic of China
(Shandong Heze Administration Mudin Branch), whereas the relevant provincial authority for issuance
of GMP is Liaoning Food & Drug Administration.
Decision of 275th meeting: Registration Board deferred the case for submission / clarification of GMP
Certificate issued by provincial / state drug administration.
Applicant
Brand Name +Dosage Form + Strength Daplos 5 mg tablet
Dapagliflozin (as propanediol monohydrate) ……. 5mg
Pack size & Demanded Price 30‟s As per PRC
Approval status of product in Reference Farxiga tablet-USFDA approved
Previous Remarks of the Evaluator. Outer carton label design shall be submitted.
Labeling & prescribing Information (to be submitted on
the pack/leaflet) specimen or draft shall be submitted.
Drug Daplos 5mg tablet
Name of
M/s PharmEvo (Pvt.) Ltd, Karachi
Manufacturer
Manufacturer of
M/s Beijing Huikang Boyuan Chemical Tech Co., Ltd, China
API/pellets
API Lot No. 160310
Description of Pack
(Container closure Alu-Alu foil blister packed in unit carton
system)
Stability Storage Real time : 30°C ± 2°C / 75% ± 5%RH
Condition Accelerated: 40°C ± 2°C / 75% ± 5%RH
Batch No. 16PD-1853-02-T 16PD-1854-03-T 16PD-1855-04-T
Manufacturing Date Jun-2016 Jun-2016 Jun-2016
No. of Batches 03
No.
1. COAs of API Yes
of country of origin or GMP certificate of Management Committee for Fluoride Industrial
API manufacturer issued by regulatory Development Zone has been submitted. The certificate
authority of country of origin. is valid upto 05-01-2019
Yes
Yes
sheets etc.
the product.
Yes
Previous Remarks Of Evaluator2
Batches.
 Revised master formulation & finished product testing method has been submitted along with stability
studies data.
Dapagliflozin propanediol monohydrate equivalent to 5 mg of Dapagliflozin whereas reference product
has used 6.15 mg of Dapagliflozin propanediol monohydrate equivalent to 5 mg of Dapagliflozin.

Previous Decision:
Deferred in 272nd meeting of registration Board for clarification/justification of following observations:
Dapagliflozin propanediol monohydrate equivalent to 5 mg of Dapagliflozin whereas reference product
has used 6.15 mg of Dapagliflozin propanediol monohydrate equivalent to 5 mg of Dapagliflozin.
 Outer carton label design has not been submitted.
 Labeling & prescribing Information has not been submitted.
Evaluation by PEC:
 Firm has stated that there was a typographical error in master formulation submitted along with
stability studies data and now has submitted correct composition as under:
“Each tablet contains 6.15 mg of Dapagliflozin propanediol monohydrate equivalent to 5 mg of
Dapagliflozin”
 Outer carton label design has been submitted.
 Labeling & prescribing Information has been submitted.
 Firm has submitted a declaration from supplier of Dapagliflozin i.e. M/s Beijing Huikang Boyuan
Chemical Tech Co., Ltd, China, stating as under:
“We Beijing Huikang hereby declare that we are manufacturing Dapagliflozin Propanediol
Monohydrate at our manufacturing iste address Flouride Industrial Park, Fuxin city, Liaoning
Province-123000, China. We have provincial GMP and manufacturing License but we don‟t have
SFDA GMP at the moment & it will take time to get SFDA GMP.
 Submitted GMP certificate of supplier is issued by Food & Drug of Peoples Republic of China
(Shandong Heze Administration Mudin Branch), whereas the relevant provincial authority for issuance
of GMP is Liaoning Food & Drug Administration.
Certificate issued by provincial / state drug administration.
1164. Name and address of manufacturer / M/s Ferozsons Laboratories Ltd. Nowshehra
Applicant
Brand Name +Dosage Form + Strength Dexia 60 mg capsules
Diary No. Date of R& I & fee Dy. No. 5313 dated 08-06-2017.
Rs. 50,000/- 12-09-2013 (duplicate)
Rs. 50,000/- 03-03-2014 (duplicate)
Dexlansoprazole modified release pellets 22.5% w/w
eq. to Dexlansoprazole ….. 60 mg
Finished Product Specification Manufacturer specifications.
Pack size & Demanded Price 2x 7‟s
As per DRAP policy.
Approval status of product in Reference Dexilant capsules, USFDA approved

GMP status GMP compliant dated 20-01-2017.
Previous Remarks of the Evaluator.  Firm has submitted a declaration from M/s RA
Chem Pharma Ltd., as under:
“We RA CHEM Pharma Ltd. manufacture and
supply Dexlansoprazole modified release pellets
22.5% w/w with two different product description
as described below. The qualitative and
quantitative composition and manufacturing
process for this product remains same except
difference in colors in composition. These colors
are added only for visual effect. This will not have
any impact on quality of the product.
Description of the product:
1. Blue & green spherical colored pellets
2. Off white to light brownish colored spherical
pellets.
Here we are declaring that RA CHEM Pharma Ltd.
will manufacture and supply the product to M/s
Ferozsons labs with both descriptions as per their
requirement.”
 It has to be clarified that how a lot with pellets of
two colors have the single batch number.
Previous Decision The case was initially presented in 272nd meeting of
Registration Board wherein the case was deferred
various observations.
The case was again presented in 273rd meeting of
Registration Board wherein Board deferred for further
discussion in light of Dex-Lansaprazole discussion as
under;
i. In contrary to reference product i.e. Dexilant
capsules of M/s Takeda Pharms (USFDA
approved) which are filled with two types of
enteric coated granules exhibiting dual delayed
release mechanism, the local manufacturers have
used only one type of enteric coated
granules/pellets.
ii. While using only one type of enteric coated
granules/pellets how it is possible to claim that in-
vivo/in-vitro release profile of locally
,manufactured products is same as that of
reference product i.e. Dexilant capsules of M/s
Takeda Pharms (USFDA approved)
Evaluation by PEC  Firm has submitted a declaration from M/s RA
Chem Pharma Ltd., (supplier of Dexlansoprazole
modified release pellets) as under:
“As per reference product strategy, test product
Dexlansoprazole pellets has been developed with two
types of pellets in 1:3 ratios. In ths product one part of
pellets are called as Delayed Immediate release pellets
(DIR) which contains 25% of Drug substance. These
DIR pellets will release the complete 25% drug when
pellets reaches proximal region of small intestine with
pH reaches approximately 5.5. the other parts of pellets
are called as Delayed Extended release pellets (DER)
which contains 75% Drug substance. These DER
pellets will release the complete 75% drug when
pellets reaches distal part of intestine where the pH
reaches approximately 6.75. As per reference product
(Dexilant) the formulation components of both the
pellets of our test product are the same except enteric
coated layer. The DIR pellets are coated with one type
of enteric polymer which will get dissolved above pH
5.5 media and Der pellets coated with other enteric
polymer will get dissolved after pH 6.75.
The reason for assigning one batch number to final mix
of both types of pellets is that the batch is defined by
the blended finished product which is a mixture of two
types of pellets.
We have option to supply white pellets for final
product or green and blue pellets blended together with
each having a separate dissolution profile and blended
together to achieve the desired dissolution of the
blended finished product ”.
 In a previous declaration submitted by M/s
Ferozsons from M/s RA Chem it was mentioned
that “The qualitative and quantitative composition
and manufacturing process for this product
remains same except difference in colors in
composition. These colors are added only for
visual effect. This will not have any impact on
quality of the product”, while now it is has been
declared that two types of pellets differ in
composition as well in dissolution profile as well.
 According to literature of reference product
(Dexilant capsules) , as one of the in-process
controls, each granule type has its own
specifications which include testing for
appearance, identification, assay, related
substances, moisture and dissolution. The granules
are tested to specifications prior to filling of the
capsules. While no details of in-process testing of
pellets have been submitted neither by firm nor
supplier of pellets which describe that each pellet
type has its own specifications.
 Also if the pellets are supplied as a blend of two
types of pellets, how it is possible for manufacturer
of final product i.e. Dexlansoprazole capsules to
ensure distinct quality profile of each type of
pellets by separate in process testing.
Registration Board regarding “Innovator’s Formulation of Dexlansoprazole”
1165. Name and address of manufacturer / M/s Ferozsons Laboratories Ltd. Nowshehra
Applicant
Brand Name +Dosage Form + Strength Dexia 30 mg capsules
Diary No. Date of R& I & fee Dy. No. 5314 dated 08-06-2017.
Rs. 50,000/- 12-09-2013 (duplicate)
Rs. 50,000/- 03-03-2014 (duplicate)
Dexlansoprazole modified release pellets 22.5% w/w
eq. to Dexlansoprazole ….. 30 mg
Finished Product Specification Manufacturer specifications.
Pack size & Demanded Price 2x 7‟s
As per DRAP policy.
Approval status of product in Reference Dexilant capsules, USFDA approved
GMP status GMP compliant dated 20-01-2017.
Previous Remarks of the Evaluator.  Firm has submitted a declaration from M/s RA
Chem Pharma Ltd., as under:
“We RA CHEM Pharma Ltd. manufacture and
supply Dexlansoprazole modified release pellets
22.5% w/w with two different product description
as described below. The qualitative and
quantitative composition and manufacturing
process for this product remains same except
difference in colors in composition. These colors
are added only for visual effect. This will not have
any impact on quality of the product.
Description of the product:
3. Blue & green spherical colored pellets
4. Off white to light brownish colored spherical
pellets.
Here we are declaring that RA CHEM Pharma Ltd.
will manufacture and supply the product to M/s
Ferozsons labs with both descriptions as per their
requirement.”
 It has to be clarified that how a lot with pellets of
two colors have the single batch number.
Previous Decision The case was initially presented in 272nd meeting of
Registration Board wherein the case was deferred
various observations.
The case was again presented in 273rd meeting of
Registration Board wherein Board deferred for further
discussion in light of Dex-Lansaprazole discussion as
under;
i. In contrary to reference product i.e. Dexilant
capsules of M/s Takeda Pharms (USFDA
approved) which are filled with two types of
enteric coated granules exhibiting dual delayed
release mechanism, the local manufacturers
have used only one type of enteric coated
granules/pellets.
ii. While using only one type of enteric coated
granules/pellets how it is possible to claim that in-
vivo/in-vitro release profile of locally
,manufactured products is same as that of
reference product i.e. Dexilant capsules of M/s
Takeda Pharms (USFDA approved)
Evaluation by PEC  Firm has submitted a declaration from M/s RA
Chem Pharma Ltd., (supplier of Dexlansoprazole
modified release pellets) as under:
“As per reference product strategy, test product
Dexlansoprazole pellets has been developed with two
types of pellets in 1:3 ratios. In ths product one part of
pellets are called as Delayed Immediate release pellets
(DIR) which contains 25% of Drug substance. These
DIR pellets will release the complete 25% drug when
pellets reaches proximal region of small intestine with
pH reaches approximately 5.5. the other parts of pellets
are called as Delayed Extended release pellets (DER)
which contains 75% Drug substance. These DER
pellets will release the complete 75% drug when
pellets reaches distal part of intestine where the pH
reaches approximately 6.75. As per reference product
(Dexilant) the formulation components of both the
pellets of our test product are the same except enteric
coated layer. The DIR pellets are coated with one type
of enteric polymer which will get dissolved above pH
5.5 media and Der pellets coated with other enteric
polymer will get dissolved after pH 6.75.
The reason for assigning one batch number to final mix
of both types of pellets is that the batch is defined by
the blended finished product which is a mixture of two
types of pellets.
We have option to supply white pellets for final
product or green and blue pellets blended together with
each having a separate dissolution profile and blended
together to achieve the desired dissolution of the
blended finished product ”.
 In a previous declaration submitted by M/s
Ferozsons from M/s RA Chem it was mentioned
that “The qualitative and quantitative composition
and manufacturing process for this product
remains same except difference in colors in
composition. These colors are added only for
visual effect. This will not have any impact on
quality of the product”, while now it is has been
declared that two types of pellets differ in
composition as well in dissolution profile as well.
 According to literature of reference product
(Dexilant capsules) , as one of the in-process
controls, each granule type has its own
specifications which include testing for
appearance, identification, assay, related
substances, moisture and dissolution. The granules
are tested to specifications prior to filling of the
capsules. While no details of in-process testing of
pellets have been submitted neither by firm nor
supplier of pellets which describe that each pellet
type has its own specifications.
 Also if the pellets are supplied as a blend of two
types of pellets, how it is possible for manufacturer
of final product i.e. Dexlansoprazole capsules to
ensure distinct quality profile of each type of
pellets by separate in process testing.
Registration Board regarding “Innovator’s Formulation of Dexlansoprazole”
1166. Name and address of manufacturer / M/s Zeta Pharmaceuticals. 494-A, Sunder Industrial
Applicant Estate, Lahore
Brand Name +Dosage Form + Strength Sofoszet Tablet 400mg
Diary No. Date of R& I & fee Form-5D Dy. No. 369, 22-12-2015
Rs. 20,000/-
Sofosbuvir…400mg
Pharmacological Group (Anti-Viral)
Type of Form Form-5 D
Finished Product Specification Manufacturer‟s Specs
Pack size & Demanded Price Rs. 70,000/- per pack of 7‟s.
Rs. 280,000/- per pack of 28‟s
Approval status of product in Reference Sovaldi Tablet USFDA approved
Me-too status Sofo Tablet 400mg by M/s Genix Pharma, Karachi.
GMP status Inspection report date 03-01-2017 stating satisfactory
Previous Remarks of the Evaluator.  Firm has submitted following:
i. Copy of GMP certificate issued by “Jiangsu
Nantong Pharmaceutical Authority, in the name of
“Nantong Chanyoo Pharmatech co., ltd. The
certificate is valid upto 03-2-2020.
ii. Copy GMP certificate of M/s Zheijiang Warrant
Pharmaceutical Co., ltd. issued by China Food and
Drug Administration Authority has been
submitted. The certificate is valid upto 29-02-
2016.
 Copy of inspection report of M/s Zeta
Pharmaceuticals. 494-A, Sunder Industrial Estate,
Lahore, conducted on 03-01-2017 stating
Previous Decision The case was presented in 269th meeting of
Registration Board along-with stability studies data
wherein the Registration Board Deferred for
provision of the following:
i. GMP Certificate of API Manufacturer
(Sofosbuvir) issued by concerned Regulatory
Authority rather than Chemical & Medical
Industry Association.
ii. Last GMP inspection report of applicant.
The case was again presented in 272nd meeting of
Registration Board wherein the case was deferred for
following points:
i. Clarification/justification for use of two
different sources of API i.e. Sofosbuvir, in
manufacturing of stability batches.
ii. Submission of GMP certificate of M/s
Nantong Chanyoo Pharmatech co., ltd. (one of
the supplier of Sofosbuvir) from concerned
Pharmaceutical regulatory body as the issuing
authority stated on submitted GMP certificate
i.e. Jiangsu Nantong Pharmaceutical
Authority is not verifiable.
Evaluation by PEC  Firm has submitted following:
i. Copy of GMP certificate of M/s Nantong

Chanyoo Pharmatech co., ltd. (one of the
supplier of Sofosbuvir) issued by Nantong
Food & Drug Administration. The certificate is
valid upto 07-09-2020.
 Firm has not submitted any clarification regarding
use of two different sources of API i.e. Sofosbuvir,
in manufacturing of stability batches.
Decision: Deferred for Clarification/justification for use of two different sources of API i.e.
Sofosbuvir, in manufacturing of stability batches.

 Cases of Stability deferred for GMP certification of M/s Nantong Chanyoo
Pharmatech Co. Ltd.
In 274th meeting of Registration Board various cases of Stability studies were deferred for
submission of GMP certificate of M/s Nantong Chanyoo Pharmatech Co. Ltd. (supplier of
API) from respective province/ state Department. Now the following documents have been
submitted by various firms and M/s Neon Chemicals (Sole distributor of M/s Nantong
Chanyoo Pharmatech Co.Ltd. in Pakistan):
1. Copy of License of Drug Production for M/s Nantong Chanyoo Pharmatech Co. Ltd,
with certificate from China Council for the Promotion of International Trade stating
that submitted copy of License (No. Su 20160512) is issued by Jiangsu Food and
Drug Administration and attached English version is true to Chinese Text.
2. Copy of “Foreign Manufacturer Certification” for M/s Nantong Chanyoo Pharmatech

Co.Ltd issued by PMDA of Japan, effective till 18-03-2020. (The same has been
verified from following website Link when visited on 18-10-2016)
“https://www.pmda.go.jp/files/000220543.pdf”
3. Copy of “Certificate of GMP Compliance of a Manufacturer” issued by “Agency for

medicinal products and medical devices of the Republic of Solvenia” for the M/s
Nantong Chanyoo Pharmatech Co.Ltd. The certificate is valid upto 05-12-2017. The
same has been verified from following website link of European Inspections database,
when visited on 18-10-32016:
“http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do?ctrl=s
earchGMPCResultControlList&action=Drilldown&param=28517”
4. Copy of “Written confirmation for active substances exported to EU” issued by

Jiangsu Food & Drug Administration for the “M/s Nantong Chanyoo Pharmatech
Co.Ltd.” having manufacturer‟s license number “Su 20160512”. This certificate
mentions the date of Inspection of the plant on 10-02-2017.
It is mentioned here that a query was made to China Food and Drug Administration at
inquires@sda.gov.cn dated 16-10-2016 to confirm the particulars of M/s Nantong Chanyoo
Pharmatech Co.Ltd. A reply was received on 17-10-2016 referring to following weblink:
http://www.jsfda.gov.cn/fwdt/bsgk/bjgs/ypsc3/201611/t20161128_1254064.html
The above cited link confirms the License number of “Su 20160512” for “M/s Nantong
Chanyoo Pharmatech Co.Ltd”.
The address for manufacturing site mentioned in all of above cited documents is as under:
“No. 2 Tonghai Si Road, Rudong Coastal Economic Development Zone, Nantong, Jiangsu
province, China.”
Cases of Stability studies which were deferred for submission of GMP certificate of M/s
Nantong Chanyoo Pharmatech Co. Ltd. (supplier of API) from respective province/ state
Department, in 274th meeting of Registration Board are now presented below for
consideration of Board:

Sr. Name & Address of Brand Name Type of Form, International Previous
No. Manufacturer / (Proprietary Name Initial Diary & Availability / DRB
Applicant + Dosage Form + Date, Fee Local Decision /
Strength), (including Availability Remarks
Composition, differential fee), (if any)
Pharmacological Demanded Price GMP
Group, / Pack size Inspection
Finished Product Report Date &
Specification Remarks
1167. M/s Global DAKLAVIR Tablets Form 5-D DAKLINZA by The Firm has
Pharmaceuticals 60mg M/s Bristol claimed
(Pvt.) Ltd. Each film coated Diary No. 12319, Myers Squibb, Manufacturer‟
tablet contains: dated 17-08-2017 USA. s
204-205, Industrial Daclatasvir Specifications
Triangle Kahuta Dihydrochloride eq. Rs. 50,000/- Not applicable .
Road, to GMP compliant
Daclatasvir…60mg As per DRAP dated
Islamabad. (Anti-viral Agent) policy. 12.07.2017.
Drug DAKLAVIR Tablets 60mg (Daclatasvir)
Name of Manufacturer M/s Global Pharmaceuticals (Pvt.) Ltd., Islamabad.
API Lot No. RD-DCL-201605151
Description of Pack HDPE Plastic Bottle.
Stability Storage Condition Accelerated: 40°C ± 2°C & 75±5%RH
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 26 Weeks
Frequency Accelerated: 0,12,16,20,24,26 (Weeks)
Real Time: 0,12,16,20,24,26 (Weeks)
Batch No. T-037(P) T-038(P) T-039(P)
No. of Batches 03
No.
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of GMP Certificate for Pharmaceutical
country of origin or GMP certificate of API Products issued by Nantong Food and Drug
manufacturer issued by regulatory authority Administration China is submitted.

sheets etc.
5. Documents confirming import of API etc. Copy of permission to import API (Daclatasvir)
issued by ADC (Islamabad) is submitted.
Rules, 1978.
Scale Batches.
Registration Board was apprised of the following Regulations for Implementation of the Drug
Administration Law of the People‟s Republic of China:
Chapter I General Provisions; Article 5:

The drug regulatory department of the people‟s government at or above the provincial level shall organize
inspections of drug manufacturers in accordance with the Good Manufacturing Practice for
Pharmaceutical Products (GMP) and the measures and schedule for implementing the GMP formulated
by the drug regulatory department under the State Council, and issue a certificate to the manufacturer that
complies with the GMP. For the manufacturer producing injections or radioactive pharmaceuticals and
for that producing biological products specified by the drug regulatory department under the State
Council, the inspection of which shall be conducted by the drug regulatory department under the State
Council. The format of GMP certificate shall be uniformly provided for by the drug regulatory
department under the State Council.
Certificate as it is not issued by respective province / state in light of above regulations.
follows:

 Additional Director DRAP, Islamabad
OR

No. Manufacturer / (Proprietary Name Initial Diary & Availability / DRB
Applicant + Dosage Form + Date, Fee Local Decision /
Pharmacological Demanded Price GMP
Group, / Pack size Inspection
Finished Product Report Date &
Specification Remarks
1168. M/s Global DAKLAVIR Tablets Form 5-D DAKLINZA by The Firm has
Pharmaceuticals 30mg M/s Bristol claimed
(Pvt.) Ltd. Diary No. 12320, Myers Squibb, Manufacturer‟
Each film coated dated 17-08-2017 USA. s
204-205, Industrial tablet contains: Specifications
Triangle Kahuta Daclatasvir Rs. 50,000/- Not applicable .
Road, Dihydrochloride eq.
to As per DRAP GMP compliant
Islamabad. Daclatasvir…30mg policy. dated
(Anti-viral Agent) 12.07.2017.
Drug DAKLAVIR Tablets 30mg (Daclatasvir)
Name of Manufacturer M/s Global Pharmaceuticals (Pvt.) Ltd., Islamabad.
Description of Pack HDPE Plastic Bottle.
Real Time: 30°C ± 2°C & 65±5%RH
Real Time: 26 Weeks
Frequency Accelerated: 0,12,20,24,26 (Weeks)
Real Time: 0,12,20,24,26 (Weeks)
Batch No. T-034(P) T-035(P) T-036(P)
No. of Batches 03
Sr.# Documents To Be Provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of Copy of GMP Certificate for Pharmaceutical
country of origin or GMP certificate of API Products issued by Nantong Food and Drug
manufacturer issued by regulatory authority Administration China is submitted.
sheets etc.
5. Documents confirming import of API etc. Copy of permission to import API (Daclatasvir)
issued by ADC (Islamabad) is submitted.
Rules, 1978.
REMARKS OF EVALUATOR
Scale Batches.
Registration Board was apprised of following regulations for Implementation of the Drug Administration
Law of the People‟s Republic of China:

The drug regulatory department of the people‟s government at or above the provincial level shall organize
inspections of drug manufacturers in accordance with the Good Manufacturing Practice for
by the drug regulatory department under the State Council, and issue a certificate to the manufacturer that
complies with the GMP. For the manufacturer producing injections or radioactive pharmaceuticals and
for that producing biological products specified by the drug regulatory department under the State
Certificate as it is not issued by respective province / state in light of above regulations.
follows:

 Additional Director DRAP, Islamabad
OR

No. Address of (Proprietary Initial Diary & Availability / Decision / Remarks
Manufacturer Name + Dosage Date, Fee Local (if any)
/ Applicant Form + Strength), (including Availability
Composition, differential fee),
Pharmacological Demanded Price / GMP Inspection
Group, Pack size Report Date &
Finished Product Remarks
Specification
1169. M/s Helix CANAT Tablets Form 5-D INVOKANA by Decision M-245:
Pharma (Pvt.) 100mg (Fast Track) M/s Janssen Two experts
Ltd. Pharms, USA. recommended the
Each film coated 05-11-13 product. Prof.
Hakimsons tablet contains: Not applicable. Muzammil Najmi also
House, A-56, Canagliflozin Rs. 150,000/- recommended the
S.I.T.E. MS… 100mg GMP compliant product during the
As per PRC for dated meeting. Registration
Karachi. (Anti-diabetic) 10‟s 09-02-2016. Board agreed to above
expert opinions.
However, the Board
advised firm to
provide data for
stability studies
conducted under zone
IV-A conditions as per
ICH / WHO
guidelines for
consideration of
Registration Board.
Drug CANAT Tablets 100mg (Canagliflozin)
Name of M/s Helix Pharma (Pvt.) Ltd. Karachi.
Manufacturer
API Lot No. RD-CLF-20160928-R1
Description of Pack Alu/Alu Blister Pack
(Container closure
system)
Frequency Accelerated: 0,1,2,3,6 (Month)
Batch No. TF 001 TF 002 TF 003
No. of Batches 03

1. COA of API Copy of COA issued by M/s Nantong Chanyoo Pharmatech
Co., Ltd. China is submitted.
2. Approval of API by regulatory Copy of GMP Certificate issued by Shaoguan Food and
authority of country of origin or Drug Administration, China is submitted for M/s Changzhou
GMP certificate of API Pharmaceutical Factory.
manufacturer issued by regulatory
3. Protocols followed for conduction Yes
of stability study and details of
tests.
4. Data of 03 batches will be Yes
supported by attested respective
documents like chromatograms,
laboratory reports, data sheets etc.
5. Documents confirming import of Copy of ADC (Karachi) attested Commercial Invoice is
API etc. submitted.
6. All provided documents will be Yes
attested (name, sign and stamp) for
ensuring authenticity of data /
documents.
stability study till assigned shelf
life of the product.
REMARKS OF EVALUATOR
Scale Batches.
 Copy of GMP Certificate issued by Shaoguan Food and Drug Administration, China is submitted for
M/s Changzhou Pharmaceutical Factory. Whereas COA of API is from M/s Nantong Chanyoo
Pharmatech Co., Ltd. China.
Registration Board was apprised of following Regulations for Implementation of the Drug

The drug regulatory department of the people‟s government at or above the provincial level shall
organize inspections of drug manufacturers in accordance with the Good Manufacturing Practice for
by the drug regulatory department under the State Council, and issue a certificate to the manufacturer
that complies with the GMP. For the manufacturer producing injections or radioactive pharmaceuticals
and for that producing biological products specified by the drug regulatory department under the State
Decision of 274th meeting: Registration Board deferred the case for submission / clarification of the
GMP Certificate as it is not issued by respective province / state in the light of above regulation.

follows:
OR
Specification
1170. M/s Helix CANAT Tablets Form 5-D INVOKANA by Decision M-245:
Pharma (Pvt.) 300mg (Fast Track) M/s Janssen Two experts
Ltd. Pharms, USA. recommended the
Each film coated 05-11-13 product. Prof.
Hakimsons tablet contains: Not applicable. Muzammil Najmi also
House, A-56, Canagliflozin Rs. 150,000/- recommended the
S.I.T.E. MS… 300mg GMP compliant product during the
As per PRC for dated 9-2-2016. meeting. Registration
Karachi. (Anti-diabetic) 10‟s Board agreed to above
expert opinions.
However, the Board
advised firm to
provide data for
stability studies
conducted under zone
IV-A conditions as per
ICH / WHO
guidelines for
consideration of
Registration Board.
Drug CANAT Tablets 300mg (Canagliflozin)
Name of M/s Helix Pharma (Pvt.) Ltd. Karachi.
Manufacturer
API Lot No. RD-CLF-20160928-R1
Description of Pack Alu/Alu Blister Pack
(Container closure
system)

Frequency Accelerated: 0,1,2,3,6 (Month)
Batch No. TF 001 TF 002 TF 003
No. of Batches 03
1. COA of API Copy of COA issued by M/s Nantong Chanyoo Pharmatech
Co., Ltd. China is submitted.
2. Approval of API by regulatory Copy of GMP Certificate issued by Shaoguan Food and
authority of country of origin or Drug Administration, China is submitted for M/s Changzhou
GMP certificate of API Pharmaceutical Factory.
tests.
5. Documents confirming import of Copy of GMP Certificate issued by Shaoguan Food and
API etc. Drug Administration, China is submitted for M/s Changzhou
Pharmaceutical Factory.
documents.
Scale Batches.
 Copy of GMP Certificate issued by Shaoguan Food and Drug Administration, China is submitted for
M/s Changzhou Pharmaceutical Factory. Whereas COA of API is from M/s Nantong Chanyoo
Pharmatech Co., Ltd. China.

GMP Certificate as it is not issued by respective province / state in the light of above regulation.
follows:
OR
Specification
1171. M/s Novamed DASVIR Tablets Form 5 DAKLINZA by The firm has claimed
Pharmaceutica 60mg Diary No. 11542 M/s Bristol Manufacturer‟s
ls (Pvt.) Ltd. dated 09-08-2017 Myers Squibb, Specifications.
28 km Each film coated USA.
Ferozepur tablet contains: Rs. 20,000/- CLAVIR by
Road, dated 09-08-2017 M/s Hilton
Daclatasvir (as Pharma,
Lahore. dihydrochloride)… Rs. 30,000/- Karachi.
60mg dated 18-08-2017 GMP compliant
(Anti-viral) As per SRO. dated 08-2-2017
Drug DASVIR Tablets 60mg (Daclatasvir)
Name of
M/s Novamed Pharmaceuticals (Pvt.) Ltd. Lahore.
Manufacturer
Description of Pack
(Container closure Plastic Jar.
system)

Batch No. TP/81/-T1/S1 TP/81/-T1/S1 TP/81/-T1/S3
No. of Batches 03
Date of Submission 15-09-2017 (Diary No. 15187)
1. COA of API Yes
2. Approval of API by regulatory Copy of GMP Certificate for Pharmaceutical Products
authority of country of origin or issued by Nantong Food and Drug Administration, China is
GMP certificate of API submitted.
tests.
5. Documents confirming import of Copy of ADC (Lahore) attested Commercial Invoice is
API etc. submitted.
documents.
Scale Batches.
 Description of Pack (Container closure system) is mentioned as Plastic Jar.

Decision of 274thmeeting: Registration Board deferred the case for submission / clarification of GMP
Certificate issued by provincial / state drug administration in light of above regulations.
follows:
 Additional Director, DRAP, Lahore
OR
Specification
1172. M/s Novamed DASVIR Tablets Form 5 DAKLINZA by The firm has claimed
Pharmaceutica 90mg Diary No. 11539 M/s Bristol Manufacturer‟s
ls (Pvt.) Ltd. dated 09-08-2017 Myers Squibb, Specifications.
28 km Each film coated Rs. 20,000/- USA.
Ferozepur tablet contains: dated 09-08-2017 CLAVIR by
Road, Lahore. Daclatasvir (as Rs. 30,000/- M/s Hilton
dihydrochloride) dated 18-08-2017 Pharma,
…..…90mg As per SRO. Karachi.
(Anti-viral) GMP compliant
dated 08-2-2017
Drug DASVIR Tablets 90mg (Daclatasvir)
Name of
M/s Novamed Pharmaceuticals (Pvt.) Ltd. Lahore.
Manufacturer
Description of Pack
(Container closure Plastic Jar.
system)
Batch No. TP/80/-T1/S1 TP/80/-T1/S2 TP/80/-T1/S3
No. of Batches 03
1. COA of API Yes
2. Approval of API by regulatory Copy of GMP Certificate for Pharmaceutical Products
authority of country of origin or issued by Nantong Food and Drug Administration, China is
GMP certificate of API submitted.
tests.
5. Documents confirming import of Copy of ADC (Lahore) attested Commercial Invoice is
API etc. submitted.
documents.
Scale Batches.
 Description of Pack (Container closure system) is mentioned as Plastic Jar.

Decision of 274thmeeting: Registration Board deferred the case for submission / clarification of GMP
Certificate issued by provincial / state drug administration in light of above regulations.
follows:
 Additional Director, DRAP, Lahore
OR
Specification
1173. M/s ATCO Canaflo 100mg Form-5-D Invokana Decision 256th RB
Laboratories Tablet (Janssen Cilag) Meeting:
Limited, B-18 Dy. No: 1336 USFDA, Deferred for
SITE, Each film coated dated 09.07.2013 MHRA. Stability studies as per
Karachi. tablet contains: 251st meeting
Canagliflozin (as Rs.50,000/- required.
hemihydrate)
MS…100mg Rs. 250/- per
Tablet for 7‟s,
(Anti-diabetic) 14‟s & 28‟s
Uses: adjunct to
diet
and exercise to
improve glycemic
control in adults
with
type 2 diabetes
mellitus
Drug Canaflo Tablet 100mg (Canagliflozin).
Name of
M/s ATCO Laboratories Limited, Karachi.
Manufacturer
Manufacturer of API M/s. Nantong Chanyoo Pharmatech Co., Ltd., China.
API Lot No. RD-CLF-201611081

(Container closure
system)
Batch No. 14B17 19B17 21B17
No. of Batches 03
1. COA of API Copy of COA submitted for Canagliflozin Hemihydrate
(Batch No. RD-CLF-201611081).
2. Approval of API by regulatory Copy of GMP Certificate issued by Nantong Chemical and
authority of country of origin or Medical Industry Association, China is submitted.
GMP certificate of API
tests.
5. Documents confirming import of Copy of ADC (Karachi) attested Commercial Invoice is
API etc. submitted for Canagliflozin Hemihydrate (Batch No. RD-
CLF-201611081).
documents.
Scale Batches.
 Copy of GMP Certificate issued by Nantong Chemical and Medical Industry Association, China is
submitted.
 The firm has requested to consider the specifications submitted with stability as “Buff color, barrel
shaped film coated tablet”, which was established during development of product.
 The firm has clarified that in application dossier due to typographical error the salt name was
mentioned as “Canagliflozin as hemihydrate” instead of “Canagliflozin” in application form,
manufacturing formula, manufacturing procedure and finished product specifications / analytical
procedure. In stability Data we have mentioned correct salt name “Canagliflozin” as per innovator‟s
claim (Invokana). The firm has submitted revised Form 5-D, Manufacturing Formula and Procedure.
 Copy of ADC (Karachi) attested Commercial Invoice and COA of API submitted for Canagliflozin
Hemihydrate (Batch No. RD-CLF-201611081).
Decision of 274thmeeting: Registration Board deferred the case for submission / clarification of the
following:
 GMP Certificate in light of above regulations as it is not issued by province / state drug
administration.
claim (Invokana). The firm has submitted revised Form 5-D, Manufacturing Formula and Procedure;
whereas copy of ADC (Karachi) attested Commercial Invoice and COA of API are submitted for
Canagliflozin Hemihydrate (Batch No. RD-CLF-201611081).
follows:
 Director DTL Karachi
 Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi
OR

No. Manufacturer / (Proprietary Name + Initial Diary Availability / DRB
Applicant Dosage Form + &Date, Fee Local Decision /
Specification
1174. M/s ATCO Canaflo 300mg Form-5-D Invokana Decision
Laboratories Tablet Dy. No: 1447 (Janssen Cilag) 256th RB
Limited, dated 26.07.2013 USFDA, Meeting:
Each film coated MHRA.
B-18 SITE. tablet contains: Rs.50,000/- Deferred for
Canagliflozin (as Stability
Karachi. hemihydrate) Rs. 550/- per studies as per
MS…300mg Tablet for 7‟s, 251st meeting
(Anti-diabetic) 14‟s & 28‟s required.
Uses: adjunct to diet
and exercise to
improve glycemic
control in adults with
type 2 diabetes
mellitus
Drug Canaflo Tablet 300mg (Canagliflozin).
Name of Manufacturer M/s ATCO Laboratories Limited, Karachi.
Manufacturer of API M/s. Nantong Chanyoo Pharmatech Co., Ltd., China.
API Lot No. RD-CLF-201611081
Description of Pack
Alu-Alu Blister Pack.
Real Time: 30°C ± 2°C & 75±5%RH
Batch No. 08B17 09B17 10B17
No. of Batches 03
1. COA of API Copy of COA submitted for Canagliflozin
2. Approval of API by regulatory authority of Copy of GMP Certificate issued by Nantong
country of origin or GMP certificate of API Chemical and Medical Industry Association, China
manufacturer issued by regulatory authority is submitted.
sheets etc.
5. Documents confirming import of API etc. Copy of ADC (Karachi) attested Commercial
Invoice is submitted for Canagliflozin Hemihydrate
(Batch No. RD-CLF-201611081).
Rules, 1978.
Scale Batches.
 Copy of GMP Certificate issued by Nantong Chemical and Medical Industry Association, China is
submitted.
claim (Invokana). The firm has submitted revised Form 5-D, Manufacturing Formula and Procedure.
 Copy of ADC (Karachi) attested Commercial Invoice and COA of API submitted for Canagliflozin
following:
 GMP Certificate in light of above regulations as it is not issued by province / state drug
administration.
claim (Invokana). The firm has submitted revised Form 5-D, Manufacturing Formula and Procedure;
whereas copy of ADC (Karachi) attested Commercial Invoice and COA of API are submitted for
Canagliflozin Hemihydrate (Batch No. RD-CLF-201611081).
follows:
 Prof. Dr. Rafeeq Alam Khan, Merotorious Professor / Member Regiatration Board.
 Director DTL Karachi
 Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi
OR
c) Verification Of Genuineness / Authenticity Of Stability Data And Associated Documents

VERIFICATION OF GENUINENESS / AUTHENTICITY OF STABILITY DATA AND
ASSOCIATED DOCUMENTS
ATCO Laboratories Limited Karachi – 04 Products
S. No. Molecule Name Product Brand Name

Agrel 90mg Tablet
1175. Ticagrelor
(Blister Alu/Alu Packing)
Agrel 60mg Tablet
1176. Ticagrelor
(Blister Alu/Alu Packing)
Background:
Registration Board in it‟s 271st Meeting decided to constitute the following panel for onsite investigation
to confirm genuineness / authenticity of stability data and associated documents, import of API, quality,
specification, test analysis, facilities etc. of above 02 Products.
Composition of Panel:
 Dr. Amanullah Khan: Chairman Committee: Director DTL, Quetta
 Dr. Saif-ur-Rehman Khattak: FGA CDL, Karachi
 Mr. Aslam Shah: Member Registration Board
Product Name: Agrel 90mg Tablet & Agrel 60mg Tablet

Date of Inspection: 10-10-2017
Detail of Investigation:
Q. No. Question Observation by panel
1. Do you have documents confirming the Ticagrelor API 2KG imported from Yichang
import TicagrelorAPI including Changjiang Pharmaceuticals Co., Ltd. for the
approval from DRAP? development of Agrel 90 mg& 60 mg Tablets with
Invoice No. 1602101 on April 01, 2016 and has got
approval from the DRAP on 19-04-2016.
2. What was the rationale behind selecting M/s Yichang Changjiang Pharmaceuticals Co., Ltd.
the particular manufacturer of API? China has selected for API Ticagrelor due to the
provision of below required documents as per their
Vendor Approval Policy:
 GMP Certificate
 Drug Manufacturing License
 Stability Data
 Drug Master File (Open Part)
3. Do you have documents confirming the Firm has imported Ticagrelor reference standard
import of Ticagrelorreference standard from M/s Yichang Changjiang Pharmaceuticals Co.,
and impurity standards? Ltd. via Supplier IRIS International with letter dated
24.04.2015,however impurity standards are not
available
4. Do you have certificate of analysis of Certificates of analysis for API and reference
the API, reference standards and standards are available.
impurity standards?
5. Do you have GMP certificate of API GMP certificate issued by Food & Drug
manufacturer issued by regulatory Administration of the People‟sRepublic of China
authority of country of origin? valid till 16-12-2018 is available.
6. Do you use API manufacturer method of API manufacturer‟s method has used for the testing
testing for testing API? of API Ticagrelor.
7. Do you have stability studies reports on API manufacturer stability studies reports are
API? available; the study was done for 06-Months
Accelerated and 24-MonthsReal Time.
8. If yes, whether the stability testing has API manufacturer has performed the stability testing
been performed as per SIM method and as per SIM method and degradation products have
degradation products have been been quantified.
quantified?
9. Do you have method for quantifying the API manufacturer‟s method available for quantifying
impurities in the API? the impurities in the API through relative retention
time.
10. Do you have some remaining quantities Some remaining quantities of the working reference
of the API, its reference standard and standard and API; however impurity standards are
impurities standards? not available.
11. Have you used pharmaceutical grade Pharmaceutical grade excipients used which include
excipients? Mannitol, MCC PH-102, HPC, Sodium Starch
Glycolate, Magnesium Stearate, Opadry White Y-1-
7000 and Iron Red Oxide.
12. Do you have documents confirming the Necessary documents confirming the import of the
import of the used excipients? used excipients are available.
13. Do you have test reports and other Firm has test reports and other records on the
records on the excipients used? excipients used.
14. Do you have written and authorized Written and authorized protocols for the
protocols for the development of development of Agrel Tablets (90mg and 60mg
Ticagrelor Tablet? Ticagrelor) are available.
15. Have you performed Drug-excipients Drug-Excipients Compatibility Studies has not been
compatibility studies? performed as the formulation is qualitatively similar
to that of innovator formulation Brillinta Tablet.
16. Have you performed comparative Comparative dissolution profile for both 90mg and
dissolution studies? 60mg tablet with innovator Brillinta 90mg and 60mg
tablet from AstraZeneca, Canada have performed.
17. Do you have product development Firm has product development (R&D) section.
(R&D) section
18. Do you have necessary equipments Dedicated manufacturing and testing equipment in
available in product development product development section are available for the
section for development of Ticagrelor development of Agrel 90mg and 60mg Tablet.
tablet?

19. Are the equipments in product The available equipments in product development
development section qualified? section are qualified.
20. Do you have proper maintenance / Proper maintenance / calibration program for the
calibration / re-qualification program for equipment used in Product Development section is
the equipment used in PD section? available.
21. Do you have qualified staff in product Firm have qualified and trained staff in product
development section with proper development section with proper knowledge and
knowledge and training in product training in product development.
development?
22. Have you manufactured three stability Three stability batches have manufactured for the
batches for the stability studies of stability studies of Agrel 90mg Tablet with batch
Ticagrelor tablet as required? numbers176J16, 188J16and 189J16.
Similarly three stability batches have manufactured

for the stability studies of Agrel 60mg Tablet with
batch numbers i.e. 172J16, 177J16 and 182J16
respectively.
The Batch sizes for these batches are 2500 tablets

each.
23. Do you have any criteria for fixing the As per statement of the firm the criteria for fixing the
batch size of stability batches? batch size of stability batches is the number of tablets
per testing frequency and number of testing
frequencies.
24. Do you have complete record of Complete record of production of stability batches is
production of stability batches? available and all the logbooks are properly
maintained.
25. Do you have protocols for stability Firm has detailed protocols for stability testing of
testing of stability batches? stability batches.
26. Do you have developed and validated Firm has developed and validated testing method for
the method for testing of stability the testing of finished product based on API‟s
batches? method.
27. Do you have method transfer studies in Firm has developed the testing method in their own
case when the method of testing being lab, hence this study is not applicable.
used by your firm is given by any other
lab?
28. Do you have documents confirming the Documents confirming the qualification of
qualification of equipments / equipment / instruments being used in the test and
instruments being used in the test and analysis of Ticagrelor API and the finished drug are
analysis of Ticagrelor API and the available.
finished drug?
29. Do your method of analysis stability Yes it‟s Stability Indicating Method.
indicating?
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant.
Compliant?
31. Can you show Audit trail reports on Audit trial reports on the testing were verifiable.
Ticagrelor testing?
32. Do you have some remaining quantities The remaining quantities of stability batches are
of degradation products and stability available.
batches?
33. Do you have stability batches kept on The firm has three stability batches kept on real time
stability testing? stability testing.
34. Do you have valid calibration status for The calibration status for the equipment used in
the equipments used in Ticagrelor tablet Agrel 90mg and 60mg Tabletproduction and analysis
production and analysis? are valid.
35. Do proper and continuous monitoring Adequate monitoring and control are available for
and control are available for stability stability chambers.
chamber?
36. Do related manufacturing area, Related manufacturing area, equipments, personnel
equipment, personnel and utilities be and utilities are GMP compliant.
rated as GMP compliant?
Conclusion:
On the basis of Risk Based Approach, the genuineness / authenticity of the Stability Data submitted by
the firm for the Registration of Ticagrelor 90mg Tablet (AGRIL 90mg TABLET) and Ticagrelor 60mg
Tablet (AGRIL 60mg TABLET) are verifiable to satisfactory level. Related manufacturing area,
equipment, personnel and utilities rated as GMP compliant to satisfactory level, however based on low
solubility and low permeability of Ticagrelor is classified as Biopharmaceutics Classification System
(BCS-IV) compound therefore bioequivalence studies may be considered.
Decision:Registration Board decided to approve registration of “Ticagrelor 90mg Tablet
(AGRIL 90mg TABLET) and Ticagrelor 60mg Tablet (AGRIL 60mg TABLET)” by M/s
ATCO Laboratories Limited Karachi. Manufacturer will place first three production batches
on long term stability studies throughout proposed shelf life and on accelerated studies for
six months.
Prilocaine Alme Cream

1177.
Lidocaine (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP)
Background:
Registration Board in it‟s 270th Meeting decided to constitute the following panel for onsite investigation
 Mr. Aslam Shah: Member Registration Board
Product Name: Alme Cream (Lidocaine 2.5% and Prilocaine 2.5% Cream, USP)
Q. No. Question Observation by panel
1. Do you have documents confirming the The firm is already using Lidocaine in one of their
import Lidocaine and Prilocaine API product; hence they used the same approved source
including approval from DRAP? of Lidocaine in the development of Alme Cream
(Lidocaine 2.5% w/w, Prilocaine 2.5% w/w).
Lidocaine 250kg received from M/s Gufic
Biosciences Limited, India with Invoice No.
GBSL/167/14-15 on January 03, 2015 and has got
approval from the DRAP on 07-01-2015.

PrilocaineAPI 130greceived from same
manufacturerfor the development of ALME Cream
with Invoice No. GBSL/EXP on June 04, 2016and
has got approval from the DRAP on 16-06-2016.
2. What was the rationale behind selecting M/s Gufic Biosciences Limited, India selected for
the particular manufacturer of API? Lidocaine and Prilocaine due to the provision of
below required documents as per their Vendor
Approval Policy:
 GMP Certificate
 Stability Data
3. Do you have documents confirming the Firm has imported Prilocaine reference standard with
import of Lidocaine and Prilocaine Prilocaine API from M/s Gufic (Pvt.) Ltd. with
reference standard and impurity invoice No. GBSL/EXP and Lidocaine reference
standards? standard from BP having Invoice No.B17-3151
dated 26-12-2016.
impurity standards?
5. Do you have GMP certificate of API GMP certificate issued by Food & Drug Control
manufacturer issued by regulatory Administration, Gandhi Nagar, Gujarat State, India
authority of country of origin? valid till 20-07-2019 is available.
6. Do you use API manufacturer method Yes, the firm has used API manufacturer method for
of testing for testing API? the testing of API.
7. Do you have stability studies reports on API manufacturer has provided the stability studies
API? of API; the study was done for Six Months
Accelerated for both APIs, Three Year Real Time for
Lidocaine and Five Years Real Time for Prilocaine.
quantified?
9. Do you have method for quantifying the The firm has used API manufacturer method for
impurities in the API? quantifying the impurities in the API.
of the API, its reference standard and standard and API; however impurity standards are
impurities standards? not available.
11. Have you used pharmaceutical grade Pharmaceutical grade excipients which include
excipients? Castor Oil, Carbomer (934P), and Sodium
Hydroxide for pH adjustment.
13. Do you have test reports and other The firm has test reports and other records on the
14. Do you have written and authorized A written and authorized protocol for the
protocols for the development of Alme development of Alme Cream is available.
Cream?
15. Have you performed Drug-excipients Drug-Excipients Compatibility Studies has not
compatibility studies? performed because composition of their Cream is
qualitatively similar to that of the Innovator Product
(EMLA Cream) from Astra Zeneca Canada.

16. Have you performed comparative The Comparative Dissolution Studies has not been
dissolution studies? performed due to the dosage form that is Cream.
17. Do you have product Firm has product development (R&D) section.
development(R&D) section
18. Do you have necessary equipments Dedicated manufacturing and testing equipment in
section for development of Alme development of Alme Cream.
Cream?
calibration / re-qualification program equipment used in Product Development section is
for the equipment used in PD section? available.
21. Do you have qualified staff in product Firm have qualified staff in product development
development section with proper section with proper knowledge and training in
knowledge and training in product product development.
development?
batches for the stability studies of Alme stability studies of Alme Cream with batch
Cream as required? numbers131H16, 133H16and 163I16respectively.
The Batch sizes for these batches are 500gm each
(50 tubes of 10gm).
batch size of stability batches? batch size of stability batches is the number of tubes
frequencies.
24. Do you have complete record of Complete records of production of stability batches
production of stability batches? are available and all logbooks are properly
maintained.
26. Do you have developed and validated As the Product is Pharmacopoeial (USP) therefore
the method for testing of stability they used USP method for the testing of finished
batches? product.
27. Do you have method transfer studies in They have used United State Pharmacopeia Method,
case when the method of testing being therefore it is not applicable.
lab?
instruments being used in the test and analysis of Lidocaine and Prilocaine API and the
analysis of Lidocaine and Prilocaine finished drug are available.
API and the finished drug?
indicating?
Compliant?
31. Can you show Audit trail reports on Audit trail reports on the testing were verifiable.
testing?
32. Do you have some remaining quantities The remaining quantities of stability batches are
batches?

33. Do you have stability batches kept on Three stability batches kept on real time stability
stability testing? testing.
34. Do you have valid calibration status for The calibration status for the equipment used in
the equipments used in Alme Cream Alme Creamproduction and analysis are valid.
production and analysis?
chamber?
Conclusion:
On the basis of Risk Based Approach, the genuineness/ authenticity of the Stability Data submitted by
the firm for the Registration of Lidocaine 2.5% and Prilocaine 2.5% Cream, USP (ALME CREAM) is
verifiable to satisfactory level. Related manufacturing area, equipment, personnel and utilities rated as
GMP compliant to satisfactory level.
Decision: Mr. Aslam Shah (Member Registration Board) apprised the Board about a typographic
mistake in inspection report regarding batch sizes and confirmed that batch sizes were same as
submitted in stability data in DRAP alongwith product development data. Registration Board
decided to approve registration of “Alme Cream (Lidocaine 2.5% and Prilocaine 2.5%
Cream,)” by M/s ATCO Laboratories Limited Karachi. Manufacturer will place first three
production batches on long term stability studies throughout proposed shelf life and on
accelerated studies for six months. However, the Board advised Mr. Aslam Shah to
recheck the variation in these batches.
1178. Roflumilast Rofl 500mcg Tablet(Blister Alu/Alu Packing)
Background:
Registration Board in it‟s 270thmeeting decided to constitute the following panel for onsite investigation
 Mr. Aslam Shah: Member, Registration Board
Product Name: Rofl 500mcg Tablet

Q.No. Question Observation by panel
1. Do you have documents confirming the Roflumilast API 10G imported from Glenmark
import Roflumilast API including Pharmaceuticals Limited for the development of
approval from DRAP? Rofl 500mcg Tabletwith Invoice No. 2007501170 on
July 20, 2016 and has got approval from DRAP on
25th July, 2016.
2. What was the rationale behind selecting M/s Glenmark Pharmaceuticals Limited. India, has
the particular manufacturer of API? selected for API Roflumilast due to the provision of
below required documents as per their Vendor

Approval Policy:
 GMP Certificate
 Stability Data
3. Do you have documents confirming the Roflumilast reference standard imported from M/s
import of Roflumilastreference standard Glenmark Pharmaceuticals Limited via DHL having
and impurity standards? number waybill: 3514102373 dated 22.07.2016
impurity standards?
5. Do you have GMP certificate of API GMP certificate issued by Food & Drug
manufacturer issued by regulatory Administration Maharashtra state, India, valid till
authority of country of origin? 23-05-2018 is available.
6. Do you use API manufacturer method API manufacturer‟s method used for the testing of
of testing for testing API? API Roflumilast.
7. Do you have stability studies reports on The manufacturer of API provided thestability
API? studies of API; the study was done for 06-Months
Accelerated and 36-MonthsReal Time.
quantified?
9. Do you have method for quantifying the API manufacturer‟s method available for quantifying
impurities in the API? the impurities in the API through relative retention
time.
of the API, its reference standard and standard and API are available.
impurities standards?
11. Have you used pharmaceutical grade Pharmaceutical grade excipients used which include
excipients? Lactose Monohydrate, Povidone K-30, Pre-
gelatinized Starch, Magnesium Stearate, Opadry
White Y-1-7000 and Iron Oxide Yellow.
13. Do you have test reports and other Firm has test reports and other records on the
14. Do you have written and authorized A written and authorized protocol for the
protocols for the development of development of Rofl 500mcg Tablet is available.
Roflumilast Tablet?
15. Have you performed Drug-excipients Drug-Excipients Compatibility Studies has not
compatibility studies? performed because composition of their tablet is
qualitatively similar to that of the Innovator Product
(Dexas 500mcg Tablet) from Takeda GmbH
Germany.
16. Have you performed comparative The firm has performed comparative dissolution
dissolution studies? profile for Rofl 500mcg Tablet with innovator
product Dexas 500mcg Tabletfrom Takeda GmbH
Germany.
17. Do you have product development Firm has product development (R&D) section.
(R&D) section

18. Do you have necessary equipments Dedicated manufacturingand testing equipment in
section for development of Roflumilast development of Rofl 500mcg Tablet.
tablet?
calibration / re-qualification program equipment used in Product Development section is
for the equipment used in PD section? available.
21. Do you have qualified staff in product Firm havetrained &qualified staff in product
development section with proper development section with proper knowledge and
knowledge and training in product training in product development.
development?
batches for the stability studies of stability studies of Rofl 500mcg Tabletwith batch
Roflumilast tablet as required? numbers i.e. 191J16, 192J16and 174J16respectively.
The Batch sizes for these batches are2500 tablets
each.
batch size of stability batches? batch size of stability batches is the number of
tablets per testing frequency and number of testing
frequencies.
24. Do you have complete record of Complete record of production of stability batches is
production of stability batches? available and all logbooks are properly maintained.
26. Do you have developed and validated Firm has developed and validated testing method for
the method for testing of stability the testing of finished product based on API method.
batches?
27. Do you have method transfer studies in Firm has developed and validated the testing method
case when the method of testing being for the finish product in theirown lab, hence this
used by your firm is given by any other study is not applicable.
lab?
instruments being used in the test and analysis of Roflumilast API and the finished drug are
analysis of RoflumilastAPI and the available.
finished drug?
indicating?
Compliant?
31. Can you show Audit trail reports on Audit trail reports on the testing were verifiable.
Roflumilast testing?
32. Do you have some remaining quantities Remaining quantities of stability batches are
batches?
33. Do you have stability batches kept on Three stability batches kept on real time stability
stability testing? testing.
34. Do you have valid calibration status for Valid calibration status for the equipment used in
the equipments used in Roflumilast Rofl 500mcg Tablet production and analysis are
tablet production and analysis? available.

chamber?
Conclusion:
On the basis of Risk Based Approach, the genuineness / authenticity of the Stability Data submitted by
the firm for the Registration of Roflumilast 500mcg Tablet (ROFL 500mcg TABLET) is verifiable to
satisfactory level. Related manufacturing area, equipment, personnel and utilities rated as GMP
compliant to satisfactory level.
Decision: Mr. Aslam Shah (Member Registration Board) apprised the Board about that batch
number of stability batches have been coorectly mentioned in inspection report. Thus the Board
deferred to inquire from M/s Atco, Karachi for variation in submitted data in DRAP and data
verified by Panel.
Scilife Pharma (Pvt.) Ltd., Karachi – 02 Products
1179.Report on Investigation of Authenticity/ Genuineness of data submitted for registration of

ROMILAST (Roflumilast 500mcg) Tablets (uncoated) by M/s. Scilife Pharma (Pvt.) Ltd.,
Karachi.
Background:
Registration Board in 272nd meeting considered the applications of M/s. Scilife Pharma (Pvt.) Ltd.,
Karachi for registration of ROMILAST (Roflumilast 500mcg tablets). Registration Board considered
scientifically rational laboratory scale data submitted by the firm as pre-requisite of registration being
new formulation and constituted a three member panel to investigate the authenticity / genuineness of
data (import of raw material and stability data). Panel was advised to conduct inspection of the firm as
per decision of Registration Board and to submit report for further consideration.
1. Prof. Dr. Rafeeq Alam Khan, Meritorious Professor / Member Registration Board.
2. Prof. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah University for Women Karachi.
(Member Registration Board).
3. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.
Tools for Investigation:
The investigation was conducted by using a structured questionnaire of DRAP. For objective evidence
physical inspection of the facilities for manufacturing and quality control, material used and retained,
personnel involved, ongoing studies, printed data and integrity and security of data in respective
databases were also audited. The details of investigation may be summarized as under:
Investigation Date and Time: 05th October, 2017 (Morning).
Investigation Site: Factory premises of M/S. Scilife Pharma (Pvt.) Ltd., Plot No.
FD-57/58-A2, Korangi Creek Industrial Park, Karachi.

Q.
Question Observation by panel
No.
1. Do you have documents confirming The Firm has imported 0.020 Kg API (Romilast) from
the import of Roflumilast API? M/S Glenmark Pharmaceuticals Limited India and has
taken approval from DRAP, Karachi for import.
2. What was the rationale behind There is proper vendor evaluation form being
selecting the particular manufacturer implemented by the firm. The parameters included in
of API? this form are, DMF status, GMP certificate, provision
of reference standard of API and impurities standards
etc. The firm has evaluated on this criteria and has
been selected accordingly.
3. Do you have documents confirming The firm imported Roflumilast raw material from M/S
the import of Roflumilast reference Glenmark Pharmaceutical Limited India. Working
standard and impurity standards? reference standard was imported from M/S Glenmark
Pharmaceutical Limited India. The firm has not
imported impurity standard because there were
Unknown impurity, however Unknown impurity were
quantified by Peak Area Normalization method.
4. Do you have certificate of Analysis of The firm has certificates of analysis for the API and
the API, reference standards and working standard for Roflumilast.
impurity standards?
5. Do you have any approval of API or The firm has GMP certificate of API manufacturer
GMP certificate of API manufacturer issued by Licensing Authority Food & Drugs
issued by regulatory authority of Administration (Maharashtra State), India
country of origin?
6. Do you use API manufacturer method The firm has used API manufacturer method of
of testing? testing.
7. Do you have stability studies reports The firm has accelerated stability studies reports of six
on API? months and real time stability studies reports for two
years on the API conducted by the API manufacturer.
8. If yes, whether the stability testing has The stability testing has been performed as per SIM
been performed as per SIM method method and degradation products have been quantified
and degradation products have been for Roflumilast by the API Manufacturer.
quantified?
9. Do you have method for quantifying The firm has method for quantifying the impurities in
the impurities in the API? the API.
10. Do you have some remaining The firm has remaining quantities of the API,
quantities of the API, its reference reference standard of API. All these material have
standard and impurities standards? been checked physically and found in order.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients.
excipients?
12. Do you have documents confirming The firm has purchased all the excipients from the
the import of the used excipients? local market although they have certificate of analysis
for all the excipients available with them.

14. Do you have written and authorized The firm has written and authorized protocols for the
protocols for the development of development of Roflumilast tablets.
Roflumilast tablets?
15. Have you performed Drug-excipients The firm has not performed Drug-excipients
compatibility studies? compatibility studies as their formulation is similar to
that of the innovator formulation (Daliresp Tablets).
dissolution studies? studies with Daliresp tablets (un-coated tablets). The
firm„s product has comparative dissolution profile
with that of the innovator product.
17. Do you have product development The firm has well equipped, exclusive product
(R&D) section development (R&D) section comprising of
equipment‟s for manufacturing whereas for analysis
the equipment‟s of routine quality control have been
used.
18. Do you have necessary equipment‟s The firm has necessary equipment for production of
available in product development tablets in product development section, however, the
section for development of Roflumilast analytical part has been performed via the routine
tablets? quality control equipment.
19. Are the equipments in product The equipment in product development section are
development section qualified? qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration / re-
calibration / re-qualification program qualification program for the equipment used in PD
for the equipment used in PD section? section.
21. Do you have qualified staff in product The firm has a team of 2 pharmacists and 3 chemist
development section with proper with a machine operator in product development
knowledge and training in product section with suitable knowledge and training in
development? product development.
22. Have you manufactured three stability The firm has manufactured three stability batches for
batches for the stability studies of the stability studies of Romilast tablet with batch
Roflumilast tablets as required? number SF001, SF002 and SF003 with batch size of
7,692 tablets each.
batch size of stability batches? batch size of stability batches is R&D Equipment
capacity, the number of tablets per testing frequency,
and the number of testing frequencies.
24. Do you have complete record of The firm has complete record of production of
production of stability batches? stability batches. Necessary log books of equipment‟s
used has been available with the firm, assuring the
traceability of manufacturing and analysis of stability
batches.
25. Do you have protocols for stability The firm has detailed protocol for stability testing of
26. Do you have developed and validated The firm has used method of testing of API

the method for testing of stability manufacturer for related substances for stability
batches? testing of their finished product (Tablets).The method
is gradient mode and has properly validated while
using the API reference standard and forced
degradation studies.
27. Do you have method transfer studies in The firm has not conducted method transfer studies,
case when the method of testing being however, they have validated their method properly.
used by your firm is given by any
other lab?
28. Do you have documents confirming The firm has proper documents confirming the
the qualification of equipments / qualification of equipment / instruments being used in
instruments being used in the test and the test and analysis of Roflumilast API and the
analysis of Roflumilast API and the finished drug.
finished drug?
29. Do your method of analysis stability The firm method of testing is stability indicating for
indicating? stability testing of their finished product as evidenced
by the forced degradation studies on their finished
product.
30. Do your HPLC software is 21CFR The HPLC software is 21CFR Compliant as per record
compliant? of the firm.
31. Can you show Audit Trail reports on Audit trail on the testing reports can be made.
Roflumilast testing? Physically the related audit trial was checked and
found in order.
32. Do you have some remaining The firm has remaining quantities of stability batches,
quantities of degradation products and and reference standard of the API (Roflumilast).
stability batches?
33. Do you have stability batches kept on The firm has completed the accelerated stability
stability testing? testing on the three stability batches however the real
time stability testing is in progress on all the three
stability batches. Currently 09 months study has been
completed.
34. Do you have valid calibration status The firm has valid calibration status for the equipment
for the equipment‟s used in used in Roflumilast tablets production and analysis.
Roflumilast tablets production in
analysis?
35. Do proper and continuous monitoring Continuous power supply and monitoring are available
and control are available for stability for stability chamber.
chamber?
36. Do related manufacturing area, The related manufacturing area, equipment, personnel
equipment, personnel and utilities be and utilities be rated as GMP compliant.
CONCLUSIONS:
1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by
the firm for registration of ROMILAST Tablets (Roflumilast 500mcg) is verifiable to highly
satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well
suited for the manufacturing of Roflumilast tables.

Decision:Registration Board decided to approve registration of “ROMILAST Tablets
(Roflumilast 500mcg)” by M/s Scilife Pharma (Pvt.) Ltd., Karachi. Manufacturer will place
first three production batches on long term stability studies throughout proposed shelf life
and on accelerated studies for six months.
1180.Report on Investigation of Authenticity/ Genuineness of data submitted for registration of
TASVIR (Daclatasvir 60mg) Tablets by M/s. Scilife Pharma (Pvt.) Ltd., Karachi.
Background:
Registration Board in 272nd meeting considered the applications of M/s. Scilife Pharma (Pvt.) Ltd.,
Karachi for registration of TASVIR (Daclatasvir 60mg tablets). Registration Board considered
scientifically rational laboratory scale data submitted by the firm as pre-requisite of registration being
new formulation and constituted a three member panel to investigate the authenticity / genuineness of
data (import of raw material and stability data). Panel was advised to conduct inspection of the firm as
per decision of Registration Board and to submit report for further consideration.
1. Prof. Dr. Rafeeq Alam Khan, Meritorious Professor / Member Registration Board.
2. Prof. Dr. Ghulam Sarwar, Dean, Faculty of Pharmacy, Jinnah University for Women Karachi.
(Member Registration Board).
3. Dr. Saif-ur-Rehman Khattak, Director / FGA, CDL, DRAP, Karachi.
Scope of investigation:
Investigation of the authenticity / genuineness of data (import of raw material and stability data),
manufacturing of stability batches and stability studies on these batches.
Tools for Investigation:

The investigation was conducted by using a structured questionnaire reference # INV/Daclatasvir/016.
Objective evidence was done via physical inspection of the facilities for manufacturing and quality
control, material used and retained, personnel involved, ongoing studies, printed data and integrity and
security of data in respective databases. The details of investigation may be summarized as under:
Q.
Question Observation by panel
No.
1. Do you have documents confirming the The Firm has imported 0.7 Kg API (Daclatasvir) from
import of Daclatasvir API? M/S Nantong Chanyoo China and has taken approval
from DRAP, Karachi for import.
2. What was the rationale behind selecting There is proper vendor evaluation form being
the particular manufacturer of API? implemented by the firm. The parameters included in
this form are, DMF status, GMP certificate, provision
of reference standard of API and impurities standards
etc. The firm has evaluated on this criteria and has
been selected accordingly.
3. Do you have documents confirming the The firm has documents confirming the import of API
import of Daclatasvir reference standard working standard and four major impurities standards.
and impurity standards?
4. Do you have certificate of Analysis of The firm has certificates of analysis for the API,
the API, reference standards and working standard of API and four major impurities
impurity standards? standards.
5. Do you have any approval of API or The firm has GMP certificate of API manufacturer
GMP certificate of API manufacturer issued by regularity authority of country of Origin i.e.
issued by regulatory authority of Nantong food and Drug Administration, China.

country of origin?
6. Do you use API manufacturer method The firm use API manufacturer method of testing.
of testing?
7. Do you have stability studies reports on The firm has accelerated stability studies reports of six
API? months and real time stability studies report on the
API conducted by the API manufacturer.
been performed as per SIM method and method and degradation products have been
degradation products have been quantified.
quantified?
9. Do you have method for quantifying the The firm has method for quantifying the impurities in
impurities in the API? the API.
10. Do you have some remaining quantities The firm has remaining quantities of the API,
of the API, its reference standard and reference standard of API and impurities standards.
impurities standards? All these material have been checked physically and
found in order.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients.
excipients?
12. Do you have documents confirming the The firm has purchased all the excipients from the
import of the used excipients? local market although they have certificate of analysis
for all the excipients available with them.
protocols for the development of development of Daclatasvir tablets.
Daclatasvir tablets?
15. Have you performed Drug-excipients The firm has not performed Drug-excipients
compatibility studies? compatibility studies as their formulation is similar to
that of the innovator formulation (Daklinza Tablets).
dissolution studies? studies in three media including pH 1.2, pH 4.5 and
pH 6.8 buffers with MyDacla 60 tablets manufactured
by M/S. Mylan, India. The firm„s product results are
comparable to that of theComparator product.
17. Do you have product development The firm has well equipped, exclusive product
(R&D) section development (R&D) section comprising of equipment
for manufacturing whereas for analysis the equipment
of routine quality control have been used.
18. Do you have necessary equipment‟s The firm has necessary equipment for production of
available in product development tablets in product development section, however, the
section for development of Daclatasvir analytical part has been performed via the routine
tablets? quality control equipment.
19. Are the equipments in product The equipment in product development section are
21. Do you have qualified staff in product The firm has a team of 2 pharmacists and 3 chemist
development section with proper with a machine operator in product development
knowledge and training in product section with suitable knowledge and training in
development? product development.
22. Have you manufactured three stability The firm has manufactured three stability batches for
batches for the stability studies of the stability studies of Tasvir tablet with batch number
Daclatasvir tablets as required? SF001, SF002 and SF003 with batch size of 2,000
tablets each.
batch size of stability batches? batch size of stability batches is the number of tablets
frequencies.
24. Do you have complete record of The firm has complete record of production of
production of stability batches? stability batches. Necessary log books of equipment‟s
used has been available with the firm, assuring the
traceability of manufacturing and analysis of stability
batches.
25. Do you have protocols for stability The firm has detailed protocol for stability testing of
26. Do you have developed and validated The firm has used method of testing of API
the method for testing of stability manufacturer for related substances for stability
batches? testing of their finished product (Tablets).The method
is gradient mode and stability indicating and has
properly validated while using the API reference
standard, impurities standards and forced degradation
studies.
27. Do you have method transfer studies in The firm has not conducted method transfer studies,
case when the method of testing being however, they have validated their method properly.
lab?
28. Do you have documents confirming the The firm has proper documents confirming the
qualification of equipments / qualification of equipment / instruments being used in
instruments being used in the test and the test and analysis of Daclatasvir API and the
analysis of Daclatasvir API and the finished drug.
finished drug?
29. Do your method of analysis stability The firm method of testing is stability indicating for
indicating? stability testing of their finished product, as supported
by forced degradation studies on their finished
product.
30. Do your HPLC software is 21CFR The HPLC software is 21CFR Compliant as per record
compliant? of the firm.
31. Can you show Audit Trail reports on Audit trail on the testing reports can be made.
Daclatasvir testing? Physically the related audit trial was checked and
found in order.
32. Do you have some remaining quantities The firm has remaining quantities of stability batches,
of degradation products and stability reference standard of the API and four major impurity
batches? / degradation standards.
33. Do you have stability batches kept on The firm has completed the accelerated stability
stability testing? testing on the three stability batches however the real
time stability testing is in progress on all the three
stability batches. Currently 09 months study has been
completed.
34. Do you have valid calibration status for The firm has valid calibration status for the equipment
the equipment‟s used in Daclatasvir used in Daclatasvir tablets production and analysis.
tablets production in analysis?
35. Do proper and continuous monitoring Continuous power supply and monitoring are available
chamber?
36. Do related manufacturing area, The related manufacturing area, equipment, personnel

equipment, personnel and utilities be and utilities be rated as GMP compliant.
CONCLUSIONS:
1. On the basis of risk based approach the genuineness / authenticity of stability data submitted by
the firm for registration of TASVIR Tablets (Daclatasvir 60mg) is verifiable to highly
satisfactory level.
2. The related manufacturing area, equipment, personnel and utilities are GMP compliant and well
suited for the manufacturing of Daclatasvir tables.
Decision:Registration Board decided to approve registration of “TASVIR Tablets
(Daclatasvir 60mg)” by M/s Scilife Pharma (Pvt.) Ltd., Karachi. Manufacturer will place
first three production batches on long term stability studies throughout proposed shelf life
and on accelerated studies for six months.
M/s Getz Pharma Pakistan Pvt. Ltd. Karachi – 04 Products
S. No Molecule Name Product Brand Name

1181. Canagliflozin Canaget Film-coated Tablets 100mg AluAlu packaging, 14 tablet
1182. Canagliflozin Canaget Film-coated Tablets 300mg AluAlu packaging, 14 tablet
Background:
Registration Board decided in its 272nd Meeting to constitute the following panel for onsite investigation
specification, test analysis, facilities etc of above 02 Products.
Composition of panel:
1. Dr. Amanullah Khan-Chairman Committee/Member Registration Board DRAP/Director DTL
Quetta.
2. Mr. Aslam Shah, Member Registration Board DRAP.
3. Dr. Saifur Rehman Khattak Federal Government Analyst CDL.
Date of Inspection: 9th October 2017

Investigation Site: M/s Getz Pharma Pakistan Pvt. Ltd. Karachi.
Details of Investigation:
Canaget (Canagliflozin) Film-coated Tablets 100mg &300mg – Pack Size: 14 Tablets
Q. Question Observation by panel

No.
1. Do you have documents confirming The firm has imported Canagliflozin raw material 1.9Kg
the import of Canagliflozin API from M/s Jiangsu Yongan Pharmaceutical Co., Ltd,
including approval from DRAP? China and has approval from DRAP for import vide
License No.1944/16-DRAP(K) dated 22.07.2016.
2. What was the rationale behind There is proper vendor evaluation process being
selecting the particular manufacturer implemented by the firm and the rationale behind vendor
of API? selection is controlled through:
 Postal Audit checklist
 Physical Site Inspection
 Testing of at least two lots of API to confirm the
consistency
 GMP approval by competent authority

3. Do you have documents confirming Firm imported Canagliflozin reference standard 100mg
the import of Canagliflozin reference from M/s Jiangsu Yongan Pharmaceutical Co., Ltd,
standard and impurity standards? China vide invoice No. 16CAGZ002 dated 30.06.2016.
4. Do you have certificate of Analysis of The firm has certificates of analysis for API and
the API, reference standards and reference standard of API.
impurity standards?
5. Do you have GMP certificate of API Firm has provided copy of valid GMP certificate from
manufacturer issued by regulatory CFDA – China for M/s Jiangsu Yongan Pharmaceutical
authority of country of origin? Co., Ltd, China for Canagliflozin valid till 31-12-
2020.The manufacturer has been permitted for
manufacturing of Canagliflozin by Huaian Market
Supervision Administration, China.
6. Do you use API manufacturer method The firm has used API manufacturer‟s method of
of testing for testing API? testing. The firm has also done method verification
studies.
7. Do you have stability studies reports The firm has stability studies reports on API.
on API?
been performed as per SIM method method and degradation products have been quantified.
and degradation products have been
quantified?
9. Do you have method for quantifying The firm has developed gradient method for quantifying
the impurities in the API? the impurities in Canagliflozin.
10. Do you have some remaining The firm has some remaining quantities of the API and
quantities of the API, its reference working standard.
standard and impurities standards?
11. Have you used pharmaceutical grade The firm have used pharmaceutical grade excipients and
excipients? include Microcrystalline Cellulose, Lactose Anhydrous,
Hydroxypropyl Cellulose, Croscarmellose Sodium,
Colloidal Anhydrous Silicaand Magnesium Stearate.
Film coating materials include Opadry Orange (for
Canaget Tablets 100mg) and Opadry Yellow (for
Canaget Tablets 300mg).
12. Do you have documents confirming The firm has necessary documents confirming the
the import of the used excipients? import of the used excipients.
14. Do you have written and authorized
The firm has written and authorized protocols for the
protocols for the development ofdevelopment of Canaget (Canagliflozin) Tablets 100mg
Canagliflozin tablets? &300mg.
15. Have you performed Drug-excipient
Since firm has used same excipients as used by the
compatibility studies? innovator. Therefore, compatibility studies were not
performed.
16. Have you performed comparative The firm has performed Comparative Studies with
dissolution studies? Invokana Tablets 100mg & 300mg distributed by
Janssen Cilag Ltd Batch# EEZTE00 & Batch #
EAZSN00. The firm also have actual pack of innovator
product.
17. Do you have product development The firm has dedicated product development (R&D)
(R&D) section section with requisite manufacturing and analysis
facilities.

18. Do you have necessary equipment The firm has necessary equipment available in product
available in product development development section for development of Canaget
section for development of (Canagliflozin) Tablets 100mg & 300mg.
Canagliflozin tablets?
19. Are the equipment in product The available equipment in product development section
development section qualified? are qualified.
20. Do you have proper maintenance / The firm has proper maintenance / calibration with re-
21. Do you have qualified staff in product The firm has qualified staff in product development
development section with proper section with proper knowledge and training in product
knowledge and training in product development. There are 40 Scientists (Pharmacist &
development? Chemist) working only in R&D Section.
22. Have you manufactured three stability The firm has manufactured three stability batches of
batches for the stability studies of Canaget Tablets 100mg & 300mg.Packed in Alu-Alu
Canagliflozintablets as required? blisters:
Canaget Tablets 100mg

Batch No. Date of Mfg. Batch Size
380DS01 Oct 2016 1000 Tablets
380DS02 Nov 2016 1000 Tablets

23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches
batch size of stability batches? is the capacity of their R&D equipment where probable
simulation of manufacturing procedure of production
batches are expected as well as quantity of tablets
required per testing frequencies.
24. Do you have complete record of The firm has complete record of production of stability
production of stability batches? batches. All the Log Books are properly maintained.
25. Do you have protocols for stability The firm has detailed protocols for stability testing of
testing of stability batches? stability batches having protocol number:

Batch No. Protocol No.
380DS01 FS-100-016
380DS02 FS-102-016
380DS03 FS-103-016

379DS01 FS-101-016
379DS02 FS-104-016
379DS03 FS-105-016

26. Do you have developed and validated The method was developed and validated for testing of
the method for testing of stability stability batches. At 9 month firm has incorporated
batches? additional test to monitor degradation product through
area normalization
27. Do you have method transfer studies The firm has developed and validated method of testing
in case when the method of testing for finished product and complete Method Validation
being used by your firm is given by Report is available. Method transfer is not applicable.
any other lab?
instruments being used in the test and the test and analysis of CanagliflozinAPI and the
analysis of CanagliflozinAPI and the finished drug.
finished drug?
29. Do your method of analysis stability
The firm has performed forced degradation (FD) study
indicating? on their product Canaget (Canagliflozin) Tablets 100mg
& 300mgfor the conformance of its stability indicating
nature. Further, degradation products are also analysed
during stability studies.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per record
Compliant? available with the firm.
31. Can you show Audit trail reports on Audit trail on the testing reports is fully available.
Canagliflozintesting?
32. Do you have some remaining The firm has remaining quantities of stability batches
quantities of degradation products and only.
stability batches?
for the equipments used in used in production and analysis of Canaget
Canagliflozintablets production and (Canagliflozin) Tablets 100mg & 300mg.
analysis?
and control are available for stability
stability chamber. Chambers are controlled and
chamber? monitored through software having alarm system for
alerts as well.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel and
equipment, personnel and utilities be utilities are in compliance.
CONCLUSION:
On the basis of risk based approach, the genuineness / authenticity of the stability data submitted by the
firm for the registration of “Canaget (Canagliflozin) tablet 100mg & 300mg” are verifiable to
satisfactory level. Related manufacturing area, equipment, personnel & Utilities are rated as GMP
Compliant, however based on low solubility and low permeability canagliflozin is classified as a BCS 4
compound therefore bioequivalence studies may be considered.
Decision:Registration Board decided to approve registration of “Canaget (Canagliflozin)
tablet 100mg & 300mg” by M/s M/s Getz Pharma Pakistan Pvt. Ltd. Karachi. Manufacturer
will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.

1183. Empagliflozin Glardin Tablets Film-coated 10mg, Alu Alu packaging.
Empagliflozin Glardin Tablets Film-coated 25mg, Alu Alu packaging.
1184.
Background:
Registration Board decided in its 273rd Meeting to constitute the following panel for onsite investigation
Quetta.

Investigation Site: M/s Getz Pharma Pakistan Pvt. Ltd. Karachi.
Glardin (Empagliflozin) Tablets Film-coated 10mg & 25mg – Pack Size: 14 Tablets.
No.
1. Do you have documents confirming The firm has imported Empagliflozin raw material 1Kg
the import of Empagliflozin API from M/s Jiangsu Yongan Pharmaceutical Co., Ltd,
including approval from DRAP? China and has approval from DRAP for import vide
License No.1762/16-DRAP(K) dated 29.06.2016.
2. What was the rationale behind There is proper vendor evaluation process being
selecting the particular manufacturer implemented by the firm and the rationale behind
of API? vendor selection is controlled through:
 Postal Audit checklist
 Physical Site Inspection
 Testing of at least two lots of API to confirm
the consistency
 GMP compliant.
3. Do you have documents confirming Firm imported Empagliflozin reference standard 100mg
the import of Empagliflozin reference from M/s Jiangsu Yongan Pharmaceutical Co., Ltd,
standard and impurity standards? China vide invoice No. 16CAGZ001 dated 30.05.2016.
The firm has method to detect and quantify impurities.
4. Do you have certificate of Analysis of The firm has certificates of analysis for API and
the API, reference standards and reference standard of API.
impurity standards?
5. Do you have GMP certificate of API Firm has provided copy of valid GMP certificate of M/s
manufacturer issued by regulatory Jiangsu Yongan Pharmaceutical Co., Ltd, China for
authority of country of origin? Empagliflozin valid till 31-12-2020.The manufacturer
has been permitted for manufacturing of Empagliflozin
by Huaian Market Supervision Administration, China.
6. Do you use API manufacturer method The firm has used API manufacturer‟s method of
of testing for testing API? testing. The firm has also done method verification
studies.

7. Do you have stability studies reports The firm has stability studies reports on API.
on API?
been performed as per SIM method method and degradation products have been quantified.
and degradation products have been
quantified?
9. Do you have method for quantifying The firm has gradient method for quantifying the
the impurities in the API? impurities in Empagliflozin.
10. Do you have some remaining The firm has some remaining quantities of the API and
quantities of the API, its reference working standard.
standard and impurities standards?
11. Have you used pharmaceutical grade The firm have used pharmaceutical grade excipients and
excipients? include Microcrystalline Cellulose, Pharmatose DCL
11, Hydroxypropyl Cellulose, Croscarmellose
Sodium,Colloidal Anhydrous Silica, and Magnesium
Stearate. Film coating materials include HPMC 6cps,
PEG 6000, Titanium Dioxide, and Ferric Oxide Yellow.
the import of the used excipients? import of the used excipients.
protocols for the development of development of Glardin (Empagliflozin) Tablets 10mg
Empagliflozintablets? & 25mg.
15. Have you performed Drug-excipient Since firm has used same excipients as used by the
compatibility studies? innovator. Therefore, compatibility studies were not
performed.
16. Have you performed comparative The firm has performed Comparative Studies with
dissolution studies? Jardiance Tablets manufactured by Boehringer
Ingelheim Pharma GmbH & Co. KG Germany Batch#
604763. The firm also have actual pack of innovator
product.(Dissolution method reference adopted from
US FDA database)
17. Do you have product development The firm has dedicated product development (R&D)
(R&D) section section with requisite manufacturing and analysis
facilities.
18. Do you have necessary equipment The firm has necessary equipment available in product
available in product development development section for development of Glardin
section for development of (Empagliflozin) Tablets 10mg & 25mg.
Empagliflozintablets?
19. Are the equipment in product The available equipment in product development
20. Do you have proper maintenance / The firm has proper maintenance / calibration with re-
21. Do you have qualified staff in product The firm has qualified staff in product development
development section with proper section with proper knowledge and training in product
knowledge and training in product development. There are 40 Scientists (Pharmacist &
development? Chemist) working only in R&D Section.

22. Have you manufactured three stability The firm has manufactured three stability batches
batches for the stability studies of ofGlardin Tablets 10mg & 25mg. Packed in Alu-Alu
Empagliflozintablets as required? blisters:
Glardin Tablets 10mg
374DS04 Dec 2016 2500 Tablets
374DS05 Dec 2016 2500 Tablets

23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability batches
batch size of stability batches? is the capacity of their R&D equipment where probable
simulation of manufacturing procedure of production
batches are expected as well as quantity of tablets
required per testing frequencies.
24. Do you have complete record of The firm has complete record of production of stability
production of stability batches? batches. All the Log Books are properly maintained.
25. Do you have protocols for stability The firm has detailed protocols for stability testing of
testing of stability batches? stability batches having protocol number:
374DS01 FS-106-016
374DS04 FS-113-016
374DS05 FS-114-016

373DS01 FS-107-016
373DS02 FS-108-016
373DS03 FS-109-016
26. Do you have developed and validated The method was developed using API method as
the method for testing of stability reference, optimized and validated for testing of
batches? stability batches
27. Do you have method transfer studies The firm has developed and validated method of testing
in case when the method of testing for finished product and complete Method Validation
being used by your firm is given by Report is available.Method transfer is not applicable.
any other lab?
instruments being used in the test and the test and analysis of Empagliflozin API and the
analysis of EmpagliflozinAPI and the finished drug.
finished drug?
29. Do your method of analysis stability
The firm has performed forced degradation (FD) study
indicating? on their product Glardin (Empagliflozin) Tablets10mg
& 25mg for the conformance of its stability indicating
nature. Further, degradation products are also analysed
during stability studies.
30. Do your HPLC software 21CFR The HPLC software is 21CFR Compliant as per record
Compliant? available with the firm.

31. Can you show Audit trail reports on Audit trail on the testing reports is fully available.
Empagliflozin testing?
32. Do you have some remaining The firm has remaining quantities of stability batches
quantities of degradation products and only.
stability batches?
for the equipments used in used in production and analysis of Glardin
Empagliflozintablets production and (Empagliflozin) Tablets 10mg & 25mg.
analysis?
stability chamber.Chambers are controlled and
chamber? monitored through software having alarm system for
alerts as well.
36. Do related manufacturing area, Related manufacturing area, equipment, personnel and
equipment, personnel and utilities be utilities are in compliance.
CONCLUSION:
firm for the registration of “Glardin (Empagliflozin) tablet 10mg & 25mg.” is verifiable to satisfactory
level. Related manufacturing area, equipment, personnel & Utilities are rated as GMP Compliant.
Decision:Registration Board decided to approve registration of “Glardin (Empagliflozin)
tablet 10mg & 25mg” by M/s M/s Getz Pharma Pakistan Pvt. Ltd. Karachi. Manufacturer
will place first three production batches on long term stability studies throughout
proposed shelf life and on accelerated studies for six months.

M/s Hilton Pharma Pakistan Pvt. Ltd. Karachi – 03 Products

Dexlan 60 mg Capsule packed in Alu Alu blister
1185. Dexlansoprazole Pellets 23%
(2x7’s).
Dexlan 30 mg Capsule packed in
1186. Dexlansoprazole Pellets 23%
AluAlublister(2x7’s).
Background:
Registration Board in its 271st Meeting deliberated that the fee for Import of pellets is not required in
case of applications that are made on Form 5D. Registration Board decided to constitute the following
panel for onsite investigation to confirm genuineness / authenticity of stability data and associated
documents, import of API, quality, specification, test analysis, facilities etc. of above 02 Products.
Quetta.

Investigation Site: M/s Hilton Pharma Pakistan Pvt.Ltd.Karachi.Plot 13-14 Sector15Korangi Industrial
Area Karachi.
S.NO Question Observation by Panel

Q.No. Do you have documents confirming Documents for import, approved by DRAP are
1 the import of API including approval Available.
from DRAP? Dexlansoprazole Pellets imported fromM/s Murli
Krishna pharma (pvt.) Ltd India.
Batch No. Date Of Invoice Quantity

Import No. Imported.
PDL/DEF-1- 14-06-2016 MKPPL/ 4.5 Kg
120416 RG/022
Q.No. Do you have any rationale behind The rationale behind selecting the API manufacturers
2 selecting the particular manufacturer of is GMP compliant.
API?
Q.No. Do you have documents confirming Firm imported Dexlansoprazole Pellets 4.50 Kg from
3 the import of reference standard and M/s Murli Krishna pharma (pvt.) Ltd, invoice No.
impurity standards? MKPPL/RG/022dated 14.06.16.Working reference
and impurity standardswere imported from M/s Murli
Krishna pharma (pvt.) Ltd.
Q.No. Do you have certificate of Analysis of The firm has certificate of analysis of API,working
4 the API, reference standards and standardand impurity standard forDexlansoprazole
impurity standards? Pellets.
Q.No. Do you have any approval of API or The firm has provided copy of GMP certificate issued
5 GMP certificate of API manufacturer by Food and Drug Administration, Maharashtra,
issued by regulatory authority of Indiadated 12.03.2017 Valid Up to 07.03.2019
country of origin? forDexlansoprazole Pellets.
Q.No. Do you use API manufacturer method The firm used API manufacturer‟s method of testing
6 of testing? for Dexlansoprazole Pellets.
Q.No. Do you have stability studies reports Yes,the firm has stability studies reports on
7 on API? Dexlansoprazole Pellets.
Q.No. If Yes, whether the stability testing has The stability testing has been performed by API
8 been performed as per SIM method manufacturer and degradation products have been
and degradation products have been quantified for Dexlansoprazole Pelletsby API
quantified? manufacturer.
Q.No. Do you have method for quantifying The manufacturer of API has quantified the
9 the impurities in the API? impurities.
Q.No. Do you have some remaining The firm has some remaining quantities
10 quantities of the API, its reference ofAPI,reference standardand impurity standard
standard and impurities standards? forDexlansoprazole Pellets.
Q.No. Have you used pharmaceutical grade The firm has used ready for filling pellets for trial.
11 excipients?
Q.No. Do you have documents confirming The firm has used ready for filling Pellets.
12 the import of the used excipients?
Q.No. Do you have test reports and other The firm has used ready for filling Pellets.
13 records on the excipients used?
Q.No. Do you have written and authorized The firm has written and authorized protocols for the
14 protocols for the development development of Dexlan 30 mg & 60 mg capsules.
ofDexlan Capsule?
Q.No. Have you performed Drug-excipient Since firm has used same ready for filling Pellets,
15 compatibility study? therefore compatibility studies were not preformed.
Q.No. Have you performed comparative The firm has performed comparative dissolution study
16 dissolution studies? for Dexlan Capsule against Innovator product that is
Dexilant capsule manufactured by Takeda America.
The capsule contains a blend of two types of pellets,
i.e. Delayed immediate release (DIR) and delayed
extended release (DER).
The release profile was compared with innovator at
pH 1.2, 5.5, 6.75 and 7.0 to confirm the dual delayed
release profile of pellets.
At pH 1.2 release NMT 10%
At pH 5.5 the release is between 10 % to 25%
At pH 6.75 the release is between 70 % to 90%
At pH 7.0 release NLT 80%
Q.No. Do you have product development The firm has dedicated product development (R&D)
17 (R&D) section? section with requisite analysis and manufacturing
facilities, however fillingand blistering were done in
production area.
Q.No. Do you have necessary equipment The firm used ready to fill pellet for
18 available in product development manufacturinghowever filling of capsules and
section for development of Dexlan blistering were done in production area.
60mg & 30mg capsules?
Q.No. Are the equipment in the product The available equipment in product development
19 development section qualified? section are qualified.
Q.No. Do you have proper maintenance and The firm has proper maintenance calibration with re-
20 calibration/re-qualification program for qualification program for the equipment used in
the equipment used in the PD Section? product development.
Q.No. Do You have qualified staff in the The firm has qualified staff in product development
21 product development section with section with proper knowledge and training in the
proper knowledge and training in the product development.There are 14 scientist
product development? (pharmacist and chemist) working in only PD Section

Q.No. Have you manufactured three stability The firm has manufactured three stability batches for
22 batches for the stability studies of the stability studies of Dexlan 30 mg & 60 mg
Dexlan 30 mg and 60 mg capsules as Capsules.Such as.
required? Dexlan 60 mg Capsules
DEX-227311-2 11.2016 2804 Capsules
DEX-227411-3 11.2016 2804 Capsules
DEX-227511-4 11.2016 2804 Capsules
Dexlan 30 mg Capsules
DEX-227611-2 11.2016 5615 Capsules
DEX-227711-3 11.2016 5615 Capsules
DEX-227811-4 11.2016 5615 Capsules
Q.No. Do you have any criteria for fixing the The criteria for fixing the batch size of the stability
23 batch size of stability batches? batches is the quantity required for testing frequency
and number of testing frequencies.
Q.No. Do you have complete record of The firm has complete record of production of
24 production batches? stability batches .All the log books are proper
maintained.
Q.No. Do you have protocols for stability The firm has detailed protocols for stability testing of
25 testing of stability batches? stability batches.
DEX-227311-2 HPL/11/16/DEX
DEX-227411-3 HPL/11/16/DEX
DEX-227511-4 HPL/11/16/DEX
DEX-227611-2 HPL/11/16/DEX
DEX-227711-3 HPL/11/16/DEX
DEX-227811-4 HPL/11/16/DEX
Q.No. Do you have developed and validated The firm has developed method and validated for
26 the method for testing of stability testing of stability batches.
batches?
Q.No. Do you have method transfer studies in The firm has developed and validated method based
27 case when the method of testing being on API manufacturer for testing of finished product,
used by your firm is given by any other but method transfer studies has not been done.
lab?
Q.No. Do you have documents confirming The firm has proper documents confirming the
28 the qualification of equipment / qualification of equipment /instruments being used in
instruments being used in the test and the test and analysis ofDexlansoprazole pellets and
analysis of Dexlan 30 mg and 60 finished product.
mgcapsulesand the finished drug?
Q.No. Do your method of analysis stability Yes, the firm has performed force degradation study
29 Indicating? on their product for conformance of its stability
indicating nature.Further degradation product is also
analyzed during stability studies.
Q.No. Do your HPLC Software 21CFR The HPLC software is 21 CFR compliant.
30 compliant.
Q.No. Can you show Audit Trail reports on Audit trail on the testing reports of Dexlan 30 mg and
31 Dexlan 30 mg and 60 mgtesting? 60 mg capsules are available.
Q.No. Do you have some remaining The firm has some remaining quantities of
32 quantities of degradation products and degradation product and stability batches at real time.

stability batches?
Q.No. Do you have commitment batches kept The firm has three stability batches kept on real time
33 on stability testing? stability testing
Q.No. Do you have valid calibration status The firm has valid calibration status for the equipment
34 for the equipment used in Dexlan used in production and analysis.
30mg and 60mgcapsules production
and analysis?
Q.No. Do proper and continuous monitoring Adequate monitoring and control are available for
35 and control are available for stability stability chamber. Stability chambers are controlled
chamber? and monitored through software having alarm system
for alerts as well.
Q.No. Do related manufacturing area, Related manufacturing area equipments, personnel
36 equipment, personnel and utilities be and utilities are GM compliant.
CONCLUSION:
firm for the registration of “Dexlan 60 mg and 30 mg Capsule” are verifiable to satisfactory level.
Related manufacturing area, equipment, personnel & Utilities are rated as GMP Compliant to highly
satisfactory level.
Decision: Mr. Aslam Shah (Member Registration Board) apprised the Board that inspection
report was submitted with a typographic mistake regarding manufacturing dates of trial batches.
Dates mentioned in data submitted by the firm is correct i.e. October, 2016. However, the Board
decided to deferfor further deliberation in the light of decision taken in 273rd meeting of
Registration Board regarding “Innovator‟s Formulation of Dexlansoprazole”

Lacolep Oral Solution Amber glass bottle 60 ml & 120 ml
1187. Lacosamide 10 mg/ml.
Packing
Background:
Registration Board in its 271st Meeting deliberated that the fee for Import of pellets is not required in
case of applications that are made on Form 5D. Registration Board decided to constitute the following
panel for onsite investigation to confirm genuineness / authenticity of stability data and associated
documents, import of API, quality, specification, test analysis, facilities etc.
1. Dr. Amanullah Khan-Chairman Committee/Member Reg. Board DRAP/Director DTL Quetta.
Investigation Site: M/s Hilton Pharma Pakistan Pvt.Ltd. Karachi. Plot 13-14 Sector15Korangi Industrial
Area Karachi.
S.NO Question Observation by Panel
Q.No. Do you have documents confirming Documents for import, approved by DRAP are
1 the import of API including approval Available.
from DRAP? Lacosamide imported from M/s Optimus Drugs Pvt.
Ltd India
Import No. Imported.
OP- 14.01.2015 209/EXP 500 gm
LAN/12/14/02
5
Q.No. Do you have any rationale behind The rationale behind selecting the API manufacturers

API?
Q.No. Do you have documents confirming Firm imported Lacosamide raw material 500 gm from
3 the import of reference standard and M/s Optimus Drugs Pvt. Ltd, invoice No. 209/EXP
impurity standards? dated 14.01.15.Working reference standard was
imported from M/s Optimus Drugs Pvt. Ltd. Impurity
standards were imported from Synpure lab India,
invoice no.SYN/PYD/001-1516 dated 16.3.15.
Q.No. Do you have certificate of Analysis of The firm has certificate of analysis of API and
4 the API, reference standards and working standard and impurity standards for
impurity standards? Lacosamide.
Q.No. Do you have any approval of API or The firm has provided copy of GMP certificate issued
5 GMP certificate of API manufacturer by Drugs Control Administration, Govt. of Telangana
issued by regulatory authority of India dated 02.01.2017 valid up to 01.01.2019
country of origin? forLacosamide.
Q.No. Do you use API manufacturer method The firm used API manufacturer‟s method of testing
6 of testing? for Lacosamide.
Q.No. Do you have stability studies reports Yes, The firm has stability studies reports on
7 on API? Lacosamide.
Q.No. If Yes, whether the stability testing has The stability testing has been performed by API
8 been performed as per SIM method manufacturer and degradation products have been
and degradation products have been quantified for Lacosamide by API manufacturer.
quantified?
Q.No. Do you have method for quantifying The manufacturer of API has quantified the
9 the impurities in the API? impurities.
Q.No. Do you have some remaining The firm has some remaining quantities ofAPI,
10 quantities of the API, its reference reference standard and impurity standards for
standard and impurities standards? Lacosamide.
Q.No. Have you used pharmaceutical grade The firm have used pharmaceutical grade excipients,
11 excipients?  Glycerine
 Carboxy methyl cellulose sodium
 Sorbitol Liquid
 Macrogol 4000
 Propylene glycol
 Sodium Chloride
 Citric Acid
 Acesulfam – K
 Polysucralose
 Maltitol Solution
 Sodium Methyl paraben
Q.No. Do you have documents confirming The firm has necessary documents confirming the
12 the import of the used excipients? import of the used excipients.
Q.No. Do you have test reports and other The firm has test reports and other records on the
13 records on the excipients used? excipients used.
Q.No. Do you have written and authorized The firm has written and authorized protocols for the
14 protocols for the development development of LacosamideOral Solution.
ofLacosamideOral Solution?
Q.No. Have you performed Drug-excipient Since firm has used same excipients as used by
15 compatibility study? innovator, therefore compatibility studies were not
preformed.
Q.No. Have you performed comparative Not applicable
16 dissolution studies?
Q.No. Do you have product development The firm has dedicated product development (R&D)

17 (R&D) section? section with requisite analysis and manufacturing
facilities, however filling was done in production
area.
Q.No. Do you have necessary equipment The firm has all the necessary equipment available in
18 available in product development product development section for product solution
section for development of Manufacturing except filling equipment.
Lacosamide Oral Solution?
Q.No. Are the equipment in the product The available equipment in product development
19 development section qualified? section are qualified.
Q.No. Do you have proper maintenance and The firm has proper maintenance calibration with re-
20 calibration/re-qualification program for qualification program for the equipment used in
the equipment used in the PD Section? product development.
Q.No. Do You have qualified staff in the The firm has qualified staff in product development
21 product development section with section with proper knowledge and training in the
proper knowledge and training in the product development. There are 14 scientist
product development? (pharmacist and chemist) working in only PD Section
Q.No. Have you manufactured three stability The firm has manufactured three stability batches for
22 batches for the stability studies of the stability studies Lacosamide Oral Solution .such
Lacosamide Oral Solution as required? as.
Lacolep Oral Solution
LAC-223910-16 10.2016 5 liters
LAC-224010-17 10.2016 5 liters
LAC-224110-18 10.2016 5 liters
Q.No. Do you have any criteria for fixing the The criteria for fixing the batch size of the stability
23 batch size of stability batches? batches is the quantity required for testing frequency
and number of testing frequencies.
Q.No. Do you have complete record of The firm has complete record of production of
24 production batches? stability batches .All the log books are properly
maintained.
Q.No. Do you have protocols for stability The firm has detailed protocols for stability testing of
25 testing of stability batches? stability batches.
Lacolep Oral Solution
LAC-223910-16 HPL/11/16/LAC
LAC-224010-17 HPL/11/16/LAC
LAC-224110-18 HPL/11/16/LAC
Q.No. Do you have developed and validated The firm has developed method and validated for
26 the method for testing of stability testing of stability batches.
batches?
Q.No. Do you have method transfer studies in The firm has developed and validated method based
27 case when the method of testing being on API manufacturer for testing of finished product,
used by your firm is given by any other but method transfer studies has not been done.
lab?
Q.No. Do you have documents confirming The firm has proper documents confirming the
28 the qualification of equipment / qualification of equipment /instruments being used in
instruments being used in the test and the test and analysis ofLacosamide API and finished
analysis of Lacosamide and the product.
finished drug?
Q.No. Do your method of analysis stability Yes, the firm has performed force degradation study
29 Indicating? on their product for conformance of its stability
indicating nature. Further degradation product is also
analyzed during stability studies.

Q.No. Do your HPLC Software 21CFR The HPLC software is 21 CFR compliant.
30 compliant.
Q.No. Can you show Audit Trail reports on Audit trail on the testing reports of Lacosamide Oral
31 Lacosamide testing? Solution are available.
Q.No. Do you have some remaining The firm has some remaining quantities of
32 quantities of degradation products and degradation product and stability batches at real time.
stability batches?
Q.No. Do you have commitment batches kept The firm has three stability batches kept on real time
33 on stability testing? stability testing
Q.No. Do you have valid calibration status The firm has valid calibration status for the equipment
34 for the equipment used in used in production and analysis.
Lacosamide Oral Solution
production and analysis?
Q.No. Do proper and continuous monitoring Adequate monitoring and control are available for
35 and control are available for stability
stability chamber. Stability chambers are controlled
chamber? and monitored through software having alarm system
for alerts as well.
Q.No. Do related manufacturing area, Related manufacturing area equipments, personnel
36 equipment, personnel and utilities be and utilities are GMP compliant.
CONCLUSION:
firm for the registration of “Lacolep Oral Solution” is verifiable to satisfactory level. Related
manufacturing area, equipment, personnel & Utilities are rated as GMP Compliant to highly satisfactory
level.
Decision:Registration Board decided to approve registration of “Lacolep Oral Solution” by
M/s Hilton Pharma Pakistan Pvt. Ltd. Karachi. Manufacturer will place first three
production batches on long term stability studies throughout proposed shelf life and on
accelerated studies for six months.
M/s Macter International Ltd., Karachi. – 01 Product
Sr. No. Molecule name Product brand name

1188. Budesonide 400 mcg + Formeterol fumerate dihydrate 12 mcg Venticort 400/12 Rotacaps
Background:
Registration Board in its 271st Meeting decided to constitute the following panel for onsite investigation
Quetta.
Date of Inspection: 10th October 2017.

Investigation site: M/s Macter International Ltd., F-216, S.I.T.E, Karachi.
S. No. Question Observation

1. Do you have documents confirming The firm has imported 300gms Budesonide API and
the import of APIs (Budesonide + 5gms Formeterol fumerate dihydrate from Aarti
Formeterol fumerate dihydrate) industries Ltd., India. There is proper approval from
including approval from DRAP? DRAP (2460/15-DRAP, 15.09.2015, invoice No.
2293/15-DRAP, 21.09.2015, Invoice No.
AAHL/EXP/122, dated 21.08.2015 and
AAHL/EXP423, dated 11.09.2013) respectively for
both API‟s.
2. What was the rationale behind The rationale behind selecting the particular
selecting the particular manufacturer manufacturer of both APIs is the vendor evaluation
of API? process based on audit and other requirements like
firm GMP status, DMF source etc.
The firm is already manufacturing the other strength
of this product that is Venticort 200/6 mcg rotacaps.
3. Do you have documents confirming The firm has imported Budesonide + Formeterol
the import of Budesonide + Fumerate dihydrate working standard from the API
Formeterol fumerate dihydrate manufacturer (Aarti industries Ltd., India). Moreover
reference standards and impurity the firm has imported reference standards and impurity
standards? standards from Eur. Ph. for both APIs.
4. Do you have certificate of Analysis of The firm has Certificate of Analysis for both APIs
the APIs, reference standards of the (Eur. Ph specification), their working standards and
APIs and impurity standards? impurities standards.
5. Do you have GMP certificate(s) of The firm has GMP certificates for Budesonide +
APIs manufacturers issued by Formeterol fumerate dihydrate issued by Joint
regulatory authorities of country of
Commissioner (HQ) & controlling Authority, FDA
origin? administration, M.S. Bandra (E), Mumbai,
Maharashtra state, India.
6. Do you use API manufacturer method The firm has used Eur. Ph method for testing of API‟s.
of testing for testing APIs?
7. Do you have stability studies reports The firm has stability studies report on APIs
on APIs? (Budesonide + formeterol fumerate dihydrate)
conducted by API manufacturers.
8. If yes, whether the stability testing has The manufacturer of both APIs has performed the
been performed as per SIM methods stability studies on APIs as per SIM method and the
and degradation products have been degradation products have been quantified.
quantified?
9. Do you have method for quantifying The firm has methods for quantifying impurities in
the impurities in the APIs? both APIs provided by Eur. Ph method. These
impurities are process related.
10. Do you have some remaining The firm has some remaining quantities of APIs
quantities of both API, its reference (Budesonide + formeterol fumerate dihydrate)
standards and impurities standards? working standard and impurity standard.
11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipient
excipients? Lactose monohydrate (respitose).
the import of the used excipients? import of the used excipient.
13. Do you have test reports and other The firm has test reports and other records for the
records on the excipients used? excipient used.
14. Do you have written and authorized The firm has written and authorized protocol for the
protocols for the development of development of Venticort (Budesonide + formeterol
Budesonide + formeterol fumerate fumerate dihydrate) 400/12 rotacaps.
dihydrate 400/12 rotacaps?
15. Have you performed Drug-excipient The firm has not performed Drug Excipient
compatibility studies? compatibility studies as composition of their product
is similar to that of innovator product (Symbicort -
AstraZeneca).
16. Have you performed comparative Not applicable because the product is intended for
dissolution studies? inhalation use only.
17. Do you have product development The firm has product development (R&D) section with
(R&D) section requisite manufacturing, storage and analysis facilities.
18. Do you have necessary equipment The firm has all the necessary equipment available in
available in product development product development section for the development of
section for development of Budesonide + formeterol fumerate dihydrate 400/12
Budesonide + formeterol fumerate rotacaps.
dihydrate 400/12 rotacaps? During the visit it was observed that the firm has
installed new sophisticated and precise micro dosing
filling machine (Bosch- Germany) for Dry Powder
Inhalers (DPIs).
19. Are the equipments in product The equipments in product development section are
21. Do you have qualified staff in product The firm has qualified staff in PD section with proper
development section with proper knowledge and training in Product Development
knowledge and training in product including 01 Ph.D., 04 Pharmacists and 04 MSc
development? Chemistry.
22. `Have you manufactured three stability The firm has manufactured three stability batches as
batches for the stability studies of follows;
Budesonide + formeterol fumerate
dihydrate 400/12 rotacaps as Sr. No. B. No. Batch size
required? 1 001P 10,000
2 002P 10,000
3 003P 10,000
The capsules are packed in Alu-Alu Blister of 30‟s
(3x10‟s).
23. Do you have any criteria for fixing the The criteria for fixing the batch size of stability
batch size of stability batches? batches is the number of capsules required per testing
frequency and number of testing frequencies.
24. Do you have complete record of The firm has complete records of production of
production of stability batches? stability batches. All log books are properly
maintained.
25. Do you have protocols for stability The firm has detailed protocol for the stability testing
testing of stability batches? of Venticort (Budesonide + formeterol fumerate
dihydrate) 400/12 rotacaps.
26. Do you have developed and validated The firm has developed and validated method for
the method for testing of stability testing of stability batches of finish product i.e.
batches? Venticort (Budesonide + formeterol fumerate
dihydrate) 400/12 rotacaps. The method is stability
indicating.

27. Do you have method transfer studies The firm has developed and validated method based
in case when the method of testing on API manufacturer for testing of finished product,
being used by your firm is given by but method transfer studies has not been done.
any other lab?
instruments being used in the test and the test and analysis of the APIs (Budesonide +
analysis of Budesonide + formeterol formeterol fumerate dihydrate) and the finished drug
fumerate dihydrate API and the Venticort (Budesonide + formeterol fumerate
finished drug? dihydrate) 400/12 rotacaps.
29. Do your method of analysis stability Yes, the method of analysis is stability indicating
indicating?
30. Do your HPLC software 21CFR The HPLC software is 21CFR compliant.
Compliant?
31. Can you show Audit trail reports on Audit Trail on the testing reports of Venticort
Venticort (Budesonide + formeterol (Budesonide + formeterol fumerate dihydrate) testing
fumerate dihydrate) testing? is available.
32. Do you have some remaining The firm has only remaining quantities of stability
quantities of degradation products and batches kept on real-time stability testing.
stability batches?
33. Do you have stability batches kept on The firm has three lab scale batches kept on stability
stability testing? studies for real time stability testing. However, 18
months real-time stability studies have been
completed.
for the equipments used in Venticort used in Venticort (Budesonide + formeterol fumerate
(Budesonide + formeterol fumerate dihydrate) 400/12 rotacaps production and analysis.
dihydrate) 400/12 rotacaps production
and analysis?
35. Do proper and continuous monitoring The firm has adequate monitoring and control system
chamber?
Conclusions:
On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm
for registration of Venticort (Budesonide + formeterol fumerate dihydrate) 400/12 rotacaps is verifiable
to satisfactory level. Related manufacturing area, equipment, personnel and utilities are also rated as
GMP compliant.
Decision:Registration Board decided to approve registration of “Venticort (Budesonide +
formeterol fumerate dihydrate) 400/12 rotacaps” by M/s Macter International Ltd., Karachi.
Manufacturer will place first three production batches on long term stability studies
throughout proposed shelf life and on accelerated studies for six months.

M/s. Hudson Pharma Pvt. Ltd. Karachi – 02 Products

1189. Ipratropium Bromide 0.5mg + Albuterol Sulfate Easehale + Respules 0.5mg/2.5mg
(Salbutamol Sulphate) 2.5mg PE Ampoules / 2.5ml
Background:
Registration Board in its 272nd Meeting deliberated that the Assay results are within specified limits
(90%- 110%) and decided to constitute the following panel for onsite investigation to confirm
genuineness / authenticity of stability data and associated documents, import of API, quality,
 Dr. Amanullah Khan, Chairman Committee/Member Registration Board DRAP/Director DTL
Quetta.
 Mr. Aslam Shah, Member Registration Board DRAP.
 Dr. Saif ur Rehman Khattak, Federal Government Analyst CDL.

Investigation Site: M/s Hudson Pharma Pvt. Ltd. D-93, North Western Industrial Zone, Port Qasim -
Karachi.
S. No. Question Observation by Panel
Q. No. Do you have documents confirming the Documents for import, approved from DRAP are
1 import of Ipratropium bromide, available. Ipratropium Bromide from M/s
Albuterol Sulfate (Salbutamol Sifavitor/Olon srl Italy.
Sulphate) API including approval from Batch No. Date Of Invoice Quantity
DRAP? Import No. Imported
9800/01/16 05-10-2016 VI/885 0.125 KG
Albuterol Sulfate (Salbutamol Sulphate) from M/s

Cipla India.
Batch No. Date Of Invoice No. Quantity
Import Imported
HDP160180 05-10-2016 CIP/EXP/006 1.2 KG
Q. No. Do you have any rationale behind The rationale behind selecting the API manufacturer
API?
Q. No. Do you have documents confirming the For Ipratropium Bromide the firm has working
3 import of Ipratropium Bromide and standard and 06 impurity standards imported from
Albuterol Sulfate (Salbutamol M/s Sifavitor srl Italy vide invoice No. VI/885 dated
Sulphate) reference standard and 22-09-2016 along with API's.
impurity standards?
Albuterol Sulfate (Salbutamol Sulphate) USP
reference standard has been imported from USP vide
invoice No. 29665882 dated 18-09-2017. Whereas
the impurities standards (01 Pharmacopeial) has not
been procured by the firm.
Q. No. Do you have certificate of Analysis of The firm has certificate of analysis for API‟s,
4 the API, reference standards and working standards of the API's and impurity
impurity standards? standards of the Ipratropium Bromide.

Q. No. Do you have any approval of API or Copy of GMP certificate M/s Sifavitor/Olon srl Italy
5 GMP certificate of API manufacturer issued by AIFA Italy Valid Up to 11-03-2019 for
issued by regulatory authority of Ipratropium bromide is enclosed
country of origin?
Copy of GMP certificate M/s Cipla India issued by
Joint Commissioner (HQ) and controlling authority
of Maharashtra India Valid Up to 20-06-2018 for
Albuterol Sulfate (Salbutamol Sulphate) is enclosed.
Q. No. Do you use API manufacturer method The firm has used Pharmacopeia methods for testing
6 of testing? of Ipratropium bromide as per U.S.P and Albuterol
Sulfate (Salbutamol) as per U.S.P.
Q. No. Do you have stability studies reports on The firm has stability studies reports on Ipratropium
7 API‟s? Bromide and Albuterol Sulfate (Salbutamol
Sulphate) API‟s.
Q. No. If Yes, whether the stability testing has The stability testing has been performed as per SIM
8 been performed as per SIM method and method and degradation products have been
degradation products have been quantified for Ipratropium bromide and Albuterol
quantified? Sulfate (Salbutamol Sulphate) by the API
manufacturers.
Q. No. Do you have method for quantifying The firm has methods for quantifying the impurities
9 the impurities in the APIs? of the APIs provided by the APIs manufacturers.
Q. No. Do you have some remaining quantities The firm has some remaining quantities of APIs
10 of the APIs, their reference standard working standard of Ipratropium Bromide and
and impurities standards? primary reference standard of Albuterol with
impurity standard for Ipratropium Bromide only.
Q. No. Have you used pharmaceutical grade The product contains only sodium chloride as
11 excipients? excipient and hydrochloric acid as pH adjuster. Both
the excipients are of analytical grades.
Q. No. Do you have documents confirming the The firm has used analytical grade excipients
12 import of the used excipients? purchased from Merck Germany through their
Pakistan Office.
Q. No. Do you have test reports and other The firm has test reports and other records on the
13 records on the excipients used? excipients used.
Q. No. Do you have written and authorized The firm has written and authorized protocols for the
14 protocols for the development of development of Easehale+ (Ipratropium Bromide
Easehale+ (Ipratropium Bromide + 0.5mg + Albuterol Sulfate (Salbutamol Sulphate
Albuterol (Salbutamol) Respules? 2.5mg) Respules.
Q. No. Have you performed Drug-excipient Since firm has used same excipient as used by
15 compatibility study? innovator, therefore compatibility studies are not
needed.
Q. No. Have you performed comparative Not applicable.
Q. No. Do you have product development The firm has product development (P.D) section
17 (P.D) section? however the development of the product concerned
has been carried out while using commercial
manufacturing area and routine quality control of the
product concerned due to specialized requirements
i.e. BFS technology. P.D area is provided with some
equipment for semi solid preparation.
Q. No. Do you have necessary equipment Refer to point no. 17
18 available in product development
section for development of Ipratropium
Bromide + Albuterol Sulfate
(Salbutamol Sulphate) Respules?
Q. No. Are the equipment in the product Not applicable, refer to point no. 17
19 development section qualified?
Q. No. Do you have proper maintenance and P.D section equipment has not been used for the
20 calibration/re-qualification program for development of this product however there is proper
the equipment used in the P.D. Section? maintenance and calibration / re-qualification
program for the equipment used in P.D section.
Q. No. Do You have qualified staff in the The firm has a qualified pharmacist as coordinator
21 product development section with for product development assisted by the staff of
proper knowledge and training in the manufacturing and quality control.
product development?
Q. No. Have you manufactured three stability The firm has manufactured three stability batches for
22 batches for the stability studies of the stability studies of Ipratropium Bromide 0.5mg +
Ipratropium Bromide + Albuterol Albuterol Sulfate (Salbutamol Sulphate) 2.5mg
Sulfate (Salbutamol Sulphate) Respules Respules as below.
as required?
Easehale + Respules
001 26-11-2016 10000 Ampoules
002 28-11-2016 10000 Ampoules
003 28-11-2016 10000 Ampoules
Q. No. Do you have any criteria for fixing the The criteria for fixing the batch size of the stability
23 batch size of stability batches? batches is the number of ampoules required for each
testing and number of testing frequencies. Moreover
the minimum workable batch size on BFS machine is
also taken into consideration.
Q. No. Do you have complete record of The firm has complete record of production of
24 production batches? stability batches.
Q. No. Do you have protocols for stability The firm has detailed protocols for stability testing of
25 testing of stability batches? stability batches (SOP No. QC/GN/OP/015 Dated:
23-02-2017 Ver: 02)
Q. No. Do you have developed and validated The firm has developed and validated method for
26 the method for testing of stability testing of stability batches of Easehale+ Respules.
batches?
Q. No. Do you have method transfer studies in The method transfer studies are not required.
27 case when the method of testing being
lab?
Q. No. Do you have documents confirming the The firm has proper documents confirming the
28 qualification of equipment / qualification of equipment /instruments being used in
instruments being used in the test and the test and analysis of Ipratropium Bromide API,
analysis of Ipratropium Bromide API, Albuterol Sulfate (Salbutamol Sulphate) API and
Albuterol Sulfate (Salbutamol finished product.
Sulphate) API and the finished drug?
Q. No. Do your method of analysis stability Yes, the firm has performed forced degradation study
29 Indicating? on their products for confirmation of its stability
indicating nature.
Q. No. Do your HPLC Software 21CFR The HPLC software is 21 CFR compliant.
30 compliant.
Q. No. Can you show Audit Trail reports on Audit trail on the testing reports of Easehale+
31 Ipratropium Bromide + Albuterol (Ipratropium Bromide 0.5mg + Albuterol Sulfate
Sulfate (Salbutamol Sulphate) Testing? (Salbutamol Sulphate) 2.5mg) Respules are available.
Q. No. Do you have some remaining quantities The firm has some remaining quantities of stability
32 of degradation products and stability batches.
batches?
Q. No. Do you have commitment batches kept The firm has three stability batches kept on real time
th
33 on stability testing? stability testing.
Q. No. Do you have valid calibration status for The firm has valid calibration status for the
34 the equipment used in Easehale+ equipment used in Easehale+ (Ipratropium Bromide
(Ipratropium Bromide 0.5mg + 0.5mg + Albuterol Sulfate (Salbutamol Sulphate
Albuterol Sulfate (Salbutamol Sulphate 2.5mg) Respules.
2.5mg) Respules production and
analysis?
Q. No. Do proper and continuous monitoring Adequate monitoring and control are available for
35 and control are available for stability stability chambers (Memmert). Chambers are
chamber? controlled and monitored through data loggers.
Q. No. Do related manufacturing area, Related manufacturing area, equipment, personnel
36 equipment, personnel and utilities be and utilities are rated as GMP compliant.
CONCLUSION:
On the basis of risk based approach, the genuineness / authenticity of stability data submitted by the firm
for the registration of EASEHALE+ RESPULES 0.5mg/2.5mg is verifiable to satisfactory level. Related
manufacturing area, personnel and utilities are rated as GMP compliant to satisfactory level.
Decision:Registration Board decided to approve registration of “EASEHALE+
RESPULES 0.5mg/2.5mg” by M/s Hudson Pharma Pvt. Ltd., Karachi. Manufacturer will
place first three production batches on long term stability studies throughout proposed
shelf life and on accelerated studies for six months.

1190. Levalbuterol HCl 0.63mg Livabel Respules 0.63mg PE Ampoules / 3ml
Background:
Registration Board in its 272nd Meeting deliberated that assay results are within specified limits (90% -
110%) and decided to constitute the following panel for onsite investigation to confirm genuineness /
authenticity of stability data and associated documents, import of API, quality, specification, test
analysis, facilities etc.
 Dr. Amanullah Khan, Chairman Committee/Member Registration Board DRAP/Director DTL
Quetta.
 Mr. Aslam Shah, Member Registration Board DRAP.
 Dr. Saif ur Rehman Khattak, Federal Government Analyst CDL.

Investigation Site: M/s Hudson Pharma Pvt. Ltd. D-93, North Western Industrial Zone, Port Qasim -
Karachi.
S. No. Question Observation by Panel
Q. No. Do you have documents confirming the Documents for import, approved from DRAP are
1 import of Levalbuterol HCl API including available.
approval from DRAP? Levalbuterol HCl has been imported from M/s
Cipla India.
Import No. Imported
HDP160198 14-11-2016 CIP/EXP/0 0.219
10 KG

Q. No. Do you have any rationale behind The rationale behind selecting the API
2 selecting the particular manufacturer of manufacturer is GMP compliant .
API?
Q. No. Do you have documents confirming the Levalbuterol HCl API and its working standard
3 import of Levalbuterol HCl reference were imported from the API manufacturer. The
standard and impurity standards? documents confirmed the import of both.
Q. No. Do you have certificate of Analysis of the The firm has certificate of analysis for API,
4 API, reference standards and impurity working standards of the API. The impurity
standards? standards (03) have been imported currently with
proper documents including COA.
Q. No. Do you have any approval of API or GMP Copy of GMP certificate M/s Cipla India issued by
5 certificate of API manufacturer issued by Joint Commissioner (HQ) and controlling
regulatory authority of country of origin? authority of Maharashtra India Valid Up to 20-06-
2018 for Levalbuterol HCl. is enclosed.
Q. No. Do you use API manufacturer method of The firm has used following testing methods:
6 testing? Levalbuterol HCl as per U.S.P
Q. No. Do you have stability studies reports on The firm has stability studies reports on
7 API? Levalbuterol HCl API provided by the API
manufacturer.
Q. No. If Yes, whether the stability testing has The stability testing has been performed as per
8 been performed as per SIM method and SIM method and degradation products have been
degradation products have been quantified for Levalbuterol HCl by the API
quantified? manufacturer.
Q. No. Do you have method for quantifying the The firm has methods for quantifying the
9 impurities in the API? impurities of the API provided by the API
manufacturer.
Q. No. Do you have some remaining quantities of The firm has some remaining quantities of API
10 the API, its reference standard and working standard, reference standard and impurity
impurities standards? standards of Levalbuterol.
Q. No. Have you used pharmaceutical grade The product contains only sodium chloride as
11 excipients? excipient and sulfuric acid as pH adjuster. Both the
excipients are of analytical grades.
Q. No. Do you have documents confirming the The firm has used analytical grade excipients from
12 import of the used excipients? M/s Merck Germany through their Pakistan Office.
Q. No. Do you have test reports and other records The firm has test reports and other records on the
13 on the excipients used? excipients used.
Q. No. Do you have written and authorized The firm has written and authorized protocols for
14 protocols for the development of the development of Livabel 0.63mg (Levalbuterol
Levalbuterol Respules? HCl) Respules.
Q. No. Have you performed Drug-excipient Since firm has used same excipient as used by
15 compatibility study? innovator, therefore compatibility studies are not
needed.
Q. No. Have you performed comparative Not applicable.
Q. No. Do you have product development (R&D) The firm has product development (P.D) section
17 section? however the development of the product
concerned has been carried out while using
commercial manufacturing area and routine quality
control of the product concerned due to specialized
requirements i.e. BFS technology. P.D area is
provided with some equipment for semi solid
preparation.
Q. No. Do you have necessary equipment Refer to point no. 17
18 available in product development section
for development of Levalbuterol
Respules?
Q. No. Are the equipment in the product Not applicable, refer to point no. 17
19 development section qualified?
Q. No. Do you have proper maintenance and P.D section equipment has not been used for the
20 calibration/re-qualification program for development of this product however there is
the equipment used in the PD Section? proper maintenance and calibration / re-
qualification program for the equipment used in
P.D section.
Q. No. Do You have qualified staff in the product The firm has a qualified pharmacist as coordinator
21 development section with proper for product development assisted by the staff of
knowledge and training in the product manufacturing and quality control.
development?
Q. No. Have you manufactured three stability The firm has manufactured three stability batches
22 batches for the stability studies of for the stability studies of Livabel 0.63mg
Levalbuterol Respules as required? (Levalbuterol HCl) Respules as below.
Livabel 0.63mg Respules

001 03-12-2016 8333 Ampoules
002 05-12-2016 8333 Ampoules
003 06-12-2016 8333 Ampoules
Q. No. Do you have any criteria for fixing the The criteria for fixing the batch size of the stability
23 batch size of stability batches? batches is the number of ampoules required for
each testing and number of testing frequencies.
Moreover the minimum workable batch size on
BFS machine is also taken into consideration.
Q. No. Do you have complete record of The firm has complete record of production of
24 production batches? stability batches.
Q. No. Do you have protocols for stability testing The firm has detailed protocols for stability testing
25 of stability batches? of stability batches (SOP No. QC/GN/OP/015
Dated: 23-02-2017 Ver: 02)
Q. No. Do you have developed and validated the The firm has performed verification of testing
26 method for testing of stability batches? method for Livabel 0.63mg (Levalbuterol HCl)
Respules, as the product is Pharmacopoeial and the
method has been proved as stability indicating on
the basis of forced degradation studies being
performed by the firm.
Q. No. Do you have method transfer studies in The method transfer studies are not required.
27 case when the method of testing being
lab?
Q. No. Do you have documents confirming the The firm has proper documents confirming the
28 qualification of equipment / instruments qualification of equipment /instruments being used
being used in the test and analysis of in the test and analysis of Levalbuterol API and
Levalbuterol API and the finished drug? finished products.
Q. No. Do your method of analysis stability Yes, the firm has performed forced degradation
29 Indicating? study on their products for confirmation of its
stability indicating nature. Further degradation
products are also analyzed during stability studies.

Q. No. Do your HPLC Software 21CFR The HPLC software is 21 CFR compliant.
30 compliant.
Q. No. Can you show Audit Trail reports on Audit trail on the testing reports of Livabel 0.63mg
31 Levalbuterol Testing? (Levalbuterol HCl) Respules are available.
Q. No. Do you have some remaining quantities of The firm has some remaining quantities of stability
32 degradation products and stability batches.
batches?
Q. No. Do you have commitment batches kept on The firm has three stability batches kept on real
33 stability testing? time stability testing.
Q. No. Do you have valid calibration status for The firm has valid calibration status for the
34 the equipment used in Levalbuterol equipment used in Livabel 0.63mg (Levalbuterol
0.63mg Respules production and HCl) Respules.
analysis?
Q. No. Do proper and continuous monitoring and Adequate monitoring and control are available for
35 control are available for stability stability chambers (Memmert). Chambers are
chamber? controlled and monitored through data loggers.
Q. No. Do related manufacturing area, Related manufacturing area, equipment, personnel
36 equipment, personnel and utilities be rated and utilities are rated as GMP compliant.
as GMP compliant?
CONCLUSION:
On the basis of risk based approach, the genuineness / authenticity of stability data submitted by the firm
for the registration of LIVABEL 0.63mg is verifiable to satisfactory level. Related manufacturing area,
personnel and utilities are rated as GMP compliant to satisfactory level.
Decision: Mr.Aslam Shah (Member Registration Board) apprised the Board about typographic
mistake in inspection report regarding batch number of API used. Correct batch number is
HDP160197 as verified from relevant documents. Registration Board decided to approve
registration of “Livabel Respules 0.63mg (Levalbuterol HCl 0.63mg)” by M/s Hudson Pharma Pvt.
Ltd. – Karachi. Manufacturer will place first three production batches on long term stability
studies throughout proposed shelf life and on accelerated studies for six months. However, the
Board advised Mr. Aslam Shah to recheck the variation in these batches.

M/s Crystolite Pharma, Islamabad. – 04 Products
Background:
Registration Board decided in its 271st Meeting to constitute the following panel for onsite investigation
specification, test analysis, facilities etc. of following 04 Products of M/s Crystolite Pharma, Islamabad.
 Dr. Muhammad Shoaib Akhter, Director, DTL, Rawalpindi.

 Dr. Muhammad Fakhruddin Aamir, Additional Director (QA&LT-II), DRAP, Islamabad.
 Dr. Hasan Afzaal, FID-III, DRAP, Islamabad.
Date of Inspection: 22-08-2017.

1191.Halovate Cream 0.05%

No.
1. Do you have documents confirming the The Firm has provided photocopy of I&E Clearance
import of API including approval from and Commercial Invoice for 30gm of Halobetasol
DRAP? Propionate Batch # NT-151001 imported from Hunan
Yuxin Pharmaceutical Co. Ltd, China.
2. Do you have any rationale behind API manufacturer is GMP certified and has provided
selecting the particular manufacturer of documents for Stability, Method of Analysis, Material
API? Safety and Data Sheets, these factors contributed in
selection of API Manufacturer
3. Do you have documents confirming the The firm has provided the copies of COA documents
import of reference standard and for Halobetasol Propionate working standard from
impurity standards? Hunan Yuxin Pharmaceutical Co., Ltd.
The firm has provided copy of undertaking Letter
certifying that working standards is shipped along
with API samples. The firm has claimed that the
working standard is cleared along with the API;
therefore the Import Documents and the invoices of
working standard are not provided, which is not as per
the usual practice of ADC (I&E) Office, Islamabad.
Impurity Standard Documents are not available.
the API, reference standards and working standard of API.
impurity standards? COA for Impurity Standard Documents is not
available.
5. Do you have any approval of API, or Photocopy of documentary evidence for GMP
GMP certificate of API manufacturer certificate from SFDA, People‟s Republic of China.
issued by regulatory authority of county
of origin?
6. Do you use API manufacturer method The firm uses USP-35 method for API testing.
of testing?
7. Do you have stability studies reports on Photocopy of documentary evidence for Accelerated
API? and Real Time Stability Study has been provided
8. If Yes, whether the stability testing has The testing has been performed indicating total
been performed as per SIM method and impurities products along with individual and other
degradation products have been impurities have been quantified.
quantified?

9. Do you have method for quantifying the Method for quantification of impurities of product was
impurities in the API? provided as per USP-35
10. Do you have some remaining quantities Remaining quantities of API and Reference were
of the API, its reference standard and present.
Impurities standards?
11. Have you used pharmaceutical grade Authorization letter from International Firm Croda for
excipients? Yosaf & Co was provided; acknowledging that the
later is the sole distributor for imported excipients
(Pharmaceutical Grade) in Pakistan.
12. Do you have documents confirming the Authorization letter from International Firm Croda for
import of the used excipients? Yosaf & Co was provided; acknowledging that the
later is the sole distributor for imported excipients in
Pakistan.
13. Do you have test reports and other COA from manufacturer/in-house was provided along
records on the excipients used? with invoice.
14. Do you have written and authorized Written and Authorized protocol was present
protocols for the development?
15. Have you performed Drug-excipient Not done
compatibility studies?
16. Have you performed comparative Not required
dissolution studies?
17. Do you have product development R&D Section has been developed at the firm
(R&D) section
18. Do you have necessary equipments Necessary equipment for Product Development have
available in product development been provided in the R&D Section including Double
section for development? Jacketed Steam Kettle, Tube Filling Machine etc.
19. Are the equipments in product Equipments used in Product Development have been
development section qualified? calibrated by third party
20. Do you have proper maintenance / Equipments used in Product Development have been
calibration / re-qualification program well maintained, Log Books were present and
for the equipment used in PD section? calibration record was also present
21. Do you have qualified staff in product Qualified staff was present dedicated for R&D Section
development section with proper
knowledge and training in product
development?
22. Have you manufactured three stability Three batches for stability studies were manufacture as
batches for the stability studies as per BMRs
required?
23. Do you have any criteria for fixing the As per the firm‟s claim criteria was followed in light
batch size of stability batches? of decision of 251st DRB Meeting
24. Do you have complete record of Record was verified
production of stability batches?
25. Do you have protocols for stability Protocol for stability testing was provided
testing of stability batches?
26. Do you have developed and validated The firm is using the same method as used for the
the method for testing of stability testing of API. This method is validated by the firm in
batches. their premises.
27. Do you have method transfer studies in Not Applicable
case when the method of testing being
lab?
28. Do you have documents confirming the Yes, relevant documents were presented
qualification of equipments /
instruments being used in the test and
analysis of API and the finished drug?
29. Is your method of analysis indicating Yes, the method of analysis indicates stability of the
stability? batches
30. Is your HPLC software 21CFR Yes, HPLC software 21CFR compliant
compliant?
31. Can you show Audit Trial reports on Audit trail report was presented
Testing?
32. Do you have some remaining quantities Remaining quantities of stability batches was present,
of degradation products and stability whereas degradation product was not provided
batches?
33. Do you have commitment batches kept Yes, The firm has three commitment batches kept on
on stability testing? stability testing for real time stability testing.
34. Do you have valid calibration status for Yes, calibration status for equipment was OK
the equipments used in production and
analysis?
35. Is proper and continuous monitoring Yes, quarterly calibration is being done.
chamber?
36. Are related manufacturing area, Yes, on the time of inspection manufacturing area,
equipment, personnel and utilities equipment, personnel and utilities be rated as GMP
being rated as GMP compliant? compliant
Conclusion:
Keeping in view the above stated observations during inspection areas visited, documents reviewed the
panel unanimously verifies the authenticity of Stability Data for above mentioned product by M/S
Crystolite Pharmaceuticals, Plot no.1 & 2, Street S-2, National Industrial Zone, Rawat – Islamabad.
Decision: Registration Board decided to approve registration of “Halovate Cream 0.05%” by M/s
Crystolite Pharmaceuticals, Plot no.1 & 2, Street S-2, National Industrial Zone, Rawat –
Islamabad. Manufacturer will place first three production batches on long term stability studies
1192.Halovate Lotion 0.05%

No.
1. Do you have documents confirming the The Firm has provided photocopy of I&E Clearance
import of API including approval from and Commercial Invoice for 30gm of Halobetasol
DRAP? Propionate Batch # NT-151001 imported from Hunan
selecting the particular manufacturer of documents for Stability, Method of Analysis, Material
API? Safety and Data Sheets, these factors contributed in
3. Do you have documents confirming the The firm has provided the copies of COA documents
import of reference standard and for Halobetasol Propionate working standard from
impurity standards? Hunan Yuxin Pharmaceutical Co., Ltd.
certifying that working standards is shipped along
with API samples. The firm has claimed that the
working standard is cleared along with the API;
therefore the Import Documents and the invoices of

working standard are not provided, which is not as per
the usual practice of ADC (I&E) Office, Islamabad.
impurity standards? COA for Impurity Standard Documents is not
available.
issued by regulatory authority of county
of origin?
of testing?
7. Do you have stability studies reports on Photocopy of documentary evidence for Accelerated
API? and Real Time Stability Study has been provided
8. If Yes, whether the stability testing has The testing has been performed indicating total
been performed as per SIM method and impurities products along with individual and other
degradation products have been impurities have been quantified.
quantified?
9. Do you have method for quantifying the Method for quantification of impurities of product was
impurities in the API? provided as per USP-35
10. Do you have some remaining quantities Remaining quantities of API and Reference were
of the API, its reference standard and present.
Impurities standards?
excipients? Yosaf & Co was provided; acknowledging that the
later is the sole distributor for imported excipients
12. Do you have documents confirming the Authorization letter from International Firm Croda for
import of the used excipients? Yosaf & Co was provided; acknowledging that the
later is the sole distributor for imported excipients in
Pakistan.
(R&D) section
development?
required?
23. Do you have any criteria for fixing the As per the firm‟s claim criteria was followed in light
batch size of stability batches? of decision of 251st DRB Meeting
27. Do you have method transfer studies in Not Applicable
case when the method of testing being
lab?
28. Do you have documents confirming the Yes, relevant documents were presented
qualification of equipments /
stability? batches
compliant?
Testing?
32. Do you have some remaining quantities Remaining quantities of stability batches was present,
of degradation products and stability whereas degradation product was not provided
batches?
33. Do you have commitment batches kept Yes, The firm has three commitment batches kept on
on stability testing? stability testing for real time stability testing.
34. Do you have valid calibration status for Yes, calibration status for equipment was OK
the equipments used in production and
analysis?
35. Is proper and continuous monitoring Yes, quarterly calibration is being done.
chamber?
Conclusion:
Decision: Registration Board decided to approve registration of “Halovate Lotion 0.05%” by M/s
Crystolite Pharmaceuticals, Plot no.1 & 2, Street S-2, National Industrial Zone, Rawat –

1193.Halovate Ointment 0.05%
No.
1. Do you have documents confirming The Firm has provided photocopy of I&E Clearance and
the import of API including approval Commercial Invoice for 30gm of Halobetasol
from DRAP? Propionate Batch # NT-151001 imported from Hunan
selecting the particular manufacturer documents for Stability, Method of Analysis, Material
of API? Safety and Data Sheets, these factors contributed in
3. Do you have documents confirming The firm has provided the copies of COA documents for
the import of reference standard and Halobetasol Propionate working standard from Hunan
impurity standards? Yuxin Pharmaceutical Co., Ltd.
certifying that working standards is shipped along with
API samples. The firm has claimed that the working
standard is cleared along with the API; therefore the
Import Documents and the invoices of working standard
are not provided, which is not as per the usual practice
of ADC (I&E) Office, Islamabad.
impurity standards? COA for Impurity Standard Documents is not available.
issued by regulatory authority of
county of origin?
of testing?
7. Do you have stability studies reports Photocopy of documentary evidence for Accelerated
on API? and Real Time Stability Study has been provided
8. If Yes, whether the stability testing The testing has been performed indicating total
has been performed as per SIM impurities products along with individual and other
method and degradation products have impurities have been quantified.
been quantified?
9. Do you have method for quantifying Method for quantification of impurities of product was
the impurities in the API? provided as per USP-35
10. Do you have some remaining Remaining quantities of API and Reference were
quantities of the API, its reference present.
standard and Impurities standards?
excipients? Yosaf & Co was provided; acknowledging that the later
is the sole distributor for imported excipients
12. Do you have documents confirming Authorization letter from International Firm Croda for
the import of the used excipients? Yosaf & Co was provided; acknowledging that the later
is the sole distributor for imported excipients in
Pakistan.

(R&D) section
development?
required?
23. Do you have any criteria for fixing the As per the firm‟s claim criteria was followed in light of
batch size of stability batches? decision of 251st DRB Meeting
27. Do you have method transfer studies Not Applicable
in case when the method of testing
being used by your firm is given by
any other lab?
28. Do you have documents confirming Yes, relevant documents were presented
the qualification of equipments /
stability? batches
compliant?
Testing?
32. Do you have some remaining Remaining quantities of stability batches was present,
quantities of degradation products and whereas degradation product was not provided
stability batches?
33. Do you have commitment batches Yes, The firm has three commitment batches kept on
kept on stability testing? stability testing for real time stability testing.

34. Do you have valid calibration status Yes, calibration status for equipment was OK
for the equipments used in production
and analysis?
35. Is proper and continuous Yes, quarterly calibration is being done.
monitoring and control are available
for stability chamber?
Conclusion:
Decision: Registration Board decided to approve registration of “Halovate Ointment 0.05%” by
M/s Crystolite Pharmaceuticals, Plot no.1 & 2, Street S-2, National Industrial Zone, Rawat –
1194.Plaiglo Cream (Each gm Contains 70mg+70mg)
No.
1. Do you have documents confirming The Firm has provided photocopy of I&E Clearance and
the import of API including approval Commercial Invoice for 1kg of Lidocaine Batch #
from DRAP? 20151226 and 0.2kg Tetracaine Batch # 15112513 both
imported from M/s Qingdao Fraken International Co.
Ltd, China
2. Do you have any rationale behind As per the firm‟s claim; API manufacturer is GMP
selecting the particular manufacturer certified and has provided documents for Stability,
of API? Method of Analysis, Material Safety and Data Sheets,
these factors contributed in selection of API
Manufacturer
3. Do you have documents confirming The firm has provided the copies of COA documents for
the import of reference standard and Lidocaine working standards from Gufic Life Sciences
impurity standards? Private Ltd.
Tetracaine working standard from Jinan Hongfangde
Pharmatech Co., Ltd.
The firm has provided undertaking Letters certifying
that working standards is shipped along with API
samples. The firm has claimed that the working
standard is cleared along with the API; therefore the
Import Documents and the invoices of working standard
are not provided, which is not as per the usual practice
of ADC (I&E) Office, Islamabad.
4. Do you have certificate of Analysis of The firm has provided copies of certificates of analysis
the API, reference standards and for the API and working standard of API of both
impurity standards? Lidocaine and Tetracaine from their respective
manufacturers.
COA for Impurity Standard Documents is not available.
issued by regulatory authority of
county of origin?

6. Do you use API manufacturer method Compendial methods for testing of API was used.
of testing? Tetracaine; USP 35 and Lidocaine; BP 2016.
7. Do you have stability studies reports Photocopy of documentary evidence for Accelerated
on API? and Real Time Stability Study has been provided.
8. If Yes, whether the stability testing The testing has been performed; the document
has been performed as per SIM pertaining to the stability study of API does not clarify
method and degradation products have the method employed and has no mention of
been quantified? degradation products.
9. Do you have method for quantifying Compendial methods for quantification of impurities is
the impurities in the API? available but the COA does not signify the method for
quantification of impurities.
10. Do you have some remaining Remaining quantities of API and Reference were
quantities of the API, its reference present.
standard and Impurities standards?
excipients? Yosaf & Co was provided; acknowledging that the later
is the sole distributor for imported excipients
(Pharmaceutical Grade) in Pakistan. The firm has also
presented the Invoices for said excipients.
12. Do you have documents confirming Authorization letter from International Firm Croda for
the import of the used excipients? Yosaf & Co was provided; acknowledging that the later
is the sole distributor for imported excipients in
Pakistan. The firm has also presented the Invoices for
said excipients.
13. Do you have test reports and other COA developed in-house was provided along with
records on the excipients used? invoice.
(R&D) section
21. Do you have qualified staff in product Yes, qualified staff was present dedicated for R&D
development section with proper Section
development?
22. Have you manufactured three stability Yes, Three batches for stability studies were
batches for the stability studies as manufacture as per BMRs
required?
23. Do you have any criteria for fixing the Yes, criteria was followed in light of decision of 251st
batch size of stability batches? DRB Meeting
24. Do you have complete record of Yes, record was verified
25. Do you have protocols for stability Yes, protocol for stability testing was provided
26. Do you have developed and validated The firm has developed HPLC based method for testing
the method for testing of stability of both Lidocaine & Tetracaine formulated in Cream
batches. form (whereas 1 gm contains 70mg+70mg each)
method is validated by the firm in their premises.
27. Do you have method transfer studies Not Applicable
in case when the method of testing
being used by your firm is given by
any other lab?
28. Do you have documents confirming Yes, relevant documents were presented
the qualification of equipments /
stability? batches
compliant?
Testing?
32. Do you have some remaining Remaining quantities of stability batches was present,
quantities of degradation products and whereas degradation product was not provided
stability batches?
33. Do you have commitment batches Yes, The firm has three commitment batches kept on
kept on stability testing? stability testing for real time stability testing.
34. Do you have valid calibration status Yes, calibration status for equipment was OK
for the equipments used in production
and analysis?
35. Is proper and continuous Yes, quarterly calibration is being done.
monitoring and control are available
for stability chamber?
Conclusion:
Decision: Registration Board decided to approve registration of “Plaiglo Cream (Each gm
Contains 70mg+70mg)” by M/s Crystolite Pharmaceuticals, Plot no.1 & 2, Street S-2, National
Industrial Zone, Rawat – Islamabad. Manufacturer will place first three production batches on
long term stability studies throughout proposed shelf life and on accelerated studies for six
months.

1195.M/s Genix Pharma (Pvt.) Ltd , Karachi – 01 Product

Tranexamic acid Haemic
17. 2Injection 1000mg/10 ml
Background:
Registration Board in its 273rd Meeting decided to constitute following panel for onsite investigation to
confirm genuineness / authenticity of stability data and associated documents, import of API, quality,

 Dr. Saif-ur Rehman Khattak: FGA CDL, Karachi
 Mr. Aslam Shah: Member Registration Board.
Firm Name & Address: M/s Genix Pharma (Pvt) Ltd , Karachi.
The product Haemic Injection (Tranexamic acid) which is a me too product and already registration is
granted by the registration board.
The me too status of the product is confirmed from the additional Director/ Secretary of the registration
board.
Therefore keeping in view the mee too status of the product the panel is of the opinion that there is no
need to carryout site inspection for confirming the authenticity stability data of the firm for their
product Haemic Injection 1000mg/10ml (Tranexamic acid).
Submitted for the information of the board.
Decision: Registration Board decided to approve registration of “Haemic Injection 1000mg/10 ml”
by M/s Genix Pharma (Pvt) Ltd , Karachi. Manufacturer will place first three production batches
on long term stability studies throughout proposed shelf life and on accelerated studies for six
months.

Case No. 08: Registration applications of categories to be considered on priority
a) Local Manufacture
b) Finished Import
a) Local Manufacture
Evaluator PEC-VI
1196. Name and address of manufacturer / M/s Werrick Pharmaceutical Islamabad
Applicant
Brand Name +Dosage Form + Strength Rux-Tab Tablet 5mg
Ruxolitinib as phosphate…………….5mg
Pharmacological Group Anti-Neoplastic
Type of Form Form-5
Pack size & Demanded Price 10‟s. 20‟s, 60‟s: As per SRO
Me-too status Jakavi (MANUFACTURED BY M/S. NOVARTIS
PHARMA STEIN AG, SCHAFFHAUSERSTRASSE,
4332 STEIN, SWITZERLAND )by Novartis, Karachi
GMP status Last inspection report 2-2-2017 The panel
unanimously recommends for the grant of renewal of
DML by way of formulation.
Remarks of the Evaluator. Tablet (Antineoplastic section) is present according to
the panel last inspection report.
Application was received through letter No.F 6-
2/2016(R-III)
in Tablet (Antineoplastic section) section in the light of decision of Registration Board in its
271st meeting regarding “Specific manufacturing requirements for certain classes of
drugs.”
Applicant
Ruxolitinib…………….15mg
Type of Form Form-5
2/2016(R-III)

drugs.”
Applicant
Ruxolitinib…………….20mg
Type of Form Form-5
2/2016(R-III)
Decision:
Deferred for confirmation/justification for manufacturing of the applied product in Tablet
(Antineoplastic section) section in the light of decision of Registration Board in its 271st
1199. Name and address of manufacturer / M/s Werrick Pharmaceutical, Islamabad
Applicant
Brand Name +Dosage Form + Strength Er-Tab Tablet 25mg
Erlotinib as Hydrochloride…………….25mg
Type of Form Form-5
Me-too status Tarceva (Imported )roche
2/2016(R-III)
Decision:
Applicant
Diary No. Date of R& I & fee Dy. No.6885; 23 -06-2017; Rs.20,000/- (21-6-2017)
Type of Form Form-5
Me-too status Tarceva(Imported) roche
2/2016(R-III)
Decision:
Applicant
Type of Form Form-5
Me-too status Tarceva (imported) roche
2/2016(R-III)
Decision:
Applicant
Brand Name +Dosage Form + Strength IM-Tab Tablet 100mg
Imatinib Mesilate Eq to Imatinib…………….100mg
Type of Form Form-5
Me-too status Glivec (imported) by Novartis
2/2016(R-III)
Decision: Deferred for confirmation/justification for manufacturing of the applied product
drugs.”
Applicant
Brand Name +Dosage Form + Strength IM-Tab Tablet 400mg
Imatinib Mesilate Eq to Imatinib…………….400mg
Type of Form Form-5
Me-too status Glivec(imported) by Novartis
2/2016(R-III)
drugs.”
Applicant
Brand Name +Dosage Form + Strength IB-Cap capsules 140mg
Ibrutinib…………….140mg
Type of Form Form-5
Remarks of the Evaluator. Capsule (Anti-Neoplastic) section is not present
2/2016(R-III)
Me-too status could not be confirmed
Decision: Deferred forconfirmation of generic / me-too status

Applicant
Brand Name +Dosage Form + Strength IXA-Cap capsules 4mg
Ixazomib as citrate…………….4mg
Type of Form Form-5
Pack size & Demanded Price 3x1‟s: As per SRO
unanimously recommends for the grant of renewal
of DML by way of formulation.
Remarks of the Evaluator. Capsule (Anti-Neoplastic) section is not present.
2/2016(R-III)
Me-too status could not be confirmed.
Decision: Deferred for confirmation of generic / me-too status
Applicant
Brand Name +Dosage Form + Strength IXA-Cap capsules 3mg
Ixazomib…………….3mg
Type of Form Form-5
2/2016(R-III)
Applicant
Brand Name +Dosage Form + Strength Sunib capsules 37.5mg
Sunitinib as malate…………….37.5mg
Type of Form Form-5
Pack size & Demanded Price 10‟s, 20‟s, 28‟s As per SRO
GMP status Last inspection report 2-2-2017. The panel

2/2016(R-III)
Applicant
Brand Name +Dosage Form + Strength Nil-Cap capsules 200mg
Nilotinib as HCl monohydrate…………….400mg
Type of Form Form-5
Me-too status Tasigna (imported) by Novartis
2/2016(R-III)
Applicant
Brand Name +Dosage Form + Strength Ceri cap capsules 150mg
Ceritinib…………….150mg
Type of Form Form-5
Pack size & Demanded Price 10‟s, 20‟s, 70‟s As per SRO
Remarks of the Evaluator. Capsule (Anti-Neoplastic) section is not present .
2/2016(R-III).
Applicant
Brand Name +Dosage Form + Strength IXA-Cap capsules 2.3mg
Ixazomib as Citrate…………….2.3mg
Type of Form Form-5
Remarks of the Evaluator. Capsule (Anti-Neoplastic) section is not Present.
2/2016(R-III).
Applicant
Brand Name +Dosage Form + Strength Nil-Cap capsules 150mg
Nilotinib as HCl monohydrate …………….150mg
Type of Form Form-5
Me-too status Tasigna (imported)by Novartis
2/2016(R-III)
1212. Name and address of manufacturer / M/s Benson Pharmaceuticals, Islamabad
Applicant
Brand Name +Dosage Form + Strength Ribaben 400mg tablet
Ribavirin………..400mg
Pharmacological Group Anti-viral
Type of Form Form-5
Pack size & Demanded Price 10‟s, 30‟s, 60‟s, As per SRO
Approval status of product in Copegus tablet by Roche
Me-too status Novia by Hilton
GMP status Last inspection conducted on 04-08-2017 stating
satisfactory level of GMP.
Remarks of the Evaluator. Application was received through letter No.F 6-
2/2016(R-III)
Decision: Approved.

b) Finished Import
Evaluator PEC-X
In 257th meeting the Registration Board decided that the applications for registration
of drugs for treatment of Chronic ailments, drugs which are in short availability, drugs for
treatment of cancer, viral diseases, thalassemia, immune suppressants, vaccine and sera, new
molecules/formulations, blood factors and bags will be given priority consideration.
1213. Name and address of Applicant M/s Novartis Pharma (Pakistan) Ltd15, West Wharf,
Karachi.
Detail of Drug Sale License Adress: Novartis Pharma Pakistan Ltd. 15, West Wharf,
Karachi.
Validity: 29/07/2017
Status: By the way of wholesale
The Firm has applied for renewal of the license on
16/05/2017.
Name and address of M/s Glaxosmithkline manufacturing S.p.A, Starda provincial
manufacturer Asolana, 90, 43056 San polo di Torrile, Parma, Italy.
Name and address of marketing M/s Novartis Europharm Limited, Frimley Bussiness Park,
authorization holder camberley GU166 7SR, United Kingdom
Name of exporting country Italy
Type of Form Form 5-A
Diary No. & Date of R& I Dy. No. 11114 Dated 04/08/2017
Fee including differential fee Rs. 50,000/- Dated 04/08/2017
Brand Name +Dosage Form + MEKINIST tablet 2mg
Strength Film Coated Tablet
Trametinib (as dimethyl sulfoxide)……… 2mg
Finished Product Specification In House
Pharmacological Group Anti-cancer
Shelf life 24 months
Demanded Price Rs. 164,888.00/- per 7 FC tablets
Rs. 706,667.00/- per 30 FC tablets
Rs. 23,555.56/- per tablet
Pack size 7‟s & 30‟s
International availability Mekinist film coated tablet (0.5mg & 2mg) By M/s Novartis,
USFDA Approved.
Me-too status New Molecule
Detail of certificates attached Original legalized CoPP (certificate No. 04/15/91219)
certified by EMA issued on 21/08/2015 confirms that the
facilities and operations conform to GMP as recommended
by WHO.
The CoPP describes 03 strengths of tablets that is 0.5mg,
1mg and 2mg.
Remarks of the Evaluator:
Storage conditions: 2-8oC
 The product is not available for free sale in exporting region. However the same product is
approved by USFDA.
 The firm has claimed In House manufacturing specifications and the product is not present in
USP/BP.
Description:
The product is a prescription medicine used to treat people with a type of skin cancer called
melanoma that has spread to other parts of the body or cannot be removed by surgery and that
has a certain type of abnormal “BRAF” gene (BRAF is a protein that is involved in sending the
signals for increasing the growth of the cells). The applied product should not be used to treat
people who have received a BRAF inhibitor 439 for treatment of their melanoma.
Decision:Registration Board was apprised that EMA CoPP does not confirm availability
of product in the region. Although firm has stated that product is approved by USFDA
but manufacturing site couldnot be confirmed. Thus the Board advised firm to provide
any reference to ensure availability of product in a reference country.
1214. Name and address of Applicant M/s Novartis Pharma (Pakistan) Limited
15, West Wharf, Karachi.
Karachi.
16/05/2017.
Name and address of M/s Glaxosmithkline manufacturing S.p.A, Starda provincial
manufacturer Asolana, 90, 43056 San polo di Torrile, Parma, Italy.
Brand Name +Dosage Form + MEKINIST tablet 0.5mg
Trametinib (as dimethyl sulfoxide )……… 0.5mg
Demanded Price Rs. 53515.70/- per 7 FC tablets
Rs. 229,353.00/- per 30 FC tablets
Rs. 7,645.00/- per tablet
International availability Mekinist film coated tablet (0.5mg & 2mg) By M/s Novartis,
USFDA Approved.
Detail of certificates attached Original legalized CoPP (certificate No. 04/15/91219)

certified by EMA issued on 21/08/2015 confirms that the
facilities and operations conform to GMP as recommended
by WHO.
The CoPP describes 03 strengths of tablets that is 0.5mg,
1mg and 2mg.
Storage conditions: 2-8oC
 The product is not available for free sale in exporting region. However the same product is
approved by USFDA.
 The firm has claimed In House manufacture ng specifications and the product is no tpresent
in USP/BP.
Description:
The product is a prescription medicine used to treat people with a type of skin cancer called
melanoma that has spread to other parts of the body or cannot be removed by surgery and that
has a certain type of abnormal “BRAF” gene (BRAF is a protein that is involved in sending the
signals for increasing the growth of the cells). The applied product should not be used to treat
people who have received a BRAF inhibitor 439 for treatment of their melanoma.
Decision: Registration Board was apprised that EMA CoPP does not confirm availability
of product in the region. Although firm has stated that product is approved by USFDA
but manufacturing site couldnot be confirmed. Thus the Board advised firm to provide
any reference to ensure availability of product in a reference country.
Karachi.
16/05/2017.
Name and address of M/s GlaxoSmithkline Inc., 7333 Mississauga Road north,
manufacturer Mississauga, Ontario L5N 6L4,Canada
M/s Glaxo Operations (UK) Ltd. (Trading as Galxo
Wellcome Operations), Priority street, ware, Hertfordshire
SG12 ODJ, United Kingdom.
Name of exporting country UK
Brand Name +Dosage Form + TAFINLAR capsule 50mg
Strength
Dabrafenib (as mesilate)……… 50mg
Demanded Price Rs. 148,401.43/- per 28 capsules
Rs. 636,000.94/- per 120 capsules
Rs. 5300.00/- per capsule
International availability Tafinlar capsule (50mg & 75mg) by M/s Novartis, USFDA
Approved.
Detail of certificates attached Original legalized CoPP (certificate no. 01/15/91152)
certified by EMA issued on 21/08/2015 confirms the free
sale of the product in exporting country. The facilities and
operations conform to GMP as recommended by WHO.
 The firm has claimed In House specifications and the product is not present in USP/BP.
Description:
The product is a prescription medicine used to treat a type of skin cancer called melanoma that
has spread to other parts of the body or cannot be removed by surgery and that has a certain
type of abnormal “BRAF” gene. It is not used to treat people with a type of skin cancer called
wild-type BRAF melanoma. It is not known if the product is safe and effective in children.
Decision: Approved with innovator’s specifications as per Import Policy for Finished
Drugs.

Karachi.
16/05/2017.
Name and address of M/s GlaxoSmithkline Inc., 7333 Mississauga Road north,
manufacturer Mississauga, Ontario L5N 6L4,Canada
M/s Glaxo Operations (UK) Ltd. (Trading as Galxo
Wellcome Operations), Priority street, ware, Hertfordshire
SG12 ODJ, United Kingdom.
Name of exporting country UK
Brand Name +Dosage Form + TAFINLAR capsule 75mg
Strength
Dabrafenib (as mesilate)……… 75mg
Demanded Price Rs. 237,440.96/- per 28 capsules
Rs. 1,017,600.84/- per 120 capsules
Rs. 8,480.00/- per capsule
International availability Tafinlar capsule (50mg & 75mg) by M/s Novartis, USFDA
Approved.
Detail of certificates attached Original legalized CoPP (certificate no. 01/15/91153)
certified by EMA issued on 21/08/2015 confirms the free
sale of the product in exporting country. The facilities and
operations conform to GMP as recommended by WHO.
 The firm has claimed In House specifications and the product is not present in USP/BP.
Description:
The product is a prescription medicine used to treat a type of skin cancer called melanoma that
has spread to other parts of the body or cannot be removed by surgery and that has a certain
type of abnormal “BRAF” gene. It is not used to treat people with a type of skin cancer called
wild-type BRAF melanoma. It is not known if the product is safe and effective in children.
Drugs.

1217. Name and address of Applicant M/s Bayer Pakistan (Pvt.) Limited,C-21, S.I.T.E Karachi
Registered Office: Bahria Complex II, 4th floor, M.T. Khan
Road, Karachi.
Detail of Drug Sale License Address: M/s Bayer Pakistan (Pvt.) Limited,C-21, S.I.T.E
Karachi
Status: By the way of retail sale
Name and address of Bulk manufacturer: M/s Bayer Weimar GmbH und Co. KG
manufacturer Dobereinerstrasse 20 99427 Weimar, Germany
Packaging and final release: Bayer Ag Mullerstrasse 178
13353 Berlin, Germany
Name and address of marketing M/s Jenapharm GmbH & Co. KG Otto-Schott-Strasse 15
authorization holder 07745 jena , Germany.
Name of exporting country Germany
Brand Name +Dosage Form + MICROLUT 0.03 mg Tablet
Strength (sugar coated)
Levonorgestrel……. 0.03mg
Pharmacological Group Oral progestogen/contraceptive
Demanded Price Not provided
Pack size 3×35‟s
International availability Available in Germany as per CoPP
Me-too status Newstrength (0.75 mg tablet is available)
Detail of certificates attached  Original (but not embassy attested) CoPP (certificate
No.317/17) certified by Thuringer Landesamt fur
Verbraucherschutz Dezernat 24/pharmazie, Germany
confirms the free sale of the product in exporting
country. The facilities and operations conform to GMP as
recommended by WHO as per COPP.
Remarks of the Evaluator.  The firm has claimed In House manufacturing
specifications while the product is present in BP.
Drugs.

Case No. 09: Registration applications of import cases
a) Import routine cases (Human)
b) Import routine cases (Veterinary)
c) Import Deferred cases
d) Incomplete Cases
a) Import routine cases (Human)
Evaluator PEC-X
1218. Name and address of Applicant M/s Novartis Pharma (Pakistan) Limited,
15 west Wharf Road P.O box 100 & 7247, Karachi
Details of Drug sale License Adress: Novartis Pharma Pakistan Ltd. 15, West Wharf,
Karachi.
The Firm has applied for renewal of the license on 16/05/2017.
Name and address of M/s Ebewe Pharma Ges.m.b.H. Nfg. KG MondseestraBe 11
manufacturer AT-4866 Unterach am Attersee-Austria.
Name and address of Marketing M/s Ebewe Pharma Ges.m.b.H. Nfg. KG MondseestraBe 11
authorization holder AT-4866 Unterach am Attersee-Austria.
Name of exporting country Austria
Brand Name+Dosage Form + ETOPOSIDE EBEWE 20mg/ml
Strength Concentrate for solution for infusion
Etoposide…… 20mg
Pharmacological Group Antineoplastic
Finished product Specification In House
Shelf life 3 years
Rs. 50,000/- Dated 04/08/2017
Pack size (1‟s×1) and (1‟s×5) (5ml vials) (100mg/5ml)
Demanded Price Rs. 794/- per vial
International Availability Etoposide 20mg/ml by medac GmbH, MHRA
Me-too status Vp-Gen Injection by Ferozsons Labs (Reg # 041805)
Detail of certificates attached Legalized and Valid CoPP (certificate No.9926850) issued by
Bundesamt fur Sicherheit im Gesundheitswesen, Austria issued
on 11/04/2017 confirms the free sale of the product in
exporting country. The operations and facilities conform to
GMP as recommended by WHO.
Remarks of the Evaluator.  The firm has claimed In House specifications while the
product is present in USP and BP.
Decision: Approved with USP specifications as per Import Policy for Finished Drugs.
1219. Name and address of Applicant M/s Novartis Pharma (Pakistan) Limited, 15 west Wharf Road
P.O box 100 & 7247, Karachi
Karachi.
Name and address of M/s Hetero Labs Ltd (Unit-VI), APIIC Pharma SEZ, S.No 410
manufacturer & 411, Polepally Village, Jadcheria (mandal) Mahaboob Nagar
(district) Pin-509301, Andhra Pradesh, India
Name and address of Marketing M/s Sandoz GmbH Biochmiestrabe 10 AT-6250 Kundi
authorization holder Austria.
Brand Name+Dosage Form + CAPECITABIN SANDOZ 500mg
Capecitabine…..500mg
Shelf life 2 years
Fee including differential fee (Rs. 50,000/- Dated 30/09/2013) + (Rs. 50,000/- Dated
01/04/2016)
Rs. 4118/- per 60‟s
Demanded Price
Rs. 25000/- per 120‟s
International Availability Capecitabine by Actavis, MHRA
Me-too status Xeloda by Roche
Detail of certificates attached Original legalized CoPP (certificate No.9935122) issued by
Bundesamt fur Sicherheit im Gesundheitswesen, Austria on
13/04/2017 confirms the free sale of the product in exporting
country.
Copy of GMP certificateGMP certificate
product is available in USP and BP.
 GMP certificate provided by the firm could not be
traced from the official site. The GMP status of the
manufacturing site from Unit I to Unit V has been verified.
However the applied product is being manufactured in Unit VI.
Decision: The Registration Board deferred the case for valid GMP certificate of Unit-VI of
the manufacturing site as webdata does not support document submitted by the firm.
Karachi.
Name and address of M/s Ebewe Pharma GES.m.b.H Nfg. KG Mondseestrabe 11
manufacturer At-4866 Unterach am Attersee, Austria
Name and address of Marketing M/s Ebewe Pharma GES.m.b.H Nfg. KG Mondseestrabe 11
authorization holder At-4866 Unterach am Attersee, Austria
Brand Name+Dosage Form + CISPLATIN EBEWE 0.5mg/ml (10mg/20ml vial)
Cisplatin…..0.5mg
Shelf life 2 years
Pack size 1‟s (20ml vial)
International Availability Cisplatin Ebewe, Ebewe Pharma, Austria
Me-too status Kemoplat by Atco Pharma (imported)
Detail of certificates attached Origibnal legalized CoPP (certificate No. 992698) certified by
Bundesamt fur Sicheit im Gesundheitswesen Schnirchgasse
confirms the free sale of the product in exporting country. The
facilities and operations conform to GMP as recommended by
WHO as per CoPP.
Karachi.
Cisplatin…..0.5mg
Shelf life 2 years
WHO as per CoPP.
Karachi.

Cisplatin…..0.5mg
Shelf life 2 years
WHO as per CoPP.
1223. Name and address of Applicant M/s Hakimsons (Impex) (pvt) Ltd.
Hakimsons building 19, Wet Wharf road, Karachi.
Detail of Drug Sale License Address:.Hakimsons (Impex) (pvt) Ltd. Hakimsons building
19, Wet Wharf road, Karachi.
Status: Drug sale license by the way of wholesale
Name and address of M/s Bharat serums and vaccines limited, plot No k-27,
manufacturer Jambivili Village, Anand Nagar, Additional MIDC,
Ambernnath (East), Thane 421501
Name and address of marketing M/s Bharat serums and vaccines limited, plot No k-27,
authorization holder Jambivili Village, Anand Nagar, Additional MIDC,
Ambernnath (East), Thane 421501
Name of exporting country India
Brand Name +Dosage Form + AMPHOLIP IV Injection 50mg/10ml
Strength (Amphotericcin B lipid complex Injection)
Amphotericin B ……. 5mg
Lipids:
 Dimyristoylphosphatidylcholine [DMPC]….. 3.4mg
 Dimyristophosphatidylglycerol [DMPG as sodium
salt] 1.5mg
Demanded Price Rs 16,600/-
International availability Abelcet 5mg/mL Concentrate for Suspension for Infusion by
M/s Teva Pharma B.V.,MHRA Approved
Me-too status Amphogen 50 by Ms Ferozsons, (Reg # 045800) (Imported)
Detail of certificates attached  Original legalized CoPP (certificate
No.COPP/CERT/KD/16842/2014/11/6613/29059) certified by
food and Drug Administration Maharashtra state, Mumbai,
India Valid till 01/04/2016 confirms that the facilities and
operations conform to GMP as recommended by WHO at the
time of inspection as per CoPP.
Remarks of the Evaluator.  Storage conditions: 2-8oC
 The product is registered in Pakistan as imported
product, however it is not being manufactured in Pakistan,
therefore the required fee is Rs. 50,000/-.
 The firm has claimed In House manufacturing
specifications while the product is present in USP/BP.
Decision: The Registration Board deferred the case for clarification whether Anti-Fungals
are importable from India or otherwise as per Import Policy Order, Ministry of Commerce.
b) Import routine cases (Veterinary)
1224. Name and address of Applicant M/s Binsadiq Iternational

89-A Canal iew Housing Society Lahore.
Detail of Drug Sale License Address: M/s Binsadiq Iternational, 89-A Canal iew Housing
Society Lahore.
Status: License to sell drugs as a Distributor
Name and address of M/s Chemifarma S.p.A Via Don Eugenio Servadei 16, 47122
manufacturer Forli, Italy.
Name and address of marketing M/s Chemifarma S.p.A Via Don Eugenio Servadei 16, 47122
authorization holder Forli, Italy.
Diary No. & Date of R& I Dy. No.455 Dated 18/09/2014
Brand Name +Dosage Form + DOXICICLINA 50% water soluble powder
Strength (for Broiler Chicken and Turkerys)
Composition Each 100 gm of powder contains:
Doxicycline hyclate Eq. to Doxicycline……… 50 gm
Pharmacological Group Tetracycline
Demanded Price Rs. 950/- per pack of 50 gm
Rs. 21310/- pr pack of 1kg
Pack size 1‟s (50gm & 1 kg pack)
International availability Altidox powder for use in drinking water by M/s Dechra
Veterinary Products Ltd, Dechra Veterinary Products Ltd, UK
Approved
Me-too status Soludox 50% by M/s Prix pharma (Reg # 032212)
Detail of certificates attached  Free sale certificate issued by Servizio sanitario regionale,
Azienda unita sanitaria locale di forli (Local joint health
unit, Regional Health Service,) Italy on 07/12/2014 States,
“The product whose composition is described herein afteris
produced and commercialized by the firm chemifarma
S.p.A who is authorized to produce, for sale purposes,
products for animal therapy int the plant located in via Don
Eugenia Servedei, 16-47122 Forli Italy as per authorization
of Ministry of Health no. 11/2012/V dated 24/04/2012”.

 GMP certificate (inspection was conducted on 3-4 april,
2013 (Expired).
specifications while the product is present in USP (but it is
for Human).
 The GMP certificate is expired but it was valid at the time
of submission of dossier.
Decision:Registrtion Board deferred the case for the submission of valid GMP certificate.
Society Lahore.
Brand Name +Dosage Form + AMOXIFARMA Soluble powder for oral solution 800mg
Strength (for Broiler Chicken and Turkeys)
Composition Each 1gm of powder contains:
Amoxicillin trihydrate……… 800mg
(Eq. to Amoxicillin…………. 696.80 mg)
Pharmacological Group B-Lactam Antibiotic (Penicillin)
Demanded Price Rs. 3850/- per 143gm
Rs. 11500/- per 500gm
Rs. 21310/- per 1430gm
Pack size 143 gm Can
500 gm Multi-layer bag
1430 gm Multi-layer bag
International availability Amatib 800 mg/g oral powder by M/s KRKA, d.d., Novo
mesto, UK Approved
Me-too status Primox 70% oral soluble powder by M/s Prix Pharma (reg #
074032)
“The product is produced (Quality control and batch release)
and commercialized by the firm chemifarma S.p.A who is
authorize to produce, for sale purposes, products for animal
therapy in the plant located in via Don Eugenia Servedei, 16-
47122 Forli Italy as per authorization of Ministry of Health
no. 11/2012/V dated 24/04/2012”.
2013) (Expired).
Remarks of the Evaluator. The firm has claimed In House manufacturing specifications
while the product is present in USP/BP.
Decision: Registrtion Board deferred the case for the submission of valid GMP certificate.
Society Lahore.
Brand Name +Dosage Form + AMROSID liquid water soluble 250mg/ml
Strength
Amprolium HCl……. 250mg
Pharmacological Group Coccidistat/Antiprotozoal
Demanded Price Rs. 1980/- per 100ml
Rs. 4280/- per 1 litre
Pack size 100ml bottle
1 litre bottle
5 litre Can
International availability 1. Aprolium 25% solution by M/s Chemifarma, Lithuania
Approved
2. Approved in UK with strengths of 226.2 mg/ml and 452
mg/ml
3. Available in Italy as per copp.
(25% powder is available)
“The product is produced and commercialized by the firm
chemifarma S.p.A who is authorize to produce, for sale
purposes, products for animal therapy int the plant located in
via Don Eugenia Servedei, 16-47122 Forli Italy as per
authorization of Ministry of Health no. 11/2012/V dated
24/04/2012”.1
2013 (Expired).
specifications while the product is present in USP (but the
product is for human).
Decision: The Registrtion Board deferred the case for the submission of valid GMP
certificate.

Society Lahore.
Brand Name +Dosage Form + TAF oral solution 25%
Strength (Should be diluted in drinking water before use)
(for broiler chicken and Turkeys)
Composition Each 100ml of solution contains:
Thiamphenicol….. 25mg
Demanded Price Rs. 1350/- per 80ml
Pack size 80ml, 1 litre, 5 litre
International availability Available In Italy as per CoPP
“The product whose composition is described herein after is
produced and commercialized by the firm chemifarma S.p.A
who is authorize to produce, for sale purposes, products for
animal therapy int the plant located in via Don Eugenia
Servedei, 16-47122 Forli Italy as per authorization of
Ministry of Health no. 11/2012/V dated 24/04/2012”.
2013 (Expired).
specifications and the product is present not in USP/BP.
 Approval in reference regulatory authorities cannot be
confirmed.
Decision: Registrtion Board deferred the case for the submission of valid GMP certificate.
1228. Name and address of Applicant M/s Eli Lilly Pakistan (Private) Ltd, 5-A, 5th floor, Al-Tijarah
Centre, 32-1-A, Block-6, PECHs, Shahra-e-Faisal, Karachi.
Detail of Drug Sale License Address: Eli lilly Pakistan (PVT) LTD. 5-A, 5th floor 10th
building floor, Al-Tijarah centre 32-1-A Block 6 PECHS
Karachi
Status: Drug license by way of whole sale
Name and address of M/s Elanco Animal Health, a division of Eli Lilly and
manufacturer Company, 10500 S. state Road 63, Clinton, Indiana (IN)
47842, United States (USA)
Name and address of marketing M/s Elanco Animal Health, a division of Eli Lilly and
authorization holder Company, 2500 Innovation way, Greenfield, Indiana 46140
Name of exporting country USA
Brand Name +Dosage Form + RUMENSIN 200 Premix
Strength (for Cattles/dairy cows)
Composition Each kg contains:
Monensin (as sodium)…… 200 g
Pharmacological Group Anticoccidial and usereducesd severity of ketosis syndrome
Shelf life 2 years
Demanded Price Decontrolled
Pack size 25 kg pack
International availability Rumensin™ 90 by M/s Elanco US INC., USFDA Approved
Me-too status Elancoban 200kg premix by M/s Eastern Agencies (Reg #
013729)
Detail of certificates attached Original legalized CoPP (certificate No. V2015-1014) certified
by USFDA valid till 28/07/2017 confirms the free sale of the
product in exporting country. The facilities and operations
conform to GMP as recommended by WHO as per CoPP.
Decision:Deferred for submission of valid legalized CoPP.
1229. Name and address of Applicant M/s Mustafa Brothers,
186-D, Peoples Colony No.1, Faisalabad.
Detail of Drug Sale License Address: Mustafa Brothers, P-186-D, Peoples Colony No.1
Faisalabad.
Name and address of M/s Cenavisa, S.L. Cami Pedra Estela, s/n, 43205 REUS,
manufacturer Spain.
Name and address of marketing M/s Cenavisa, S.L. Cami Pedra Estela, s/n, 43205 REUS,
authorization holder Spain.
Name of exporting country Spain
Brand Name +Dosage Form + CENVIMOX 500
Strength Oral powder for solution
(for Poultry use)
(for Broiler, Ducks, Turkeys)
Composition Each gm of powder contains:
Amoxicillin trihydrate….. 500mg
(Eq. to Amoxicillin……... 435.6mg)
Shelf life 2 years
Demanded Price 21.10 €/L
Pack size Pack of 100gm, 250gm, 500gm, 1kg.
International availability AMOXICILLIN GLOBAL VET HEALTH 500 by M/s
Vetsonic Ltd UK, VMD UK Approved.
Me-too status Primox 50% water soluble powder by M/s Prix pharma (Reg #
063899)
Detail of certificates attached  Original legalized CoPP certified by Agencia espanola De
Medicamentos Y Productos Sanitarios, Spain issued on
22/12/2014 confirms the free sale of the product in exporting
country. The facilities and operations conform to GMP as
recommended by WHO.
Remarks of the Evaluator.  The firm has claimed for In House manufacturing
specifications while the product is present in BP.
 The product is not available in the market of exporting
country for free sale.
Decision: Approved with B.P. specifications as per Import Policy for Finished Drugs.
1230. Name and address of Applicant M/s Huzaifa International,
Commercial area, Aziz Bhatti, Town Sargodha Pakistan.
Detail of Drug Sale License Address: Huzaifa International, A-E Commercial Area Aziz
Bhatti Ton Sargodha
Status: License to sell drugs in pharmacy
Name and address of M/s KOMIPHARM International Co. Ltd., 17, Gyeongje-RO,
manufacturer Siheung-SI, Gyeonggi-DO, The Republic of Korea.
Name and address of marketing M/s KOMIPHARM International Co. Ltd., 17, Gyeongje-RO,
authorization holder Siheung-SI, Gyeonggi-DO, The Republic of Korea.
Name of exporting country Korea
Brand Name +Dosage Form + KOMI TRIMISOLE 19.5%
Strength Oral Solution for cattle and sheeps
Composition Each 1 litre contains:
Triclabendazole………………… 120gm
Levamisole Hydrochloride…….. 75gm
Pharmacological Group Anti-helmintic
Shelf life 3 years
Pack size Pack of 100ml, 250ml, 500ml, 1 litre, 5 litre.
International availability Combinex Cattle Oral Suspension by M/s Elanco Europe Ltd,
VMD UK Approved
Me-too status Endox 19.5% solution by M/s Hawk Bio Pharma (reg #
079119)
Detail of certificates attached  Original legalized free sale certificate certified by Animal
and Plant Quarantine Agency of the Ministry for
Agriculture food and Rural affairs, Korea on 11/09/2015 is
attached, according to which, “The product is manufactured
in Korea and freely sold in foreign countries according to the
Pharmaceutical Affairs Law of the Republic of Korea”.
 GMP certificate
specifications and the product is not present in BP/USP.
Decision: The Registration board deferred the case for the submission of original legalized
and valid free sale certificate confirming the free sale status of the applied product in the
exporting country.

1231. Name and address of Applicant M/s Huzaifa International,
Commercial area, Aziz Bhatti, Town Sargodha Pakistan.
Detail of Drug Sale License Address: Huzaifa International, A-E Commercial Area Aziz
Bhatti Ton Sargodha
Status: License to sell drugs in pharmacy
Name and address of M/s KOMIPHARM International Co. Ltd., 17, Gyeongje-RO,
manufacturer Siheung-SI, Gyeonggi-DO, The Republic of Korea.
Name and address of marketing M/s KOMIPHARM International Co. Ltd., 17, Gyeongje-RO,
authorization holder Siheung-SI, Gyeonggi-DO, The Republic of Korea.
Name of exporting country Korea
Brand Name +Dosage Form + FLOSTAR Solution 10%
Strength (Oral Solution)
(For poultry)
Composition Each 1 litre contains:
Florfenicol……. 100 g
Pharmacological Group Phenicols antibiotics
Shelf life 3 years
Pack size Pack of 100ml, 500ml, 1 litre, 5 litre, 10 litre
International availability Nefincol 100mg/ml oral solution by M/s Vetpharma Animal
Health, S.L., Netherlands Approved
Me-too status Naflor oral solution 100mg/ml by M/s Nawan Pharaceuticals
(Reg # 049514)
Detail of certificates attached  Original legalized free sale certificate certified by Animal
and Plant Quarantine Agency of the Ministry for
Agriculture food and Rural affairs, Korea on 11/09/2015 is
attached, according to which, “The product is manufactured
in Korea and freely sold in foreign countries according to the
Pharmaceutical Affairs Law of the Republic of Korea”.
 GMP certificate
specifications and the product is not present in BP/USP.
Decision: The Registration board deferred the case for the submission of original legalized
and valid free sale certificate confirming the free sale status of the applied product in the
exporting country.

B). Veterinary Cases for Expert opinion:
1. Case I
The Registration board in 272nd meeting considered the following application for
registration of drug applied by M/s U.M. Enterprises, Plot No. 12, Sector 15, Korangi
Industrial Area, Karachi as per detail below:-
1232. Name and address of Applicant M/s. U.M. Enterprises, Plot No.12, Sector 15, Korangi
Industrial Area, Karachi
Name and address of manufacturer M/s. Eagle Vet. Tech. Co. Ltd.,
256-46 Dukok-RI, Shinam-Myun, Yesan-Kun,
Chungchongnam -Do, Korea.
Name and address of Product License M/s. Eagle Vet. Tech. Co. Ltd.,
Holder 256-46 Dukok-RI, Shinam-Myun, Yesan-Kun,
Chungchongnam -Do, Korea.
Exporting Country Republic of Korea
Brand Name +Dosage Form + Strength Eagle Catofull Injection
Diary No. Date of R& I & fee Dy No. 725, 26-09-2014
Rs.100,000/- 25-09-2014
Butaphosphan…………..100mg
Cyanocobalamin……….0.05mg
Pharmacological Group Metabolic Pathway Stimulator, Vitamin
Finished Product Specification Firm has claimed in house specification
Pack size & Demanded Price 20ml: Rs. 310/-
50ml: Rs. 430/-
100ml: Rs. 535/-
Approval status of product in  Catosal Injection by Bayer (Germany Approved)
Reference Regulatory Authorities.  Original, legalized CPP issued by Animal and Plant
Quarantine agency of Korea on 08-07-2013 confirms
its free sale in exporting country.
Me-too status Catosal 10% injectable solution by Bayer Pakistan
(Import)
CoPP/GMP/ Free sale certificate Original, legalized CPP issued by Animal and Plant
the GMP status of manufacturing facility and free sale
in exporting country
GMP certificate issued by Animal and Plant
the GMP status of manufacturing facility
Remarks of the Evaluator.  The pack size mentioned in CoPP is 100ml, while
firm has applied for 20, 50 and 100ml pack sizes
 Firm has claimed inhouse specifications without
providing documents as per the requirements of 267th
RB meeting
Decision: Deferred for review of case by Dr.Qurban Ali, Member Registration Board
Expert Opinion:
The views/opinion of Dr. Qurban Ali (DVM;PHD) are as under;
“The indicated preparation is an injectable form for prevention or treatment of deficiencies of the
nutrient in animal, typically pre and post-partum dairy cows convalescene and or ketosis etc.
The preparation has no withdrawal period for milk, meat and eggs and safe for use in veterinary
medical care purpose. The preparation with same strengths also carries approval is SRAs.
The product is recommended for registration.
Decision: The Registration Board Approved the case with Innovator’s specifications as per
Import Policy for Finished Drugs.
1. Case II
The Registration Board in its 259th Meeting held on 30-31st May, 2016 deferred the
case for expert opinion, toxicity data and stability requirements of Head pharmacology,
UVAS, Arid and UAF.
1233. Name and address of M/s Prix Pharmaceutica, 26-Abbot Road, Lahore.
Applicant
Name and address of M/s Fatro S.p.A, Via Emilia, 285-40064 Ozzano, Emilia
manufacturer (Bologna), Italy.
Name and address of Product M/s Fatro S.p.A, Via Emilia, 285-40064 Ozzano, Emilia
license holder (Bologna), Italy.
Exporting country Italy
Brand Name+Dosage Form Tirsan 200 Oral Solution
+ Strength
Thiamphenicol…….……200mg
Pharmacological Group Antimicrobial agent for systemic use
Finished product
Manufacturer‟s Specifications.
Specification
Shelf Life 2years
Fee including differential fee Rs. 50,000/-
Pack size Bottle of 1 1iter, 5 liter, 10 liter
International Availability Tirsan 200 oral solution, Mexico;
Tirsan 200, Italy
Me-too status Cannot be confirmed
Detail of certificates attached 1. Free sale issued dated 31-OCT-2012.
2. GMP issued dated 20-2-2009.later firm has submitted 20-3-
14.
Remarks of the Evaluator. 1. Free sale certificate describes the composition as:
“1gm contains 200mg Thiamphenicol”
2. The approval status in reference regulatory authorities
and Pakistan cannot be confirmed.
Previous Decision:
Registration Board in its 259th Meeting held on 30-31st May, 2016 deferred the case for expert
opinion, toxicity data and stability requirements of Head pharmacology, UVAS, Arid and UAF.
The comments of the experts are as under:
Prof. Dr. Muhammad Ashraf (T.I),
Professor of Emeritus, (Department of Pharmacology and Toxicology, University of Veterinary
Animal Sciences, Lahore).
1. Thiamphenicol is an analogue chloramphenicol in which P-nitro group of
Chloramphenicol has been replaced with Methyl Sulphonyl group.
2. Thiamphenicol is a broad spectrum antibiotic having similar properties as
chloramphenicol.
3. Chloramphenicol is banned for use in veterinary practice due to association of aplastic
anemia which is not linked with thiamphenicol.
4. Thiamphenicol was introduced in veterinary practice as a replacement of
chloramphenicol.
5. Thiamphenicol toxicity profile resembles with chloramphenicol without its association
to lethal idiosyncratic aplastic anemia.
6. Chloramphenicol and thiamphenicol cause bone marrow depression leading to
reversible anemia which is time and dose depended and is reversed with the cessation of therapy.
7. Chloramphenicol also cause another type of bone marrow depression which is
idiosyncratic in nature (not dose and time depended) and is irreversible leading to lethal aplastic
anemia in human. Such type of toxicity is not associated with thiamphenicol.
8. Chloramphenicol is mainly metabolized by Liver (about 90%) while thiamphenicol is
mainly eliminated (70%) unchanged by renal excretion.
9. Tirsan 200 oral solution contains thiamphenicol 200mg/ml which has good
bioavailability and stability.
Recommendations:
Product “TIRSAN 200 ORAL SOLUTION” may be approved for therapeutic use only
in veterinary practice.
Dr. Mazhar ul Haq
Assistant Professor (Pharmacology), (Arid Agricultural University Rawalpindi, Department of
Biomedical Sciences, Faculty of Veterinary and Animal Sciences, Rawalpindi).
1. I am interested to ask whether this product (drug; Thiamphenicol) is registered already
with the Registration Board in Pakistan?
2. In order to review the toxicity and stability of the formulation, the information of the
product with the pharmaceutics detail (e.g. excipients/vehicles used) what the firm has submitted
with the application for registration, is required, please.
3. You are therefore requested to furnish the above said information to accomplish the
report, please.
Dr. Faqir Muhammad
Associate Professor,(University of Agriculture, Faisalabad, Pakistan Institute of Pharmacy,
Physiology, and Pharmacology).
1. The product under consideration contains thiamphenicol as active ingredient with
antibacterial activity. The available international published literature on thiamphenicol‟s stability
suggest a shelf life of 5 to 6 years, but no specific statements or recommendations are made by
the sponsor, other than a statement that the product is stable if stored in closed containers, and
protected from humidity and excessive heat.
2. The available literature on the toxicity of thiamphenicol particularly residues in food
animals indicated that thiamphenicol concentrations were present above the limit of
quantification (LOQ) in the plasma of cattle at 34 hours post the last dose. While in sheep, the
thiamphenicol concentrations in all body fluids declined to below the limit of detection (LOD)
by 24 hours after the cessation of doing. In chickens, by 56 hours after the completion of dosing,
the birds on the highest dose have plasma levels below the LOQ. When killed 5 days after
dosing, less than 1% thiamphenicol remained in the carcase. Results indicate that during the first
120 hours after dosing, 92% of the administered dose was excreted in feces. Tissues containing
the highest levels were the liver, kidney and gizzard. Skeletal muscle showed low levels at six
hours post dose.
3. Tissues residue depletion studies in cattle indicate that liver, lung and spleen have
appreciable concentrations for longer than other tissues, but all were below the LOQ eight
cessation of dosing. In lactating cows, on the first day after cessation after treatment mean
thiamphenicol concentrations were 764±133 µg/L, on the next day levels in six of the eight cows
were below the LOQ (20 µg/L), and on the following day levels in seven cows were below the
LOQ. All milk samples were below the LOQ on the fourth day of dosing was completed. In
chicken, seven days after the cessation of dosing, levels of thiamphenicol in the eggs from 7/15
birds where below LOQ. The following day, the drug was detected in 1 egg only and on the 9th
day after dosing ceased, no eggs were positive for thiamphenicol residues.
4. Based upon these available studies, it may be recommended for veterinary use provided
the recommended drug withdrawal times are observed strictly to avoid objectionable residues in
milk, meat or eggs. It is worth mentioning over here that above studies are conducted and
withdrawal times are established in foreign countries in their animal species. The same drug
withdrawal times might not be applicable to our local animal species because of differences in
genetics, nutrition and environment. Thus there is need to validate these drug withdrawal in our
local food animal species in order to validate drug withdrawal times for avoiding violative
residues in animal derived foods. It is therefore suggested to make this mandatory for
manufacturers/importers to get this type of studies done in Pakistan for establishing/validating
drug withdrawal times in local species of food animals.
Decision: Registration Board endorsed the decision of the experts. However the Registration
Board deferred the case for the submission of:
 Original, legalized and valid Free Sales Certificate with correct composition
 Valid copy of GMP certificate
c) Import deferred cases
1234. Name and address of M/s AGP (Private) Limited, B-23, S.I.T.E, Karachi
Applicant
Detail of Drug sale license Address: M/s AGP (Private) Limited, B-23-C,S.I.T.E,Karachi
Status: Drug license by the way of wholesale
Name and address of M/s Mylan Laboratories Limited, F-4 & F-12, MIDC,
manufacturer Malegaon, TAL.Sinnar, Nashik 422113 Maharashtra state,
India.
Name and address of M/s Mylan Laboratories Limited, F-4 & F-12, MIDC,
marketing authorization holder Malegaon, TAL.Sinnar, Nashik 422113 Maharashtra state,
India.
Corporate Office:
House No8-2-293/82/J-III, Plot No. 564/A/22, Road No. 92,
Jubilee Hills, Hyderabad-500 033, India
Name of exporting country India
Brand Name +Dosage Form + NEVIMAT 200mg
Strength (Immediate release, Uncoated)
Nevirapine…….. 200mg
Demanded Price Rs. 2520/- per Bottle
Pack size 60 tablet per HDPE bottle
International availability Nevirapine by Aurobindo,USFDA
Me-too status Pivir by Hilton Pharma Karach
Detail of certificates attached Legalized and Valid CoPP (certificate No.
COPP/CERT/NKD/52114/2016/11/17212/88870) issued by
Food and Drug Administration, M.S. Bandra, Mumbai, India
valid till 30/03/2018 confirms the free sale of the product in
exporting country. The facilities and operations conform to
GMP as recommended by WHO as per CoPP.
Remarks of the Evaluator. The firm has claimed In House Manufacturing specifications
but the product is present in USP.
Decision:
Deferred for the clarification whether anti-viral drugs can be imported from India or otherwise.
Evaluation by PEC:
The firm has stated that the product is not included in the SRO No. 280 (I)/2012 “list of items
not imported from India” therefore the product can be imported. The list has been checked the
antivirals are not included in the list. Moreover the Registration Board has approved a Product
“VIRPAS film coated tablet 90/400 mg” (Ledipsavir+Sofosbuvir) by M/s Novartis Pharma in
274th meeting.
Decision: Registration Board approved product as per Import Policy for Finished Drugs

1235. Name and address of M/s Allmed Laboratories, A-21/3, KDA Scheme 1, EXT.,
Applicant Opposite National Stadium, Karachi
Detail of Drug sale License Address:M/s Allmed Laboratories, A-21/3, KDA Scheme 1,
EXT., Opp National Stadium, Karachi
Validity:09/11/2018
Status:Drug license by way of wholesale
Name and address of M/s Solupharm Pharmazeutische Erzeugnisse GmbH
manufacturer Industriestr. 3 34212 Melsungen, Germany
(Site responsible for manufacturing of bulk ampoules/vials,
assembly and labeling)
M/s Wasserburger Arzneimettelwerk GmbH Herderstrabe 1,2
und Molkerei-Bauer-Strabe 18 83512 Melsungen, Germany
(Site responsible for manufacturing of bulk ampoules/vials,
assembly and labeling)
M/s Scanpharm A/S Topstykket 12 Birkerod, 3460, Denmark
(Site responsible for Secondary packaging, Assembly and
labeling only)
M/s Stradis 29 rue Leon Faucher Reims, 51100, France
(Site responsible for Secondary packaging, Assembly and
labeling only)
Name and address of M/s Pharmacosmos A/S Roervagsvej 30 Holbaek Denmark
marketing authorization
holder
Name of exporting country Denmark
Brand Name +Dosage Form MONOFER Solution for Injection/Infusion (IV)
+ Strength
Iron (III) Isomaltoside 1000 …….. approx. 834mg
(Eq. to Iron…… 200mg)
Finished Product In House
Specification
Pharmacological Group Anti-anemic
Shelf life 3 years
Diary No. & Date of R& I Dy. No. 1251 (PEC) (DUPLICATE Dossier)
(Date of submission of original Dossier 29/11/2010)
Fee including differential fee Rs. 100,000/-
Demanded Price Rs. 2,000/- per Apmoule
Pack size 5 × 1‟s (2ml Ampoule)
International availability Monofer by Pharmacosmos, MHRA
Me-too status Wisofer by Welmark Pharmaceuticals (Reg. No. 078521)
Detail of certificates attached Copy of CoPP (certificate No. 2013121187) issued by Danish
Health and Medicines Authority, Denmark on 11/12/2013
WHO.
specifications and the product is not present in USP/BP.
 The composition of the drug product in CoPP is given below
Each 2ml contains:
Iron (100mg) as iron (III) isomaltoside….. approx. 834mg
Which is not correct because 2ml of ampoule contains 200mg
Iron.
Decision:
The Registration Board in 272nd meeting Deferred for the clarification regarding difference in
composition mentioned in CoPP and form 5-A.

Evaluation by PEC:
The firm has submit another CoPP (certificate No. 2017083045) issued by Danish Medicine
Agency on 23/08/2017confirms the free sale of the product in exporting country. The facilities
and operations conform to GMP as recommended by WHO.
The composition is correct in CoPP and is stated as followos;
Each ampoule of 2ml contains:
Iron (III) isomaltose 1000……… 834mg
(Eq. to Iron………………………. 200mg)
Decision: Registration Board was approised that applicant has confirmed following sites
involved in manufacturing od product, thus the Board approved product with following
sites:
M/s Solupharm Pharmazeutische Erzeugnisse GmbH Industriestr. 3 34212 Melsungen,
Germany(Site responsible for manufacturing of bulk ampoules/vials, assembly and labeling)
M/s Stradis 29 rue Leon Faucher Reims, 51100, France(Site responsible for Secondary
packaging, Assembly and labeling only.
1236. Name and address of Applicant M/s Ghazali Brothers, 1st floor Azzainab Court, Campbell
Street, Karachi
Name and address of M/s Anhui Double-Crane Pharmaceutical Co., Ltd., Anhui
manufacturer Province Fanchang Economy,
Name and address of Marketing M/s Anhui Double-Crane Pharmaceutical Co., Ltd., Anhui
authorization holder Province Fanchang Economy,
Name of ecportng country China
Shelf life 5 years
Brand Name+Dosage Form + LUKOZE 5% IV Injection
Strength
Composition Each HDPE Bottle of 500ml contains:
Glucose…. 25g
Pharmacological Group Electrolyte Replacement Fluid Agent
Fee including differential fee Rs. 15,000/- Dated 11/08/2010 + Rs. 85,000/- Dated
27/01/2015
Pack size 1‟s (500ml HDPE bottle)
Demanded Price As per brand leader
International Availability Dextrose 5% by ICU Medcl, USFDA
Me-too status Dexsol by Vision Pharmaceuticals
Detail of certificates attached Original legalized CPP (certificate No. 201704046) issued by
Anhui Food and Drug Administration On 28/04/2017
confirms the free sale of the product in exporting country.
The facilities and operations conform to GMP as
recommended by WHO.
Remarks of the Evaluator. 1. The firm has claimed for In House specifications while the
formulation is present in USP and BP
2. The results of assay of long term stability studies are same
for various time points detailed as under:
 99.3% from initial to 36 months for batch No. AB403.
Similarly for Accelerated stability studies,
The case is hereby presented before the Registration Board.
Previous Decision:
In 270th meeting Registration Board deferred the case since the data/assay values in the stability
studies are unjustifiable/irrational with no change throughout the period of study.
Evaluation by PEC:
1. The firm has re-submitted the stability data along with the certificate of analysis.
2. An undertaking is submitted in which the firm has stated that the stability data is not fake and
it is according to manufacturer‟s knowledge.
3. The justification provided by the firm is unacceptable.
Previous Decision:
Registration Board in 271st meeting deferred the case for verification of stability data from the
source/manufacturer.
Fresh Evaluation by PEC:
1. The firm has submitted letter of explanation from the manufacturer M/s Anhui Double-Crane
Pharmaceutical Co., Ltd., Which states that;
“We are sorry to declare that the previous test had the wrong data printed on it
due to typo and human errors. We hereby accept that the previous stability test
report is not valid and hence we are submitting the revised data for your kind
reference”
2. The firm has submitted long ter and accelerated stability data which have been
checked.
3. The stability data and the letter of explanation are endorsed by CHINA COUNCIL
FOR THE PROMOTION OF INTERNATIONAL TRADE.
Decision: Registration Board deliberated the matter in detail and decided to approve the
case with USP specifications. Registration Board advised PE&R Division to send the
submitted stability data to panel of experts for verification of authenticity/genuiness of
submitted stability data at the time of inpection.
Street, Karachi
Name and address of M/s Anhui Double-Crane Pharmaceutical Co., Ltd., Anhui
manufacturer Province Fanchang Economy,
Exporting country China
27/01/2015
Brand Name+Dosage Form + LUKOZE 5% in normal Saline 0.9% IV Injection
Strength
Composition Each bottle (250ml) contains:
Glucose…..12.5g
Sodium Chloride….. 2.25g
Pharmacological Group Electrolyte replacement fluid agent
Shelf life 5 years
Pack size 1‟s (250ml HDPE Bottle)
International Availability Dextrose and Sodium chloride by ICU Medcl, USFDA
Me-too status Dexsol DS by Vision Pharmaceuticals
recommended by WHO.
Remarks of the Evaluator. 1. The firm has claimed In House manufacturing
specifications while he formulation is available in USP & BP
2. The results of assay of long term stability studies are same
for various time points detailed as under:,
 99.7% from initial to 60 months for amount of

Glucose for batch No. 030801.
 99.2% from initial to 60 months for Sodium chloride
for batch No. 030801.
Previous Decision:
Evaluation by PEC:
3. the justification provided by the firm is unacceptable.
Decision:
Registration Board deferred the case for verification of stability data from the
reference”
checked.
Street, Karachi
Name and address of M/s Anhui Double-Crane Pharmaceutical Co., Ltd., Sanshan
manufacturer Green-Food Industrial Park, Wuhu Economy & Technology
Development Area, China
Name of exporting country China
Type of Form From 5-A
Fee including differential fee Rs. 15,000/- Dated 11/08/2010 (Copy) + Rs. 85,000/- Dated
27/01/2015
Brand Name+Dosage Form + MTZ INJECTION 0.5% 100 ml With Hanger
Strength
Composition Each HDPE Resin bottle of 100ml Contains:
Metronidazole…….0.5% (500mg)
Pharmacological Group Imidazole derivative/Anti protozoal
Finished product Specification USP specifications
Shelf life 5 years
Pack size 100ml HDPE resin bottle
Demanded Price HDPE Resin Bottle 100ml
International Availability FLAGYL I.V. RTU by Baxter Hlthcare, USFDA
Me-too status Metronidazole Infusion By Ghazali Brothers

recommended by WHO.
Remarks of the Evaluator. 1. The results of assay of long term and accelerated stability
studies are same for various time points that is from initial
to final time point for all 03 batches.
Previous Decision:
Evaluation by PEC:
Decision:
reference”
checked.
Street, Karachi
Name and address of M/s Anhui Double-Crane Pharmaceutical Co., Ltd.,
manufacturer Sanshan Green-Food Industrial Park, Wuhu Economy &
Technology Development Area, China
authorization holder Province Fanchang Economy, (form 5A and Sole agency)
Shelf life 5 years
Brand Name+Dosage Form + SODIOMIDE 0.9% INJECTION ( IV)
Strength
Composition Each 500ml HDPE bottle contains:
Sodium chloride…. 4.5g
Pharmacological Group Electrolyte replacement fluid agent
27/01/2015
Pack size 1‟s
International Availability Sodium Chloride 0.9% By Baxter Hlthcare USFDA
Me-too status Celine by Surge Labs
Detail of certificates attached Original legalized CPP (certificate No. 201704045) issued

by Anhui Food and Drug Administration On 28/04/2017
recommended by WHO.
Remarks of the Evaluator. 1. The firm has claimed for In House manufacturing
specifications while the product is present in USP.
2. The results of assay of long term and accelerated
stability studies shows the same value for assay from initial
to final test for all 03 batches.
Decision:
Evaluation by PEC:
Decision:
reference”
checked.
Street, Karachi
Name and address of M/s Anhui Double-Crane Pharmaceutical Co., Ltd., Sanshan
manufacturer Green-Food Industrial Park, Wuhu Economy & Technology
Development Area, China
Shelf life 5 years
Brand Name+Dosage Form + SOLAC RINGER‟s INJECTION (IV)
Strength
Composition Each HDPE bottle of 500ml Contains:
Sodium Lactae……. 1,55g
Sodium Chloride….. 3.0g
Potassium Chloride… 0.15g
Calcium Chloride….. 0.1g
Pharmacological Group Electrolyte Replacement Fluid agent

27/01/2015
Pack size 1‟s (500ml HDPE Bottle)
International Availability Lactated ringer by Baxter Hlthcare, USFDA
Me-too status Safesol ringer solution by Ahad International
pharmaceuticals
recommended by WHO.
Remarks of the Evaluator. 1. The firm has claimed for In House specifications while the
product is present in USP.
2. The results of assay of long term and accelerated stability
studies are same for various time points that is from initial
to final time point for all 03 batches.
Previous Decision:
Evaluation by PEC:
Decision:
reference”
checked.

B. Miscelleneous cases.
RRR SECTION
Case No.01 Communication of Renewal/Acknowledgement Letters

It is submitted that due to the devolution of erstwhile Ministry, the pendency of
communicating the renewal status of routine renewal applications suffered the efficiency of
RRR Section of PE&R Division. Lack of consolidated records of Renewal Application due to
devolution of erstwhile Ministry and frequent shifting of offices, compelled the deputed staff
(which includes Assistant Director ,1 steno typist and an Assistant ), to start working on
compilation of data from available records and approximately 33,152 Registered products
(includes imported and local products) data has been compiled till to date. Available record
of previous five years i.e. from 2013-2017 (July) has been compiled and data of year 2017 is
attached. PE&R Division has decided to consider the Renewal Applications received after the
establishment of DRAP i.e. from 2012 and start the process of issuance of renewal letters as
per practice in vogue received in the year of 2017.
Furthermore to streamline the function of RRR Section for the processing of these
application following proposal has been contemplated for approval:
i. Registration Board may set a criteria for processing the Renewal application of
current years and consideration of Renewal Application submitted in previous
years i.e. (to consider last renewal, second last renewal or otherwise).
ii. We may start communicating the Renewal letters, as per adopted mechanism by
the predecessor‟s officers of the said section.
iii. Before issuance of renewal of registration on the format illustrated in point 1, we
may confirm the Registration status (Whether de-registered, suspended or
otherwise) and post Registration Variation (if any) from the concerned
Registration section.
iv. For confirmation of Renewal of imported products explicit orders may be taken
from Registration Board as per Rule 27 of Drugs (Licensing, Registering and
Advertising) Rules, 1976. Condition of prevailing import policy will pertain on
the imported product at the time of renewa5l.
v. Renewal application received late but within 60 days and submitted application
along with differential fee or prescribed, case will be placed in the Registration
Board for explicit order.
vi. Renewal application received after 60 days, case will be processed as per S.R.O
1005(I)/2017.
vii. Confirmation of section from Licensing Division held by the firm, may help to
substantiate the renewal status of product which requires a separate section for
manufacturing.
viii. Moreover, services of Legal Affair Division may co-opt by PE &R Division for
framing a prescribed form of Renewal Certificate under Drugs (Licensing,
Registering & Advertising) Rules, 1976.

The proposed format for communication of renewal status is as under for
F. No. ….-…. /…. - RRR
Government of Pakistan
Ministry of Health Services, Regulations and Coordination
Drug Regulatory Authority of Pakistan.
*****
SAY NO TO CORRUPTION
Islamabad the October, 2017
Subject: - RENEWAL OF REGISTRATION OF DRUGS UNDER DRUGS ACT
1976, AND RULES FRAMED THEREUNDER
Dear Sir,
I am directed to refer to your application(s) on the subject captioned above. The
following drugs has/have been renewed for further period. Detail is as under;
Sr. No. Reg. No. Product Name Validity / Date of Renewal
CONDITIONS:
i) The registration shall remain valid unless earlier suspended or cancelled.
ii) The drug(s) shall be manufactured in compliance to the provision of Drugs Act,
1976 and Rules framed thereunder
Decision: Registration Board deliberated on the matter in detail. The Registration
Board on the request of the representative of the stakeholders decided to
pend the case for their comments. Registration Board further adviced the
representative of the stakeholders to submit their comments by 10th
November, 2017.
Case No.02 Renewal Status of products of M/s. Global Veterinary and Technical
Services Pvt. Limited, Multan.
Registration Board in its 273rd meeting deferred the case for consideration in
forthcoming meeting. The case is as under;
Registration Board in its 269th meeting deferred the case for detail history of
application for change of manufacturer name from R-I section.
Accordingly comments from R-I section are as under;
The firm initially applied for change of name of manufacturer with renewal of drugs
which was on 19-01-2007 which was within due renewal period (Due date 03-09-2008). The
GMP status of manufacturer abroad i.e., M/s Eagle Vet Tech. Co. Ltd., Korea was declared
satisfactory and recommended by the Board in its 212th Meeting held on June, 2008.

Regarding change of business address, the case is yet to be decided as the firm claim that they
have submitted application in renewal section.
After scrutiny of documents in the light of comments furnished by R-I section, it is
revealed that the renewal application of year 2013 of their products are submitted on
12.12.2011 with fee of Rs.7,500/- i.e., 2 year in advance. Fee schedule has been revised in
2012 and fee for imported drug at present is Rs.20,000/- subject to prevailing import policy.
Differential fee of Rs.12500/- for each product is required for further processing the case.
Decision: Registration Board advised the firm to submit fee as per revised fee
schedule for consideration of the Board.
Case No.03 M/s Ambrosia Pharmaceuticals, Rawat-Islamabad.
It is submitted that due date for renewal of registration of products of the firm was
12.07.2015, while the firm submitted application on 13.07.2015 which is within 60 days after
expiry of registration of their product.
Accordingly, firm has submitted a letter in which they have stated that they have
deposited Rs.240,000/- in DRAP account on 10.07.2015 for renewal of following drugs
which due on 12.07.2015 and they have deposited in R&I section on 13-07-2015. Being
holiday DRAP office is closed on 11-07-2015 and 12-07-2015 for Saturday and Sunday.
S.# Reg. Name of Drug & Initial date of Application
No. Composition Registration Receiving date
1. 040794 Amroquin 500mg tablet 13-07-2005 13-07-2015
2. 040795 Amrroquin 250 mg tablet -do- -do-
3. 040796 Hoxidal 200mg tablet -do- -do-
4. 040797 Pefrocia 400mg -do- -do-
5. 040800 Sparosia 100mg tablet -do- -do-
6. 040801 Amiclar 250mg tablet -do- -do-
7. 040802 Amiclar 500mg tablet -do- -do-
8. 040803 Ambrorox 150mg -do- -do-
9. 040804 Ambrorox 300mg tablet -do- -do-
10. 040805 Azisia 250 mg tablet -do- -do-
11. 040806 Norasia 400mg tablet -do- -do-
12. 040807 Amozol cream -do- -do-
13. 040808 Ambricil Cream -do- -do-
14. 40809 Ambrofax Ointment -do- -do-
15. 40810 Nizozole Cream -do- -do-
16. 40811 Ambrodic Cream -do- -do-
17. 40812 Ambrodic Ointment -do- -do-
18. 40813 Amfac Gel -do- -do-
19. 40814 Ambronol Cough Syrup -do- -do-
20. 40815 Amrotose Complex Syrup -do- -do-
21. 40816 Fambria Suspension -do- -do-
22. 40817 Sudofin Syrup -do- -do-
23. 40818 Ambrillium Syrup -do- -do-
24. 40819 Weborant Syryp -do- -do-
Decision: Registration Board acceded to request of the firm and decided the grant
of renewal of above mentioned products till 12-07-2020.

Case No.04 Applications Received with Shortcomings
This section apprised the Board that Directorate of (PE&R) is dealing with number of
applications submitted for renewal of drugs which are incomplete or have shortcoming
especially with reference to the submitted prescribed renewal fees.
The following applications for renewal of drugs are submitted on Form 5-B after the
expiry of validity of the certificate of registration but within sixty days after validity of
certificate of registration. The applications for renewal are incomplete with reference to
renewal application fee or having some other deficiency.
RULE 27Drug (Licensing, Registering & Advertising) Rules, 1976 (Duration of
certificate of registration). A certificate of registration under this chapter, [shall unless
earlier suspended or cancelled, be in force for a period of five years from the date of
[Registration of the drug] and may thereafter be renewed for period not exceeding five years
and a certificate to this effect shall be issued within one month] at a time.
Provided that an application for the renewal of registration shall not be entertained unless it
has been made within sixty days after the expiry of the registration and when an application
has been made aforesaid the registration shall subject to the orders passed on the application
for the renewal continue in force for the next period of five yearsand a certificate to this
effect shall be issued within one month].
Provided further that in case of an imported drug, the renewal may be granted and a renewal
certificate shall be issued, if in the opinion of the Registration Board it is necessary to do so
in the public interest.
Following cases are placed below for consideration of the Registration Board.
i) Cases for imported pellets

a) M/s. Getz Pharma (Pvt.) Ltd., Karachi.
Case is referred by R-II section regarding confirmation of renewal status.
Sr. Reg. Initial date of
Product Name Application Receiving date
No. No. Registration
1 061529 Tamsolin 0.2mg Capsule 31-05-2010 Due date (30-05-2015)
Each modified release Fee of Rs.10,000/- deposited on
capsule contains:- 15-04-2015. As these are imported
Tamsulosin HCl as pellets from M/s RA Chem Pharma Ltd,
Modified release pellets … Clinical Research and Bio Science India
0.2mg (Pvt) Ltd. Remaining fee of Rs10,000/-
is deposited on 14-06-2017.
Decision: Registration board acceded to request of the firm and decided to grant the
renewal till 30-05-2020.

c) M/s. Arsons Pharmaceuticals Industries (Pvt) Ltd., Lahore.
Case is referred by R-V section.
1 071415 Romperazole-20 Capsule 18-08-2011 Due date (17-08-2016)
Each capsule contains:- Fee of Rs.10,000/- deposited on
Omeprazole … 20mg 16-08-2016. As these are imported
pellets from M/s Titan Laboratories
(Pvt.) Ltd., Mumbai India. Remaining
fee of Rs10,000/- is deposited on 18-
08-2017.
renewal till 17-08-2021
ii) With differential fee

a) M/s. Arsons Pharmaceuticals Industries (Pvt) Ltd., Lahore.
Case is referred by Pricing Division.
1 046023 Arso-Tulle 14-03-2007 Due date (13-03-2017)
Sterile Guaze Tulle Fee of Rs.10,000/- deposited on
Dressing impregnated with 05-04-2017. As application received
chlorhexidine acetate 0.5% within 60 days after expiry of Reg. So
in white soft paraffin fabric remaining fee of Rs.10,000/- deposited
& Silicon Release paper in on 28-08-2017.
single unit foil sachet.
Decision: Registration Board deferred the case for confirmation of sterile facility from
QA&LT Division
b) M/s. Gray’s Pharmaceuticals, Islamabad.

1 072450 Rizidro 35mg Tablet 18-08-2011 Due date (17-08-2016)
Each film coated tablet Fee of Rs.10,000/- deposited on
contains:- 01-09-2016. As application
Risedronate Sodium … 35mg received within 60 days after
expiry of Reg. So remaining fee
of Rs.10,000/- deposited on 07-
09-2016.
2 072451 Rabep 20mg EC Tablet Do Do
Each tablet contains:-
Rabeprazole Sodium … 20mg
3 072452 Grazeth 500mg Tablet Do Do
Each film coated tablet
contains:
Azithromycin as Azithromycin
dehydrate … 500mg
4 072453 Infladex 20mg Dispersible Do Do
Tablet
Each dispersible tablet contains:
Piroxicam (as
betacyclodextrin)… 20mg
5 072454 Coatesinate Super Tablet Do Do
Artimether … 80mg
Lumifantrine … 480mg
(Case referred by R-III Section)
6 072456 Ecomin 500mcg Injection Do Do
Each ampoule (1ml) contains:-
Mecobalamine … 500mcg
7 072457 Water for Injection Do Do
Each ampoule contains:-
Sterile water for injection …
5ml
8 072458 Arestinate Injection Do Do
Each ml contains:-
Artimether … 80mg
9 072459 Diclogray Plus Injection I/M Do Do
Each 2ml ampoule contains:-
Diclofenac Sodium … 75mg
Lidocain Hydrochloride…
20mg
Decision: Registration Board acceded to request of the firm and decided to grant the
renewal till 17-08-2021
c) M/s Mac & Rains Pharmaceuticals (Pvt.) Ltd., Lahore.

Case is referred by R-V section.
Sr. Initial date of
Reg. No. Product Name Application Receiving date
No. Registration
1 048046 Macsol Laevulose Infusion 5% 10-01-2008 Due date (09-01-2013)
Each 100ml solution contains:- Fee of Rs.10,000/- deposited on
Laevulose (Fructose) … 5gm 10-01-2013. As application
received within 60 days after
expiry of Reg. So remaining fee
of Rs.10,000/- deposited on
23.05.2017.
2 048047 Macodialysis AC+BC Do Do
Each 1 liter contains:-
Sodium Chloride … 210.69gm
Potassium Chloride … 5.22gm
Glacial Acetic Acid … 6.31gm
Calcium Chloride 2H2O
….6.43gm
Magnesium Chloride 6H2O …
3.56gm
Dextrose Anhydrous … 35.0gm
renewal till 09-01-2018.
d) M/s Amson Vaccines & Pharma (Pvt.) Ltd., Islamabad.

1 029974 Awazi Capsule 06-03-2003 Due date (17-08-2014)
Transfer of reg. Fee of Rs.10,000/- deposited on
date 19-08-2014 (Evidence is photocopy).
18-08-2004 As application received within 60 days
after expiry of Reg. So remaining fee of
Rs.10,000/- deposited on 19-09-2017.
Decision: Registration board acceded to request of the firm and decided to grant
the renewal till 17-08-2019.
Registration-I
Case.No:05 Registration of Qlaira Tablet by M/s. Bayer Pakistan (Pvt) Ltd.,

Karachi.
Registration Board in its 240th meeting approved the following product of Bayer
Pakistan (Pvt) Ltd., Karachi as Biological Drug as per following details.
S.# Name of Name of Drug & Demanded 4th ECBD Decision
Manufacturer / Composition Price & Recommendation
Importer. Pack Size.
1 Bayer Pakistan Qlaira Pack of 1 Recommended Approved
(Pvt) Ltd., Karachi (eastradiol x 28‟s based upon the
valerate/Dienogest) tablets approval process
Manufacturer M/s. Hormone Combination Rs.1900/- adopted by the
BayerWeimer respective SRA
GmbH und Co. Film Coated Tab of the country of
KG contains: 2/3mg origin. Date of
Doebereinerstrasse eastradiol application
20 99427 Weimer, valerate/Dienogest as received
Germany active ingredient 29.08.2011
Main indications:
Oral contraceptive;
treatment of heavy
menstrual bleeding in
women without organic
pathology who desire
oral contraceptive
The composition of the said product approved in Registration Board meeting is

“2/3mg Eastradiol Valerate/Dienogest”. The DPC also fixed the price of product as per
aforementioned approved composition.
Subsequently, in September 2017 the Biological Division forwarded the registration
application including dossier to the PER Division for further processing claiming that the
product is of synthetic origin. On scrutiny of the documents/dossier received from the BE&R
Division following points were observed.
i. As per Form-5A and CoPP the composition of the product is as under:
Part I (2 dark yellow film coated tablets-Core)
Estradiol valerate….3.000 mg
Part II (5 medium red film-coated tablets-Core)
Dienogest………….2.000 mg
Part III (17 light yellow film-coated tablets-Core)
Dienogest………….3.000 mg
Part IV (2 dark red film-coated tablets-Core)
Part V (2 white film-coated tablets-Core)
None
While the composition as per Registration Board meeting and DPC meeting minutes
is as mentioned in the above table.
ii. The CoPP issued by German Authorities mentions M/s. Jenapharm GmbH & Co. KG,
Otto-schott-Strasse 15, 07745 Jena, Germany as product license holder which is not
mentioned in the minutes.
Decision: Registration Board approved the composition of Qlaira Tablet by M/s.
Bayer Pakistan (Pvt) Ltd., Karachi in accordance with CoPP and Form-
5A as mentioned in Sub Para (i) above. Reference shall be sent to the
Costing & Pricing for price fixation/ confirmation.
Case.No:06 Registration of Ventolin Evohaler for import by M/s. GSK Pakistan,

Karachi
M/s. GlaxoSmithKline Pakistan Limited, Karachi has requested for registration of
following locally manufactured drug for import in finished form as per following details:
S.No Product Name and Reg.No Approved Approve Manufacturer & Product
Composition (as per Packaging d MRP License Holder (as per
CoPP) CoPP)
1. Ventolin Evohaler 041195 200- Rs.200/- Manufacturer/Packager:
Per unit dose contains: Actuations M/s. Glaxo Wellcome SA,
Salbutamol Avenida De Extremadura
Sulphate…120.500mcg 3, Aranda De Duero,
Burgos, E-09400, Spain.
Product License Holder:
M/s. Smithkline Beecham
Limited, Stockley Park
West, Uxbridge,
Middlesex, UB11 1BT,
United Kingdom.
The brief history of the case is as follow:

a. The product was initially registered dated 27-03-2006 in favor of M/s.
GlaxoSmithKline Pakistan Limited, Karachi for finished import from Spain.
b. Later on, the firm was granted permission dated 07-09-2016 for local manufacturing
of the said product at licensed premises at DML 000017.
c. Subsequently, the firm has requested that due to some technical issues at their
manufacturing premises (West Wharf factory), delay in availability of imported
packaging components of the product and to carry out some revalidation of processes
and equipment of CFC free manufacturing area,they are unable to start local
manufacturing of the Ventolin Evohaler, which can lead to potential risk of supplies
and availability of Ventolin Evohaler in local market so the firm was granted
permission dated 10-05-2017 to import Ventolin Evohaler for six months.
d. Now the firm has informed that GSK has reconsidered its original intent to
manufacture the product in Pakistan and decided to continue import of the said
product from the same global supply site initially approved.
In support of the request, firm has submitted the following supporting documents;
a. Application on Form 5A (with all details) along with fee of Rs.100,000/-
b. Original, valid and legalized CoPP issued by MHRA.
Meanwhile, National Program Manager from Ministry of Climate Change (National

Ozone Unit), Government of Pakistan informed DRAP that:
a. GSK may not be given any further permission for import of drug;
b. DRAP may take steps to get the commitment under MOA, on part of GSK to be
fulfilled;
c. GSK may be conveyed about the meeting with DRAP and its recommendations with
advice to sort technical impediments and ensure implementation of remaining
activities under the MOA.
In response, GSK Pakistan Ltd., Karachi vide a letter No. Nil dated 13 July, 2017 informed
DRAP that:
“We have also appraised the Ministry of Climate Change (National Ozone Unit) about GSK
Pakistan decision to discontinue the project of Ventolin MDI local manufacturing. We have
also advised them about the refund of their dispersed amount in this project.”
The case was discussed in 272nd meeting of Registration Board and decided as follow:
“Registration Board deliberated the matter in detail and advised M/s GSK Pakistan Ltd.,
Karachi to settle their case with Ministry of Climate Change (National Ozone Unit). Further
processing of instant case shall be considered after settlement of matter.”
The temporary permission for import of the said product is valid uptill 09-11-2017.
M/o Climate change has been requested to update the current status of the case on priority
basis. Their response is awaited.
Decision: Registration Board noted that the drug is expected to be in high demand
in the coming months as the winter season starts. In order to avoid
shortages of the drug the Board decided to extend the permission for
temporary import of Ventolin Evohaler, manufactured by M/s. Glaxo
Wellcome SA, Avenida De Extremadura 3, Aranda De Duero, Burgos, E-
09400, Spain and packed by M/s GlaxoSmithKlin, Australia Pvt Ltd.,
Australia, for another 45 days from the date of expiry of previous
permission. The Board further advised M/s GSK to immediately settle the
matter with Ministry of Climate Change under intimation to the Board
for further action.
Case.No.07 Request of M/s. OBS Pakistan, Karachi for change in presentation (from
ampoule to vial) for their registered products.
M/s. OBS Pakistan, Karachi has requested for change in presentation of their already
registered human imported products as per following details.
S.No Product Name and Composition Reg.No Current New Manufacturer &
(as per CoPP) Primary Proposed Product License
Packaging Primary Holder (as per
Packaging CoPP)
1 Pregnyl powder for solution for 001095 Ampoule Vial M/s. N.V
injection 1500 I.U Organon,
Each vial with powder for solution Kloosterstraat 6,
for injection contains: 5349 AB Oss,
Chorionic gonadotropin (hCG) … The Netherlands
1500 I.U
2. Pregnyl powder for solution for 013044 -do- -do- -do-
injection 5000 I.U
Each vial with powder for solution
for injection contains:
Chorionic gonadotropin (hCG) …
5000 I.U

The firm has deposited Rs. 5000/- for each product and submitted the following supporting
documents:
i. Copy of registration letters and renewal status.
ii. Justification for proposed change; the firm informed that the manufacturer abroad has
changed the primary packaging from ampoules to vials.
iii. Original and legalized CoPP for both products issued by country of origin i.e
Netherland.
iv. Notarized copy of GMP certificate.
v. Stability data for both aforesaid products.
The change in presentation by the country of origin i.e Netherland has been verified
online from their official website.
The product also contain a solvent i.e Sodium Chloride Solution for injection 9mg/ml. the
solvent is manufactured, packaged and tested by M/s. Jubilant Hollisterstier LLC, 3525 North
Regal Street, Sponkane, Washington 99207, USA.
Decision: Registration Board acceded to the request of M/s. OBS Pakistan, Karachi
for change in primary packaging (from ampoule to vial) for their above
mentioned registered drug products.
Case.No.08 Request for Change of Company Status by M/s. AGP Ltd., Karachi.
M/s. AGP Ltd, Karachi has applied for change of company status of their following
registered imported drugs as per detail mentioned alongside:-
S. No. Reg. Name of Drugs/Composition Title/Name of Requested change in
No. company (as per the title (as per DSL)
Registration letter)
1. 021083 Magnus MR 30mg Capsule M/s. AGP (Pvt) Ltd., M/s. AGP Ltd.,
Each capsule contains:- B-23, SITE, Karachi, B-23, SITE, Karachi,
Morphine Sulphate………..30mg
2. 021084 Magnus MR 10mg Capsule -do- -do-
Each capsule contains:-
Morphine Sulphate………10mg
3. 085247 MyDekla 30mg -do- -do-
Film coated Tablet
Each film coated tablet contains:-
Declatasvir Dihydrochloride eq. to
Declatasvir ……..30 mg
(As per innovator Spec‟s)*
4. 085247 MyDekla 60mg -do- -do-
Film coated Tablet
Each film coated tablet contains:-
Declatasvir Dihydrochloride eq. to
Declatasvir ……..60 mg
(As per innovator Spec‟s)*
The have deposited required fee Rs.100,000 x 4 = Rs.400,000/- and submitted

following supporting documents:-
i) Copies of registration letters.
ii) Renewal status.
iii) Copy of change of brand name.
iv) Copy for change of source and manufacturer of Magnus Capsule.

v) Copy of letter for change of title/management of M/s. AGP Ltd., Karachi
(DML No.000348) Formulation.
vi) Copy of CRF.
vii) Undertaking.
viii) Labels.
ix) Copy of Drug Sale License.
The firm has provided a letter of approval for change of name of M/s. AGP (Pvt) Ltd.,
B-23, SITE, Karachi, DML No.000348 to M/s. AGP Ltd., Karachi, issued by the Secretary,
Central Licensing Board. The registration letters of the above products were issued on the
same address as the firm also possesses the drug sale license in the same premises.
As per delegation of powder to the Chairman, registration Board, the Chairman is
authorized to grant approval for change of name of manufacturer abroad, however, for the
change name of importer no such delegation is specifically provided.
Moreover, the spelling of Daclatasvir in registration letter is inadvertently mentioned
as “Declatasvir” for products at Sr.No.3 & 4 which also needs to be corrected.
Decision: Registration Board agreed to the firm's request for change in company
status/ name from M/s. AGP (Pvt) Ltd., B-23, SITE, Karachi to M/s.
AGP Ltd., B-23, SITE, Karachi on same terms and conditions and also
approved to correct the spellings of "Daclatasvir" through corrigendum

VETERINARY
Case No.09 Inspection of Manufacturer Abroad/Issuance of Registration Letter.

The sub-committee in its 237th meeting held on 25-04-2013 approved various
products of M/s. Hassan Brothers, Faisalabad manufactured by M/s. Samyang Anipharm Co.
Ltd. Seoul, Korea subject to inspection of manufacturer abroad as per import policy and
verification of storage facility (where applicable) as per detailed mentioned against each:-
S.No. Name of Name of drug(s) & Composition Decontrolled/ Shelf Life
Manufacturer/ Packs Size
Importer
1. M/s. Hassan Amoxicoli Water Soluble Powder 500gm 03 years
Brothers, Each Kg contains:- 1 Kg
Faisalabad. / Amoxicillin 2.5 Kg
manufactured by Trihydrate…………………100g 5 Kg
M/s. Samyang Colistin Sulfate…400 x 106 I.U
Anipharm Co. Glucose or Lactose………...Q.S
Ltd. Seoul,
Korea.
2. -do- SY Ampicol Water Soluble Powder 500gm 03 years
Each Kg contains:- 1 Kg
Ampicillin trihydrate …....100g 2.5 Kg
Colistin Sulfate..250,000,000 IU 5 Kg
Excipient (Glucose or
Lactose)…………………....Q.S.
3. -do- Peperoxin Solution 500gm 03 years
Each Litre contains:- 1 Kg
Pefloxacin………………...100g 2.5 Kg
(as Pefloxacine 5 Kg
methanesulfonate………139.6g)
Excipients (Purified water
etc)………………………...Q.S.
With respect to above mentioned products the following details are submitted:-
(i) The firm has deposited the differential fee Rs. 85000 x 3 = Rs.255,000/-
(ii) Storage facility of the importer has also already been verified by the Area FID.
(iii) The approved shelf life for the above products is 03 years for each product as
mentioned in the table. However, the firm requested for granted shelf life of
02 years as it was mentioned in Form-5A and informed by the principle for
correction in shelf life vide letter.
(iv) In compliance, inspection of the manufacturer abroad M/s. Samyang

Anipharm Co. Ltd. Seoul, Korea was carried out by the nominated panel
comprising of Mr. Rehmat Ullah Baig Alvi, Federal Inspector of Drugs, Drug
Regulatory Authority of Pakistan, Peshawar and Dr. Fakhruddin Aamir,
Federal Inspector of Drugs, Drug Regulatory Authority of Pakistan, Islamabad
on 08th& 09 February, 2017. The panel of inspectors rated the manufacturing
facility as “Good” (Recommended).
(v) The original free sale certificate submitted by the firm along with applications
has expired. However, now the firm has submitted valid and legalized original
Free Sale Certificate and GMP Certificate for the above products. Moreover,
the address of manufacturer abroad mentioned on GMP certificate i.e M/s.
Samyang Anipharm Co. Ltd. 442-10, Seorun-dong, Pecheon-si, Gyeonggi-do,
Korea submitted with initial application is different from the address
mentioned on inspection report i.e M/s. Samyang Anipharm Co. Ltd. 35,
Songseon-ro 265beon-gil, Pocheon-si, Gyeonggi-do, Korea. A letter from
manufacturer is attached with inspection report explaining that Korean
Government has replaced land lot –based address system with one based on
road name to make it easier for foreigner and Korean residents.
(vi) For products at Sr. No.2 the brand name in minutes has been inadvertently
mentioned incorrect i.e. Ampicol. However as per Form-5A and Free Sale
Certificate the correct brand name is Ampicoli which may be corrected.
(vii) With respect to the above products the excipients are also mentioned in
minutes which may not be incorporated in registration certificate as only
active pharmaceutical ingredients are mentioned in registration certificate.
Decision: Registration Board, in view of the position explained above, decided as

under:
a. The approved shelf life for the above products is changed from
3 to 2 years as requested by the firm.
b. The address of manufacturer abroad in respect of above
products is approved to be changed to M/s. Samyang
Anipharm Co. Ltd. 35, Songseon-ro 265beon-gil, Pocheon-si,
Gyeonggi-do, Korea as mentioned on GMP Certificate.
c. For products at Sr. No.2 the brand name has been corrected to
Ampicoli as per Form-5A and Free Sale Certificate. The
excipients mentioned in composition of above products shall
not be incorporated in registration certificate as only active
pharmaceutical ingredients are mentioned in these certificates.

Registration-II
Case No.10: Issuance of duplicate registration certificate
M/s Wyeth Pakistan Limited, Karachi has requested for issuance of duplicate
registration letter of Entox-P Tablets 500mg (Reg No. 008998). The firm has further stated
that Entox-P tablet 500mg was registered in the name of Wyeth Laboratories (Pakistan)
Limited, Lahore on 09th March, 1986. The firm has stated that the registration letter was lost
and FIR has been registered in Police Station. The firm has provided FIR/Report of loss of
Registration letter of Entox-P 500mg.
The firm has provided following documents in support:
i) Request with Rs.5,000/-
ii) Transfer of registration from Lahore Plant to Karachi plant.
iii) Renewal status.
iv) FIR by the firm.
Decision: Registration Board deferred the request of firm for verification of

registration renewal status of Entox-P Tablets.
Case No.11: Change of pack size of approved product.

Registration Board in its 268th meeting approved following product of M/s
Elko Organization, Karachi as mentioned in the last column:
Name of Drug(s) Packed Decision of 268th meeting of
size Registration Board
Nasomet Aqueous Nasal Spray 15ml Registration Board approved the
Each Spray contains:- grant of registration of Nasomet
Mometasone Furoate….50mcg Aqueous Nasal Spray in the name of
(Topical glucocorticosteroid) M/s Elko Organization, Karachi.
At the time of issuance of Registration letter, it was pointed out that price for the
Mometasone Furoate 0.05% spray has been fixed in 8th DPC as “doses” , whereas firm
initially applied for packing of 15 ml.
Now M/s Elko Organization has submitted a request wherein the firm has requested to
grant them price of 140 dz (14 ml) instead of 15ml.
Decision: Registration Board approved pack size of “140 doses”for Nasomet
Aqueous Nasal Spray instead of 15 ml.

Case No.12: Deferred products
Registration Board in its 267th meeting has deferred the following products of
M/s Espoir Pharmaceuticals PCSIR KLC, Shahrah-e-Dr. Salim-uz-Zaman Siddiqui, Off
University Road, Karachi-72480, Pakistan. The case was considered in 235th meeting of
Registration Board initially. The reasons for deference are stated in the last two columns of
below table:
S. Name of drug(s) & Composition Dy, Form, Decision of Decision of
No Fee Registration Board in Registration
235th Board in 267th
1. Zorg 20mg Capsule 07-09-2012 Deferred for review of Deferred
Each Capsule contains: 1540 Formulation by experts products for
Omeprazole ……….20 mg Form-5 and 5 products per submission of
Sodium bicarbonate.1100mg Rs.8000/- Section Policy remaining fee
(Antipeptic / ulcerant/ antacid) Rs. 12,000/-.
2. Zorg 40mg Capsule 07-09-2012 Deferred for review of -do-
Each Capsule contains: 1539 Formulation by experts
Omeprazole ……….40 mg Form-5 and 5 products per
Sodium bicarbonate.1100mg Rs.8000/- Section Policy
(Antipeptic / ulcerant/ antacid)
For products at S.No 1 and 2 of above table, Registration Board in its 267 th meeting
approved the Omeprazole and sodium bicarbonate capsules and sachets keeping in view the
approval of these formulations in FDA.
Now the firm has deposited balance fee amounting to Rs. 12,000/- per product and
requested for issuance of registration letter.
Decision: Registration Board deferred the case for submission of latest GMP report
of M/s Espoir Pharmaceuticals, Karachi.
Case No.13: Change of Registration status of drugs from one manufacturer to

another.
a. M/s Scilife Pharma (Pvt) Ltd.,Plot No. FD-57/58-A2, Korangi Creek
Industrial Park (KCIP), Karachi has requested for change of registration from M/s Dyson
Research Laboratories (Pvt) Ltd., 28-KM, Ferozepur Road, Lahore to their name. Details of
products are as under:
S.# Regn Name of product Date of International Availability
No. registration
1. 078850 Nibovo Tablet 10mg 31.12.2013 Approved in US FDA
Each tablet contains: Bystolic 10 mg Tablet by
Nibivolol (as HCl)…….10mg Forest Labs
2. 078846 Nibovo Tablet 2.5mg 31.12.2013 Approved in MHRA, UK
Each tablet contains: Nebivolol 2.5 mg Tablets by
Nibivolol (as HCl)…...2.5mg Concordia International
3. 078842 Nibovo Tablet 5mg 31.12.2013 Approved in MHRA, UK
Each tablet contains: Nebivolol 5 mg Tablets by
Nibivolol (as HCl)…….5mg Actavis UK Ltd.,
In support to above the firm has provided following documents:

i) Request with prescribed fee amounting to Rs. 20,000/- for each product.
ii) Form 5.
iii) Initial Registration letter
iv) Updated Section approval, inspection report dated 31.12.2016.
v) NOC dated 24.07.2017 from Dyson Research Laboratories for transfer
permission for products.
vii) Undertaking.
Decision: Registration Board decided as follows:

 Cancellation of products above mentioned product from the name of
M/s. Dyson Research Laboratories. Lahore
 Approved registration of above mentioned product in the name of M/s.
M/s Scilife Pharma (Pvt) Ltd., Karachi
 Reference will be sent to Cost and Pricing Division for confirmation of
Maximum Retail Price (MRP)
b. M/s Pharmatec Pakistan (Pvt) Limited, Karachi have applied for the
registration of following drug which was registered in the name of M/s CCL Pharmaceutical,
Lahore. The details of the product is given below:
S.No Reg. Name of Drug(s) & Composition Pack Date of registration and renewal
No Size status
1 036271 Sucrofer Injection Initial Registration dated
Each 5 ml contains: 25.01.2005
Iron Sucrose Complex eq. to ii) Letter from RRR dated
Elemental Iron……………..100mg 28.06.201 valid up to 24.01.2015
iii) Last Renewal dated 13.01.2015
Moreover, RRR section has informed that renewal application of year 2015 for the
above product was received within time.
In support to above the firm has provided following documents:
i) Request with prescribed fee amounting to Rs. 20,000/- for the product.
ii) Form 5.
iii) Initial Registration letter
iv) Updated Section approval, inspection report dated 10.03.2016.
v) NOC dated 29.05.2017 from M/s CCL Pharmaceuticals (Pvt) Ltd., 62,
Industrial Estate Kot Lakhpat, Lahore for transfer permission for above
product.
vii) Undertaking of not have same product registration already.
M/s. CCL Pharmaceuticals, Lahore
M/s M/s Pharmatec Pakistan (Pvt) Limited, Karachi.

Case No.14: Registration of drugs in lieu of deferred products
Registration Board in its 269th meeting deferred the following product of M/s
MediFlow Pharmaceutical (Pvt) Limited, Karachi for the reason given in the last column
below:
Products Deferred in Products approved and New Products Decision of
M-251st granted registration in M- applications and Registration Board
256th in lieu of deferred volume/Pack Size to be in 269th meeting
products in previous column replaced in lieu of the
(to be considered as previously deferred
additional volume of already products
registered products)
I II III IV
3.) Each 100ml Flow RL IV Infusion Flow Lactate D IV Deferred for
contain: Injectable. Infusion clarification as
Dextrose Anhydrous Each 100ml contain: Each 100 ml contains: product
BP…5.0gm Sodium Chloride Sodium Chloride..0.6 gm mentioned at
Potassium Chlorde BP….0.6gm Sodium Lactate… 0.31 S.No.03 (column
BP…0.150gm Sodium Lactate BP….0.32gm gm
II) is different
Sodium Chloride Potassium Chloride Potassium Chloride…
BP…0.216gm BP….0.04gm 0.03 gm product from
Calicum Chloride Calcium Chloride 2H2O Calcium Chloride already registered
2H2O BP…….0.027gm 2H2O… 0.02 gm product of the
B.P…0.022gm Water for injection qs Dextrose firm (Registration
Sodium to…….100ml monohydrate..5.0 gm No. 080619).
Acetate.3H2O (Compound Sodium Lactate) Water for Injection qs.to
B.P…0.313 (BP specs) 100ml
Water for injection (1000 ml) (Compound Sodium
qs to….100ml Lactate and 5 %
Dextrose)
(500 ml and 1000 ml)
The gist of the case is presented as follows:
 Registration Board in its 251st meeting deferred the above mentioned product of M/s
MediFlow Pharmaceuticals, Karachi.
 In 256th meeting, Registration Board approved the product as mentioned in second (II)
column of above table on the request of firm.
 M/s MediFlow Pharmaceuticals, Karachi then requested the Board that they want to
withdraw the product noted in column (II) and in lieu apply for registration of product
as mentioned in column (III).
 However, Registration Board deferred the case for the reason as noted in the last (IV)
column.
Meanwhile, firm requested to consider this product as they have not yet received
complete number of molecules in the ten molecule policy. Accordingly, firm has received
following registrations as depicted by following data:
Registration Board Meeting No. of molecules Approved
251st meeting 07
267th meeting 02
Total 09
th
Claim of the firm has been verified from the available record. In this regard the firm
has submitted following:
S.No Name of Drug(s) & composition Dy.No. date & Pack
Fee Size
1. Flow Lactate D IV Infusion 292, 500 ml
Each 100 ml contains: 06-02-2017
Sodium Chloride… 0.6 gm Rs. 20,000/-
Sodium Lactate… 0.31 gm
Potassium Chloride… 0.03 gm
Calcium Chloride 2H2O… 0.02 gm
Dextrose monohydrate.. 5.0 gm
Water for Injection qs. to 100 ml
(Compound Sodium Lactate and 5 % Dextrose)
2. Flow Lactate D IV Infusion 11775 (Fee), 1000 ml
Each 100 ml contains: 11-08-2017
Sodium Chloride… 0.6 gm Rs. 20,000/-
Sodium Lactate… 0.31 gm
Potassium Chloride… 0.03 gm
Calcium Chloride 2H2O… 0.02 gm
Dextrose monohydrate.. 5.0 gm
Water for Injection qs. to 100 ml
(Compound Sodium Lactate and 5 % Dextrose)
Decision: Registration Board approved separate registrations of Flow Lactate D IV

Infusion 500 ml and 1000 ml in the favour of M/s MediFlow
Pharmaceutical (Pvt) Limited, Karachi.
Case No.15: Cancellation of Registration of Azicure 500 mg Capsules of M/s Semos

Pharmaceuticals (Pvt) Limited, Karachi
In response to show cause notice dated 16th September, 2016 M/s Semos
Pharmaceuticals (Pvt) Ltd. Plot No. 11, Sector 12-A, North Karachi Industrial Area, Karachi
has stated that it was me too pharma guide of competitor at that time, mostly all local Pharma
in practices to applied me too product as well, the only reason they have not yet applied for
this product de-registration with immediate effect. The firm has accepted DRAP decision for
de-registration of their product Azicure 500mg Capsule with following composition.
S.No Reg. No Name of drug(s) & Composition Packing Date of registration
1 067354 Azicure 500 mg Capsules 3 „s 5th January, 2011
Each capsule contains:
Azithromycin…. 500 mg
The firm has further stated that as per decision of 250th meeting, they requested for
registration of the same generic in tablet dosage as approved by US-FDA so that they could
be able to market this product without any shortage in market as per compliance of Drug Act
1976 (L R &A). The case was discussed in 271st meeting of Registration Board, wherein the
Board decided as follows:
“Registration Board deferred request of firm for submission of Form-5 with
prescribed fee for registration of product in tablet dosage form.”
Now M/s Semos Pharmaceuticals (Pvt) Limited have submitted the requisite with following
Details:
Name and Semos Pharmaceuticals (Pvt.) Ltd.
Address of Plot No. 11, Sector 12-A North Karachi, Karachi-75850, Pakistan
Manufacturer
Brand Azicure 500 mg Tablet
(Proprietary)
Strength of Each film coated tablet contains:
active Azithromycin dehydrate eq. to Azithromycin… 500 mg
ingredient
Dy Date, 12387. 17.8.2017, Form-5, Fee Rs. 20,000/- endorsed on 30-10-2016
Form, Fee
Pack Size, 3‟s, 6‟s, 12‟s & 100‟s. As per PAC
Unit Price
Me too Plazo, Platinum Pharma
Status

 Cancellation of Azicure 500 mg Capsules (Reg.No 067354) from the name
of M/s Semos Pharmaceuticals (Pvt) Limited, Karachi.
 Approved registration of Azicure 500 mg Tablet in the favour of M/s
Semos Pharmaceuticals (Pvt) Limited, Karachi.
Case No.16: Adoption of pharmacopoeial specification of registered products

M/s Atco Laboratories Limited, Karachi have applied for the adoption specification
for their following registered products:
S.No Reg.No Name of Drug(s) & Date of Existing Adoption of
Composition Registration Specification Specifications
1 083211 Conaz 2 % w/w Cream 15th March J.P Specification B.P. Specification
Each gm contains: 2017
Ketoconazole…. 2 % w/w
2 083213 Adapco Forte 0.3 % w/w 15th March As per B.P. Specification
Gel 2017 Innovator‟s
Adapalene…. 3.00 mg Spec.
Firm has requested that both finished products i.e. Ketoconazole cream and
Adapalene Gel has been included in British Pharmacopoeia-2016, therefore, they want to
shift to the specifications of latest edition of British Pharmacopoeia.
Firm has submitted:
 Fee of Rs. 5000/- endorsed by STO on 21-08-2017 for each product
 Finished Product monograph f both products from British Pharmacopoeia-
2016
Decision: Registration Board approved B.P. Specification for above products of M/s
Atco Laboratories, Karachi.

Case No.17: Renewal of sterile liquid ampoule section of M/s Pharmatec Pakistan (Pvt)
Ltd. By Central Licensing Board.
Secretary Central Licensing Board (CLB) has intimated that CLB in its 251 st meeting
held on 6th December 2017 has considered and deliberated the case of M/s Pharmatec
Pakistan (Pvt) Ltd., D-86/A, S.I.T.E, Karachi under DML No. 000024 by way of formulation
and decided to allow grant of renewal section for sterile Liquid ampoule section with the
direction that Registration Board be informed about approval of sterile Liquid ampoule
section only.
Moreover, he has directed in his letter to area FID to verify that no hormonal products
are being manufactured in sterile Liquid ampoule section which is only meant for General
products. Meanwhile, few products of M/s OBS Pakistan, Karachi were manufactured by M/s
Pharmatec Pakistan by permission vide letter no. F.3-3/2015-Reg-II (M-249) dated 26th
August, 2015. The permission is valid for 30-06-2020.
Decision: Registration Board deliberated that as per decision of Central Licensing

Board only sterile liquid ampoule section of M/s Pharmatec Pakistan (Pvt)
Ltd., Karachi has been renewed. Accordingly, a show cause notice to M/s
OBS Pakistan, Karachi shall be issued for their hormonal products which
were being manufactured by M/s Pharmatech Pakistan (Pvt) Ltd., Karachi
on contract basis.
Case No.18: Adoption of Pharmacopoeial Specification
M/s Atco Laboratories Limited, Karachi have applied for adoption of

Pharmacopoeial Specification of their registered drug product with following details:
S.No Reg,No Name of Drug(s) & Date of Existing Proposed

Composition Registration Specificatio Specification
n
1 084771 Umbilica Gel 08thSeptmenb As per USP Specification
Contains:- er, 2017 Innovator‟s Global Health
Chlorhexidine Gluconate specification Monographs in USP
7.1 % w/w eq. to 40
Chlorhexidine… 4 % w/w
Firm has submitted Original Deposit slip of Fee of Rs. 5000/-, copy of Registration
certificate and copy of Finished product monograph of United States (USP) Pharmacopoeia.
Decision: Registration Board approved USP Specification for Umbilica Gel (Reg.
No. 084771) of M/s Atco Laboratories, Karachi.

Case No.19: Deferred Products
a) M/s Pakistan Pharmaceutical Products Pvt Ltd, D-122, S.I.T.E. Karachi

Registration Board in its 262nd meeting deferred the case of M/s Pakistan
Pharmaceutical Products Pvt Ltd, D-122, S.I.T.E. Karachi as stated in the last column:
1. Pakistan Levi 250mg Form 5 Not Provided SRA Deferred for

Pharmaceutic tablet 04/4/201 reference not confirmation
als Products Levetiracetam + 3 D#214 Lerace Provided of approval
(Pvt)Ltd, tablet + 250mg Fee status by
Karachi Eah film coated submitted Hilton Undertaking reference
tablet contains is 20,000 regarding no regulatory
2198 levetiracetam Price as Inspection banned authorities,
250mg per policy report excipient, product
Antiepileptics Pack of Dated 8/6/2012 follow specifications
Specs not 10‟s “GMP innovator
Provided tablets inspection” brand, &
“Overall GMP stability
Compliance is studies not
good” provided.
DML, CD
not provided
Now the firm has submitted that they have applied for grant of registration of Levi
250mg Tablet (Levetiracetam 250mg) which was “deferred for confirmation of approval of
status by reference regulatory authorities” product specification as decided by the
Registration Board in its 262nd meeting. Thereafter, the Registration Board in its 265th
meeting has approved the same product. The firm has provided a copy of minute‟s 265th
meeting of Registration Board.
Decision: Registration Board deferred the request of firm for submission of latest
GMP inspection report.
b) M/s The Searle Company, Karachi.
The Registration Board in its 261st meeting deferred the following product of
M/s The Searle Company, Karachi with the condition mentioned in the last column.
Sermin-D Tablet 10‟s Rs.150/ 16-11-2011 Registration Board

Each tablet contains: - Dy.No.337 deferred the case for
Ossien mineral complex Form-5 complete formulation
……....830mg Rs.8000/- and confirmation of
Vitamin D……………400IU Rs.52,000/- atomic absorption
(Multinutrient) 29-1-2013 spectrophotometer
Accordingly, the decision of Registration Board taken in its 261st meeting

communicated to the firm and now the firm has provided a signed letter of Mr. Abdul Rasool
Shaikh Federal Inspector of Drugs, DRAP, Karachi. Wherein the FID has intimated that
during the routine GMP inspection of M/s The Searle Limited located at Plot NO. 319,

S.I.T.E. Karachi it was noted that the firm has all equipment in their QC Lab required for the
testing of all their registered drugs including Atomic Absorption Spectrophotometer. The
equipment was seen well installed and in good working condition
Decision: Registration Board deferred the request of the firm for submission of
complete formulation of Ossein mineral complex
c) M/s The Searle Company, Karachi.

The Registration Board in its 262st meeting deferred the following product of
M/s The Searle Company, Karachi with the condition mentioned in the last column. The case
was also deferred in 257th Meeting for confirmation of approval status of reference regulatory
authorities.
S.# Reg. Brand Name(s) and Date of International Decision of the
No. formulation / registration availability Board
generic name
1. 039262 Relispa Tablets 01/6/2005 Luthuania Deferred products for
Drotaverine HCl Romania confirmation of
40mg Bulgaria approval status by
Lativia reference regulatory
2. 039263 Relispa Forte Tablet 01/6/2005 Luthuania authorities
Drotaverine HCl Romania
80mg Lativia
3. 053344 Relispa Injection 15/12/2008 No-Spa 40mg Inj
Drotaverine HCl Hungary
40mg/2ml No-Spa 40mg
Vietnam
Now, the firm has submitted that the above products are available in reference
regulatory authority of Lativia, Lithuania, Bulgaria and Romaniaand requested for issuance
of transfer letter at the earliest.
Decision: Registration Board referred the case to PE Cell for verification of
approval status of Drotaverine 40 & 80 mg Tablets and Injection 40 mg/
2ml by regulatory authorities of 03 European countries as provided by
the firm.
d) M/s Kaizen Pharmaceuticals (Pvt) Limited, Karachi have requested for registration of
following products which were deferred in the 236th meeting of Registration Board due to
the reasons mentioned in the last column below:
S.No Name of Drug(s) Pack Form, Date Deferred for
Size and Diary,
Fee
1. Legraf 5mg Capsule 10‟s 18-10-2012 Confirmation of
Each capsule contains: 20‟s Dy.No.1662 section required
Tacrolimus………5 mg 30‟s Form-5
(Immunosuppresant) Rs.20000/-
2. Legraf 0.5mg Capsule 10‟s 18-10-2012 Confirmation of
Tacrolimus ……..0.5 mg 30‟s Form-5

3. Legraf 1mg Capsule 10‟s 18-10-2012 Confirmation of
Tacrolimus ……..1 mg 30‟s Form-5
Applicant firm has submitted that as per decision of 271st meeting of Registration Board,
wherein case for specific manufacturing requirement for certain classes of drugs was
discussed, it was decided that:
There is no need for segregated / dedicated / self contained premises / facilities for the
production of drugs belonging to the categories namely immunosuppressants,
aromatase inhibitors (letrozole, anastrozole) and clomiphene.
M/s Kaizen Pharmaceuticals has further stated that they undertake for providing necessary
and protective measures for workers and personnel those in direct contact or are involved
in close handling of these drugs.
Decision: Registration Board approved the registration of product at S.no 1-3 in the
name of M/s Kaizen Pharmaceuticals (Pvt) Limited, Karachi with the
direction to ensure protective measures for workers and personnel those in
direct contact or are involved in close handling of these drugs
e. Product of M/s Reign Pharmaceuticals, Karachi deferred in 271st meeting of

Registration Board.
The Registration Board in its 271st meeting discussed the following products of M/s
Reign Pharmaceutical PCSIR KLC, Karachi as stated in the last column:
1. Opra 20 Sachet 7‟s Rs.11/- 12-9-2012 Registration Board

Each sachet Contains: Per 1580 deferred the
Omeprazole……. 20 mg sachet From -5 request of M/s
Sodium bi carbonate…..1680mg Rs.8000/- Reign
(Protom Pump Inhibitor) Pharmaceuticals,
Karachi for
submission of
latest GMP report.
2. Opra 40 Sachet 7‟s Rs.18.20 12-9-2012 -do-
Each sachet Contains: /- 1573
Omeprazole……. …40 mg Per From -5
Sodium bi carbonate……1680 mg sachet Rs.8000/-
(Protom Pump Inhibitor)
Firm has deposited balance fee amounting to Rs. 12,000/- for each product and requested for
grant of registration of above products. Now the firm provided a copy of latest GMP reported
dated 27.01.2017 and requested for issuance of registration of letter above products.
Decision: Registration Board approved the registration of product at S.no 01 and

02 of abovetable in the name of M/s Reign Pharmaceuticals, Karachi

f. Product of M/s Reign Pharmaceuticals, Karachi deferred in 271st meeting of
Registration Board.
Registration Board in its 271st meeting discussed the following products of M/s Reign
Pharmaceutical PCSIR KLC, Karachi as stated in the last column:
1 Anafe-F Syrup As per As per 21-05-2013 Registration
Each 15ml contains: PRC PRC Dy.No.527 Board deferred
Iron Protein Succinylate….800mg Form-5 the request of
eq. to elemental Iron…….40 mg Rs.20,000/- M/s Reign
Folic acid………..2.5 mg Pharmaceuticals
(Anaemia, Haematinic) , Karachi for
submission of
fresh Form-5
with prescribed
fee and latest
GMP report.
Now the firm deposited an amount of Rs. 20,000/- prescribed fee as well as latest
GMP reported dated 27.01.2017 and requested for issuance of registration of letter above
products.
Decision: Registration Board approved the registration Anafe-F Syrup in the name
of M/s Reign Pharmaceuticals, Karachi
g. Products of Cibex (Private) Limited

Following products were considered in the 271st meeting of Registration Board wherein
Board directed the firm to submit latest GMP certificate.
S. Name of drug(s) Form Decision in 245th Decision in

No Meeting 271st
Meeting
1 Batema-F Tablet Form 5 Deferred for Deferred
Each chewable tablet contains 28-04-2014 confirmation of for latest
Iron Protein Succinylate…400 mg 20,000 availability or GMP
Folic Acid USP……2.5 mg As per PRC registration status
(Anti-anemic) Pack size of 20‟s in Stringent
Regulatory
Agencies (SRA‟s)
as well as local.
2 Bakke 4mg Capsule Form-5 Deferred for Deferred
Each Capsule contains: 30-04-2014 (627) review of for latest
Thiocolchicoside…4mg Rs.20,000/- formulation by the GMP
(Muscle Relaxant) As per SRO/20 Review
Capsules Committee.
3 Cadista Sachet Form-5 Deferred for Deferred
Each Sachet contains: 30-04-2014 (595) review of for latest
Dioctahedral Smectite …3g Rs.20,000/- formulation by the GMP
(Anti-Diarrheal) As per SRO/10 Review
Sachets Committee.
4 Maclid 400mg Tablet Form-5 Deferred for Deferred
Each film coated Tablet contains: 30-04-2014 (572) review by the for latest
Linezolid …400mg Rs.20,000/- Review GMP
(Antibiotic) As per SRO/12 Committee.
Tablets
Now the firm has stated that:
a. For Product No. 1 they have submitted multiple products for registration to DRAP, which
were reviewed in the 245th meeting of the Registration Board held on 29-30th September,
2014. One of the product reviewed was BATEMA-F chewable tablet (Iron Protein
Succinylate 400mg & Folic Acid 2.5mg).The product registration was deferred by the Board
for lack of an SRA reference. This product is being currently manufactured in Pakistan by
several reputable companies such as Noa Hemis, Mass Pharma, Nexpharm etc, despite them
not having SRA reference.Furthermore, in RB 265th held on 24-25 January, 2017, the board
approved this very same product for Dyson Research Laboratories (peptide Plus Tablet)
without them providing an SRA reference either. On this basis, the product sould be approved
without delay. As it would be discriminatory for one company to gain approval, but not their
company, under identical circumstance.
b. For product at S.No 2 firm has stated that they have submitted multiple products for
registration to DRAP, which were reviewed in the 245th meeting of the Registration Board
held on 29-30th September, 2014. One of the products in the agenda was BAKKE Capsule
(Thiocolchicoside 4mg). the product was deferred by the Registration Board for the review of
formulation by the Review Committee. The product is available all over the Europe, and is
approved by the EMA, evidence of which has been submitted. Since then the Board has
approved this product, most recently in RB 264th, held on 28-29 December, 2016 for Nexus
Pharma. On the basis their product should be approved without delay, as it would be
discriminatory for one company to gain approval this recently, under identical circumstance.
c. For product at S.No 3 firm has stated that they have submitted multiple products for
held on 29-30th September, 2014. One of the products in the agenda was CadistaSachet
(Dioctahedral Smectite 3g). The product was deferred by the Registration Board for the
formulation by the Review Committee. In RB 250, it was decided that this product will be
approved since it was also available in France, and the SRA reference was valid. Since then
the Board has approved this product for multiple companies, including as recently as DRB
264, held on 28-29 December, 2016 for three companies including DeMont Research
Laboratories (Demecta,) Based on the Review Committee‟s decision, and the fact that the
Board is approved this very product for other companies they have requested for registration
of their product without delay, as it would be discriminatory for one company to gain
approval under these identical circumstance.
d. For product at S.No 4 firm has stated that they have submitted multiple products for
held on 29-30th September, 2014. Their product in the agenda was Maclid Tablet (Linezolid
400mg). The product was deferred review by the Review Committee. Since then the Board
has approved this product, most recently in DRB 264, held on 28-29 December, 2016 for four
different companies including Atco Laboratories (Avotrexid tablets). On this basis, their
product should be approved without delay, as it would be discriminatory for one company to
gain approval this recently, under identical circumstance.
Now the firm has also submitted GMP Certificate date 28th September, 2017.
Decision: Registration Board approved the registration of products at S.no 01-04 of
above table in the name of M/s Cibex (Private) Limited, Karachi

h. Products of M/s Akhai Pharmaceuticals (Pvt) Limited
M/s Akhai Pharmaceuticals, Karachi have requested for registration of their following
products which were deferred in 242nd meeting of Registration Board due to the reasons
mentioned in the last column of the table below:
Name of Drug(s) & composition Form, Diary, Fee Section Approval Decision in 242nd
Meeting of
Registration
Board
Cortimol Cream Form-5 Manufacturers. Deferred for
Each gm contains: Fast Track Cream / Ointment confirmation of
Hydrocortisone ……1% As per PRC 4.31- General (No. F. 4- manufacturing
Clotrimazole………1 % 05-2012 2/2005-Lic dated requirements for
4.Dermatological Dy.No.871 20/06/2008) steroidal
Rs.8000/- Inspection report preparations
(Original) 31-7- dated 11/10/2011
2013 Rs.52,000/- provided.
Steron Cream Form-5 Manufacturers. Deferred for
Each gram contains:- Fast Track Cream / Ointment confirmation of
Isoconazole (Nitrate)……..1% w/w As per PRC/- General (No. F. 4- manufacturing
Diflucortolone (Valerate)…. 0.1% 10gm & 20gm 2/2005-Lic dated requirements for
w/w 4.13-06-2012 20/06/2008). steroidal
Dy.No.1024 Inspection report preparations.
Rs.8000/- dated 11/10/2011
(Original) 31-7- provided.
2013 Rs.52,000/-
Now the firm has submitted the extract taken from the 239th Meeting of Central
Licensing Board held on Thursday, 22 nd January, 2015 in which the said Board decided for
steroidal topical preperations like eye/ear drops, sterile eye ointment, external preperations
i.e. cream/ointment/Gel, Lotions, Spray/aerosols, suppositories, vaginal preperations, intra
oral preperations, Nasal drops etc shall be manufactured in general facility/area subject to
following conditions that the:-
a. Manufacturers shall have segregated dispensing booths, cleaning validation
and controls studies for processes and adequate system to minimize the
potential risk of cross contamination,
b. Commercial marketing of above products shall be allowed by Registration
Board after confirmation and verification of conditions as in (1.a) above.
Decision: Registration Board deferred the case for clarification from M/s Akhai
Pharmaceuticals (Pvt) Limited regarding confirmation of separate
dispensing booth for such products

Case No.20: Request for approval of additional packaging site for interim period
M/s GlaxoSmithKline Pakistan, Limited, Karachi have applied for approval of
additional packaging site for interim period for following product:
S.No Reg. No Name of Drug(s) Packing Date of Initial
registration
1 000401 Fefol Spansules 20 24-03-1976
Eachh spansule capsule contains:- Spansules
Exsiccated ferrous sulphate… 150mg
Folic acid… 0.5 mg
The firm has requested that Punjab Government have awarded them a tender of about
4.2 million packs of Fefol (Each pack of 56 capsules) that should be supplied during first half
of 2018.
Currently, abovementioned product is manufactured and packed at West Wharf site
(DML No. 000017). Due to large number of tender quantities and challenging timelines, they
have planned to carry out packaging of Fefol stocks additionally at our F 268 site (DML No.
0000233) as well to deliver the stock to Punjab Government on time.
M/s GSK Pakistan Limited have requested to grant one-time special permission to
carry out packaging of Government supplies of Fefol at F-268 site as well till May 31, 2018,
while manufacturing will remain at west wharf site.
The firm has submitted following documents:
 Fee of Rs. 5000/-
 Initial Registration Letter dated 24-03-1076
 Renewal applications for 2008 and 2013
 Registration in name of GSK Pakistan
 Updated CRF
 GMP certificate of F-268 site
Decision: Registration Board directed the firm to submit the following for further
consideration by the Board:
 Clarification regarding quality control release site
 Evidence of award of tender for 4.2 million packs of Fefol Spansules
(Reg.No. 000401) (Each pack of 56 capsules)and acceptance of
Punjab Government regarding packaging and quality control release
on another site (F-268 site) as well.
 Batch wise breakup of quantities to be packed at West Wharf factory
(DML No. 000017) and F-268 factory (DML No. 0000233) with clear
risk assessment and management plan.

Case No.21: Confirmation of Registration Status
RRR section requested to confirm the registration status of following products. RRR
has informed that M/s Opal Laboratories, Karachi issued an NOC dated 13th October, 2009 to
M/s Akhai Pharmaceuticals, Karachi. Later on, M/s Opal Laboratories, Karachi vide a letter
dated 12th November, 2014 cancelled the said NOC.
S.No Reg. No Name of Product Date of Registration
1 039224 Furalox Ds Tablet 26.05.2005
2 029319 Furalox Suspension 12.12.2002
3 029309 Ulcoat Suspension 1 gm/ 5ml 20.12.2012
4 029311 Lactil Syrup 67 gm/ 100 ml 20.12.2002
5 029318 Furalox Film Coated Tablet 12.12.2002
6 029310 Nexole Capsule 30 mg 20.12.2002
However, as per available record the products mentioned at S.No 1 -5 are registered in
the name of M/s Opal Laboratories, Karachi. Whereas, product at S.no 6 was registered in the
name of M/s Akhai Pharmaceuticals, Karachi. Furthermore, the said NOC dated 13th
October, 2009 and cancellation of NOC after 5 years dated 12th November, 2014 could not be
traced. On above mentioned basis, M/s Opal Laboratories have applied for renewal of
products at S.No 1-5 and RRR requested for confirmation of registration status.
Decision: Registration Board deliberated on the matter and decided to provide

opportunity of personal hearing to M/s Opal Laboratories for
clarification regarding issuance of NOC and its cancellation after 05 years
in the forthcoming meeting
Case No.22: Request of M/s AGP, Karachi for purchse of Psudoephedrine Sulphate
Registration Board in its 269th meeting considered the request of M/s AGP, Karachi that
they applied for registration of following products dated 08-12-2016 on Form 5-D containing:
1. Loratidine 5 mg + Pseudoephedrine sulphate 120 mg dated 26-10-2015
2. Cetirizine HCl…. 5mg + Pseudoephedrine HCl… 120 mg dated 08-12-2016
The firm requested that they want to purchase 900 grams each of Psudoephedrine
Sulphate and Pseudoephedrine HCl from Alpha Chemicals (Pvt) Ltd 430 G-1 Johar town,
Lahore. Therefore, it is requested to please allow us to purchase the above mentioned API for
the stability studies and onward submission to DRAP.
Registration Board decided as follows:
Registration Board acceded to request of firm for provision of requisite
quantity of Pseudoephedrine HCl for Cetirizine HCl…. 5mg +
Pseudoephedrine HCl and Pseudoephedrine sulphate for Cetirizine HCl….
5mg + Pseudoephedrine HCl… 120 for performance of stability studies and
referred the case to Controlled Drug Division forfurther approval. The Board
further directed the firm to submit the breakup of quantity of Pesudoephedrine
sulphate and HCl for further consideration.
Now, M/s AGP have submitted following break down for Pseudoephidrine HCL and
Sulphate for their applied products:
1. Clarinase Tablet
Product Strength (mg) Quantity Batch Size Quantity Quantity
Name required per (Tablet) required for required for
Tablet (mg) Trial Batch 3 Trial batch
(gm) (kg)
Clarinase Loratadine 5 2500 12.5 0.0375
Tablet Pseudoephedrine 120 2500 300 0.900
sulphate
2. Rigix-D Tablet
Product Strength (mg) Quantity Batch Size Quantity Quantity
required per (Tablet) required for required for
Name
Tablet (mg) Trial Batch 3 Trial batch
(gm) (kg)
Rigix-D Cetirizine HCl 5 2500 12.5 0.038
Tablet Pseudoephedrine 120 2500 300 0.900
HCl

 Approved the request of M/s AGP, Karachi for purchase of 0.900
Kg of Pseudoephedrine sulphate and HCl each for stability trial
batches based on the breakup of amount of Pseudoephedrine
sulphate and HCl provided by the firm.
 Referred the case to Controlled Drugs Division for further
processing at their end
Case No.23 Suspension of DML
The registration Board in its 264th meeting had suspended the registration status of all
Drugs of M/s Medimarker‟s Pharmaceutical A-104, SITE Area, Hyderabad vide letter NO. F.
30-1/2017-Reg-II(M-264), dated 7th April, 2017.
Now the firm has provided a copy of letter of Dr. Muhammad Usman, Assistant Director
(Lic) vide No. F. 2-4/2003-Lic (Vol-I) dated 26th July, 2017 wherein the Licensing Division
has intimated that the firm may conduct production activities for manufacturing of drugs
under the Drugs Act, 1976 and rules framed thereunder
Decision: Registration Board deliberated that keeping in view the intimation from
Licensing Division that firm may conduct production activities for
manufacturing of drugs, the suspended status of registered products in
the name of M/s Medimarker’s Pharmaceutical, Hyderabad is withheld

Case No.24 Suspension of Drug Manufacturing License NO. 000272 (Formulation) of
M/s Spencer & Company (Pvt) Ltd, Karachi.
The Secretary, Central Licensing Board has intimated that in continuation to
Licensing Division‟s Show Cause Notice of even number dated 23rd June, 2017 and Personal
Hearing letter dated 7th August, 2017 on the subject cited above. The case was pleased before
255th meeting of Central Licensing Board held on 16th& 17th August, 2017. The Central
Licensing Board considered fact and your reply and decided as under:
“Mr. Abdur Rehman, Manager North, Mr. Mujeeb ur Rehman, Regional
Manager and Mr. Tanveer appeared before the Board. They contended that
documents for issuance of NOC for CRF has also be submitted with budget
and Accounts Division. He also contended that they have from-29 issued by
SECP and would submit soon. After hearing the representative the firm and
facts on record, the Board decided to suspend the Drug Manufacturing
License of M/s Spencer & Company (Pvt) Ltd., D-105, S.I.T.E. Karachi, DML
No. 000272 by way of formulation with immediate effect under Section 41 of
the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering
and Advertising) Rules, 1976 till settlement of CRF and other condal
formalities”
The said Manufacturing License is suspended with immediate effect under Section 41 of the
Drug Act, 1976 and Rule 12 of Drugs (Licensing, Registering & Advertising) Rules, 1976
and rules framed there under. Manufacturing of Drugs in the name of said license and at said
premises is prohibited and punishable under section 23 and 27 of the Drugs Act 1976 and
rules framed there under:
Decision: Keeping in view the suspension of manufacturing License of M/s Spencer
& Company, Karachi, Registration Board suspended the registration
status of products in the name of M/s Spencer & Company, Karachi
(DML No. 000272)
Case No.25: Change of Specification from Innovator to USP Specification

The Registration Board in its 270th meeting approved the Cordiclean Gel 4%
in the name of M/s Zafa Pharmaceutical Laboratories, L-1/B Block-22 Federal B Industrial
Area, Karachi as per following details:
S.# Regn No. Name of Drug(s) & Composition
1. 084778 Cordiclean Gluconate Gel 7.1%
Contains:
Chlorhexidine Gluconate 7.1% w/w eq.
To Chlorhexidine...........4% w/w
(as per *Innovator‟s Specification)
Now the firm has intimated that the registration was granted as Innovator‟s Specification
wherein the same composition is available in USP Specification. Firm has submitted fee of
Rs. 5,000/-.
Decision: Registration Board approved USP specification for Cordiclean Gluconate

Gel 7.1 % (Reg.No. 084778) of M/s Zafa Pharmaceuticals Laboratories,
L-1/B Block-22, Federal B Industrial Area, Karachi

Case No.26 Extension/ permission for local manufacturing Ropen 500mg Injection
(Reg No. 055843) and Ropen 1gm Injection (Regn No. 055844)
M/s Macter International F-216, SITE, Karachi has submitted a request for
their following products, which are being contract manufactured from M/s Cirin
Pharmaceutical (Pvt) Limited, Hattar valid till 30.06.2020.
S.No Reg.No Name of Drug(s) & Composition
1 055843 Ropen Injection 500 mg

Each vial contains:-
Meropenem as trihydrate… 500 mg
USP Specs.
2 055844 Ropen Injection 1000 mg
Meropenem as trihydrate… 1000 mg
USP Specs.
However, the management at M/s Cirin was change to ICI Pakistan Limited due to
acquisition. Later on, Import subject product is applied received at DRAP dated 16.05.2016
which is under process.
Now, M/s Macter International has submitted that they shall be granted permission for
manufacturing on campaign basis of said product in their dedicated facility at M/S Macter
International , E-40/A, SITE, Karachi DML 000641. The firm has submitted that they will
follow stringent protocols for cleaning validation.
Decision: Registration Board deferred the case for further deliberation.
Case No.27 Change of coating of Epival of M/s Abbott Laboratories, Karachi.

M/s Abbott Laboratories (Pakistan) Limited, Karachi has requested for change
of coating material of Epival 250mg Tablet Reg. No. 007160 and Epival 500mg Tablet
registration No. 007161 from Acetone to other solvent, Acryl-Eze. The firm has further stated
that change in coating of Epival 250mg tablet and Epival 500mg tablet will have no effect in
existing label claims, efficacy, quality and safety of these products.
2. In support the firm have provided following documents:
i) Current and revised formulations of Epival 250mg & Epival 500mg tablet.
ii) Protocols, Stability Data and Chromatograms of Epival 250mg & 500mg for
all batches (three trial batches & one Routine batch) with new aqueous coating
material named Acryl-Eze, Stability studies comply with the testing method and
results are within specification limits.
iii) Copy of registration letter with renewal status.
iv) NOC for CRF.
v) Undertaking to conduct stability studies for complete shelf life.
vi) Original Rs. 5000/- fee for each product.
Decision: Registration Board deferred the case for further deliberation inlight of
processing of Controlled Drugs Division.
Case No.28: Registration in the name of new title of M/s. Brookes Pharma (Pvt) Ltd.,
Karachi (site remains the same).
a) Central Licensing Board in its 230th meeting dated 31st August, 2012 has
approved the change in the title of M/s Brookes Pharmaceutical Laboratories (Pakistan) Ltd
to M/s Brookes Pharma, (Pvt) Ltd., 58-59, Sector No. 15, Korangi Industrial Area, Karachi
with site remains the same (DML No. 000275). Accordingly, the firm has requested for
registration of following products to their new title:-
S.# Regn .No. Name of Drug(s) & Initial Renewal Applied for
Composition Registration submission Transfer
Letter Date date Date
1. 076161 RTX Plus Tablet 13.01.2014 Renewal not 21.06.2017
Each tablet contains: yet due (Renewal is
Artemether............80mg Ok)
Lumefantrine........480mg
The firm has submitted following documents in support:

i) Approval of change of company name/title dated 18.09.2012
ii) Copy of initial registration alongwith updated renewals
iii) The firm has deposited Rs. 20,000/- for the product.
iv) NOC for CRF
v) Inspection reported dated 30.01.2017
vi) Certificate of GMP dated 24.04.2017.
Decision: Registration Board approved the change of registration status of RTX
Plus Tablet (Reg. No. 076161) from the old title of the firm to the new title
i.e. M/s Brookes Pharma (Pvt) Limited, 58-59, Sector No. 15, Korangi
Industrial Area,Karachi
Case No.29 : Registration in the name of new title of M/s. AGP (Pvt) Limited to AGP
Limited Karachi (site remains the same).
a) Central Licensing Board in its 250th meeting held on 27.10.2016 has approved
the change in the title of M/s AGP (Pvt) Ltd. To AGP Limited B-23, SITE, Karachi with site
remains the same (DML No. 000348 by way of formulation). Accordingly, the firm has
requested for registration of following products to their new title:-
S.# Regn. No. Brand Name with Generic Initial Applied for Status in
Registration Transfer reference
Letter Date Date drug agencies
1 081105 Febuxin 80mg Tablet 22.06.2016 29.09.2017 Approved by
Each film coated tablet (Renewal is MHRA
contains: Ok)
Febuxostat........80mg
2. 076211 Mecovate 500mcg/ml 23.02.2016 -do-
Injection
Each ml contains:
Mecobalamin............50mcg
3. 081102 Briax 20mg tablet 22.06.2016 02.10.2017
Each tablet contains: (Renewal is
Piroxicam B Ok)
Cyclodextrin.......20mg

4 081104 Febuxin 40mg Tablet 22.06.2016 29.09.2017 Approved by
Each film coated tablet (Renewal is MHRA
contains: Ok)
Febuxostat........40mg
5. 076152 Urso Suspension 07.01.2014 11.10.2017 Approved by
Each 5ml contains: (Renewal is MHRA
Ursocoxycholic Ok)
Acid.....250mg
6. 081107 Urgesin 10mg Tablet 22.06.2016 11.10.2017 Approved by
Each tablet contains: (Renewal is MHRA
Solifenacin Succinate....10mg Ok)
7. 081106 Urgesin 5mg Tablet 22.06.2016 11.10.2017 Approved by
Each tablet contains: (Renewal is MHRA
Solifenacin Succinate....5mg Ok)
The firm has submitted following documents in support:

i) Approval of change of company name/title alongwith new
management dated 29.12.2016
ii) Copy of initial registration alongwith updated renewals
iii) The firm has deposited Rs. 20,000/- for the product.
iv) NOC for CRF
v) Certificate of GMP dated 18-09-2017conducted by Dr. Shoaib Ahmed
FID with conclusion of overall good compliance level.
Decision: Registration Board decided approved the registration of products at S.no

01-07 of above table in the new title of the firm i.e. M/s AGP Limited,
Karachi
Case No.30 : Transfer of registration from M/s Zanctok Pharmaceutical, Karachi to

M/s Kaizen Pharmaceutical, Karachi.
M/s Kaizen Pharmaceutical, Plot NO. E-127, E-128 and E-129 North Western
Indistrial Zone, Bin Qasim, Karachi has requested for transfer of following already products
from the name of M/s Zanctok Pharmaceutical Laboratories, Hyderabad to their name. It is
submitted that Registration letter was issued on 26.04.2017 and renewal not required in the
case:
S.# Regn. No. Brand Name with Generic Initial Applied for Status in
Registration Transfer reference
Letter Date Date drug
agencies
1 083976 Lacomide 100mg tablets 26.04.2017 02.10.2017 MHRA
Each film coated tablet contains: (Renewal is
Lacosamide....100mg Ok)
2. 083977 Lacomide 150mg tablets 26.04.2017 02.10.2017 MHRA

5. 083980 Nilergy 10mg Tablet 26.04.2017 02.10.2017
Ebastine.............10mg Ok)
6. 083981 Orifax 550mg tablet 26.04.2017 02.10.2017 MHRA
Rifaximin..................550mg Ok)
In support to the request the firm has provided following documents:

i) Application with prescribed fee amounting to Rs. 20,000/- for each product.
ii) Initial Registration Letter dated 26.04.2017 as renewal not due.
iii) NOC dated 15.09.2017 from M/s Zantock, Karachi

M/s. Zanctok Pharmaceuticals,Hyderabad
Kaizen Pharmaceuticals, Karachi.
Case No.31 New indication for Duphaston 10mg “Luteal support in In-Vitro
Fertilization (IVF)
M/s Abbott Laboratories (Pakistan) Limited, Karachi has intimated that new
approved indication of Duphaston 10mg Tablet in the country of origin (Netherland)
Duphaston tablet is now also indicated in “Luteal support in In-Vitro Fertilization (IVF)”.
The firm has informed that they are updating their local PIL with new indication of
Duphaston approved in the country of origin by their regulatory authority, as per Drugs (LR
& Advertising) Rules, 1976, chapter 3, Rule 30, Section 10(b) which says that “if a clinical
information for a drug is approved by the Drug Regulatory Authority in any of the said
country (USA, European Union Countries, Canada, Japan, Australia), the same clinical
information shall be considered as approved for drug registration in Pakistan unless
modified by the Registration Board on the basis of scientific data available to it, and such
clinical information may include indications contra-indications, side effects precaution,
dosage, etc”.
The firm have provided following documents:
i) CPP of Duphaston from country of origin with SmPC.
ii) Comparison table of new and proposed changes in CCDS
iii) The MEB (NL Health authority) approval letter for this new indication.
iv) Rationale for studying Dupaston for an RT treatment indication.
v) Clinical Overview-Luteal Support as part of an ART treatment.
vi) Synopsis of Clinical study.
vii) Deposit slip of Rs. 5000/- as a fee of new indication.
viii) Updated PIL of Duphastan.
ix) Copy of CRF clearance
x) Copy of Registration and renewal letter.
Decision: Registration Board deferred the case for confirmation of approval of
Assisted Reproductive Technology (ART) as a new indication for
Duphaston 10 mg Tablet in the reference regulatory authorities (other
than Netherlands) as specified by the Board

Registration-III
Case No.32: Correction in minutes of 263rd meeting of Registration Board

Registration Board in its 263rd meeting approved the following product of M/s Valor
Pharmaceuticals, Islamabad and decided as recorded in 2nd last column below.
Sr. Name of the Brand Name & Demanded Approved Decision Remarks
rd
No. Firm Composition MRP. And MRP and of 263
Pack Pack Size Meeting
of Reg.
Board
1. M/s Valor Olopet Eye 2.5ml Rs.170/5ml Approved a) The firm
Pharmaceuticals Drops 1% Price: not applied with
Islamabad Each ml provided Manufacturer‟s
contains:- Specifications
Olopatadine and the product
hydrochloride is available in
eq. to USP.
Olopatadine …. b) The firm has
1mg now requested
to change the
Anti-allergic brand name to
Valadaine from
(Manufacturer‟s previously
Specifications.) proposed name
Olopet.
The registration letter of the above product was withheld for confirmation of
percentage from the dossier. The approval status in reference regulatory authorities is as 0.1%
w/v Olopatadine as hydrochloride (USFDA) and me-too status is also available as 0.1% w/v
Olopatadine as hydrochloride (Winolap of Atco Labs). Now, the percentage has been
confirmed from the original dossier and it has been found that firm actually applied for 0.1%.
If approved, correction in minutes may be approved regarding correction in percentage of
Eye drops as 0.1% instead of 1%.
Decision: Registration Board approved the correction in the percentage of above
product as Valadaine Eye Drops 0.1% with USP Specification
Case No.33: Correction in address of the firm in the registration letter:

It has been pointed out by the RRR section that registration letter no. F. 13-
6/2006-Reg-II (M-202) dated 12-02-2007 pertaining to registration of 29 products has been
issued to the firm with wrong address as per following details while the DML (Drug
Manufacturing License) of the firm shows different address.
Sr. Existing Address appeared/mentioned Corrected/approved Address of the firm as
No. on the Registration letter per approval by the Licensing Board
1. M/s Miracle Pharmaceuticals (Pvt.) Ltd, M/s Miracle Pharmaceuticals (Pvt.) Ltd, Plot
Plot No.08, Street# 5 National Industrial No.08, Street No. S-5, National Industrial Zone,
Zone, Hattar. Rawat, Islamabad.

The case is submitted before the board for correction in address of firm in the
registration letter.
Decision: Registration Board approved the correction in the address of the firm in
the registration letter as M/s Miracle Pharmaceuticals (Pvt.) Ltd, Plot
No.08, Street No. S-5, National Industrial Zone, Rawat, Islamabad. The
Board advised the section to issue the corrigendum for correction in the
registration letter F. 13-6/2006-Reg-II (M-202) dated 12-02-2007
accordingly
Case No.34: Correction/change in composition/strength of formulation:

Registration Board in its 224th meeting approved following product of M/s Global
Pharmaceuticals, Islamabad as per following details:
Sr. No. Reg. No. Name of Drug and Composition Packing MRP
1. 068820 Transolide Injection 1gm 5ml Rs.97/-
Each 5ml contains:
Tranexamic acid ….1gm
Now, the firm has applied for correction/change in composition of above product as
per approval in reference regulatory authorities (Cyklokapron (Tranexamic acid) 100mg/ml
(1gm/10 ml) of M/s Pfizer Pharmaceuticals USFDA and Tranexamic acid 500mg/5ml
Solution for Injection of Concordia International UK-MHRA). Formulation Tranexamic acid
500mg/5ml Solution for Injection is already registered by DRAP. Firm has applied for the
pack size of 10ml.
The firm has provided following documents for this purpose:
i. Fee of Rs.5,000/- dated 20-07-2016 and Rs.15,000/- dated 19-07-2017.

ii. Copy of initial registration letter (dated: 26-02-2011) and renewal status
(renewal applied on 22-01-2016).
Decision: Registration Board acceded to request of M/s Global Pharmaceuticals,

Islamabad for coorection in strength of the above product in 10ml with
following composition:
Transolide Injection 1gm
Each 10ml contains:
Tranexamic acid ….1gm

Case No.35: Contract manufacturing of already registered products:
a) M/s Swan Pharmaceuticals (Pvt.) Ltd. Islamabad:
M/s Swan Pharmaceuticals (Pvt.) Ltd. Islamabad has requested for contract
manufacturing of their following already registered products from M/s. Bio-Labs, Islamabad
as per detailed below:
No. Name of Applicant Name of Drug (s) & Reg. Date of Initial Approval status
and Manufacturer Composition No. Registration in RRAs and
and Renewal Me-too status
status
1. M/s Swan Mebwan 500mg/100ml 079156 04-09-2015  UK-MHRA
Pharmaceuticals Infusion (Renewal is not Approved
(Pvt.) Ltd. Islamabad Each 100ml contains required)  Flagyl Infusion
contract Metronidazole ….. of Sanofi
manufacturing from 500mg Aventis
M/s. Bio-Labs,
Islamabad USP Specifications
2. -do- Swanflox 200mg/100ml 079157 04-09-2015  UK-MHRA
Infusion (Renewal is not Approved
Each 100ml contains required)  Nafcin Infusion
Ciprofloxacin (as lactate) of Global
….. 200mg
USP Specifications
3. -do- Levowan 500mg/100ml 075044 11-12-2012  UK-MHRA
Infusion (Renewal is not Approved
Each 100ml contains required)  Levocin
Levofloxacin (as Infusion of
hemihydrate) ….. 500mg Amros

i. Application on Form-5 with fee of Rs.50,000/- for each product.
ii. Copy of initial registration letter.
iii. Latest GMP inspection report of M/s. Bio-Labs, Islamabad (Dated
15.12.2016) with conclusive remarks of “The panel unanimously recommends
for the issuance of GMP certificate”.
iv. Evidence of section approval (Infusion 100ml (General)) of M/s Bio-Labs,
Islamabad granted by CLB dated 23-07-2012.
v. Copy of DML.
vi. Contract manufacturing agreement b/w M/s Swan Pharmaceuticals, Islamabad
and M/s Bio-Labs, Islamabad (dated 23-01-2015).
Evaluation of case:
 M/s Swan Pharmaceuticals (Pvt.) Ltd. Islamabad has submitted the reasons for
contractmanufacturing that they do not have manufacturing facility for Infusion
100ml (General).
 M/s Swan Pharmaceuticals (Pvt.) Ltd. Islamabad has four sections approved by
CLB dated 18-07-2016 and they have already been granted registration of 09
products for contract manufacturing from M/s Bio-Labs, Islamabad (Validity
date: 30-06-2020).
 Further the product at S. No. 3 is available in Japan Pharmacopoeia.
Decision: Registration Board acceded to the request of M/s Swan Pharmaceuticals
(Pvt.) Ltd. Islamabad for contract manufacturing of above mentioned
products by M/s. Bio-Labs, Islamabadas per rule 20-A of Drugs (Licensing,
Registering and Advertising) Rules, 1976. Permission shall be at same terms
and conditions and valid for 05 years. The approval of product at S. No. 3 is
with JP Specifications
b) M/s Amson Vaccines and Pharma (Pvt.) Ltd. Islamabad:

M/s Amson Vaccine and Pharma (Pvt.) Ltd. Islamabad have requested for contract
manufacturing of their following already registered products from M/s NovaMed
Pharmaceuticals, Lahore as per detailed below:
S.No. Name of Applicant Name of Drug (s) & Reg. Date of Initial Approval
and Manufacturer Composition No. Registration and status in
Renewal status RRAs
1. M/s Amson Vaccine Cesod 500mg IV 033749 03-09-2004 USFDA
and Pharma (Pvt.) Injection 1st renewal due: Approved
Ltd. Islamabad Each vial contains 02-09-2009
contract Ceftriaxone (as sodium) 2nd renewal due:
manufacturing from ….. 500mg 01-9-2014
M/s. NovaMed USP Specifications Renewal applied:
Pharmaceuticals, 28-08-2014
Lahore
2. -do- Cesod 1gm IV Injection 033750 03-09-2004 USFDA
Each vial contains 1st renewal due: Approved
Ceftriaxone (as 02-09-2009
sodium)….. 1gm 2nd renewal due:
USP Specifications 01-9-2014
Renewal applied:
28-08-2014
3. -do- Cesod 250mg IV 029061 31-12-2002 USFDA
Injection Initially registered Approved
Each vial contains in name of M/s
Ceftriaxone (as sodium) Amson Farmaco
….. 250mg biologico.
USP Specifications Transfer of
registration in
name of M/s
Amson Vaccines
and Pharma dated
18-08-2004
1st renewal due:
17-08-2009
2nd renewal due:
17-08-2014
Renewal applied:
15-08-2014
4. -do- Cesod 2gm IV Injection 052403 11-09-2008 USFDA
Each vial contains Renewal due: Approved
Ceftriaxone (as sodium) 10-09-2013
….. 2gm Renewal applied:
USP Specifications 09-09-2013

i. Application on Form-5 with fee of Rs.50,000/- for each product.
ii. Copy of initial registration letter and renewal status.
iii. Latest GMP inspection report of M/s. NovaMed Pharmaceuticals, Lahore
(Dated 08-02-2017) with conclusive remarks of “The firm was considered to
be operating at good level of compliance with GMP guidelines”.
iv. Evidence of section approval (Cephalosporin Dry powder Injectable) of M/s.
NovaMed Pharmaceuticals, Lahore confirmed from panel inspection report
dated 08-02-2017.
v. Copy of DML.
vi. Contract manufacturing agreement b/w M/s Amson Vaccine and Pharma
(Pvt.) Ltd. Islamabad and M/s. NovaMed Pharmaceuticals, Lahore (dated
24.07.2017).
Evaluation of case:
 M/s Amson Vaccine and Pharma (Pvt.) Ltd. Islamabad has submitted the reasons
for contractmanufacturing that the concerned section is under construction.
 M/s Amson Vaccine and Pharma (Pvt.) Ltd. Islamabad has five sections approved
as evident from GMP certificate (valid upto: 05-04-2018) and they do not have
any product already registered for contract manufacturing.
 For S. No. 2 it has been noted that registration has been granted as Ceftriaxone
IM/IV injection instead of separate registration.
Decision: Registration Board deferred the request of M/s Amson Vaccine and Pharma
(Pvt.) Ltd. Islamabad for submission of timeframe for completion of
construction of their own manufacturing facility/section alongwith layout
plan of said section by CLB
Case No.36: Registration and contract manufacturing of Tazonem Injection for local
manufacture.
M/s Medera Pharmaceuticals (Pvt) Ltd., plot # 2, street # N-4 National Industrial
Zone Rawat have requested for the registration of the following products along with the
contract manufacturing by M/s Global Pharmaceuticals, (Pvt) Ltd. Islamabad.
S.No Brand Name Registration Date of Status in reference
No. registration authorities
1. Tazonem Injection 070758 18-08-2011 USFDA approved

Each vial contains:
Piperacillin as sodium… 4gm
Tazobactum as sodium…. 500mg
2. Tazonem Injection 070759 18-08-2011 USFDA approved
Each vial contains:
Piperacillin as sodium… 2gm
Tazobactum as sodium…. 250mg
Previously, these products were registered in name of M/s Reagent Laboratories,

Karachi, contract manufactured by M/s Cirin Pharma, Hattar (Extension in contract
manufacturing permission granted on 04-01-2016 which is valid upto 30-06-2020). Now M/s
Reagent Laboratories, Karachi, has provided an NOC that they have no objection in

transferring the above mentioned products in the name of M/s Medera Pharmaceuticals (Pvt)
Ltd., Rawat (NOC dated: 17-06-2017).
M/s Medera Pharmaceuticals (Pvt) Ltd., Rawat further informed that they have made
an agreement with M/s Global Pharmaceuticals (Pvt) Ltd, Plot No.204-205, Industrial
Triangle Kahuta road, Islamabad and authorize M/s Global Pharmaceuticals to manufacture
the said products as per contract agreement. The firm also undertakes that they will transfer
the manufacturing of the said products at their own facility in future after fulfilling the
requirements necessary to manufacture the above mentioned products.

 Form 5 along with fee Rs. 50,000/- per product.
 Copy of initial registration letters and the extension in contract manufacturing letter.
 Copy of NOC for transfer of registration to M/s Medera Pharmaceuticals (Pvt) Ltd.,
Rawat by M/s Reagent Laboratories, Karachi dated 17-06-2017.
 Contract manufacturing agreement between M/s Medera Pharmaceuticals (Pvt) Ltd.,
Rawat and M/s Global Pharmaceuticals (Pvt) Ltd, Islamabad dated 07-08-2017.
 Evidence of Section approval (Dedicated penicillin facility) of M/s Global
Pharmaceuticals (Pvt) Ltd, Islamabad confirmed from inspection report of area FID
dated 24-08-2016.
 Inspection Report of M/s Global Pharmaceuticals (Pvt) Ltd, Islamabad dated 12-07-
2017 with conclusive remarks: “The firm is operating at good level of compliance
with GMP guidelines”.
Evaluation of case:
 M/s Medera Pharmaceuticals (Pvt) Ltd., Rawat has five sections approved by CLB
dated 15-06-2011 and there are 03 products already registered in their name for
contract manufacturing.
 M/s Cirin expresses their resrvations regarding the above case. According to them:
“We are still in contract manufacturing (permission valid upto 30-06-2020)
with Reagent laboratories, Karachi through distributor Laderly Biotech, Karachi and
there is a significant quantity of raw material, semi-finished and finished products
lying at our facility. We have not received any intimation regarding such intention
from Reagent or Laderly as in our case we have plenty of raw material lying with us
which is specifically been imported for contract product Tazonem.”

a. Cancellation of above products from M/s Reagent Laboratories, Karachi.
b. Registration of above products in the name of M/s Medera
Pharmaceuticals (Pvt) Ltd., plot # 2, street # N-4 National Industrial Zone
Rawat for contract manufacturing by M/s Global Pharmaceuticals (Pvt)
Ltd, Islamabad as per rule 20-A of Licensing, Registering and
Advertising, Rules 1976.Permission shall be at same terms and conditions
and valid for 05 years.
c. Reference will be sent to Cost & Pricing Division for MRP of products.

Case No.37: Change in Specifications.
M/s Siam Pharmaceuticals, Islamabad have requested for change in specification of
their following registered product as per following details:-
S.No. Reg.No. Name of drug(s) & Desired Change in Specification
Composition
1. 072913 Monticell Tablets Monticell Tablets
Each film coated tablet contains:- Each film coated tablet contains:-
Montelukast as sodium….10mg Montelukast as sodium…….10mg
(Siam‟s Specifications) (USP Specifications)
The details of requirement as per SOPs and the documents submitted by the firm are as
under:-
Requirement as per SOPs Documents submitted by the Firm.
Application with required fee as per relevant Fee of Rs.5000/- product deposited.
SRO. If error is on part of firm.
Copy of registration letter and renewal Initial Reg.Renewal Renewal
status. Due Applied
12-09-2012 11-09-2017 11-09-2017
NOC for CRF clearance. Copy of CRF (valid up to 31-12-2017)

Documents in support of proposed The firm has provided copy of USP
correction monograph.
Now, the firm has request for change in Specification of above product form Siam‟s
Specifications to “USP”.
Decision: Registration Board approved the change in product specifications of
Monticell Tablets10 mg from Siam’s Specificationsto USP specifications.
Case No.38: Registration of drugs deferred in different meetings of Registration

Board:
a) Product of M/s Wilson Pharmaceuticals deferred in 242nd meeting:
Registration Board in its 242nd meeting considered the following applications of M/s
Wilson‟s pharmaceuticals and decided as recorded in 2nd last column below:
S.# Name of Firm Name of drug(s) & Dy. No. Decision of Status in
Composition Demanded Registration reference
Pack & Price Board in its authorities
and Fee 242nd meeting
1. M/s Wilson‟s Sofvasc Trio Tablet Each Form-5-D Deferred for USFDA
Pharmaceuticals Tablet contains: Fast Track final reminder Approved
, I-9, Industrial Olmesartan medoxomil 10‟s,20‟s & regarding fee.
Area Islamabad. ….40mg Amlodipine as 30‟s Rs.542/-
besylate …….10mg Tablet
Hydrochlorothiazide 11-12-2010/
……...12.5mg 336 17-05-
Anti-Hypertensive agent 2013/3125
Diuretic Rs.60,000/-

2. -do- Sofvasc Trio Tablet Each Form-5-D -do- USFDA
Tablet contains: Fast Track Approved
Olmesartan medoxomil 10‟s, 20‟s &
….20mg 30‟s Rs.410/-
Amlodipine as besylate per tablet 11-
…..5mg 12-2010/339
……..12.5mg 3125
Anti-Hypertensive agent Rs.60,000/-
Diuretic
….40mg 30‟s Rs.522/-
Amlodipine as besylate per tablet 11-
…..….5mg 12-2010/337
…….25mg 3125
Anti-Hypertensive agent Rs.60,000/-
Diuretic
…..….40mg 30‟s Rs.559/-
Amlodipine as besylate per tablet
…..….10mg 11-12-2010/
Hydrochlorothiazide 335
……….25mg 17-05-2013/
Anti-Hypertensive agent 3125
….40mg 30‟s Rs.502/-
Amlodipine as besylate per tablet
….5mg 11-12-2010/
Hydrochlorothiazide 338
….12.5mg 17-05-2013/
Anti-Hypertensive agent 3125
Now as the Fast Track registration policy has no longer valid. So, the firm has
requested to consider the above mentioned products for registration. Firm has also submitted
the latest panel inspection report dated 24-10-2016 and the report concludes that firm was
considered to be operating at good level of compliance with GMP guidelines.
Decision: Registration Board deferred products for submission of stability data as per
guidelines approved in 251st meeting.

b) Product of M/s Werrick Pharmaceuticals deferred in 242nd meeting:
Registration Board in its 242nd meeting considered the following applications of M/s
Werrickpharmaceuticals and decided as recorded in 2nd last column below:
S. Name of Name of drug(s) & Dy. No. Decision of Status in

# Firm Composition Demanded Registration reference
Pack & Price Board in its authorities
and Fee 242nd meeting
1. M/s Triday Tablet Form-5-D Fast Deferred for USFDA

WerrickPh Each Tablet contains: Track 10‟s, 20‟s final reminder Approved
armaceutic Olmesartan medoxomil & 30‟s regarding fee
als, I-9, ….40mg Rs.540/Tablet and latest
Industrial Amlodipine as besylate 13-12-2010/ 396 GMP
Area ….10mg 17-05-2013/ 3126 inspection
Islamabad. Hydrochlorothiazide Rs.60,000/- report.
….12.5mg
Anti-Hypertensive
agent Diuretic
2. -do- Triday Tablet Form-5-D Fast -do- USFDA
Each Tablet contains: Track 10‟s, 20‟s Approved
Olmesartan medoxomil & 30‟s
….20mg Rs.410/Tablet
Amlodipine as besylate 13-12-2010/ 349
….5mg 17-05-2013/ 3126
Hydrochlorothiazide Rs.60,000/-
….12.5mg
Anti-Hypertensive
agent Diuretic
….5mg 17-05-2013/ 3126
….25mg
Anti-Hypertensive
agent Diuretic
….10mg 17-05-2013/ 3126
….25mg
Anti-Hypertensive
agent Diuretic

….5mg 17-05-2013/ 3126
….12.5mg
Anti-Hypertensive
agent Diuretic
6. -do- Sunib Capsule Form-5 Deferred for USFDA
Each Capsule contains: Fast Track confirmation Approved
Sunitinib as malate 10‟s,30‟s As per of
…….25mg SRO manufacturing
Receptor tyrosine 13-12-2010/ 383 facility.
kinase inhibitor/ 13-05-2013/ 2869
Antineoplastic Rs.60,000/-
7. -do- Sunib Capsule Form-5 -do- USFDA

Each Capsule contains: Fast Track Approved
Sunitinib as malate 10‟s,30‟s As per
…….50mg SRO
Receptor tyrosine 13-12-2010/ 398
kinase inhibitor/ 13-05-2013/ 2869
Antineoplastic Rs.60,000/-
8. -do- Sunib Capsule Form-5 -do- USFDA

Each Capsule contains: Fast Track 10‟s, Approved
Sunitinib as malate 30‟s As per SRO
…….12.5mg 13-12-2010/ 384
Receptor tyrosine 13-05-2013/ 2869
kinase inhibitor/ Rs.60,000/-
Antineoplastic
Now as the Fast Track registration policy has no longer valid. So, the firm has
requested to consider the above mentioned products for registration. Firm has also submitted
the latest panel inspection report for renewal of DML dated 02-02-2017 and the report
concludes that panel unanimously recommends for the grant of renewal of DML. The
sections (Tablet Anti-neoplastic and Tablet General) have also been verified from the panel
inspection report for renewal of DML.
a. Deferred products at S.No. 1-5 for submission of stability data in the light
of guidelines approved by Registration Board, in its 251st meeting.
b. Approved the products mentioned at S.No. 6-8 for manufacturing in the
Capsule (General) section. Firm shall provide protective measures as
discussed in 271st meeting.

Case No.39: Replacement through deregistration of already granted contract
Manufacturing permission with newly applied deferred drug (Deferred in
262ndMeeting).
Registration Board in its 267th meeting considered the subject request and deferred the
following product (column III) of M/s Medizan Laboratories contract manufactured from M/s
Nimrall Laboratories, Rawat Islamabad for “submission of Form-5 with correct formulation
400 mg / 250ml instead of 400 mg /100 ml Moxifloxacin infusion”. The Registration Board
approved the firm‟s request for de-registration of product mentioned in column VI which was
approved for contract manufacturing in M-252 meeting for contract manufacturing from M/s
Weather Folds, Hattar.
S. Name of Applicant & Brand name International Registration Brand name &
No. Manufacturer and composition availability No. (of the composition of
and me-too products to already registered
status be replaced) Products to be
replaced
I II III IV V VI
1. M/s Medizan Morex Infusion International 045060 Glazidim 500mg
Laboratories (Pvt) Ltd, Each 100ml vial availability not Injection
Plot 313, industrial contains:- Provided, Each vial
triangle kahota road, Moxifloxacin Not found in contains:-
Islamabad (as 400mg/100ml Ceftazidime
Contract Manufactured by HCl)…..400mg instead 400mg Pentahydrate with
M/s Nimrall Laboratories, (Quinonones / /250ml is sodium carbonate
Plot 24, street SS 3, Broad Spectrum approved in eq. to Ceftazidime
Rawat Antibiotic) USA and UK (anhydrous)
210 (NA) Molox by ……….500mg
Approved in UK CCL (USP Specs.)
and USA as , contract
400mg /250ml. manufacturing.
the Board has
already advised
the firm to
convert their
formulation
containing
Moxifloxacin
I.V infusion as
400mg/250ml
The firm has submitted an undertaking that they are withdrawing the application of
the product mentioned in column III of above table and that they will never apply for its
registration in future.
Now, the firm has requested that they want to replace the product mentioned in
Column III of above table with “Lumeart Injection” for contract manufacturing from M/s
Nimrall laboratories, Islamabad with which was earlier deferred by the Registration Board in
its M-262nd meeting “for confirmation of already approved products for contract
manufacturing to comply with Contract Manufacturing policy” as per following details.

S.No. Name of Applicant & Brand Name and Dy. No., International
Manufacturer Composition Date, Fee, Availability And
Demanded Me-Too Status
Pack and
Price
M/s Medizan Laboratories Lumeart Injection Form5 WHO Approved,
1. (Pvt) Ltd, Plot 313, Each ml contains:- 30-5-13 Arteza of Zafa
industrial triangle kahota Artemether Dy.No.3470 Pharmaceuticals
road, Islamabad (CP)…..80mg Rs.50,000/=
Contract Manufactured by (Anti-Malarial) As Per SRO
M/s Nimrall Laboratories, USP Specifications 1mlx5„s
Plot 24, street SS 3, Rawat
203
Decision: Registration Board acceded to the firm’s request for:

a. Cancellation of registration of product mentioned in the column VI of
Table No. 1.
b. Rejection of the product mentioned in column IIIof Table No. 1.
Grant of registration of Lumeart Injection (as per details mentioned in Table No. 2) in
the name of M/s Medizan Laboratories, Islamabad with the permission for contract
manufacturing by M/s Nimrall Laboratories, Rawat as per rule 20-A of Licensing,
Registering and Advertising, Rules 1976. Permission shall be at same terms and
conditions and valid for 05 years
Case No.40: Registration of Product of M/s Tas Pharmaceuticals Deferred in 224th

Meeting of Registration Board:
Registration Board in its 224th meeting held on 21st& 22ndApril, 2010 deferred the
following dossiers of registration of M/s TAS Pharmaceuticals, Islamabad for manufacturing
on contract basis till the finalization of contract policy:-
S. Name of Firm Name of drug(s) & Dema Dema Date of Decision of
# Composition nded nded application Registration
Pack price Board taken in
its 224th meeting
1. M/s. TAS Fiximtas Capsules 10‟s As Per 15-4-2009 Deferred till the
Pharmaceuticals, Each capsule contains:- SRO finalization of
Islamabad. Cefixime Trihydrate contract policy.
contract ≡ Cefixime……200 mg
manufactured (Antibiotic)
by M/s. Biorex
Pharmaceuticals,
Islamabad
2. -do- Fiximtas Capsules 10‟s -do- -do- -do-
Cefixime Trihydrate
≡ Cefixime……400 mg
(Antibiotic)
3. -do- Ceftas 250 mg I/M Per -do- -do- -do-
Injection Each vial vial
contains:-
Ceftriaxone Sodium
≡Ceftriaxone….250 mg
(Antibiotic)

4. -do- Ceftas 500 mg I/M Per -do- -do- -do-
Injection vial
Ceftriaxone Sodium
≡Ceftriaxone…….500mg
(Antibiotic)
5. -do- Ceftas 1 gm I/V Per -do- -do- -do-
Injection vial
Ceftriaxone Sodium
≡ Ceftriaxone…...1gm
(Antibiotic)
6. -do- Tasocefix 200 mg Dry 30ml -do- -do- -do-
Suspension
Each 5ml contains:
Cefixime…..200mg
(Cephalosporin)
7. -do- Cephratas 125 mg Dry 60ml -do- -do- -do-
Suspension
Each 5ml contains:
Cephradine….125mg
(Cephalosporin)
8. -do- Cephratas DS 250 mg Dry 60ml -do- -do- -do-
Suspension
Each 5ml contains:
Cephradine….250mg
(Cephalosporin)
9. -do- Cephratas 250 mg Capsule 10‟s -do- -do- -do-
Cephradine….250mg
(Cephalosporin)
10. -do- Cephratas 500 mg Capsule 10‟s -do- -do- -do-
Cephradine….500mg
(Cephalosporin)
11. -do- Ceftoxin 250 mg Injection Per -do- -do- -do-
Each vial contains: vial
Cefotaxime (as
sodium)….250mg
(Cephalosporin)
12. -do- Ceftoxin 500 mg Injection Per -do- -do- -do-
Cefotaxime (as sodium)
….500mg
(Cephalosporin)
13. -do- Ceftoxin 1gm Injection Per -do- -do- -do-
Cefotaxime (as
sodium)….1gm
(Cephalosporin)
14. -do- Tasoprom 500 mg Per -do- -do- -do-
Injection vial
Each vial contains:
Cefpirome (as sulphate)
….500mg
(Cephalosporin)
15. -do- Tasoprom 1gm Injection Per -do- -do- -do-
Cefpirome (as sulphate)
….1gm
(Cephalosporin)
The firm then applied for products at S. No. 1-5 along with the fee of Rs:50,000/- for
each products and requested to change the name and manufacturing site/unit from M/s.
Biorex Pharmaceuticals, Islamabad to M/s. Bio-Lab (Pvt) Ltd., Islamabad. The case was
considered in 248th meeting of the Registration Board and the Board approved the products at
S. No. 1-5 on contract manufacturing basis from M/s. Bio-Lab (Pvt) Ltd., Islamabad for 05
years as per Rule 20-A of Drugs (L R & A) Rules, 1976.
Now the firm has applied for product at S. No 6 and requested to change the name of
the product from “Tasocefix Dry Suspension” to “Tasocef Dry Suspension” and
manufacturing site/unit from M/s. Biorex Pharmaceuticals, Islamabad to M/s. Bio-Lab (Pvt)
Ltd., Islamabad.
Evaluation of case:
The dossier has been evaluated as per check list approved in 251st meeting of Registration
Board. Following documents are submitted by the firm:
 Form 5 along with fee Rs.8,000/. dated 09-04-2009 and Rs.42,000/- dated 17-03-
2016.
 Copy of contract manufacturing agreement between M/s Tas Pharmaceuticals (Pvt)
Ltd., Islamabad and M/s. Bio-Lab (Pvt) Ltd., Islamabad dated 23-01-2015.
 Evidence of Section approval (Dry Powder Suspension Cephalosporin) of M/s. Bio-
Lab (Pvt) Ltd., Islamabad granted by CLB dated 22-10-2008.
 Latest GMP inspection report of M/s. Bio-Labs, Islamabad (Dated 15-12-2016) with
conclusive remarks of “The panel unanimously recommends for the issuance of GMP
certificate”.
 Latest inspection report of M/s. Tas Pharmaceuticals, Islamabad (Dated 29-03-2017)
shows that premises was under renovation. Firm has applied for renewal of DML in
November 2015.
M/s Tas Pharmaceuticals (Pvt) Ltd., Islamabad has three sections confirmed from
inspection report for renewal of DML dated 07-03-2011 and there are 5 products already
registered in their name for contract manufacturing.
Decision: Registration Board deferred for updated status of GMP of M/s Tas
Pharma, Islamabad.

Case No.41: Change of Registration of products previously Manufactured on Contract
basis to the own facility of M/s Candid Pharmaceutical. Pasrur.
Registration Board considered the case of M/s Candid Pharmaceuticals, Pasrur in its
rd
263 meeting for transfer of registration of following products which were being previously
manufactured by M/s Sharooq Pharmaceuticals (Pvt) Ltd., Lahore (S. No. 1-2) and by M/s
Cirin Pharmaceuticals, Hattar (S. No. 3-8) for M/s Candid Pharmaceutical, Pasrur on contract
manufacturing basis and deferred the case for confirmation of renewal of registration of
above mentioned products:
S.# Name of Name of Reg. No Name of Initial Extension Reason for
Applicant previous drug(s) & Permission in Transfer of
Contract Composition of contract permission Registration
Manufactur Manufactu of Contract
er ring Manufactur
ing
1. M/s Candid M/s 061052 Distaclor 125 04-11-09 Nil Approval of

Pharmaceutic Sharooq mg/ 5ml Dry (M-199) Dry Powder
al, Pasrur Pharmaceuti Suspension Extended Suspension
cals, Lahore Cefaclor as till Section on
Monohydrate (30-6-10) 03-02-2014
…125 mg
2. -do- -do- 061057 Planex 125 04-11-09 Nil Approval of
mg/ 5ml Dry (M-199) Dry Powder
Suspension Extended Suspension
Cephradine till Section on
….125 mg (30-06-10) 03-02-2014
3. -do- M/s Cirin 028381 Cefcan 21-8-2002 18-09-2008 Approval of
Pharmaceuti Injection (M-171) (M-212) Dry Powder
cals, Hattar Cefotaxime Extended Injectable
(as sodium) till Section on
….250 mg (30-06-10) 03-02-2014
New
Extension
NIL
4. -do- -do- 028382 Cefcan 21-8-2002 18-09-2008 Approval of
Injection (M-171) (M-212) Dry Powder
Cefotaxime Extended Suspension
(as till Section on
sodium)….50 (30-06-10) 03-02-2014
0 mg New
Extension
NIL
5. -do- -do- 028383 Cefcan 21-8-2002 18-09-2008 Approval of
Injection (M-171) (M-212) Dry Powder
Cefotaxime Extended Suspension
(as till Section on
sodium)….10 (30-06-10) 03-02-2014
00mg New
Extension
NIL
6. -do- -do- 028384 Efxone 21-8-2002 18-09-2008 Approval of
Injection IV (M-171) (M-212) Dry Powder
Ceftriaxone Change of Extended Suspension
(as sodium) Brand till Section on
….250 mg Name (30-6-10) 03-02-2014
(5-10-02) New
Extension
NIL
Injection IM (M-171) (M-212) Dry Powder
(as sodium) Brand till (30-06- Section on
….250 mg Name 2010) 03-02-2014
(05-10-02) New
Extension
NIL
Injection IV (M-171) (M-212) Dry Powder
(as Brand till Section on
sodium)….10 Name (30-06-10) 03-02-2014
00mg (05-10-02) New
Extension
NIL
There is no evidence of extension in contract after 30-06-2010.

Now the firm has requested for manufacturing of the above products at its own approved
facility. The firm has submitted following documents in this regard:
1. Form-5
2. Fee of Rs. 20,000/- for each product in head of account 1404 i.e. Drug Registration
Fee.
3. Additional Section Approval (Dry Powder Suspension Cephalosporin) dated 03-02-
2014 from CLB.
4. Inspection Report dated 15-12-2016 which concludes that firm was found to be
operating at a satisfactory level of GMP compliance.
5. Undertaking that said products are not registered in the name of M/s Candid
Pharmaceutical, Pasrur.
Decision: Registration Board approved the above products in the name of M/s
Candid Pharmaceuticals, Pasrur for manufacturing of above products at
its newly approved manufacturing facility.
Case No.42: Change in Specifications

a) M/s Crystolite Pharmaceuticals:
M/s Crystolite Pharmaceuticals, Islamabad have requested for change in finished

product specifications of their following registered products as per details below:-
S.No. Reg.No. Name of drug(s), Composition Name of drug(s), Composition with
and Specifications desired Specifications
1. 077623 Smep-40 Capsules Smep-40 Capsules
Each capsule contains:- Each capsule contains:-
Esomeprazole enteric coated Esomeprazole enteric coated pellets
pellets eq. to Esomeprazole eq. to Esomeprazole…….40mg
…….40mg (USP Specifications)
(Crystolite‟s Specifications)
2. 077622 Smep-20 Capsules Smep-20 Capsules

Each capsule contains:- Each capsule contains:-
Esomeprazole enteric coated Esomeprazole enteric coated pellets
pellets eq. to Esomeprazole eq. to Esomeprazole…….20mg
…….20mg (USP Specifications)
(Crystolite‟s Specifications)
under:-
Application with required fee as per relevant Fee of Rs.5000/- for each product deposited.
Copy of registration letter and renewal Initial Reg. Renewal Renewal
status. Due Applied
23-10-2013 22-10-2018 Renewal is not
required.
Documents in support of proposed correction The firm has provided copy of USP
monograph.
Now, the firm has requested for change in finished specifications of above products form
Crystolite‟s Specifications to “USP”.
Decision: Registration Board approved the change in product specifications of above
products fromCrystolite’s specifications to USP specifications.
b) M/s Shaigan Pharmaceuticals:
M/s Shaigan Pharmaceuticals, Rawalpindi have requested for change in specifications

of their following registered products as per following details:-
S.No. Reg.No. Name of drug(s), Composition Name of drug(s), Composition with
and Specifications desired Specifications
1. 054492 Glykin-500mg Injection Glykin-500mg Injection
Each 2ml vial contains:- Each 2ml vial contains:-
Amikacin as sulphate…….500mg Amikacin as sulphate…….500mg
(USP Specifications) (BP Specifications)

under:-
Copy of registration letter and renewal
Initial Reg. Renewal Due Renewal Applied
status. 31-03-2009 29-03-2014 24-02-2014

Documents in support of proposed The firm has provided copy of BP
correction monograph.
Firm has submitted that they are facing problem in availability of Amikacin sulphate
with USP Specifications that ultimately result in product shortage. Therefore, they want to
procure raw material of BP Specifications and manufacture the product as per BP
Specifications. Now, the firm has requested for change in specifications of above products
form USP Specifications to “BP”.
Decision: Registration Board approved the change in product specifications of above
productsfrom USP to BP specifications.
c) M/s Global Pharmaceuticals:

i. M/s Global Pharmaceuticals, Islamabad have requested for change in label
claim and specifications of their following registered product as per following details:-
S.No. Reg.No. Name of Drug(s) & Composition Desired Change in label claim &
on Initial Registration Letter Specifications
1. 025148 G-Lac Syrup G-Lac Syrup
Each 15ml contains:- Each 100ml contains:-
10gm Lactulose, less than 1.65gm 66.7gm Lactulose
Galactose and 0.9gm Lactose (USP Specifications)
under:-
Application with required fee as per relevant Fee of Rs.5000/- deposited.
Copy of registration letter and renewal status. Initial Registration for contract manufacturing: 06-
08-1999
Change in brand name: 15-01-2002
Permission for contract manufacturing: 11-8-2003
Extension in contract manufacturing: 20-10-2008
Transfer of product to M/s Global
Pharma:13.2.2010
Renewal due: 12-02-2015
Renewal applied: 06-02-2015
Documents in support of proposed correction The firm has provided copy of USP monograph and
brand leader‟s pack (Duphalac of Abbott).

Now, the firm has requested for above mentioned changes in label claim with USP
specifications for the said product.
Decision: Registration Board deferred the case for confirmation of renewal status of
above product by RRR section.
ii. M/s Global Pharmaceuticals, Islamabad have requested for change in

specification of raw material of their following registered product as per following details:-
1. 016836 Pelton Tablets Pelton Tablets
Each tablet contains:- Each tablet contains:-
Domperidone USP……10mg Domperidone BP……10mg
(BP Specifications)
2. 016830 Fadiphine 20mg Tablets Fadiphine 20mg Tablets
Famotidine…… 20mg Famotidine USP…… 20mg
(USP Specifications)
3. 016831 Fadiphine 40mg Tablets Fadiphine 40mg Tablets
Famotidine…… 40mg Famotidine USP…… 40mg
The details of requirement as per SOPs and documents submitted by the firm are as under:-
Copy of registration letter and renewal status. Product at S. No. 1:
Initial Registration: 16-05-1997
Change of premises: 30-04-2003
1st renewal due: 29-04-2008
2nd Renewal due: 29-04-2013
2nd Renewal applied: 05-03-2013
Product at S. No. 2:
2nd Renewal applied: 22-04-2013
2nd Renewal applied: 05-12-2013 (Rs.20,000/-
submitted)
Verification of renewal is required from RRR
section.
Documents in support of proposed correction The firm has provided copy of BP monograph for
product at S. No.1 and USP monograph for
product at S. No. 2 & 3.
Now, the firm has requested for:

 Change in raw material specifications of product at S. No. 1 form USP
Specifications to “BP” as the product is not available in USP. The BP
monograph for finished product at S. No. 1 is also available.
 Approval of “USP Specifications” for raw material and finished product for
products mentioned at S. No. 2 & 3.

a. Approved the change in product specifications of product at S. No. 1 to
BP specifications.
b. Approved the change in product specifications of product at S. No. 2to
USP specifications.
c. Deferred the request for change in product specifications for product at S.
No. 3 for confirmation of renewal status by RRR section
Case No.43: Registration and contract manufacturing of Ospexindrug products

M/s Herbion Pakistan (Pvt) Ltd., Islamabad have requested for the registration of the
following drugs along with the permission of contract manufacturing by M/s Agror Pharma
(Pvt) Ltd:
S.No Brand Name Registration Date of Status in reference
No. registration authorities
1. Ospexin 125mg/5ml 012178 07-02-1991 MHRA approved
(Cephalexin) Suspension
2. Ospexin 250 007473 27-02-1990 MHRA
(Cephalexin) Granules Approved
3. Ospexin 250mg 012179 07-02-1991 USFDA/MHRA approved
(Cephalexin) Capsules
Previously, these products were registered in the name of M/s Novartis Pharma,
Karachi along with permission of contract manufacturing by M/s Opal Labs, Karachi which
was valid till 30.06.2015. Now, M/s Novartis Pharma, Karachi has issued an NOC for
transfer of these products to M/s Herbion Pakistan (Pvt) Ltd. Islamabad, under an agreement
between M/s Novartis Pharma (Pakistan) Ltd, Karachi and Herbion Pakistan (Pvt) Ltd.
Islamabad. Furthermore, the firm M/s Herbion Pakistan (Pvt) Ltd. Islamabad, informed that
due to unavailability of separate cephalosporin manufacturing area, they have authorized M/s
Agror Pharma (Pvt) Ltd, Plot No.4, street SS4, National Zone, Rawat, to manufacture the said
products as per contract agreement. The firm has also undertaken that they will transfer the
manufacturing of the said products at their own facility in future after fulfilling the
requirements necessary to manufacture the above mentioned products.

 Form 5 along with fee of contract manufacturing Rs. 50,000/ product.
 Copy of initial registration letters and the renewal status.
 Copy of NOC for transfer of registration to M/s Herbion Pakistan (Pvt) Ltd by M/s
Novartis Pharma (Pak) Ltd, Karachi dated 01-08-2016
 Contract manufacturing agreement between M/s Agror Pharma (Pvt) Ltd and M/s
Herbion Pakistan (Pvt) Ltd dated 28-07-2016.
 Evidence of Section approval (Capsule - cephalosporin and Dry Powder Suspension-
cephalosporin) of M/s Agror Pharma (Pvt) Ltd by CLB dated 12-02-2014.
 Inspection Report of M/s Agror Pharma dated 09-12-2016 with conclusive remarks:
“the company is found complying GMP and the panel recommendation of grant of
GMP certificate”.
 It is pertinent to mention here that M/s Novartis Pharma (Pakistan) Ltd, Karachi
mentioned that their contract manufacturing agreement was valid till 30-June-
2015 but they have discontinued the manufacturing of said products before the
expiry period due to expiry of GMP certificate of M/s Opal Labs and have not
been manufacturing these products after the permission validity. Therefore,
contract manufacturing renewal was not submitted however the products
registration has been renewed dated 03-02-2015.
 Renewal of products needs verification form the Renewal section.
 Registration Board deferred the case in its 271st meetingfor clarifications as the
applicant has applied for the transfer of registrations of above products after the
validity period of the previous contract manufacturing permission i.e. 30.06.2015.
Now the firm has requested to reconsider the case on the basis of renewal applied on
03-02-2015.
Decision: Registration Board deferred the case for submission of differential fee up
to Rs.50,000/- since the firm has applied for registration of above
products after the validity period of the previous contract manufacturing
permission i.e. 30.06.2015.
Case No.44: Change in Registration Holder:

M/s Ambrosia Pharmaceuticals, Islamabad have applied for change in registration /
marketing authorization holder of following products from M/s Spensor Pharma, Karachi,
which was approved by registration Board in its 246th meeting after verification of renewal
and price from C & P Division.
S. Name of Name of Date of Registration Name of product with
No. applicant(s) existing application, No. composition
manufacturer Diary No. &
Form
1. M/s Ambrosia M/s Spencer 29-10-2014 006348 Calcipan-T 50 mg
Pharmaceuticals, & Dy.No.634 Tablet
Rawat Co, Karachi Form-5 Each tablet contains:-
Rs.20,000/- Calcium Pantothenate ..50mg
2. -do- -do- 29-10-2014 067454 Infacol 40 mg Drops
Dy.No.635 Each ml contains:-
Form-5 Simethicone……40 mg
Rs.20,000/-
3. -do- -do- 29-10-2014 008801 Infacol Suspension
Dy.No.633 Each 5 ml contains:-
Form-5 Dicyclomine HCl….5 mg
Rs.20,000/- Simethicone ……50mg
The product at S. No. 3 namely Infacol Suspension could not be transferred due to
following reasons:

a) The product‟s composition and dosage form are different in the initial registration
letter and the minutes of 246th meeting of Registration Board as indicated in the table
below.
b) Due to above ambiguity, the renewal of product couldn‟t be confirmed by the RRR
section.
The details mentioned in initial registration letter dated 24-02-1986 are as follows:
S. Registration Name of product with
No. No. Composition
1. 008801 Ifacol Syrup
Each 5ml contains:
Dicyclomine HCl……….0.10% w/v
Simethicone …...……… 3.33% w/v
Since approval by the Registration Board was after verification of renewal and price
from C & P, Division which couldn‟t be confirmed. The firm claimed to have approval of
change in composition and dosage form, for which the case was forwarded to registration
section dealing with the registration matter of M/s Spencer Pharma, Karachi but no evidence
of change in composition and dosage form was found out.
Now the firm has requested to issue the registration letter as per details mentioned in
the initial registration letter. However, the approval of said product by reference regulatory
authorities could not be confirmed.
Decision: Registration Board deferred the case for evidence of approval of applied
formulation by reference regulatory authorities
Case No.45: Recommendation of PQCB for Cancellation/Suspension of Registration of

Product:
A letter (No. PQCB/ R-441-07/2016) was forwarded by PQCB, Government of

Punjab dated 28-07-2017 regarding following product of M/s Gulf Pharmaceuticals:
Sr.No. Registration Brand Name & Composition

No.
1. 077947 Diartin 50mg Tablet
Each enteric coated tablet contains:
Diclofenac sodium …..50mg
(BP Specifications)
The proceedings and decision of the case by PQCB are as follows:

“Case was considered by the Provincial Quality Control Board, under section 11 of
Drugs Act, 1976 in its 166th meeting held on 28-07-2017. Drug inspector briefed the Board
about facts of the case and request for permission for prosecution against the accused persons
and also requested for suspension / cancellation of registration certification of subject drug.
Counsel for the firm argued that

 At the time of sampling five portions were not made by the Drug Inspector which is
an illegality on the part of Drug Inspector.
 Specific time for Disintegration of the said product is not mentioned by the
Government analyst in the test report.
 He further argued that there is a conflict of interest in violation of section 11(A) of
Drugs Act, 1976 as CDC Punjab/ Chief Drug Inspector is simultaneously working as
member of PQCB as well as Central Licensing Board. He is simultaneously working
as prosecutor as well as judge.
The Board after scrutiny of the record and discussion and keeping in the view the
statements of the counsel of the firm, decided to grant permission for prosecution against the
following accused persons.
1. M/s Gulf Pharmaceuticals Plot No.49, street No. S-5, Rawalpindi
Industrial Zone, Rawat through its Manager Director Innyat Ullah
2. Innayat Ullah Managing Director
3. Saqib Aslam Production Manager
4. Kalid Qayyam Quality Control In-charge / Warrantor
of M/s Gulf Pharmaceuticals Plot No.49, street No. S-5, Rawalpindi
Industrial Zone, Rawat Islamabad for the offences of:
a) manufacturing for sale / stocking for sale of substandard drug
b) issuance of false warranty
c) provision of incomplete, misleading and incorrect information
The Board keeping in view the failure of multiple batches of the said product of M/s
Gulf Pharmaceuticals Islamabad sent by different area Drug inspectors to different Drug
Testing Laboratories as well as NIH Islamabad, and on the special request of Drug inspector,
decided to recommend Drug Regulatory Authority of Pakistan for cancellation / suspension
of Registration of said product.
Decision: The Board decided to call the firm’s representative for personal hearing
to clarify their position on above matter
Case No.46: issuance of registration letter

i. M/s Miracle Pharmaceuticals:
Registration Board in its 239th meeting approved the following products of M/s
Miracle Pharmaceuticals, Islamabad as per details below:
Sr.No. Name & Deman Decision of Availability in Remarks
Composition of ded 239th meeting RRAs and Me-
Product (s) pack of too status
and Registration
price Board
1. Dimet DS Tablets 15‟s The  Availability  Not found in any
Each film coated As per Registration in reference pharmacopoeia.
tablet contains:- SRO Board after regulatory
Diloxanide Furoate thorough authorities
...500mg deliberation could not be
Metronidazole…. on the case confirmed.
400mg approved the  Anizole of
(Nitroimidazole, products. M/s Pharmix
Amoebicide)
2. Marither Forte 4‟s -do-  WHO  Available in
Each tablet contains:- As per approved International
Artemether… 80mg SRO  Arceva of Pharmacopoeia.
Lumefantrin…480mg M/s Sami
(Synthetic Anti-
Malarial derived from
Artemisinin synthetic
Recemic Flourene
Mixture)
The product at S.No.1 is not found approved in any reference regulatory authority
while product at Sr.No.2 is found approved / pre-qualified by reference regulatory authority
that is WHO. The firm has also requested to change the brand name of the product at Sr.No.2
from Marither Forte to Merither TS.
Further, theproduct at Sr.No.1 is not available in any pharmacopoeia while the
product at Sr.No.2 is available in International Pharmacopoeia.
a. Approved the product at S. No. 2.
b. Deferred the product at S. No. 1 for evidence of approval by reference
regulatory authorities
ii. M/s Caraway Pharmaceuticals:
Registration Board in its 270th meeting approved the following product of M/s Caraway
Pharmaceuticals, Rawat Islamabad but the registration letter was withheld due to the reason
stated in last column below:
Sr. Name & Composition of Diary #, Date, Appro Decision of 239th Reason for
No. Product (s) Fee, Demanded ved meeting of withholding the
pack & Price pack & Registration registration letter
price Board
1. Dicrays 50mg Tablets Dy.No.3034 Rs. Approved with The registration
Each tablet contains:- (16-11-2011) 60/20‟s Innovator‟s letter was withheld
Diclofenac Sodium …… Rs.8000/= specifications. as the applied
50mg Rs.12,000/=(24 product is only
-04-2015) approved as
20‟s As Per gastro-resistant /
SRO enteric coated
tablet by reference
regulatory
authorities and also
after verification
from BNF 73, the
formulation is
found as enteric
coated tablet.
Now the firm has agreed to change the formulation from plain tablet to “enteric
coated tablet” and submitted the revised form-5 and revised master formula for this purpose.
The firm has not submitted the fee for the said change.
Decision: Registration Board deferred the case due to paucity of time.
iii. M/s Rotex Pharma (Pvt) Ltd:
Registration Board in its 271st meeting approved the following product of M/s Rotex
Pharmaceuticals, Islamabad but the registration letter was withheld due to the reason stated in
last column below:
Sr. Name & Composition of Diary #, Date, Approv Decision of Reason for
No Product (s) Fee, ed pack 239th meeting withholding the
Demanded & price of registration letter and
. pack & Price Registration remarks
Board
1. Fluxifarm 5mg Tablets 10‟s Rs. Approved Registration letter was
Each film coated tablet As Per SRO 410/10‟ withheld since the
contains:- s product is approved as
Solifenacin succinate each tablet contains 5
….5mg mg Solifenacin
succinate,
Antimuscrinic corresponding to 3.8
mg Solifenacin by
(Manufacturer‟s reference regulatory
Specification) authorities.
The firm has now

requested to change the
Brand name to Soliget.
The firm applied with

Manufacturer’s
Specifications and the
product is not found in
any pharmacopoeia.
Innovator‟s
specifications may be
given.
It is therefore proposed that the above product may be approved as per approval by
reference regulatory authorities i.e. each film coated tablet contains 5 mg Solifenacin
succinate, corresponding to 3.8 mg Solifenacin.

Case No.47: Change in Specifications
M/s Global Pharmaceuticals, Islamabad have requested for change in specifications of
raw material of their following registered products as per details below:-
S.No. Reg.No. Name of Drug(s) & Desired Change in label claim &
Composition on Initial Specifications
Registration Letter
1. 066490 Miso 100mcg Tablets Miso 100mcg Tablets
Misoprostol (BP)……100mcg Misoprostol dispersion (USP) eq. to
Misoprostol ……100mcg
2. 066326 Miso 200mcg Tablets Miso 200mcg Tablets
3. 066600 Miso Plus Tablets Miso Plus Tablets
Diclofenac sodium…..50mg Diclofenac sodium…..50mg
under:-
Copy of registration letter and renewal Product at S. No. 1:
status. Initial Registration: 28-10-2010
Documents in support of proposed correction The firm has provided copy of USP
monograph.
Now, the firm has requested for change in raw material specifications of products
mentioned above form BP Specifications to “USP” as the Misoprostol dispersion is available
in USP.

Case No.48: Change in Specifications and packaging:
M/s Global Pharmaceuticals, Islamabad has requested for change in packaging and
specifications of finished product of their following registered product as per details below:-
S.No. Reg.No. Name of Drug(s) & Name of drug(s), Existing Desired

Composition on Initial Composition with packaging packaging
Registration Letter desired Specifications and price
1. 066341 Graniton 3mg Injection Graniton 3mg Injection Rs.633/- 3mlx1‟s
Each 3ml ampoule Each 3ml ampoule Vial + glass
contains:- contains:- Solvent ampoule
Granisetron as Granisetron as
hydrochloride……3mg hydrochloride……3mg
(Global‟s Specifications) (USP Specifications)
under:-
Application with required fee as per relevant Fee of Rs.20,000/- deposited.
Copy of registration letter and renewal status. Initial Registration: 23-09-2010
Documents in support of proposed correction The firm has provided copy of USP monograph.

 Change in finished product specifications of above product form Global‟s
Specifications to “USP” as the product is available in USP.
 Change in packaging from vial to ampoule of 3ml. The product is approved in
3ml glass ampoule packaging by MHRA and 4ml vial packaging by USFDA.
Case No.49: Correction in registration letter:

M/s Global Pharmaceuticals, Islamabad have requested for correction in spelling of
generic names along with the change in specifications of their following registered products
as per details below:-
1. 063418 Graniton Tablets Graniton Tablets
Granisteron as Granisetron as hydrochloride……1mg
hydrochloride……1mg (USP Specifications)
(Global‟s Specifications)
2. 063419 Tropit Injection Tropit Injection
Each 5ml ampoule contains:- Each 5ml ampoule contains:-
Tropisteron as Tropisetron as hydrochloride……5mg
hydrochloride……5mg (As per Innovator‟s Specifications)
(Global‟s Specifications)

3. 024581 Tazimin 250mg Injection Tazimin 250mg Injection
Each vial contains:- Each vial contains:-
Ceftazadime……250mg Ceftazidime……250mg
4. 024582 Tazimin 500mg Injection Tazimin 500mg Injection
Ceftazadime……500mg Ceftazidime……500mg
5. 024583 Tazimin 1gm Injection Tazimin 1gm Injection
Ceftazadime……1gm Ceftazidime……1gm
under:-
Application with required fee as per relevant Fee of Rs.20,000/- for each product mentioned at
SRO. If error is on part of firm. S. No 1 & 2 deposited.
Fee of Rs.5000/- for each product mentioned at S.
No. 3-5 deposited.
Copy of registration letter and renewal status. For products at S. No. 1 & 2:
For products at S. No. 3-5:
Change of brand name: 06-03-2004
Renewal letter issued by authority: 29-07-2008 &
02-11-2011
2nd renewal due: 05-03-2014
Documents in support of proposed correction The firm has provided copy of USP monograph
and copy of pages from BNF as evidence of
correct spelling of generic for product at S.No.1
& S. No. 3-5 while the evidence of approval of
product at S. No. 2 by TGA has also been verified
for correct spelling of generic.

 Change in finished product specifications form Global‟s Specifications to
“USP” as the products are available in USP for product at S. No. 1 & S. No. 3-5.
 Correction in spelling of generic names in registration letter for above
products.

Case No.50: Change of title of manufacturer
Registration Board considered the case of M/s Rotex Pharma in its 271st meeting
where the firm has requested to change the registration of their registered 78 products from
their previous name of the firm i.e. Rotexmedica (Pvt) Ltd. Industrial Triangle, Kahuta Road,
Islamabad, to their new name of the firm i.e. Rotex Pharma (Pvt) Ltd. Industrial Triangle,
Kahuta Road, Islamabad, along with exemption of transfer fee as the firm has been granted
approval for the change in title of the firm from M/sRotexmedica Pakistan (Pvt) Ltd. to M/s
Rotex Pharma (Pvt) Ltd vide letter no. F.1-53/2003-Lic by the Central Licensing Board in its
240th meeting held on 6th March, 2015.
Registration Board acceded to the firm‟s request for change of registration of already
registered products except the following products and decided as stated in last column below:
S. Reg. # Product Generic name Reference Pack Decision of

No. Name Agency size Registration Board
in its 271st meeting
1. 060805 Kelac 20mg Ketorolac Not verified 10‟s Deferred for
Tablet tromethamine evidence of approval
status by reference
regulatory agencies.
2. 068688 Ribatec Ribavirin Not verified 10‟s, -do-
400mg 20‟s,
Capsule 30‟s
3. 056700 Setrovel 5mg Tropisetron (as Not verified 5‟s -do-
Capsule HCl)
4. 056701 Volden Fort K Diclofenac Diclofenac 20‟s Deferred for review

75mg Tablet potassium Potassium is not of formulation since
registered in any diclofenac potassium
is not registered in
reference
any reference
authority in dose country
more than in strength more
50mg. than 50mg.
Now the firm has provided evidence of approval of product mentioned at S. No. 3 by
Swiss Medica “Navoban Capsules 5mg of Alkopharma SA, 1920 Martigny” which has been
verified. Approval of other products has not been submitted by the firm and also could not be
verified from reference regulatory authorities.

Registration-IV
Case No.51: Revision of formulation of Nocer 10 Suspension (Reg. No. 042966).

M/s. Bryon Pharmaceuticals, Peshawar has requested for revision of formulation
of their registered product Nocer 10 suspension in the light of decision of M-250 that is
reproduced below:
90. FAMOTIDINE 10 MG/5ML LIQUID SUSPENSION
International availability Me too status Remarks
Not available in reference ACICON of M/s Barret Not approved by reference drug
authorities Hodgson, Karachi regulatory agencies. Internationally
CAPSID of M/s Olive available formulation is dry powder for
Labs, Islamabad suspension in the strength of 40mg/5ml.
(Ref: US FDA)
Decision:
i. Applicants shall revise their formulation as per innovator (new registration application with
complete fee) within six months if manufacturing facility is approved by CLB.
ii. For already registered drugs, same procedure as mentioned above (at Sr. No. i) shall be
adopted. Otherwise show cause notice shall be issued for de-registration of registered drugs in
this formulation.
iii. All such application shall be processed on priority basis.
The firm has submitted a fresh dossier with revised formulation as per following details:
Reg. No. Previous formulation Revised formulation

042966 Nocer 10 suspension Nocer 40 Dry Suspension
Each 5ml contains: Each 5ml contains:
Famotidine……..10mg Famotidine……..40mg
Detail of submissions:
i) Application on form-5 with fee of Rs.20,000/-
ii) Copy of Registration letter dated 13-04-2006
iii) Last renewal submitted on 31-03-2016 (verified from copies of submissions to the
renewal section)
iv) Last inspection report dated 15-02-2017
v) Data regarding Accelerated stability study conducted on 3 batches (from Oct-
2016- Apr-2017).

Case No.52: Revision of Formulation of Zithrox Capsule (Reg. No. 052518)
M/s. MKB Pharmaceuticals, Peshawar has requested for revision of formulation of
their registered product Zithrox Capsule in the light of decision of M-250 that is reproduced
below:
12. AZITHROMYCIN 500MG CAPSULES
International availability Me too status Remarks
Not approved in reference AZOGEN of M/s Not approved in reference drug agencies.
drug agencies. Only 250 mg Rogen, Islamabad. Only 250 mg capsules are approved.
capsules are approved. AZOTINE of M/s However, 500 mg tablets are available.
However, 500 mg tablets are Nimral Pharma, When azithromycin capsules were
available. Islamabad administered with food, the rate of
Zithromax of M/s Pfizer, UK. absorption (Cmax) of azithromycin was
reduced by 52% and the extent of
absorption (AUC) by 43%.
Zithromax 250 mg capsules should be
given as a single daily dose. In common
with many other antibiotics Zithromax
Capsules should be taken at least 1 hour
before or 2 hours after food.
(Ref: MHRA)
Decision:
i. Applicants shall either revise their formulation to tablet dosage form, if not registered
previously and if manufacturing facility is approved by CLB (new registration application with
complete fee) or,
ii. Shall submit Pharmaceutical development data including stability, bioavailability/
bioequivalence studies within six months period.
iii. For already registered drugs, same procedure as mentioned above (at Sr. No. i & ii) shall be
adopted. Otherwise show cause notice shall be issued for deregistration of drug in this
formulation.
iv. All such application shall be processed on priority basis.
The firm has submitted a fresh dossier with revised formulation as per following details:
Reg. No. Previous formulation Revised formulation
052518 Zithrox Capsules Zithrox Tablet
Each capsule Each film coated tablet
contains: contains:
Azithromycin as Azithromycin as
dihydrate……..500mg dihydrate……..500mg
Detail of submissions:
i) Application on form-5 with fee of Rs.20,000/-
ii) Copy of Registration letter dated 18-09-2008
iii) Last renewal submitted on 09-09-2013 (verified from copies of submissions to the
renewal section)
iv) Last inspection report dated 26-12-2016
v) Data regarding stability study i.e 6 months accelerated &12 months real time
conducted on 3 batches (from Mar-2016- Mar-2017).

Case No.53: Cases referred by Drug Court Gilgit- Baltistan.
a) Recommendation of Central Licensing Board for Suspension of Registration of
Fixil Suspension of M/s. Alson Pharmaceutical, Peshawar.
Registration Board in 262nd meeting considered the direction of Drug Court Gilgit-
Baltistan, referred by Secretary Central Licensing Board, regarding suspension of registration
of Fixil Suspension (Reg No.031652) of M/s. Alson Pharmaceuticals, Peshawar as the
accused was not interested in contesting the show cause. The brief back ground of the case
and decision taken by the Board is as under:-
i. The Drug Court, Gilgit-Baltistan in the case “State versus 1.Saif Islam, M.D
2. Roohullah, Production Inchrage 3. Miss Nosheen Raza, Quality Control
Incharge of M/s. Alson Pharmaceuticals, 169-7th Road, Industrial Estate,
Hayatabad, Peshawar, Pakistan”, vide court order dated 27th Oct 2015,
directed to suspend the manufacturing license of M/s. Alson Pharmaceuticals,
Peshawar to the extent of product Fixil Suspension Reg.No.031652, batch
no.3 and communicate the decision to the Court.
ii. The Court earlier issued the show cause notice against the
accused/respondent in offence under section 27/23 of Drugs Act,1976, with
the direction to contest the show cause. The accused was not interested in
contesting the show cause; therefore, the court passed the above mentioned
orders.
iii. Decision “Registration Board discussed legal implications of the case with
respect to jurisdiction of the Drugs Court, Gilgit-Baltistan. The representative
of Ministry of Law Justice & Human Right Division was of the opinion that
the jurisdiction matter needs to be clarified. The Board decided to send the
reference to the Ministry of Law, Justice & Human Rights Division to
enquire about the law under which the drugs are regulated in the Gilgit-
Baltistan as whether the DRAP/Drugs Act 1976 is enforce in the area or the
Legislative Assembly of Gilgit-Baltistan has enacted it own legislation.”
As per above decision of the Board the case was referred to Legal Affair Division,
DRAP for taking the necessary action. The Legal Affair Division, DRAP views are as under:-
“Gilgit-Baltistan (GB) is part of Pakistan for all intents and purposes by virtue
of Article 1 (2)(d) of the Constitution. Presently, it is being governed under
GB (Empowerment and Self-Governance Order), 2009. As per Article
47(2)(c) of the Order ibid, the GB Council has the power to adopt any
amendment in the existing laws or any new law in force in Pakistan. The
Drugs Act, 1976 has been adopted by the GB Council for enforcement in the
territory of GB. Accordingly, Drug Court has been established in Gilgit to
adjudicate cases under the Act ibid. The orders of Drug Court, Gilgit would be
enforceable under the Drugs Act, 1976”.

b) Request for Cancellation of Registration of drug of M/s. Alliance
Pharmaceuticals (Pvt) Ltd., Peshawar by Drug Court, Gilgit Baltistan.
Chairman, Drug Court Gilgit Baltistan, Gilgit has forwarded three courts orders
dated 3rd April, 2017, 13th April, 2017 and 18th May, 2017 regarding the counterfeit Ponstan
Forte Tablets and Painton Fort Tablets by M/s. Alliance Pharmaceuticals (Pvt) Ltd.,
Peshawar as explained below:-
i. The Drug Court vide order dated 3rd April, 2017 and 13th April, 2017 requested
for cancellation of registration of Ponston Forte Tablets, Batch No. 470
manufactured by M/s. Alliance Pharma Labs, 12-A Hyatabad industrial Estate
Peshawar.
ii. while the same court vide order dated 18th May, 2017 requested for
cancellation of Painton Fort Tablet Batch No. 470 manufactured by M/s.
Alliance Pharma Labs, 12-A Hyatabad industrial Estate Peshawar.
The court cited the reason of non attendance of accused in the court with regard to the
above noted case, for passing the aforementioned order. With reference to above mentioned
case following facts are submitted:-
i. Ponston Forte Tablets is not the registered product of M/s. Alliance Pharma,
where as the firm has a product registered with brand name of Painton Fort
Tablets. 500mg, Reg. No. 044564 dated 28th August, 2006, containing
Mefenamic Acid.
ii. Ponstan Forte Tablets is registered product of M/s. Pfizer Pakistan Ltd.,
Karachi.
iii. No detail of case is provided by the Court.
The case was referred to Ministry of Kashmir Affairs and GB and the GB Council to confirm
about the Law which regulates the Drugs in GB. In response, GB Council Secretariat has
stated that:
"M/o Kashmir Affairs & Gilgit- Baltistan has adopted Drug Act, 1976, which is in
force in Gilgit- Baltistan while the Drug Regulatory Authority of Pakistan (DRAP)
Act, 2012 has not been adopted by M/o Kashmir Affairs and Gilgit Baltistan, as yet.
The Drug Court was established in 1994 in Gilgit under Drug Act, 1976 and all cases
are tried in that Court under the said Act. "
The Council has requested the M/o NHS, R & C to take further necessary action in
the matter under intimation to the Council Secretariat.

Case No.54. Correction of Formulation of Mexipim Injection 500mg & 1000mg.
Following products of M/s Polyfine, Peshawar were approved in M-270 containing Cefepime
hydrochloride eq. to Cefepime regardless of stating L- arginine.
Name of Product & Composition Demanded Pack size Decision of

& Price Registration Board
Mexipim Injection 500mg IM/IV Pre sterilized glass vial Approved.
Each vial contains:- As per SRO
Cefepime hydrochloride eq. to Cefepime
…500mg
( USP Specifications)
Mexipim Injection 1000mg IM/IV Pre sterilized glass vial Approved
Each vial contains:- As per SRO
Cefepime hydrochloride eq. to Cefepime
……1000mg
As per formulation approved by USFDA the L-arginine is a part of the standard

formulation as an excipient and is used as buffer to control the pH of constituted solution.
Moreover the label claim approved by USFDA conspicuously states L-arginine for pH
adjustment without mentioning its quantity. However, as per pricing record one price is fixed
without mentioning arginine while in other case quantity of L- arginine is specified (250mg
L- arginine for 500mg Cefepime Inj. & 500mg L- arginine for 1gm Cefepime Inj.).Therefore
the formulation needs to be standardized as per Reference Regulatory Authority for sending a
reference to the Pricing Division for making necessary amendment/ review.
Case No.55.Deferred Products of M/S Rakaposhi Pharmaceuticals, Peshawar
A number of registration applications of M/s Rakaposhi, Peshawar were

deferred in M-271 for confirmation of availability in reference regulatory authorities. For the
following products the firm has submitted revised dossier in accordance with the
formulations approved by the reference regulatory authorities as per details mentioned
against each.
S.No. Name of product & previous Name of product & revised Remarks
composition composition
1. Lomexin 200 mg tab Lomexin 400 mg tab Approved by
Each tablet contains:- Each film coated tablet contains:- ANSM France
Lomefloxacin HCl eq. to Lomefloxacin HCl eq. to
Lomefloxacin…..200mg Lomefloxacin…400mg
Reg.No.035628
2. Ralfate 500mg Tablets Ralfate 1g Tablets Approved by
Each tablet contains:- Each tablet contains:- USFDA
Sucralfate…………500mg Sucralfate…………1g
Reg.No.038165

3. Deasma Syrup Same formulation. Approved by
Each 1ml contains:- ANSM France
Ketotifen Fumarate eq, to
Ketotifen ….0.2mg
Reg.No.033973
Case No.56 Request of M/s Rakaposhi Pharmaceutical, Peshawar For Grant of Contract
Manufacturing Permission For Gesteron 10mg Tablet.
The Registration Board in 271st meeting considered various registration applications

of M/s. Rakaposhi Pharmaceutical, Peshawar of the products which earlier became invalid
due to non renewal of DML. One of such approved product viz. Gesteron 10mg Tablets (for
export purpose only) containing hormone dydrogesterone could not be manufactured by the
firm for not possessing the required facilities. Therefore the registration letter was not issued.
Now the firm has requested to grant permission for contract manufacturing of aforementioned
product from M/s Aries Pharmaceutical, Peshawar. In this regard firm has submitted
complete fresh dossier furnishing requisites of application on contract manufacturing basis.
Brand Name & Composition Deposit slip/ Date Submitted Fee

Gesteron 10mg Tablets 0583872 Rs.20000/-
Each tablet contains:- 12-6-2017
Dydrogesterone.10mg
Reg.000866-EX
Case No.57 Change of Registration Status of Resile Syrup (Reg.No. 056343) From
Contract Manufacturing To Own Manufacturing Facility.
The request of M/s. Weather Fold Pharma, Hattar for extension of Toll manufacturing
of their following product was deferred in M-250 of Registration Board for evaluation of
registration application.
Registration Contract Reg. No. Brand Name & Date of Application/
Holder Manufacturer Composition Dy. No./Fee
M/s. Weather M/s. Dyson 056343 Resile Syrup 02-07-2015
Fold Pharma, Research Labs, Each 5ml contains:- Dy. 1046
Hattar Lahore Lactulose …..3.35gm Rs.50,000/-
(Manufacturer‟s Spec)
The firm was asked to provide finished product specifications along with
manufacturing method for further processing the case. However the requisite information was
not provided at that time.

The firm was later granted approval of liquid syrup (General) section vide letter
No.F.3-6/2007-Lic (Vol-I) dated 03-04-2015. Now the firm has requested for changing the
registration status from M/s. Dyson Research Labs, Lahore to their own manufacturing
facility and submitted following documents.
i. Fee of Rs. 100,000/-
ii. COA of Lactulose Solution USP From Fresinus Kabi, Austria
iii. Stability study of three batches at storage conditions stated as under:
a. 40 ºC ± 2 ºC /75%RH ± 5% (6 Months)
b. 30 ºC ± 2 0C /65%RH ± 5% (24 Months)
iv. Copy of GMP certificate issued by Austrian Medicine & medical Devices Agency in
favourof M/s Fresinus Kabi, Austria GmbH.
Case No.58. Deferred Product of M/s Genome Pharmaceuticals, Hattar.
Tofan Tablet of M/s Genome Pharmaceuticals, Hattar was deferred in 218th meeting
of Drug Registration Board held on 8-6-2009 for review of formulation.The details of the
case along with current status is given as under.
Brand Name & Previously Decision of Decision of M-269 Remarks

Composition Demanded M-218
pack &
price
Tofan Tablets 3x10‟s/ Deferred for Keeping in view present Claimed
Each sugar coated tablet Rs.300.00 review approval status of above Specifications:
contains:- committee. formulations in ANSM Manufacturer's/
Phloroglucinol…….80mg France, Registration Innovator.
Trimethyl Board approved the Formulation is
Phloroglucinol…….80mg formulation of non
(Anti Spasmodic) Phloroglucinol pharmacopeial.
80mg/Trimethylphloroglu Demanded Pack:
cinol 80mg tablet. The As per SRO
Board also advised to Demanded Price:
evaluate registration As recommended
applications as per the by PRC
checklist approved in
251st meeting for further
consideration of
Registration Board.
The firm has now deposited complete fresh fee of Rs.20,000/- alongwith form-5 & other relevant
documents in accordance with the approved check list.

Case No.59. Approved Products of M/s Aries Pharmaceuticals, Peshawar.
Following products of M/s Aries Pharmaceuticals, Peshawar were approved with
change of brand name in 271st meeting of Registration Board. The details of the case along
with current status is given as under.
S.No Brand Name & Composition Demanded Decision of M- Remarks
pack size & 271
price
1 Segon Injection 30mg 1ml x 5 Approved with 1. The registration letter has been
Each ml contains: ampoules change of brand with held as another strength
Pentazocine (as / Rs: name. (25mg tablet) is already
lactate)…………30mg 125/-
registered in favour of firm
(BP Specs) under the same brand name
(M-218, dated 12-8-2009).The
salt however is HCl which may
also requires re consideration.
2. The same brand name has
been granted to M/s Saydon
(M-227) dated 28-09-2010
which may also require to be
changed.
3. Sosegon is registered brand
name of M/s Sanofi Aventis.
2 Neurozone Injection 500mcg 1ml x 10 Approved with The registration letter has been with
Each 1ml ampoule contains: ampoules Innovator‟s held as another strength (500mcg
Mecobalamin …500mcg / specifications and tablet) is already registered in
(As per Innovator‟s Rs: 936/- change of brand favour of firm under the same brand
Specification) name. name (M-212, dated 22-07-2008).
Case No.60. Registration of Astoxil 500mg Capsule of M/s. Astellas Pharmaceuticals,

Peshawar.
Following product of M/s Astellas Pharmaceuticals, Peshawar was approved in 270TH
meeting of Drug Registration Board. However registration letter was with held for correction
in form-5/ label claim in accordance with the standard formulation approved by Reference
Regulatory Authorities i.e. Cefadroxil as monohydrate….500mg.
Name of Manufacturers Name of Drugs with composition. Demanded pack Decision

size & price
M/s. Astellas Astoxil 500mg Capsule 10‟s Approved.
Pharmaceuticals (Pvt.) Ltd, Each capsule contains: As per SRO
Hayatabad, Peshawar Cefadroxil monohydrate…500mg
The firm has now submitted a fresh form 5 along with relevant documents stating "Cefadroxil
as monohydrate…….500mg" & requested for issuance of registration letter.

Registration -V
Case: No.61: Registration of M/s. Pharma Lord, Layyah.
Registration Board in its 237th meeting approved the following products of M/s.
Pharma Lord, Layyah as per below mentioned details.
S. Name of Firm and Demanded Decision Remark
No. Composition MRP & Pack
Size
1 Paralord 500mg Tablets 3x10‟s Approved subject to Firm has
Each tablet contains:- Rs.175.0 submission of submitted
Paracetamol B.P…500mg dissolution test method dissolution test
(NSAID, antipyretic) method
(USP)
2 Diclord 50mg Tablets 2x10‟s Approved subject to Firm has
Each enteric coated tablet Rs.90.00 submission of dissolution submitted
contains:- test method. The firm dissolution test
Diclofenac sodium…..50mg shall claim enteric method
(anti-rheumatics) coating in composition (USP)
and Label which was not
mentioned in the file
3 Tramol 37.5 + 325mg Tablets 1x10‟s Approved subject to Firm has
Each tablet contains:- Rs.115.00 submission of dissolution submitted
Tramadol…..37.5mg test method. The firm dissolution test
Paracetamol…..325mg shall claim film coating method
(analgesic/xanthine in composition and Label (USP)
which was not mentioned
in the file.
4 Ferro+F 200/0.1mg Capsules 30‟s Rs.58.94 Approved subject to
Each capsule contains:- submission of dissolution
Ferrous Sulphate……200mg test method.
Folic acid…..0.1mg
(Haemitinic/vitamin)
5 Irofit 50mg Dry powder 10‟s bottle Approved. Approved but
Suspension packing registration
Each 5ml contains:- Rs.70.00 letter not issued
Iron elemental Iron…..50mg Formulation
Folic acid…..0.35mg clarification
(haematonic prevention required
&treatment of iron deficiency Regarding iron
anemia) salt
Last GMP inspection report has been submitted by firm dated 26-5-2017. Firm has
been requesting for issuance of Registration letters.
Decision: Registration Board approved products mentioned at Sr. no. 1-4 and
deferred product mentioned at Sr. no. 5 for clarification of formulation

Case No.62: Corrections in formulation of M/s Star Laboratories (Pvt) Ltd, Lahore.
M/s Star Laboratories (Pvt) Ltd, Lahore has requested for correction in formulation of
following products is available as per detailed below:-
Sr.# Reg. Product Name Proposed Change in International
no. Formulation availability
1. 043378 Neuro Plus 250mg injection Neuro Plus 250mg injection ANSM France
Citicoline Sodium…..250mg Citicoline (as sodium)…250mg
2. 043377 Neuro Plus 1g injection Neuro Plus 1g injection Spain
Citicoline Sodium…..1g Citicoline (as sodium)…..1g
3. 024389 Aspar Injection Aspar Injection MHRA
Each 2ml contains Each 2ml contains
Ranatidine……….50mg Ranatidine (as HCl)...50mg
The firm has submitted the following documents:-

i. Fee Rs.5,000/- for each product.
ii. Copy of registration Letter and renewal status
iii. Copy of NOC for CRF.
Decision: Registration Board approved correction in formulation of above products.
Case No.63: Change of specification of M/s. Unexolabs (Pvt) Ltd, Lahore

M/s. Unexolabs (Pvt) Ltd, Lahore has requested for change of thickness of tablet as
per detailed below:
S.No Product name Registration no.
1. Unexin 500mg tablet 068123
Each tablet contains:
Naproxen sodium---500mg
It is submitted that customers‟ feedback regarding present parameter/thickness is that

tablet thickness is unappealing to the patients. Following documents have been submitted by
the firm as per SOP approved by the Registration Board in its 240th meeting for the purpose
of change of excipients of products.
1.
Application with required fee as per relevant SRO
2.
Copy of registration letter and renewal status
3.
NOC for CRF clearance
4.
Specification of existing and proposed excipients / Flavour / Colour
5.
Document confirming that proposed excipient / inactive is of pharmaceutical grade
6.
Data for 06 months accelerated stability studies

7.
Undertaking that real time stability studies would be continued till whole of shelf life and in case
of OOS (out of specifications), the applicant will inform PE&R accordingly.
Detail of excepients has been provided by the firm as:
Sr.no Excipients Maximum Optimum Previous Proposed

Range according to
FDA/tablet
For Core Tablet
1. Lactose 453.6mg 300mg 100mg
2. Starch 160mg 60mg 130mg
3. P.V.P K30 42mg 10mg 20mg
4. Magnesium Stearate 28.31mg 6mg 10mg
5. Sodium Starch Glycolate 90mg 10mg 30mg
6. Microcrystalline Cellulose (Avicel) 152mg Nil
7. Methyl paraben 2mg Nil
Total 290mg
For Coating
8. Isopropyl Alchol (as solvent) NA 220mg 220mg
9. Titanum Dioxide 24.23mg 8mg 1mg
10. Talcum(magnesium silicate) 14.3mg 16mg 2mg
11. Eudragit E-100 7.2mg 6mg 2mg
(dimethylaminoethyl methacrylate,
butyl methacrylate, and methyl
methacrylate copolymer)
12. Carnauba Was 5mg Nil 0.3mg
13. Carbon Tetrachloride Nil 6mg
14. Color Blue Nil 10mg
Total 26mg
Decision: Registration Board deferred for further deliberation in forthcoming meeting.
Case No.64: Registration of M/s. Unison Chemical Labs, Lahore.

Following application of M/s. Unison Chemical works Lahore was approved in 226 meeting
as per policy 10 molecules. The firm applied 31 applications for new section. At the time of
issuance of registration the firm was granted registration of ten molecules (15 products) dated
16th September, 2010. Now the firm has requested grant the registration of following
approved product:-
Sr. No. Drug name and composition Demanded Demanded
Pack size Price
1. Cloneron 2mg Tablets 30‟s As per
Each tablet contains:- SRO
Clonazepam…..2mg
The case was presented before Registration Board in 241st meeting and decided as follows:
Decision: Request of the firm was deferred till decision of CLB for Controlled drugs.
The firm has informed that they have manufactured the granted products and
requested for issuance of registration of above product. They have deposited differential fee

of Rs. 12000/-. They have informed that they possess separate approved Tablet Psychotropic
section. They have also provided copy of approval letter by Licensing Section.
The case presented before R.B in 255th meeting and decided as follows:
Decision: Registration Board deferred the case and advised concerned section to apprise
the Board about date of submission of registration application.
It is submitted that above mentioned application was submitted on 15th July 2010
(Rs.8,000/-) and differential fees (Rs 12000/-) was deposited on 29th November 2013.
Decision: Registration Board approved above mentioned product of M/s. Unison

Chemical Labs; Lahore
Case No.65: Registration of M/s. Pharma Lord (Pvt) Ltd, Layyah.

Registration Board in 237th meetings defer the following products of following
product of M/s. Pharma Lord, Layyah for review of formulation as per detailed below:-
S. No Name of Product Decision Remarks
1 Anlid 100mg Tablets Dissolution test Nimesulide 100mg has been
Each tablet contains:- not present. approved by R.B in 269th meeting.
Nimesulide……100mg Molecule under
(anti-rheumatics) review
Since the above mentioned formulation has been approved by the Board in 269th
meeting hence the firm has requested for granting registration. Last GMP inspection report
has been submitted by firm dated 26-5-2017.
Decision: Registration Board approved above mentioned product of M/s.Pharma Lord;
(Pvt) Ltd, Layyah
Case No.66: Registration of M/s Pharmix Laboratories, Lahore.

M/s. Pharmix Laboratories, Lahore has requested for registration of following product
for export purpose only:-
S. No Name of Products
1. Iropal Syrup 15mg
Each 5ml contains:
Iron Protein Succinylate to elemental iron…….15mg
2. Iropal Tablets 15mg
Each Chewable Tablet contains:
Iron Protein Succinylate to elemental iron…….15mg
The firm has submitted the following documents.

a. Fee of Rs. 50000/- each product for this purpose.
b. Form-5.
c. Copy of GMP inspection.
d. Export orders.
c. NOC for CRF.
e. Approval of section by CLB.

The case was discussed in 258th meeting of Registration Board and decided to defer the
case for submission of Form-5D, differential fee of Rs: 30,000, approval status by reference
regulatory authorities as the product is a new formulation and not registered locally.
The firm has completed the required fee of Rs. 50000/- per product and reference of
Philippines has been provided as international availability for product at serial no 02. For
serial no 01 no authentic reference has been provided. These products are to be exported to
Botswana Africa.
The case was presented again in 259th meeting and decided as follows:
Decision: Registration Board observed that neither me-too status of applied formulations
was confirmed neither these drugs were approved by reference regulatory
authorities; also the applicant failed to produce any evidence in this regard.
However, case was deferred for confirmation whether these formulations were
approved in importing country or previously these formulations were
registered exclusively for export purpose.
The firm has submitted registration certificates / evidence of registration of above
mentioned products in countries such as Lao, Timor Leste and Burundi where firm intends to
export.
Decision: Registration Board approved above mentioned products of M/s. Pharmix

Laboratories, Lahore for export purpose
Case No.67: Registration of M/s. Wilshire Laboratories (Pvt) Ltd , Lahore.
Registration Board in its various meetings approved the following product of M/s.
Wilshire Laboratories (Pvt) Ltd, Lahore as per below mentioned details.
S.No. Name of Name of drug and Demanded Decision Remarks
firm composition MRP/Pack
size
M/s. Zave 3/25mg Capsule 10‟s Approved Deficient
Wilshire Each capsule contains:- 20‟s subject to the documents already
Laboratorie Olanzapine…………3mg 30‟s submission submitted.
s, Lahore. Fluoxetine as HCl…25mg 14‟s of stability Formulation is
data.(M-215) FDA approved.
As Per
SRO
-do- Zave 6/25mg Capsule 10‟s -do- Deficient
Each capsule contains:- 20‟s documents already
Olanzapine………..6mg 30‟s submitted.
Fluoxetine as HCl…25mg 14‟s Formulation is
As Per FDA approved
SRO
-do- Mucinex Tablet 10‟s Approved FDA approved
Each tablet contain:- 20‟s (M-227) formulation
Pseudoephedrine 30‟s is extended
Hydrochloride….60mg release
Guaifenesin…… 600mg As per
SRO

-do- Mucinex D Tablet 10‟s -do- FDA approved
Each tablet contains:- 20‟s formulation
Pseudoephedrine HCl 30‟s is extended release
….120mg
Guaifenesin …….1200mg As per
SRO
Firm has been requesting for issuance of Registration letters.

Differential fees of above mentioned products have been submitted by the firm
Decision: Registration Board approved products of M/s. Wilshire Laboratories (Pvt)

Ltd , Lahore, mentioned at Sr. no. 1-2 and deferred products mentioned at
Sr. no. 3-4 for clarification of formulation
Case No.68: Correction in minutes regarding product of M/s. Pharma Lord, Layyah.
Registration Board in its 237th meetings approved the following product of M/s.
Pharma Lord, layyah, Lahore as per below mentioned details.
Name of product. Proposed correction Demanded Date of
MRP/ Pack Submission
size
Cpro 250mg Dry Powder Cpro 125mg Dry Powder 60ml 22.01.2013
Suspension Suspension Rs.220.00
Ciprofloxacin……250mg Ciprofloxacin……125mg
(anti-infectives, quinolones) (anti-infectives, quinolones)
In minutes of 237th meeting of Registration Board there was typographic error where
Ciprofloxacin 250mg Dry Powder Suspension was mentioned instead of Ciprofloxacin
125mg Dry Powder Suspension however Ciprofloxacin 250mg Dry Powder Suspension is
already registered (076845) in the name of Pharma Lord.
Since the above mentioned formulation has been approved in 269th meeting of
Registration Board. Firm requested for granting registration for above mentioned
formulation.
Decision: Registration Board deferred for further delioberation.
Case No.69: Grant of registration for export purpose of M/s. Pacific Pharmaceuticals
(Pvt.) Ltd; Lahore.
Registration Board in 256th meeting deferred the case of M/s. Pacific Pharmaceuticals
(Pvt.) Ltd; Lahore as per below mentioned decision of the Registration Board for export
purpose only:-
S. No Name of Products Remarks
1. Ethambutol 100mg Tablet The firm has submitted international
Each tablet contains: availability in New Zealand and
Ethambutol Hydrochloride BP….100mg Indonesia.

Decision: Registration Board deferred as follows:
 Products at S.No. 1, 2 and 3 for confirmation of section for Narcotic Drugs and
Psychotropic substances from Licensing division.
 Products at S.No.4-7 for confirmation of approval status in reference regulatory
authorities.
Now the firm has submitted the reference of MHRA where ethambutol hydrochloride
100mg tablet is available hence it is requested for granting registration letter of product
mentioned at Sr.No.04.
Decision: Registration Board approved above mentioned product of M/s. Pacific
Pharmaceuticals (Pvt.) Ltd; Lahore for export purpose.
Case No.70: Change Of Specification M/S. The Searle Company Limited, Lahore.
The Searle Company Limited, Lahore has applied for change of specifications of their
already registered products as at the time of initial registration the specs were mentioned as
manufacturer but now these products are mentioned in latest USP-38. Now the firm has
request for change the specification as given below:
Sr. Proposed Renewal
Reg. No. Name of Drug(s) with formulation
No. Change status
From 04th May
Lumark Tablet 750mg
1. Manufacturer 2019
054507 Each tablet contains:
Specification to
Levetiracetam……………………500mg
USP
 Fee Deposit slips Rs. 5,000 Each product
 Copy of the registration letter and renewal status.
 Copy of reference (USP 38 NF 33, 2015).
Decision: Registeration Board acceded to the request of M/s Searl Company Ltd,
Lahore and approved USP Specifications for above mentioned drug.
Case No.71: Registration of M/s. Searle IV Solutions (Private) Limited, Lahore.

Registration Board in its 236th meeting approved the following product of M/s. Searle
IV Solutions (Formerly M/s Mac &Rains Pharma (Pvt) Ltd, Lahore as per detailed below:-
Name of firm Product Name Pack Demanded Remarks

size MRP
M/s. Mac & Rains Aqua Mac 5ml Rs.5.00 Approved.
Pharma, Lahore. Each 5ml contains:-
Water for injection……5ml
The firm has submitted balance fee Rs.12000/- on 14.03.2016 and requested for

Decision: Registration Board approved above mentioned product of M/s. Searle IV
Solutions (Formerly M/s Mac &Rains Pharma (Pvt) Limited Lahore.

Case No.72: Registration of ARSOPORE tape of M/s Arsons Pharmaceutical Industries
(Pvt) Ltd, Lahore
Registration Board in its 202nd meeting approved the application of M/s Arsons
Pharmaceuticals Industries (Pvt.) Ltd; Lahore for their product “Arsopore” (Permeable Non-
woven Surgical Synthetic Adhesive Tape) held on 08thDecember, 2006. M/s Arsons
Pharmaceuticals Industries (Pvt.) Ltd; Lahore have requested for issuance of registration
letter. At the time of issuance of registration letter it was observed that product is just
adhesive tape without medicament. It can also be used for other purpose.
The case was presented before Registration Boards in 254th meeting as follows:
Name and address Brand Name Type of Form Remarks on the Remarks by
of manufacturer / (Proprietary formulation (if Evaluator
Applicant name + Dosage Initial date, diary any) including
Form + Strength) International
Fee including status in stringent
Composition differential fee drug regulatory
agencies /
Pharmacological Demanded Price / authorities
Group Pack size
Me-too status
Finished product GMP status as
Specification depicted in latest
inspection report
(with date) by the
Evaluator
M/s Arsons Arsopore Tape Form-5 International International
Pharmaceuticals, Permeable Non- Rs.8,000/- availability not availability not
Lahore woven Surgical Rs.12,000/- confirmed. confirmed.
Synthetic 1.25cmx3.5cm
Adhesive Tape. 1.25cmx4m
(B.P) 1.25cmx4.5m Me-too:Nichipore
1.25cmx5m by M/s Uniferoz
Rs.115/- Karachi.
Rs.131.10/-
Rs.148.35/-
Rs.164.50/-
Decision: Case was deferred for opinion/ comments of Medical Devices Division.
Letter (along with original dossier) was sent to MD&MC division for furnishing comments
on above mentioned product. Accordingly comments were forwarded by concerned division.
After examination of documents following comments/opinion from this division is
submitted as follow;
i. It is submitted that applicant has provided reference of British Pharmacopoeia 1988
Volume II as evidence for tests conducted. Please Refer to policy of PE&R for
version of Reference standard for making any decision.
ii. It is submitted that applicant was asked to clarify that source of raw material that is
from 3M industrial adhesives and Tape division, it reveals that it is designed to use
for minimize foaming voids when packing containers due to high permeability of
material used. It is also pertinent to mention that manufacturer mentioned above
claimed best results when applied to clean dry surface between 60-80 ˚F (15-27 ˚C)
however, Human body temperature normally regulated and maintained at 98.6 ˚F or
37 ˚C temperature. Furthermore, due to sweating skin is not dry all the time.

iii. Applicant firm has replied that due to typographically mistake, they provided VENT
TAPE 3294 OF 3MTM Company instead of PAPER TAPE 2214 of 3MTM Company
which can withstand use in temperature upto 200 ˚F or 93˚C for upto 30 minutes.
iv. Upon further evaluation of case it is revealed that the product is Non Sterile adhesive
tape (Adhesive Plaster) without any medicament. Furthermore, it is submitted that
under DRAP Act, 2012 Schedule-I, Section 2 (b) Product mentioned above is defined
as drug;
“Abortive and contraceptive substances, agents and devices, surgical
ligatures, sutures, bandages, absorbent cotton, disinfectant, bacteriophages,
adhesive plasters, gelatin capsules and antiseptic solution”.
v. It is submitted that under Section 7 of the Drugs Act, 1976 Above mentioned product
shall be dealt by PE&R Division till amendment in DRAP Act, 2012.
Decision: Keeping in view comments of MD&MC division, Registration Board approved

the above mentioned product of M/s Arsons Pharmaceuticals, Lahore.
Case No.73: REGISTRATION OF M/S. SAFFRON PHARMA, FAISALABAD.

Registration Board considered following products of M/s. Saffron Pharma, Faisalabad
in various meetings and decided as follows:
S. Name of Name of the Products Demanded Decision of SRA
No Firm MRP/ Pack Registration Board/ approval
size meeting no. status
1. M/s. Saffron Angitryl 6.5mg Tablets 30‟s Approved subject to the Not
Pharma Each tablet contains:- Rs.185.80 Good GMP Inspection confirmed
Faisalabad Glyceryl in last one year and
trinitrate…..6.5mg first ten molecules per
section. (M-224)
2. -do- Angitryl Tablet 2.5mg 30‟s -do- Not
Each tablet contains:- Rs.157.22 confirmed
Glyceryl Trinitrate
…..2.5mg
(B.P Specs)
3. -do- Loclot Tablet 75mg 10‟s -do- FDA
Each tablet contains:- Rs 140.00 aaproved
Clopidogrel as 30‟s
bisulphate…..75mg Rs 360.00
4. -do- Prosdin Tablet 3mg 1‟s Approved MHRA
Each tablet contains:- Rs.480.00 (M-225) approved
Dinoprostone (BP) Vaginal
….3mg tablet
5. Tricol Tablets 10‟s Approved subject to FDA
Each tablet contains:- Rs.130.00 fulfillment of policy. approved
Tramadol HCl BP (M-225)
……… 37.5mg
Paracetamol BP..325mg
(Saffron‟s Specs)
6. -do- Prosdin Gel 3g Deferred for expert MHRA
Each gram contains: - Rs.150.00 opinion. approved
Dinoprostone BP ….. (M-225) Me-too
0.02% w/w available
Dinoprose
(Himont),

Glandin
(Nabiqasim)
7. -do- Clear 0.3% w/w Cream 15gm Approved FDA
Each gram contains:- Rs.400.00 (M-218) approved
Adaplene……0.3% w/w
Firm has submitted last GMP inspection report dated 28th Nov, 2016. Now the firm has
requested for granting registration letters.
Differential fees of above mentioned products is submitted by the firm (dated 18.12.2013)
Decision: Registration Board considered the request of M/s Saffron Pharma, Islamabad
and decided as follows:
a) Approved products mentioned at Sr. no. 3, 5 and 7
b) Deferred products mentioned at Sr. no 1-2 for confirmation of approval
status in reference countries.
c) Deferred products mentioned at Sr. no. 4 and Sr. no. 6 for confirmation of
section where products to be manufactured
d) Deferred product mentioned at Sr. no. 4 for clarification of applied route of
administration
Case No.74: Transfer of Registration of M/S Synchro Pharmaceuticals, Lahore

M/s Synchro Pharmaceuticals, Lahore has requested for transfer of registration of below
mentioned product from M/s. PDH Pharmaceuticals (Pvt) Ltd, Lahore to M/s Synchro
Pharmaceuticals, Lahore as per detailed below:-
S.No Reg No Name of Drug & Composition Approval status
in reference countries
1 028047 Macrol Tablet 100mg Not confirmed
Roxithromycin……………………100mg
2 028048 Macrol Tablet 150mg TGA approved
Each tablet contains:- Film coated tablet
3 028049 Macrol Tablet 300mg TGA approved
Each tablet contains:- Film coated tablet
4. 000711 Ferrodin Syrup (iron preparation)
5. 018609 Ranit Tablet Film coated tablet
Each tablet contains: MHRA approved
Ranitidine as Hydrochloride……..150mg
The firm submitted the following documents:-
ii. NOC from M/s PDH pharma Lahore (dated 17.07.2017)
iii. Form-5
iv. Copy of registration Letter and renewal
v. Copy of DML
vi. Copy of last DML inspection report conducted on 29.03.2016.
Registration Board decided as follows:
 Deferred request for product mentioned at Sr. no. 1 for confirmation of
approval status in reference countries.
 Deferred request for product mentioned at Sr. no. 4 for clarification of
formulation.

 Cancellation of products mentioned at S.No 2,3 and 5 from the name of
M/s PDH pharmaceuticals (Pvt) Ltd Lahore.
 Approved registration of products mentioned at S.No 2,3 and 5 in the
name of M/s Synchro pharmaceuticals, Lahore.
Maximum Retail Price (MRP.
Case No.75: Correction in composition of M/s. Seatle (Pvt) Ltd, Lahore.

M/s. Seatle (Private) Limited, Lahore for issuing corrigendum for below mentioned
registered product as per following details:
S.No Reg.No. Existing Name of Drug Proposed Name & International
(s) & Composition Composition availability
1. 071442 Femestelle-35 Tablet Femestelle-35 Tablet Co pyrindiol (MHRA
Each tablet contains Each tablet contains approved)
Cypretonone Cyproterone acetate…2mg Cyproterone acetate 2
acetate…2mg Ethinyl Estradiol…..0.035mg milligrams and
Ethinyl ethinylestradiol 35
stradiol…..0.035mcg micrograms
2. Plantar lotion Plantar lotion Salactol Collodion
071440 Each5ml contains:- Each ml contains:- approved in
Salicylic Acid ….16.7% Salicylic Acid ….16.7% UK/MHRA i.e
LacticAcid……….16.7% LacticAcid……….16.7% Salicylic Acid 16.7%,
LacticAcid 16.7%
The firm has submitted following documents.
i. Application with fee of Rs.5000/-
ii. NOC for CRF
iii. Copy of registration letter and renewal.
There is typographic error in formulation mentioned at Sr,no. 1, verified from formulation
approved in reference Regulatory Authority. However proposed correction in formulation
mentioned at Sr. no. 2 is as per maketing requirement, regardless of approval status in SRA.
Decision: Registration Board aceeded to request of M/s seatle (pvt) Ltd, Lahore for
correction in formulationof above mentioned drugs
Case No.76 Registration of M/s. BJ Pharmaceuticals, Lahore.

Registration Board in its 237th meeting approved following products of M/s. BJ
Pharmaceuticals, Lahore as per below mentioned details.
S. Name of firm Product Name Pack MRP Dated of Remarks
# size Submission
1. M/s. BJ Artrin Tablets 2x8‟s As 29-6-2012 WHO approved
Pharmaceutica Each tablet contains:- 2x10‟s Per formulation
ls, 19Km Artementher…..20mg 3x10‟s SRO
Sheikhupura Lumefantrine..120mg
Road Lahore (antimalarials)
2. -do- Metazole 200mg 10x10‟s -do- -do-
Tablets 20x10‟s MHRA
Each tablet contains:- 1x500‟s approved
Metronidazole...200mg 1x1000‟
(amoebicides) s
3. -do- Xeforge 5/80mg 2x7‟s -do- -do- MHRA
Tablets 4x7‟s approved
Each tablet contains:- 2x10‟s
Amlodipine…..5mg 4x10‟s
Valsartan……80mg
(calcium antagonist)
4. -do- Metazol 400mg Tablets 10x10‟s -do- -do- MHRA
Metronidazole..400mg 50x10‟s
(amoebicides) 1x500‟s
1x1000‟
s
5. -do- Befen 400mg Tablets 10x10‟s -do- -do- MHRA
Ibuprofen….400mg 10x25‟s
(Propionic acid) 10x50‟s
1x250‟s
1x500‟s
6. -do- Xeforge5/160mg 2x7‟s -do- -do- MHRA
Amlodipine….5mg 4x10‟s
Valsartan…..160mg
7. -do- Xeforge10/160mg 2x7‟s -do- -do- MHRA
Amlodipine….10mg 4x10‟s
Valsartan…..160mg
8. -do- E-Ome-20 Capsule 1x14‟s -do- -do- Source
Each capsule contains:- 2x14‟s m/s vision
Esomeprazole as 1x10‟s pharma
magnesium 2x10‟s Islamabad
trihydrate…..20mg
(antipeptic ulcerants) FDA approved
9. -do- Ome-20 Capsule 1x14‟s -do- -do- Source
Each capsule contains:- 2x14‟s m/s Vision
Omeprazole….20mg 1x10‟s pharma
(antipeptic ulcerants) 2x10‟s Islamabad
10. -do- Ome-40 Capsule 1x14‟s -do- -do- Source
Omeprazole….40mg 1x10‟s pharma
(antipeptic ulcerants) 2x10‟s Islamabad
FDA approved
11. -do- E-Ome-40mg Capsule 1x14‟s -do- -do- Source
Esomeprazole as 1x10‟s pharma
magnesium trihydrate 2x10‟s Islamabad
……40mg FDA approved
(antipeptic ulcerants)
Last GMP inspection report dated 24.03.2017 is submitted (Fair compliance). Firm has
Firm has submitted differential fees for above mentioned products.
Decision: Registration Board approved above mentioned products of M/s. BJ
Pharmaceuticals, Lahore
Case N0.77 REGISTRATION OF M/S. BJ PHARMACEUTICALS , LAHORE.
Registration Board in its 237th meeting approved the following product of M/s. BJ
The case was presented before Registration Board in 272nd meeting and decided as follows:
Name of firm Name of product and Demanded Remarks
composition MRP/ Pack
size
M/S. BJ B-Compound Tablets 1000‟s Approval status in
Pharmaceuticals Each tablet contains:- 10x100‟s SRA not confirm
,Lahore. Vitamin B1…..1mg
Vitamin B2…..1mg As per SRO
Nicotinamide…..15mg
Decision: Registration Board deferred product for confirmation of approval status by

reference regulatory authority.
The applied formulation is found in BNF 73 (March –Sept 2017) hence firm requested for
approval of above mentioned formulation for registration.
Last GMP inspection report dated 24.03.2017 is submitted (Fair compliance). Firm has
Decision: Registration Board deferred product for confirmation of approval status by
reference regulatory authority.

Case No.78: Correction in Minutes (271st Meeting).
Registration Board in its 271st meeting approved following products of M/s Aptcure
pharma, Lahore for contract manufacturing by M/s English Pharmaceutical, Lahore:
No. Applicant Contract Name of Drug (S) & Remarks
Manufacture Composition
1. M/s. Aptcure M/s. English Aptxone 250mg IV Injection Firm has submitted
(Pvt) Ltd Lahore Pharmaceutical, Each vial contains:- remaining fee of
Lahore Ceftriaxone Sodium USP Eq. to Rs.42,000/- on
Ceftriaxone…………250mg 08.07.2013
2. -do- -do- Aptxone 500mg IV Injection -do-
Each vial contain:-
Ceftriaxone sodium eq. to
Ceftriaxone…. 500mg
3. -do- -do- Aptxime 1 gm Injection -do-
Each vial contain:-
Cefotaxime Sodium….1000mg
4. -do- -do- Aptcef 1g Injection -do-
Cefoperazone Sodium .500mg
Sulbactam Sodium ….500mg
5. -do- -do- Aptcef 2g Injection -do-
Cefoperazone as sodium
1000mg
Sulbactam as sodium
…1000mg
6. -do- -do- Aptpime 500mg Injection -do-
Cefipime HCl………..500mg
7. -do- -do- Aptpime 1g Injection -do-
Cefipime HCl…1000mg
8. -do- -do- Aptzime 250mg Injection -do-
Cefotaxime as sodium ...250mg
9. -do- -do- Aptzime 100mg Suspension -do-
Each 5ml contains:-
Cefixime………….100mg
10 -do- -do- Aptzime 400mg Capsule -do-
Cefixime………….400mg
Decision of 271st meeting of Registration Board.
Decision: Registration Board acceded to request of M/s Aptcure pharma, Lahore for
contract manufacturing of above mentioned products by M/s English
Pharmaceutical, Lahore as per Rule 20A of drugs (L, R & A) Rules, 1976.
Products mentioned at Sr. 3 and 8 were erroneously included in agenda instead following
products were supposed to be added as per detailed below:
S.No Name of Product& formulaion Applied/corrected name of product

and formulaion
1 Aptxime 1 gm Injection Each Atone 1g Injection
vial contain:- Cefotaxime Each vial contains:-
Sodium….1000mg Ceftriaxone (as sodium)….1000mg
2 Aptzime 250mg Injection Aptzime 200mg DS Suspension
Each vial contains:- Each 5ml contains:-
Cefotaxime as sodium ...250mg Cefixime………….200mg
Decision: Registration Board noted the correction in minutes of 271st meeting.
Case No.79: Clarification of Formulation (M/sMediceena Pharma, Lahore).

Letter received from Assistant Director (I&E), Lahore wherein they have requested
for clarification of formulation as per detailed below:-
Reg.No Name of firm Name of the drugs with composition
071160 M/s. Mediceena Omefill Infusion
Pharma, Lahore Each 10ml contains:-
Omeprazole sodium eq toOmeprazole……40mg
It is stated that firm applied for issuance of clearance for import of 6-kg omeprazole
sodium sterile however above registration shows that product is registered as infusion rather
than lyophilized powder for injection.
The registration of product under discussion has been verified form original
registration letter wherein formulation is mentioned as“Each 10ml contains:-Omeprazole
sodium eq. to Omeprazole 40mg”. whereas Registration Board approved formulation as
“Each vial contains:-Omeprazole sodium eq. to Omeprazole40mg”
Keeping in view position explain in above para‟s corrigendum may be issued to firm
regarding correction in formulation, however same may be communicated to field office.
Decision: Registration Board approved correction as “Each vial

containsOmeprazole sodium eq. to Omeprazole40mg”
Case No.80: Grant of drug manufacturing license (DML) No.000732 of M/s Fizi
Pharmaceuticals & Chemical Laboratories, Lahore.
Central Licensing Board in its 253rd meeting considers the case of M/s. Fizi
Pharmaceuticals, Lahore for the grant of Drug Manufacturing License.
The Central Licensing Board in its 253rdmeeting held on 15-16thMay 2017 has considered the
panel inspection report and did not approve the grant of Drug Manufacturing Licenseafresh
by the way of formulation.
Decision: Registration Board noticed that renewal of Drug Manufacturing License
of M/s Fizi Pharmaceuticals& Chemical Laboratories, Lahore (DML
No.000732) was due on 23.06.2016. However, firm did not submit renewal
application in time. Accordingly, Central Licensing Board in 250th
meeting decided that DML of M/s Fizi Pharmaceuticals& Chemical
Laboratories, Lahore is not valid and same was communicated on
08.12.2016. Furthermore, the firm applied for re-grant of DML and
Central Licensing Board in its 253rd meeting held on 15th-16th May 2017
did not approve the grant of Drug Manufacturing License afresh by the
way of formulation. Keeping in view aforementioned position,
Registration Board decided that all products registered in the name of
M/s Fizi Pharmaceuticals, Lahore stand invalid w.e.f 08.12.2016.

Case No.81: Correction in Specification of Products of M/s Next Pharmaceutical (Pvt)
Ltd, Lahore.
M/s. Next Pharmaceutical Products (Pvt) Ltd, Lahore has requested for correction in
specification as per detailed below:-
Sr.# Regn # Product Name & existing Specification Proposed Specification
1 084468 Glinext MR tablet Glinext MR tablet
Each modified release tablet contains:- Each modified release tablet contains:
Gliclazide………………………..30mg Gliclazide…………………..30mg
(BP Specification) (As per innovator‟s specification)
2. 084468 Glinext MR tablet Glinext MR tablet
Each modified release tablet contains:- Each modified release tablet contains:
Gliclazide……………………..60mg Gliclazide………………..60mg
(BP Specification) (As per innovator‟s specification)

i. Application for change of specification.
ii. Copy of registration letter.
Applied formulation (modified release) does not exist in BP monograph.
Decision: Registration Board acceded to the request of M/s. Next Pharmaceutical

Products (Pvt) Ltd for correction in specification.
Case No.82: Registration of M/s. Don Valley Pharmaceutical (Pvt) Ltd, Lahore.
Registration Board in its 228th meeting approved the following product of M/s. Don
Valley Pharmaceutical (Pvt) Ltd, Lahore as per detailed below:
Sr.No Name of product and formulation Pack Demanded Remarks
. size Price
1. Clamentin Drops 62.5mg/ml 20ml As per Approved
Each ml contains:- SRO SRA approval
Amoxicillin….50mg not confirm
Clavulanic acid (as Potassium)…….12.5mg
(Anti-biotic)
The firm has requested for issuance of registration letter of above mentioned
product.The required section i.e. Dry powder suspension (penicillin) is approved by Central
Licensing Board (dated 21st June, 2009).
Decision: Registeration Board deferred the request of firm for confirmation of

approval status in reference countries

Case No.83: Contract Manufacturing.
Registration Board in its 250th meeting approved the following products of M/s.
Hamaz Pharmaceuticals (Pvt.) Ltd; Multan for contract manufacturing of below mentioned
products by M/s Novamed Pharmaceutical, Lahore.
S# Applicant Contract Name of Drug (S) & Reg# Date of
Manufacture/ Composition Application
transfer of /Fee
contract
manufacturing
product
1. M/s. Hamaz M/s. Novamed Teraxone Injection 1gm 052901 14-06-2017
Pharmaceutic Pharma, Lahore to Each vial contains:- Rs. 20,000/-
als (Pvt.) Ltd; M/s. Hamaz Ceftriaxone as sodium …..1gm
Lahore Pharmaceuticals (USP Specs)
(Pvt.) Ltd; Lahore
2. -do- -do- Teraxone Injection 500mg 052905 -do-
Ceftriaxone as sodium.500mg
(USP Specs)
3. -do- -do- Teraxone Injection 250mg 052913 -do-
Ceftriaxone as sodium..250mg
(USP Specs)
4. -do- -do- Ravicef Injection 1gm 052902 -do-
Cefazoline as sodium..1gm
(USP Specs)
5. -do- -do- Bactazime Injection 500mg 052903 -do-
Ceftazidime as
Pentahydrate….500mg
(USP Specs)
6. -do- -do- Ravicef Injection 500mg 052906 -do-
Cefazoline as sodium…500mg
(USP Specs)
7. -do- -do- Ravicef Injection 250mg 052908 -do-
Cefazoline as sodium…250mg
(USP Specs)
8. -do- -do- Bactazime Injection 250mg 052910 -do-
Ceftazidime………250mg
(USP Specs)
9. -do- -do- Bactazime Injection 1gm 052911 -do-
Ceftazidime……….1gm
(USP Specs)
10. -do- -do- Foxime Injection 1gm 052907 -do-
Cefotaxime as sodium…1gm
(USP Specs)
11. -do- -do- Foxime Injection 500mg 052914 -do-
Cefotaxime as sodium..500mg
(USP Specs)
12. -do- -do- Foxime Injection 250mg 052915 -do-
Cefotaxime as sodium..250mg
(USP Specs)
Decision: Registration Board extended contract manufacturing permission of above

products for further 05 years i.e. 30.06.2020 in light of Rule 20 A (Contract manufacturing)
of Drugs (Licensing, Registering & Advertising) Rules, 1976.
Now the firm has requested for transfer of above mentioned products his own plant as the
CLB has granted cephalosporin injectable section (dated 03.08.2015) to M/s. M/s. Hamaz
Pharmaceuticals (Pvt.) Ltd; Multan.
Decision: Registration Board granted permission to M/s. Hamaz Pharmaceuticals

(Pvt.) Ltd;Lahore for manufacturing above mentioned registered
products from contract manufacturing basis to own manufacturing site.
Case No.84: Registration of M/s Dyson Research Laboratories, Lahore.
Registration Board in its 236th meeting approved the following product of M/s Dyson
Research Laboratories, Lahore subject to the product specific inspection of the firm.
S Name of the drugs with Pack Proposed Decision Remarks

.No composition Size Price
1. Dyalfa 0.25mcg Tablets 10‟s As per Approved subject to the PMDA
Each tablet contains:- SRO product specific (Japan)
Alfacalcidol………..0.25mcg inspection of the firm. Approved
(Vitamin D Analogue)
2. Dyalfa 0.5mcg Tablets 10‟s As per Approved subject to the PMDA
Each tablet contains:- SRO product specific (Japan)
Alfacalcidol……….0.5mcg inspection of the firm. Approved
3. Dyalfa 1mcg Tablets 10‟s As per Approved subject to the PMDA
Each Tablet contains:- SRO product specific (Japan)
Alfacalcidol…………..1mcg inspection of the firm. Approved
4. Dyflomide Tablets 10mg 30‟s Rs.600.00 Approved subject to the MHRA
Each film coated tablet product specific approved
contains:- inspection of the firm.
Leflunomide USP………10mg
(Immunomodulatory Agent,
Dissease modifying anti-
rheumatic drug)
5. Dyronate Tablets 70mg 4‟s Rs.1000.00 -do- MHRA
Each film coated tablet approved.
contains:-
Alendronate (as sodium)
USP…70mg
(Drugs for treatment of bone
diseases, Bisphosphonates)
6. Dyfeb Capsule 67mg 30‟s Rs.300.00 Approved. MHRA
Each capsule contains:- approved
Fenofibrate BP………..67mg
(Hypolipidaemic)
7. Dyfeb Capsule 200mg 10‟s Rs.200.00 Approved. MHRA
Each capsule contains:- approved
Fenofibrate BP…….200mg
(Hypolipidaemic)
8. Dymet 1gm Tablets 30‟s Rs.105.00 Approved. MHRA

Each film coated tablet approved
contains:-
Metformin HCl USP…1gm
(Anti-hyperglycemic)
Now the firm has submitted the latest GMP inspection report conducted on 01.08.2017.and
requested for registration of above mentioned product.Firm has submitted differential fees for
above mentioned products dated 26.10.2017
Decision: Registration Board approved above mentioned products of M/s. Dyson

Research Laboratories, Lahore.
Case No.85: Registration of M/s Novamed Pharma (Pvt) Ltd, Lahore.
M/s. Novamed Pharma (Pvt) Ltd, Lahore has requested for registration of following product
for export purpose only:-
S .No Name of the drugs with composition Me too status
1. Novasolam Xanax (Pfizer)
Alprazolam……………….0.5mg
2. Sumpamol CF Tablet Panadol CF (GSK)
Paracetamol BP…………..500mg
Pseudoephedrine Hydrochloride BP……….60mg
Chlorpheniramine Maleate BP……………….4mg

b. Form-5.
c. Copy of GMP inspection (08.02.2017)
d. NOC for CRF.
e. Approval of section by CLB (yet to be confirmed)
f. Undertaking for export only purpose

 Deferred the product mentioned at Sr. No. 1 for approval status of psychotropic/
narcotic section by CLB
 Approved the grant of registration of product mentioned at Sr. no. 2.
Manufacturer will comply following conditions before export of drugs:
i. Manufacturer will export the product after complying all the
requirements as required under Drug Act, 1976 and relevant rules
including No Objection Certificate from concerned DRAP office.
ii. Manufacturer will also furnish export documents endorsed from
custom authorities (if required for any query) in order to ensure
the export of the product.

Case No.86: Registration of M/s Unison Chemical Works, Lahore.
M/s. Unison Chemical Works has requested for registration of following product for export
purpose only:-
S .No Name of the drugs with composition Me too status
1. O‟ Serene 1mg Tablet Ativan (pfizer)
Lorazepam……………………….1mg
b. Form-5.
c. Copy of GMP inspection (12.07.2017)
d. NOC for CRF.
e. Approval of section by CLB (25.08.2010)
f. undertaking for export only purpose
Decision: Registration Board approved the grant of registration of O’ Serene 1mg
Tablet. Manufacturer will comply with following conditions before export
of drugs:
i. Manufacturer will export the product after complying all the
requirements as required under Drug Act, 1976 and relevant rules
including No Objection Certificate from concerned DRAP office.
ii. Manufacturer will also furnish export documents endorsed from
custom authorities (if required for any query) in order to ensure
the export of the product
Case No.87 Correction In Formulation Of M/S Star Laboratories (Pvt) Ltd, Lahore
M/s Star Laboratories (Pvt) Ltd, Lahore has requested for correction in formulation of
following products is available as per detailed below:-
Sr.# Regn # Product Name Required Change in Formulation Remarks
on Registration Letter
1. 043364 Amicin Injection 500mg Amicin Injection 500mg FDA
Each 2ml contains:- Each 2ml contains:- approved
Amikacin Sulphate………500mg Amikacin (as sulphate)………500mg
2. 043363 Amicin Injection 250mg Amicin Injection 250mg FDA
3. 005609 Licobect Injection Licobect Injection FDA
Each ml contains:- Each ml contains:- approved
Lincomycin HCl….300mg Lincomycin (as HCl)….300mg
4. 052737 Lignocaine 1% Injection Lignocaine 1% Injection FDA
Lignocaine as HCl…………10mg Lignocaine HCl…………10mg
5. 043362 Amicin Injection 100mg Amicin Injection 100mg MHRA
6. 043375 Montel Tablet Montel Tablet FDA
Each tablet contains:- Each tablet contains:- approved
Montelukast Sodium…..5mg Montelukast (as sodium)………..5mg
7. 043376 Montel Tablet Montel Tablet FDA
Each tablet contains:- Each tablet contains:- approved
Montelukast Sodium…..10mg Montelukast (as sodium)…..10mg

ii. Copy of registration Letter/renewal status.
iii. Copy of NOC for CRF.
Decision: Registration Board acceded to the request of M/s Star Laboratories (Pvt) Ltd,
Lahore for correction in formulation.
Case No.88: Correction/change of specifications.
a) M/s. Stallion Pharmaceuticals (Pvt) Ltd, Lahore has applied for change of
specifications of already registered product as at the time of initial registration the
specs were mentioned as manufacturer‟s specification. Since applied formulation
available in BP hence firm has requested for change the specification as given below:
Sr. Reg. Proposed Renewal
Name of Drug(s) with formulation
No. No. Change status
1 Ampistal Dry Powder Suspension From Valid
Each 5ml contains: Manufacturer‟s
077228
Ampicillin Trihydrate eq to Specification
Ampicillin……………………..…125mg TO BP

 Fee Deposit slips Rs. 5,000 for this purpose.
 Copy of the relevant registration and renewal letters
 Copy of NOC for CRF.
 Reference of BP.
Decision: Registration Board acceded to the request of M/s Stallion
Pharmaceuticals (Pvt) Ltd, Lahore for change of specifications from
Manufacturer’s Specification to BP.
b) M/s. Friends Pharmaceuticals (Pvt) Ltd, Lahore has applied for correction of
specifications of already registered product as at the time of initial registration the specs
were mentioned as BP specification whereas applied formulation is not available in any
official monograph hence firm has requested for correction of specification of below
mentioned product:
Sr. Renewal status
Reg. No. Name of Drug(s) with formulation
No.
1 Ferifend tablet 20mg Valid
046029 Each tablet contains:
Piroxicam …..20mg

 Application / request for correction of specification
Decision: Registration Board approved innovator's specifications.

Case No.89: Transfer Of Registration M/S. EnglishPharmacetuicals Industries, Lahore.
M/s. English Pharmaceuticals industries, Lahore has requested for transfer of

registered product from M/s. Ferroza International (Pvt), Ltd. Lahore as per detailed below:-
Sr. No Reg. No Name of product & formulation

1. 085215 Onefer Injection
Each 5ml contains
Iron sucrose complex eq. to:-
Elemental iron………………..100mg
(USP Specification)
The firm has submitted following documents.

i. Application with fee of Rs.20000/- for this purpose.
ii. Form-5
iii. NOC from M/s. Ferroza International (Pvt) , Ltd. Lahore (dated 17th
September,2017).
M/s. Ferroza International (Pvt), Ltd. Lahore
English Pharmaceuticals industries, Lahore
Case No.90: Allocation Of Quota For Control Substances Ephedrine HCl for the year
2017 to M/S Sharex Laboratories, Sadiqabad.
Letter received from Assistant Director (CD) (Dated 21st Sep, 2017) wherein it has been
stated that M/s Sharex Laboratories, sadiqabad applied for quota allocation of product
“Tracodil syrup (Reg. 003158). The case was presented before 43rd meeting of committee on
allocation of controlled drug held on 26th July, 2017, the comittee deferred the case for
issuance of show cause by DRAP for manufacturing of Tracodil syrup (Reg. 003158) 60ml,
400ml pack without approval.
It was requested to verify the status of product registration of Tracodil syrup (Reg. 003158)
400ml pack size.
The approved pack sizes of product “Tracodil Syrup” (Reg no. 003158) have been verified as
per available record i.e 120ml, 450ml (National Formulary 1981) and 60ml (dated 27 th
October 1988).
Decision: Registration decided to call M/s Sharex Laboratories, Sadiqabad for

personal hearing and for deliberating above mentioned matter before the
Registration Board

Case No.91: Registration of M/s. Don Valley Pharmaceutical (Pvt) Ltd, Lahore
Registration Board in its 218th meeting approved the following product of M/s. Don
Valley Pharmaceutical (Pvt) Ltd, Lahore as per detailed below:
Sr.No Name of product and formulation Pack Demanded Remarks
. size Price
1. Clamentin –Duo Dry powder suspension 5ml Rs.8.50 Approved
400/57mg
Each 5ml contains:- MHRA approved
Amoxycillin trihydrate….400mg AUGMENTIN DUO®
400/57 co-amoxiclav
Clavulanic acid ….57mg
(amoxicillin and
clavulanic acid)
Last GMP inspection was conducted on 19.05.2017. The firm has requested for issuance of
registration letter of above mentioned product.
The required section i.e Dry powder suspension (penicillin) is approved by Central Licensing
Board (dated 21st June, 2009). Demanded pack size as clarified by the firm is 70ml.
Decision: Registration Board approved above mentioned product of M/s Don Valley
Pharmaceutical (Pvt) Ltd, Lahore
Case: No.93 REGISTRATION OF M/S. BJ PHARMACEUTICALS, LAHORE.

Registration Board in its 237th meeting approved following products of M/s. BJ
S.No Name of firm Product Name Pack size MRP Remarks
1. M/s. BJ 2x10‟s As MHRA approved
Pharmaceutica 3x10‟s per Each tablet consists
Orotec 50/200mcg
ls, 19Km 4x10‟s SRO of a gastro-resistant
Tablets
Sheikhupura core containing
Each Tablet Contains:
Road Lahore 50mg diclofenac
Diclofenac
sodium surrounded
Sodium……...50mg
by an outer mantle
Misoprostol …..200mcg
containing 200mcg
misoprostol.
2. -do- Bemol Suspension 60ml As
Each 5ml Contains: 90ml per MHRA aaproved
Paracetamol………........ 400ml SRO
.............120mg 450ml
3. Metazole Syrup 60ml As MHRA aaproved
Each 5ml Contains: 90ml per
Metronidazole as 120ml SRO Oral suspension
benzoate..…200mg 400ml
4. Recta Sachet 10‟s As ANSM approved
Each Sachet Contains: 20‟s per
Dioctahedral Smectite 30‟s SRO
…………….3gm 40‟s
Last GMP inspection report dated 24.03.2017 is submitted (Fair compliance). Firm has been
requesting for issuance of Registration letter and sunmitted differential fee.
 Deferred product at S.No.01 for confrmation of manufacturing technology.
 Approved products at S.No.02-04.

Case No.94: Registration of M/s. Fynk Pharmaceuticals, Lahore.
a) Registration Board in 226th meetings deferred the following products of M/s. Fynk
Pharmaceuticals, Lahore for review of formulation as per detailed below:-
Name of firm Name of drug & composition Demanded Demanded Decision
pack size MRP
M/s. Fynk Nim 100mg Tablets 2x10‟s Rs.90.00 Referred to
Pharmaceuticals, Each tablet contains:- review
Sheikhupura Lahore Nimesulide……………..100mg committee
The above mentioned formulation has been approved by Registration Board in 269th
meeting as follows:
Decision: Registration Board deliberated the case and decided as follows:
Keeping in view the approval status of Nimesulide 100mg tablet in EMA, the Registration Board
approved the formulation of Nimesulide Tablets 100mg with a pack size of 15 tablets as per
recommendations of EMA only for the following clinical indications as a second line choice.
 Treatment of acute pain
 Primary dysmenorrhea.
The case was presented before Registration Board in 271st meeting and decided as follows:
Decision: Registration Board deferred the request of M/s Fynk Pharmaceuticals,
Sheikhupura, Lahore for latest GMP inspection conducted during last 01 year
and clarification differential fees (Rs.12,000/-) for each product.
The firm has submitted differential fees (12,000/-) dated 12.10.2017 and latest GMP
inspection report dated 20.09.2017.
Decision: Registration Board approved Nim 100mg Tablets ofM/s. Fynk
Pharmaceuticals, Lahore.
b) Registration Board in 226th and 228th meetings deferred the following

products of M/s.Fynk Pharmaceuticals, Lahore for review of formulation as per
detailed below:-
Name of Product Decision Decision of 268th meeting
Piram Tablets Deferred forKeeping in view present approval status of above
Each tablet contains:- review formulations in ANSM France the Registration
Piracetam….800mg committee(M- Board approved the above formulation of
228) Piracetam 800mg tablets. The Board also advised
to evaluate above registration applications as per
the checklist approved in 251st meeting for further
consideration of Registration Board.(M-268)
The case was presented before Registration Board in 270th meeting and decided as follows:
Decision: Registration Board deferred request of M/s Fynk Pharma, Lahore for
submission of GMP report during last one year.
The firm has submitted latest GMP inspection report dated 20.09.2017 and submitted
differential fee.
Decision: Registration Board approved Piram Tablets ofM/s. Fynk Pharmaceuticals,

Lahore

c) Registration Board deferred the following product of M/s. Fynk Pharmaceuticals,
Lahore in 237th meeting for review of formulation as per detailed below:-
S. No Name of Product Decision 237th Decision of 268th meeting
meeting
1 OME-S Capsule F.Ins.report?? Decision: Keeping in view the
Each capsule contains:- Active ingredient approval status of above
Omeprazole…………40mg manuf: formulations in USFDA,
Sodium bicarbonate..1100mg specifications Registration Board approved
(Anti-ulcer) details? following formulations of
Formulation omeprazole, sodium bicarbonate
currently deferred
2. OME-S Capsule Formulation -do-
Each capsule contains:- currently deferred.
Omeprazole……….20mg Active ing:s manuf:
Sodium bicarbonate…1100mg specifications
(Anti-ulcer) details??
The firm has requested for registration of above mentioned product as above formulation
approved in 267th meeting. Last GMP inspection report has been submitted by firm (dated
20.09.2017) indicating overall GMP compliance and submitted differential fee.
Decision: Registration Board approved above products ofM/s. Fynk Pharmaceuticals,

Lahore

Case No. 95. Registration of Sims Pharmaceuticals (Pvt) Ltd.
M/s. Simz Pharma Lahore has requested for granting registrations of
following products approved in 241st meeting.
S. Name of Firm Name of the drugs with Demanded Decision
No composition MRP/Pack
1. M/s. SIMZ Diclosim-75m g Tablets Each size 10‟s Not confirmed
Pharmaceuticals (Pvt)Ltd, tablet contains:-Diclofenac As per SRO
Sundar Industrial Estate, Potassium ….75mg ( ana l g
Raiwind Road, Lahore es ic)
New Licenses
i. Tablet (General/
General Antibiotic)
ii. Capsule (General/
General Antibiotic)
iii. Liquid Syrup Section
iv.Dry powder suspension
(General/General
Antibiotic).
2. -do- Simfexo 60mg Tablets Each 10‟s Approved
tablet contins:- As per SRO Approved in SRA
Fexofenadine HCl….60mg
(anti allergic)
3. -do- Simfexo 120m g Tablets Each 10‟s Approved
tablet contins:-Fexofenadine As per SRO Approved in SRA
HCl….120mg (anti allergic)
4. -do- Simfexo 180m g Tablets Each 10‟s Approved
tablet contins:-Fexofenadine As per SRO Approved in SRA
HCl….180mg (anti allergic)
5. -do- Zithosim 500m g Tablets Each 6‟s Approved
tablet contains:- As per SRO Approved in SRA
Azithromycin as
dihydrate…500mg
(macrolide antibacterial)
6. -do- Simclar 250m g Tablets 10‟s Approved
Each tablet contains:- As per SRO Approved in SRA
Clarithromycin….250mg
(antibiotic)
7. -do- Simclar 500m g Tablets Each 10‟s Approved
tablet contains:- As per SRO Approved in SRA
Clarithromycin…..500mg
(antibiotic)
8. -do- Fansimz 80-480mg Tablets 7‟s Approved
Each tablet contains:- As per SRO WHO approved
Artemether….80mg
Lumefentrine….480mg (anti
malarial)
The firm has submitted GMP inspection report dated 19.08.2017 showing GMP COMPLIANCE on
Decision: Regiostration Board decided as follows:
 Deferred products at S.No.01 and 08 for approval status in reference regulatory
authorities.
 Approved products at S.No.02-08 for registration.

Case No.96: Correction in formulation/specification of M/S. CCL Pharmaceuticals,
Lahore.
M/s. CCL Pharmaceuticals (Pvt) Lahore has requested for correction in

formulation/specification as per detailed below:-
Sr.# Regn # Product Name Proposed correction in formulation

on Registration Letter
1. 035755 Montair Chewable tablet 4mg Montair Chewable tablet 4mg
Each tablet contains:- Each Chewable tablet contains:-
Montelukast (as sodium)……..4mg Montelukast sodium eq to.
Montelukast …………………..4mg
2. 029951 Montair tablet 5mg Montair Chewable tablet 5mg
Each tablet contains:- Each chewable tablet contains:-
Montelukast ……..5mg Montelukast sodium eq to:-
3. 029952 Montair tablet 10mg Montair tablet 10mg
Each tablet contains:- Each film coated tablet contains:-
Montelukast ……..10mg Montelukast sodium eq to:-
The above mentioned proposed corrections are as per FDA approved formulations
 Fee Deposit slips Rs. 5,000 for each product.
 Copy of NOC for CRF.
 Reference of USP .
Decision: Registration Board acceded to the request of M/s. CCL Pharmaceuticals
(Pvt) Lahore for correction in formulation

Item No. IV: Biological Evaluation & Registration Division
Case Details of application No. of

No. applications
1. Application for Imported Human Biologicals from Reference Countries 5
2. Application for Imported Human Biologicals from Non-reference 2
Countries
3. Application for Imported Human Biologicals from Reference Countries 2
(New Molecule/Formulation in Pakistan)
4. Applications for Imported Veterinary Biologicals from Non-reference 2
countries
5. Miscellaneous/ Deferred cases of previous meeting 16
Total Cases 27

Case No.01: Applications for Imported Human Biologicals from Reference Countries.
1. Name of Importer M/s AJM Pharma (Pvt) Ltd. 1st Floor, Shafi Court Merewether
Road, Civil Lines Karachi
Name of Manufacturer M/s BLES Biochemicals Inc. 60 Pacific Court, Unit 8 London,
Ontario Canada N5V3K4
Brand Name +Dosage Form + BLES, Suspension, 27mg/ml
Strength
27mg phospholipids and 176-500mcg surfactant-associated
proteins Band C
Finished product Manufacturer‟s Specs
specifications
Approval status of this Canada
product in Reference countries
Pharmacological Group Lung surfactants, natural phospholipids
Shelf life 36 months at -10oC, 10 months at 2-8oC
International Availability of Canada, India, New Zealand, South Africa, Bolivia, Iran,
this product Moldova, Ecuador, Saudi Arabia, Gulf Cooperation, Georgia,
Ukraine, Chile
Similar Product already Survanta of Getz Pakistan.
registered in Pakistan
Type of Form Form 5-A,
Dy No & Date of application, Dy. No. 5880(R&I) Date: 13-06-2017
Fee submitted Rs. 50,000/- Date: 09-06-2017
Demanded Price/ Pack size Rs. 11,250/3ml
General documentation Legalized CoPP No 66292 issued on 18-05-2017 expire 1 year
from date of issue.
Product is available in country of origin.
Remarks of Evaluator The firm has submitted
(Muhammad Sarfraz Nawaz i. Phase-I, open, single dose, single centre.
AD) ii. Phase-II, randomized, double-blind, placebo-controlled,
single dose, single centre, 2-year follow up.
iii. Phase-III, randomized, comparative (with Exosurf
Neonatal and Survanta) double-blind, multi-dose, multi-
centre.
iv. Published efficacy data of drug product is available.
v. Copy of Sole Agency Agreement is provided.
Decision:
Keeping in view valid legalized CoPP and approval of Health Canada (Reference
Regulatory Authority/country); Registration Board approved the product subject to
price fixation by the Federal Government and compliance of current Import Policy
for Finished Drugs.
2. Name of Importer M/s AJM Pharma (Pvt) Ltd. 1st Floor, Shafi Court Merewether
Road, Civil Lines Karachi
Name of Manufacturer M/s BLES Biochemical Inc. 60 Pacific Court, Unit 8 London,
Ontario Canada N5V3K4
Brand Name +Dosage Form + BLES, Suspension, 27mg/ml
Strength
27mg phospholipids and 176-500mcg surfactant-associated
proteins Band C
Finished product Manufacturer‟s Specs
specifications
Approval status of this Canada

Pharmacological Group Lung surfactants, natural phospholipids
Shelf life 36 months at -10oC, 10 months at 2-8oC
International Availability of Canada, India, New Zealand, South Africa, Bolivia, Iran,
this product Moldova, Ecuador, Saudi Arabia, Gulf Cooperation, Georgia,
Ukraine, Chile
Similar Product already Survanta of Getz Pakistan.
Demanded Price/ Pack size Rs. 18,750/5ml
General documentation Legalized CoPP No 66291 issued on 18-05-2017 expire 1 year
from date of issue
Remarks of Evaluator The firm has submitted
(Muhammad Sarfraz Nawaz) i. Phase-I, open, single dose, single centre.
ii. Phase-II, randomized, double-blind, placebo-controlled,
single dose, single centre, 2-yr follow up.
iii. Phase-III, randomized, comparative (with Exosurf
Neonatal and Survanta)double-blind, multi-dose, multi-
centre.
iv. Published efficacy data of drug product is available
v. Copy of Sole Agency Agreement is provided.
Decision:
Keeping in view valid legalized CoPP and approval of Health Canada (Reference
Regulatory Authority/country); Registration Board approved the product subject to
price fixation by the Federal Government and compliance of current Import Policy
for Finished Drugs.
3. Name of Importer M/s Novo Nordisk Pharmapvt. Ltd
113, Shahrah e Iran, Clifton, Karachi
Name of Manufacturer Manufacturer (Also responsible for batch release in the EU and
primary packaging):
M/s Novo Nordisk A/S, Novo Alle`,DK-2880 Bagsvaerd,
Denmark
Sites responsible for secondary packaging:
M/s Novo Nordisk A/S, Brennum Park,3400Hillerod, Denmark
[AND] Recipharm Stockholm AB, Legervagen 7,13650 Jordbro,
Sweden.
Brand Name +Dosage Form + FiaspFlexTouch 100 units/ml
Strength Solution for injection in pre-filled pen
Composition Each ml of solution contains….100 units (600 nmol) of insulin
aspart (equivalent to 3.5 mg)
One pre-filled pen contains 300 units of insulin aspart in 3 ml
solution.
Finished product In-house based on Ph. Eur. Specs
specifications
Approval status of this Available in Reference country
International Availability of EU
this product
Similar Product already Not registered .
Shelf life 30 months at 2-8 0C
Dy No & Date of application, Dy. No. 11869(R&I) DRAP Date: 15-08-2017
Demanded Price/ Pack size Pack sizes of 1 (with and without needle),5(without needles) pre-
filled pens and multipack containing 10(2 pack of 5) (without
needles) pre-filled pens.
General documentation Legalized CoPP No.04/17/110085 dated 16-06-2017
GMP No.DKH 00062915 dated 22/09/2015
Remarks of Evaluator: Copy of Sole Agency Agreement is provided.
(Mr. Saadat Ali Khan)
Decision:Keeping in view valid legalized CoPP and approval of European Medicine
Agency (EMA) (Reference Regulatory Authority); Registration Board approved the
product subject to price fixation by the Federal Government and compliance of
current Import Policy for Finished Drugs.
4. Name of Importer M/s Novo Nordisk Pharma Pvt., Ltd

113, Shahrah e Iran, Clifton, Karachi.
Name of Manufacturer Manufacturer (Also responsible for primary packaging):
Denmark
M/s Novo Nordisk A/S, Hallas Alle`,4400Kalunborg, Denmark.
Brand Name +Dosage Form + FiaspPenfilled100 units/ml
Strength Solution for injection in Cartridge
Composition Each ml of solution contains….100 units (600nmol) of insulin
aspart (equivalent to 3.5 mg)
One Cartridge contains 300 units of insulin aspart in 3 ml
solution.
specifications
Approval status of this Product is approved in reference country
International Availability EU
Similar Product already Not registered.
Anatomical therapeutic A10AB05
chemical (ATC) code

Demanded Price/ Pack size Pack sizes of 5 and 10 Cartridges

GMP No. DKH 00062915 dated 22/09/2015
Remarks of Evaluator Copy of Sole Agency Agreement is provided.
(Mr. Saadat Ali Khan)

5. Name of Importer M/s Novo Nordisk Pharmapvt Ltd
113, Shahrah e Iran, Clifton, Karachi
Name of Manufacturer Manufacturer (Also responsible for batch release in the EU and
primary packaging):
Denmark.
M/s Novo Nordisk A/S, HallasAlle`,4400 Kalunborg, Denmark.
Brand Name +Dosage Form + Fiasp100 units/ml
Strength Solution for injection in vial
Composition Each ml of solution contains….100 units of insulin aspart
(equivalent to 3.5 mg)
One vial contains 1000 units of insulin aspart in 10 ml solution.
specifications
Approval status of this Not applicable, product is available in EU.
International Availability of EU
this product
Similar Product already Not Available.
Anatomical therapeutic A10AB05
chemical (ATC) code
Demanded Price/ Pack size Pack sizes of 1 vial, 5 vials and multipack containing 5(5 pack of
1).
GMP No.DKH 00062915 dated 22/09/2015
Remarks of Evaluator Copy of Sole Agency Agreement is provided.
(Mr. Saadat Ali Khan )
Decision:
Keeping in view valid legalized CoPP and approval of European Medicine Agency
(EMA) (Reference Regulatory Authority); Registration Board approved the product
subject to price fixation by the Federal Government and compliance of current
Import Policy for Finished Drugs.

Case No.02: Application for Imported HumanBiologicals from Non-reference
Countries.
1. Name of Importer Amson Vaccines &Pharma (Pvt.) Ltd.,
115, Industrial Triangle, kahuta Road, Islamabad
Name of Manufacturer M/s Biological E. Limited, Plot No.1,S.P.Biotechnology Park

Phase-II, Kolthur Village ShameerpetMandalRanga Reddy
District-500 078,Telangana,India
Brand Name +Dosage Form + BETdDiphtheria and Tetanus Vaccine (Adsorbed, Reduced
Strength Antigen(s) Content)
Composition Each dose of 0.5 ml contains:
Diphtheria Toxoid….2 Lf( ≥ 2 IU)
Tetanus Toxoid……8.8 Lf( ≥ 20 IU)
Adsorbed on Aluminiumphosphate……≥ 1.5 mg
Preservative: Thiomersal BP………0.01% w/v
Finished product In house specs
specifications
Approval status of this WHO Prequalified vaccine, as on 17.10.2017
International Availability of Nepal, Ukraine, Ivory Coast
this prodcut
Similar Product already This combination is meant for booster injection in adults and is
registered in Pakistan needed due to resurgence of diphtheria in population.

Demanded Price/ Pack size Not Provided/1 Dose Vial
General documentation Legalized CoPPNo.MHL/MDCHL/COPP/29/12/2016/02 Valid

upto 16-12-2018
Remarks of Evaluator Sole Agency Agreement is provided.

(Mr. Saadat Ali Khan AD)
Decision:
Keeping in view valid legalized CoPP and WHO prequalification of the product;
Registration Board approved the product subject to price fixation by the Federal
Government and compliance of current Import Policy for Finished Drugs.
1. Name of Importer Amson Vaccines &Pharma (Pvt.) Ltd.,
115, Industrial Triangle, kahuta Road, Islamabad
Name of Manufacturer M/s Biological E. Limited, Plot No.1,S.P.Biotechnology Park

Phase-II, Kolthur Village ShameerpetMandalRanga Reddy
District-500 078,Telangana,India
Brand Name +Dosage Form + BETdDiphtheria and Tetanus Vaccine (Adsorbed, Reduced
Strength Antigen(s) Content)
Composition Each dose of 0.5 ml contains:

Diphtheria Toxoid….2 Lf( ≥ 2 IU)
Tetanus Toxoid……8.8 Lf( ≥ 20 IU)
Adsorbed on Aluminium Phosphate……≥ 1.5 mg
Preservative: Thiomersal BP………0.01% w/v
specifications
Approval status of this WHO Prequalifed vaccine as on 17.10.2017
International Availability of Nepal, Ukraine, Ivory Coast
this product
Similar Product already This combination is meant for booster injection in adults and is
registered in Pakistan needed due to resurgence of diphtheria in population.

Demanded Price/ Pack size Not Provided/10 Dose Vial/
General documentation Legalized CoPP No. MHL/MDCHL/COPP/29/12/2016/02 Valid

upto 16-12-2018
Remarks of Evaluator Sole Agency Agreement is provided.

(Mr. Saadat Ali Khan AD)
Decision:
Keeping in view valid legalized CoPP and WHO prequalification of the product;
Registration Board approved the product subject to price fixation by the Federal
Government and compliance of current Import Policy for Finished Drugs.

Case No.03: Application for Imported Human Biologicals from Reference Countries
(New Molecule/Formulation in Pakistan)
1. Name of Importer M/s Eli Lilly (Private) Limited, Karachi
Name of Manufacturer Product License Holder:
M/s Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ
Utrecht, The Netherlands.
Name of Manufacturer:
M/s Eli Lilly and company, Lilly Corporate Center, Indianapolis,
Indiana 46285, USA
Site responsible for batch release in the EU, quality control and
secondry packaging:
M/s Lilliy S.A., Avda. De la Industria 30, Alcobendas, 28108
Madrid, Spain.
Site responsible for quality control:
M/s ImClone Systems LLC, 33 ImClone Drive, Branchburg, NJ
08876, USA.
Brand Name +Dosage Form + Lartruvo 500mg/50ml (10mg/ml) Concentrate for solution for
Strength infusion
Composition Each ml of concentrate for solution for infusion contains:
Olaratumab…………..10mg
Finished product Innovator Specs.
specifications
Approval status of this FDA approved
Pharmacological Group Anti-Cancer
Shelf life 2 years at 2-8oC.
International Availability of US, EU, UK, South Korea, Lebanon and Sweden.
this product
Similar Products already New monoclonal antibody
Demanded Price/ Pack size Not Provided/Pack of 1 Vial of 50ml. /
General documentation Legalized CoPP No 02/17/111515 issued on 04-08-2017.
Remarks of Evaluator i. As per submitted CoPP, Community Marketing Authorization
(ZubairMasood) is under conditional approval and the product is subject to
additional monitoring. Healthcare professionals are asked to
report any suspected adverse reactions.
ii. As per submitted CoPP, Marketing Authorization Holder is
Utrecht, The Netherlands while the product will be imported
from Spain as per Form-5A.
iii. Clinical trial data is not provided instead summary of Clinical
data is provided.
FDA approval status On October 19, 2016, the U.S. Food and Drug Administration
granted accelerated approval to olaratumab (LARTRUVO, Eli
Lilly and Company) for the treatment of patients with soft tissue
sarcoma (STS) not amenable to curative treatment with
radiotherapy or surgery and with a histologic subtype for which an
anthracycline-containing regimen is appropriate.
FDA granted olaratumab fast track and breakthrough therapy
designation, priority review status, and accelerated approval for
this indication. As a condition of the accelerated approval, Eli
Lilly and Company is required to conduct a randomized,
controlled trial to verify and further describe the clinical benefit of
olaratumab given with doxorubicin in patients with STS.
Olaratumab also received orphan drug designation.
2. Name of Importer M/s Eli Lilly (Private) Limited, Karachi
Name of Manufacturer Product License Holder:
Utrecht, The Netherlands
Name of Manufacturer:
M/s Eli Lilly and company, Lilly Corporate Center, Indianapolis,
Indiana 46285, USA
Site responsible for batch release in the EU, quality control and
secondry packaging:
M/s Lilliy S.A., Avda. De la Industria 30, Alcobendas, 28108
Madrid, Spain.
Site responsible for quality control:
M/s ImClone Systems LLC, 33 ImClone Drive, Branchburg, NJ
08876, USA.
Brand Name +Dosage Form + Lartruvo 190mg/19ml (10mg/ml) Concentrate for solution for
Strength infusion
Composition Each ml of concentrate for solution for infusion contains:
Olaratumab…………..10mg
Finished product Innovator Specs.
specifications
Approval status of this FDA approved
Pharmacological Group Anti-Cancer
Shelf life 2 years at 2-8oC.
International Availability of US, EU, UK, South Korea, Lebanon and Sweden.
this product
Similar Product already New monoclonal antibody
Demanded Price/ Pack size Not Provided/Pack of 1 Vial of 19ml
General documentation Legalized CoPP No 06/17/111512 issued on 04-08-2017.
Remarks of Evaluator i. As per submitted CoPP, Community Marketing
(ZubairMasood) Authorization is under conditional approval and the
product is subject to additional monitoring. Healthcare
professionals are asked to report any suspected adverse
reactions.
ii. As per submitted CoPP, Marketing Authorization Holder is
M/s Eli Lilly Nederland B.V., Papendorpseweg 83, 3528
BJ Utrecht, The Netherlands while the product will be
imported from Spain as per Form-5A.
iii. Clinical trial data is not provided instead summary of
Clinical data is provided.
FDA approval status On October 19, 2016, the U.S. Food and Drug Administration
granted accelerated approval to olaratumab (LARTRUVO, Eli
Lilly and Company) for the treatment of patients with soft tissue
sarcoma (STS) not amenable to curative treatment with
radiotherapy or surgery and with a histologic subtype for which an
anthracycline-containing regimen is appropriate.
FDA granted olaratumab fast track and breakthrough therapy

designation, priority review status, and accelerated approval for
this indication. As a condition of the accelerated approval, Eli
Lilly and Company is required to conduct a randomized,
controlled trial to verify and further describe the clinical benefit of
olaratumab given with doxorubicin in patients with STS.
Olaratumab also received orphan drug designation.
Decision: Keeping in view valid legalized CoPP and approval of European Medicine Agency
(EMA) (Reference Regulatory Authority); Registration Board approved the product subject
to price fixation by the Federal Government and compliance of current Import Policy for
Finished Drugs.
Veterinary Biologicals
Case No.04: Applications for Imported Veterinary Biologicals from Non-reference
countries.
1. Name of Importer M/s Huzaifa International, Sargodha
Name of Manufacturer M/s VETAL HayvanSagligiUrunleriA.S.(Vetal Animal Health
Products Co.)
GolbasiKarayoluUzeri7.Km ADIYAMAN/TURKEY
Brand Name +Dosage Form + AFTOVAC
Strength (Inactivated Gel Adjuvant Vaccine)
Composition Each 3 ml dose contains:
Inactivated Foot and Mouth disease virus not less than 6 PD50
Serotype O….6 mcg
Serotype A …..3 mcg
Serotype Asia 1…..3 mcg
Aluminium Hydroxide 0.9%
Saponin 0.06%
Thiomersal (Meritiolate) 0.01%
specifications
Approval status of this FMD vaccine is approved in reference countries but strains are
productin Reference countries recommended as per their epidemiological needs.
International Availability of Not Applicable
this product
Similar Product already FMD vaccine by M/s Mustafa Brothers, Faisalabad
Demanded Price/ Pack size Decontrolled /50ml Vial
General documentation Legalized CoPP No.10/11/2004-B067429-B067430-B067431-
B067432-B0677433-B0677434-B0677435 dated 18/07/2017
(Mr. Muneeb AhmedCheema)
Decision: Vetrinary expert apprised the Board that national requirement is purified FMD
vaccine as it enables the differentiation of infected and vaccinated animals. Thus purification
process is an important from domestic point of view. Keeping in view the recommendation of
veterinary expert and valid legalized CoPP; Registration Board approved the product subject
to compliance of current Import Policy for Finished Drugs. The Board also decided that
inspecting panel should verify the purification process resulting into a vaacine based on
structural proteins only and non-structural proteins have been removed. Same verification
procedure shall be applied to all FMD vaccines across the board.

2. Name of Importer M/s Huzaifa International, Sargodha
Name of Manufacturer M/s VETAL HayvanSagligiUrunleri A.S. (Vetal Animal Health
Products Co.)
GolbasiKarayoluUzeri 7. Km ADIYAMAN/TURKEY
Brand Name +Dosage Form + AFTOVAC
Strength (Inactivated Oil Adjuvant Vaccine)
Composition Each 3 ml dose contains:
Inactivated Foot and Mouth disease virus not less than 6 PD50
Serotype O….5 mcg
Serotype A …..3 mcg
Serotype Asia 1…..3 mcg
Montanide ISA 50…50%
Chloroform 0.5%
Glycine 0.25%
specifications
Approval status of this FMD vaccine is approved in reference countries but strains are
product in Reference countries recommended as per their epidemiological needs.
International Availability of Not applicable
this similar this product
Similar Product already Oil adjuvant FMD vaccine applied by M/s Mustafa Brothers
registered in Pakistan Faisalabad approved in 262nd meeting of Registration Board

Demanded Price/ Pack size Decontrolled /50ml Vial

General documentation Legalized CoPP No.10/11/2004-B027857- B027858- B027859-
B027860- B027861- B027862- B027863- B027864 dated
18/07/2017
(Mr. Muneeb Ahmed Cheema)
Decision:Vetrinary expert apprised the Board that national requirement is purified
FMD vaccine as it enables the differentiation of infected and vaccinated animals. Thus
purification process is an important from domestic point of view. Keeping in view the
recommendation of veterinary expert and valid legalized CoPP; Registration Board
approved the product subject to compliance of current Import Policy for Finished
Drugs. The Board also decided that inspecting panel should verify the purification
process resulting into a vaacine based on structural proteins only and non-structural
proteins have been removed. Same verification procedure shall be applied to all FMD
vaccines across the board.

Case No. 5: Miscellaneous/ Deferred cases of previous meeting
a. Imported human Biologicals applied by M/s Popular International (Pvt.) Ltd.,

Karachi deferred in 262nd meeting of Registration Board.
Following products of M/s Popular International (Pvt.) Ltd., Karachi were
deferred in 262nd meeting of Registration Board as per following details:
1 Name of Importer M/s Popular International Pvt.Ltd.,,141,Justice Inamullah Road,
. Block7&8 K.M.C.H.S, Near Hill Park, Karachi
Name of Manufacturer M/s Hualan Biological Bacterin Co., Ltd., JIA No.1-1 Hualan
Ave., Xinxiang Henan, China
Brand Name +Dosage Form + Influenza Vaccine (Split Virion),Inactivated 0.5ml vial
Strength
Composition Each 0.5 ml vial contain:
H1N1 …. 15ug hemagglutinin
H3N2…….15ug hemagglutinin
B……….. 15ug hemagglutinin
(Haemaglutinin of influenza virus strain of current year as
recommended by WHOfor trivalent vaccine for season of 2017-
2018 for Northern hemisphere, each year the composition may
change as per WHO recommendations,
Finished product specifications In house Specs
Approval status in Reference

countries of similar products Fluarix, this combination is appoved by WHO and
similarvaccines are internationally available.
International Availability of this Not provided
product
Similar Products already Fluarix of GSK.
Type of Form Form 5A
Dy No & Date of application,
Fee submitted 1794/2016(R&I) dated 19-05-2016
287-DIR(BD) dated 20-05-2016
Rs.100000 dated 18-05-2016
Demanded Price/ Pack size Rs.712/Pack of 1 vial (0.5ml)
General documentation Legalized GMP certificate No. CN20130151 dated 06-06-2013
valid till 05-06-2018
Legalized Free Sale certificate No. HA20160042 dated 23-12-
2016 valid till 31-12-2018
Decision of Registration Board Deferred for submission of following:
a. Legalized CoPP/GMP & FSC certificate

b. Clarification is required as applicant has submitted both pack
size 0.25ml & 0.5ml vial in Form-5.
c. Specimen labels
d. Complete product composition along with excipients and their
roles.
e. Details of testing methods under finished product
specifications
f. Step wise details of manufacturing method and the control of
critical steps of manufacturing process.
g. Details of water processing system.
h. Soft copy not attached.
i. Accelerated and long term Stability data.
Remarks of Evaluator The firm has provided following documents:
(Muhammad ZubairMasood) a. Legalized GMP & FSC certificate
b. 0.5ml vial is WHO PQ, hence the same may be considered by
the Board.
(https://extranet.who.int/gavi/PQ_Web/PreviewVaccine.aspx?
nav=0&ID=292)
c. Specimen Labels
d. Product Composition
e. Details of testing methods under finished product
specifications.
f. Step wise details of manufacturing method and the control of
g. Details of water processing system.
h. Soft copy is not provided.
i. Accelerated & long term stability studies are not conducted
on the same batches.
Decision: Keeping in view valid legalized GMP & FSC and WHO prequalification of
the product; Registration Board approved the product subject to price fixation by the
Federal Government and compliance of current Import Policy for Finished Drugs.
2 Name of Importer M/s Popular International Pvt.Ltd.,,141,Justice Inamullah Road,
. Block7&8 K.M.C.H.S, Near Hill Park, Karachi
Name of Manufacturer M/s Hualan Biological Bacterin Co., Ltd., JIA No.1-1 Hualan
Ave., Xinxiang Henan, China
Brand Name +Dosage Form + Meningococcal Polysaccharide Vaccine(Group ACYW135)
Strength
Composition Each Human dose (0.5ml) contains:
200µg of meningococcal polysaccharideGroup ACYW135(50µg
for each serogroup A,C,Y and W 135)
Finished product specifications Manufacturer‟s Specs
Approval status of this product Not yet.
in Reference countries
International Availability of this Not provided.
product.
Similar Products already Mencevax ACWY of GSK
Type of Form Form 5A
Dy No & Date of application, 1795/2016(R&I) dated 19-05-2016
Fee submitted 288-DIR(Bio) dated 20-05-2016
Rs.100000 dated 18-05-2016
Demanded Price/ Pack size Rs.787/Pack of 1 vial (0.5ml)
General documentation Legalized GMP certificate No. CN20130151 dated 06-06-2013
Legalized Free Sale certificate No. HA20160042 dated 23-12-
2016 valid till 31-12-2018
Decision of RB in 262nd Deferred for submission/ rectification of following:
meeting
a. Legalized CoPP/ GMP & FSC certificate.
b. As 0.5 ml solvent is also the part of product so separate fee
along with the dossier needs to be submitted for the solvent.
c. Specimen labels
d. Evidence of availability in reference drug agencies
e. Evidence of local availability
f. Complete product composition along with excipients and their
roles.
g. Details of testing methods under finished product specification
h. Step wise details of manufacturing method and the control of
i. Details of water processing system.
j. Soft copy not attached.
k. Accelerated and long term Stability data.
Remarks of Evaluator The firm has provided following documents:
a. Legalized GMP & FSC certificate
b. The matter regarding separate fee for diluent in combo pack
has already been decided in 274th meeting of Registration
Board.
c. Specimen Labels
d. Menomune ACYW135 by M/s Sanofi Pasteur Inc. USA
e. Mencevax ACWY of GSK.
f. Product Composition.
g. Details of testing methods under finished product
specification.
h. Step wise details of manufacturing method and the control
of critical steps of manufacturing process.
i. Details of water processing system.
j. Soft copy is not provided.
k. Accelerated & long term stability studies are provided.
Decision:Keeping in view valid legalized GMP & FSC; Registration Board approved
the product subject to price fixation by the Federal Government and compliance of
current Import Policy for Finished Drugs
b. Change of manufacturer applied by M/s Roche Pakistan Limited, Karachi for

their under registration products Kadcyla 100mg vial and Kadcyla 160mg
vial.(Evaluator: Muhammad ZubairMasood)
M/s Roche Pakistan Limited, Karachi applied for the change of manufacturer
of their under registration products Kadcyla 100mg vial and Kadcyla 160mg vial as per
following details:
Sr. Brand Name & Composition Name of manufacturer Applied Name of
th
No. approved in 257 manufacturer
meeting of registration
Board
1. Kadcyla M/s DSM M/s Hoffmann-La Roche
(Powder for concentrate for solution for Pharmaceuticals, Inc Ltd., Wurisweg, 4303
infusion) 5900 Martin Luther Kaiseraugst,
Each vial contains: King Jr. Highway Switzerland.
TrastuzumabEmtansine………100mg Greenville, NC USA
2. Kadcyla
(Powder for concentrate for solution for
infusion)
Each vial contains:
TrastuzumabEmtansine………160mg
The firm has submitted following documents:

a. Application on Form-5A along with fee of Rs. 50000/- for each product.
b. Valid Legalized CoPP vide no. 04/17/110936 dated 13-07-2017issued by EMA
c. Comparative stability studies of batches from previous manufacturing site and new
manufacturing site.
d. Site Master File

It is submitted that aforementioned products were approved by the Registration Board
in its 257th meeting held on 24th-25th March, 2016. Accordingly, reference was sent to
Pricingdivision for price fixation and response is not yet received. Moreover, the firm has
applied for the approval of M/s Hoffmann-La Roche Ltd., Wurisweg, 4303 Kaiseraugst,
Switzerland as new manufacturing site but the submitted CoPP is indicating two
manufacturing sites recorded in above table.
Decision:Keeping in view the approval of European Medicine Agency (EMA),

Registration Board approved the change of manufacturer of Kadcyla 100mg vial and
500mg vial from M/s DSM Pharmaceuticals, Inc 5900 Martin Luther King Jr. Highway
Greenville, NC USA to M/s Hoffmann-La Roche Ltd., Wurisweg, 4303 Kaiseraugst,
Switzerlandas per valid legalized CoPP and current Import Policy for Finished Drugs.
c. M/s Medibid, Karachi applied for biological drug which was considered in 260th meeting of
Registration Board. The details are as under;
S.#. Name of Importer Brand Name Type of Form Document Remarks Decision of
& Manufacturer & Dy No & Date details Registration
Composition of application (CoPP) Board
Fee submitted Me too
Pack size/ status/New
Demanded molecule
Price
1. M/s Medibid First KXING- Form 5-A COPP No. Valid and Deferred for
floor, Shafi Court GCSF WHO- legalized expert opinion
Merewether Road, 300ug/ml Dy No. 2232 CPP- COPP/ of following
Civil Lines, PFS R&I 15-4- CERT-JN- FSC and valid
Karachi. 2013 131211 along legalized
Recombinant dated 17- with GMP COPP/FSC &
human Fee deposited 2-2013 Certificate GMP:
Shandong granulocyte Rs. 15000/- from need to be a. Brig.
KexingBioproducts colony- dated 19-4- Republic submitted Tariq
Co., Ltd. stimulating 2012 + Rs. of China as per Satti,
Mingshui factor 35000/- dated above AFBMTC
development Zone, injection 13-11-2013 + Product decision ,
Zhangqiu, Rs. 50000/- License of 255th Islamabad
Shandong, China. Strength of dated 12-1- No. GYZZ meeting. .
active 2015 S20103004 b. Brig.
ingredients: dated 29- Qamar-
300ug/ml/Pre Shelf life: 24 4-2010 un-Nisa,
Filled months AFBMTC
Syringe Pack size: Free Sale ,
300ug/ml Pre Certificate Islamabad
filled No. 2013- c. DrShamsi,
syringe/small 023 dated Karachi
carton, 10 17-2-2013
syringes/middle valid for
carton, 320 two years
syringes/big
carton
Demanded
Price.
Rs.4500/- per
vial.

As per decision of Registration Board, letter for expert opinion were issued to above
mentioned experts. Reply of Brig. Tariq Satti, AFBMTC, Islamabad and Brig. Qamar-un-
Nisa, AFBMTC, Islamabad has been received while reply of DrShamsi, Karachi has not been
received even after sending a reminder letter.
The replies from Brig. Tariq Satti, AFBMTC, Islamabad and Brig. Qamar-un-Nisa,
AFBMTC, Islamabad are as under;
1. Brig. Qamar-un-Nisa AFBMTC, Islamabad
The product (G-CSF) is used in various fields including oncology and Haematopoietic stem
cell transplantation. However numerous other brands of the same product including local
brands are freely available in the market.
We do not have any laboratory facility to assess or analyze the product stability or efficacy.
2. Brig. Tariq Satti, AFBMTC, Islamabad
I have gone through documents related to product KXING-GSF 300µg/ml PFS. It is one of
the biological products and there are more than ten brands of same ingredient are available in
market.
Unfortunately there is no authentic laboratory in Pakistan, who can assess or analyze the
stability and efficacy of the product.”
Decision: Registration Board referred the application to the working

group/committee constituted in 273rd meeting of Registration Board.
d. Transfer of registration of Ol-Vac vaccine (Reg. No. 012893) from M/s Well
Pharmaceuticals, Lahore to M/s Forward Solutions, Lahore approved in 271st
meeting of Registration Board.(Evaluator: Muhammad ZubairMasood)
M/s Forward Solutions, Lahore applied for the transfer of registration of

already registered veterinary vaccine OL-VAC (Reg.012893) in their name from M/s Well
Pharmaceuticals, Lahore. The case was approved in 271st meeting of Registration Board as
per following details:
Name of Brand Name Brand Document Decision of RB in 271st
Manufacturer & Composition as Name & details meeting
per Form-5A & Compositio (CoPP)
minutes of meeting n as per
CoPP
Product License OL-VAC Ol-Vac Legalized Registration Board
Holder: (012893) (Emulsion CoPP No. cancelled the registration in
M/s FatroS.p.A- for µ9/C dated name of M/s Well Pharma,
Via Emilia, 285 – Inactivated vaccine Injection) 21-05-2013 Lahore and granted the
40064–Ozzano in oil emulsion for Each dose registration in name of M/s
Emilia (Bologna), injection against contains: Legalized Forward Solutions, Lahore
Italy Newcastle disease Inactivated CoPP No. as per import policy for
Virus Titre: Not less Newcastle 180/2016/C finished drugs and as per
Manufacturer: than 100 PD50 for Disease dated 12-07- valid legalized CoPP. The
M/s FatroS.p.A- New castle disease virus La 2016 last renewal submission
Via Molino Virus. Sota strain. shall be verified before
Emili, 2 – 25030 Titre: not issuance of marketing
–Maclodio (BS) Shelf life: 24 months less than authorization.
Italy 100PD50

During processing the case for verification of renewal submission as per decision of
Registration Board, it was observed that the aforementioned product was initially registered
on 04-06-1996 andRRR section reported non-tractabilityof renewal submission as per
available record. Moreover, the same was indicated in the extract of note sheet provided by
RRR section for another case.
As the product registration was not valid at the time of consideration by the board, hence the
application of M/s Forward Solutions, Lahore may be considered as new registration instead
of transfer of registration.
Decision: Keeping in view the position explained above, Registration Board approved
the product as per Import Policy for Finished Drugs. The decision of
Registration Board in its 271st meeting on the product is void ab-initio.
e. Imported Veterinary Biologicals applied by M/s Vet line International, Lahore

deferred in 273rd meeting of Registration Board. (Evaluator: Muhammad
ZubairMasood)
Following products of M/s Vet line International, Lahore were deferred in
rd
273 meeting of Registration Board as per following details:
Sr. Name of Importer M/s Vet line International, Lahore
No.
1. Name of Manufacturer M/s Zhengzhou Bio-Pharmaceutical Factory of QYH Biotech
Company Limited, Shibalihe, South Surburbs, Zhengzhou City,
China.
Brand Name Avian influenza Vaccine Inactivated
(H9 Subtype SD696 Strain)
Composition Each 0.2ml of vaccine contains:
Avian Influenza Virus.........≥108.0EID50
Finished product specifications Chinese Pharmacopeia Specs
Pharmacological Group Veterinary Vaccine
Approval status of this product This product is not yet registered in reference countries but
is in reference countries similar Avian Influenza vaccine is available in USDA
International Availability of This productis available in China only
this this product
Products already registered in Bio-Avian (019003)of Bio-labs Islamabad.
Pakistan
Type of Form Form-5A
Dy No & Date of application Dy. No. 6602 Dated 19-06-2017
Fee submitted Rs. 100,000/- Dated 19-06-2017
Pack size 250ml/ Bottle
General documentation Legalized GMP certificate no. (2014) 220 dated 16-10-2014
Legalized FSC dated 22-01-2017
rd
Decision of RB in 273 Decision: Registration Board decided to defer the application
meeting and advised the firm to submit the following documents.
i. Complete stability data.
ii. Declaration of N type strain of Avian Influenza virus.
Remarks of Evaluator The firm has submitted complete stability data along with
(ZubairMasood) declaration that N2 type strain of Avian Influenza virus is used.
Decision:Keeping in view the recommendation of veterinary expert, Registration Board
approved the product as per valid legalized GMP and Free Sale Certificate subject to
compliance of current Import Policy for Finished Drugs. Veterinary expert advised to write
H9N2 in the brand name of the product

2. Name of Importer M/s Vetline International, Lahore
Name of Manufacturer M/s Zhengzhou Bio-Pharmaceutical Factory of QYH Biotech
Company Limited, Shibalihe, South Surburbs, Zhengzhou City,
China.
Brand Name New Castle Disease and Avian Influenza (H9 Subtype) Vaccine,
Inactivated (La SotaStrain+F Strain)
Composition Each 0.1ml of vaccine contains:
Newcastle disease virus...... ≥108.5EID50
Avian Influenza Virus.........≥107.5EID50
Finished product specifications Chinese pharmacopeia Specs
Pharmacological Group Veterinary Vaccine
Approval status in reference This product is not yet registered in reference countries but
countries similar Avian Influenza vaccine is available as Influenza ND
vaccine Intervet Mexico
International Availability of This product is available Only in China
this product
Similar Product already AIolvac 077561 Forward solutions import from Italy
Type of Form Form-5A
Dy No & Date of application Dy. No. 6601 Dated 19-06-2017
Fee submitted Rs. 100000/- Dated 19-06-2017
Pack size 250ml/ Bottle
General documentation Legalized GMP certificate no. (2014) 220 dated 16-10-2014
Legalized FSC dated 22-01-2017
Decision of RB in 273rd Decision: Registration Board decided to defer the application
meeting and advised the firm tosubmit the following documents.
i. Complete stability data.
ii. Declaration of N type strain of Avian Influenza virus.
Remarks of Evaluator The firm has submitted complete stability data along with
(ZubairMasood) declaration that N2 type strain of Avian Influenza virus is used.
Decision:
Keeping in view the recommendation of veterinary expert and valid legalized GMP & FSC;
Registration Board approved the product subject to compliance of current Import Policy for
Finished Drugs. Veterinary expert advised to write H9N2 in the brand name of the product
f. Transfer of Registration of ImportedHuman Biologicals from M/s Century

Pharmaceuticals (Pvt) Ltd, Karachi to M/s Shamco Traders (Pvt) Ltd. Lahore
deferred in 269th meeting of Registration Board.(Evaluator: Muhammad Sarfraz
Nawaz)
M/s Shamco Traders (Pvt) Ltd. Lahore has requested for transfer of following
registered imported drugs from the name of M/s Century Pharmaceuticals (Pvt) Ltd, Karachi
to their name. The case was deferred in 269th Meeting Registration Board held on 27-28th
April, 2017.

The products detail is as under:
Sr. Reg. No. Manufacturer Brand Name and Date of application /
No. Composition Fee status / Packing /
MRP/ Other
Documents
1 023638 M/s Dong-A ST Co., Ltd. Eporon® Injection Form – 5A
(Dong-A Pharmaceutical 2000/1.0ml Dy.No.294 R&I
Co., Ltd. Before Split-Off on Each ml contain DRAP
March 5th 2013) (Recombinant human dated 15-3-2017
(N-dong, B-dong Section 2) erythropoietin….2000IU/ml Fee deposited
493 Nongong-ro, Nongong- Rs.100,000/-
eup, Dalseong-gun, Daegu, Shelf life. 02years dated 09-03-2017
Republic of Korea GMP valid up to
23-08-2018.
FSC issue date
30-Nov-2016
2 023637 M/s Dong-A ST Co., Ltd. Eporon® Injection Form – 5A

(Dong-A Pharmaceutical 4000/1.0ml Dy.No. 295 R&I
Co., Ltd. Before Split-Off on Each unit dose contain DRAP
March 5th 2013) (Recombinant human dated 15-3-2017
(N-dong, B-dong Section 2) erythropoietin….4000IU/ml Fee deposited
493 Nongong-ro, Nongong- Shelf life. 02years Rs.100,000/-
eup, Dalseong-gun, Daegu, dated 09-03-2017
Republic of Korea GMP valid up to
23-08-2018.
FSC issue date
30-Nov-2016
The firm has submitted following documents:-
(i) Application on Form 5-A with Fee of Rs.100, 000 /- for each product.
(ii) Copy of registration letter and last renewal status.
(iii) Termination letter (original) from manufacturer for previous importer.
(iv) Authority letter/sole agent letter (original) from manufacturer.
(v) NOC from existing registration holder for transfer of registration.
(vi) Free sale issued on 30-11-2016 and GMP valid up to 23-08-2018.
Decision of 269th meeting of RB:
“Registration Board deferred the products for verification of renewal status of
the products”
The firm has provided biosimilarity data as per following details:
WHO Biosimilarity Guidelines Data Submitted by the firm
Quality Comparison Elucidation of Chemical Structure
1. Physicochemical i. Peptide Map by RP-HPLC.
Characterization ii. Amino acid Composition by Acid hydrolysis and
HPLC.
iii. Amino acid sequence and Disulfide bond by Trypsin
digestion and RP-HPLC
iv. Higher order structure by CD spectroscopy.
v. Capillary zone electrophoresis for patterns of Eporon.
vi. Monosaccharide analysis by Acid hydrolysis and Bio-
LC (HPAEC-PAD)
vii. N-glycan structure by Deglycosylation and HPLC
viii. UV spectra by UV spectroscopy
ix. Molecular weight by SDS-PAGE
x. Isoelectric focusing
xi. Biological Activity Biological activity in vivo potency test by using PLA
(Parallel line assay).
xii. Immunochemical properties Polyacrylamide gel electrophoresis and immunoblotting

test/Western blot
xiii. Impurities Product related impurities by SE-HPLC/RP-HPLC (Non-

comparative)
Stability Studies Stability study is provided.

Non-clinical Comparison Pre-clinical Studies
i. In-vitro Studies i. Pharmacokinetics study in rat for bioequalence.
ii. In-vivo Studies ii. Pharmacokinetics study in beagle dog for bioequalence.
a. Biological/ Pharmacodynamic Toxicology
activity i. Acute intravenous toxicities of DA-3285 (Eporon) were
b. Non- clinical toxicity as investigated in Sprague-Dawley rats.
determined in one repeat dose ii. The acute toxicity of DA-3285 (Eporon) was tested in
toxicity study beagle dogs.
iii. The study was conducted to investigate the subacute
intravenous toxicity of DA-3285
(Eporon) in Sprague-Dawley rats.
iv. The subchronic toxicity study of DA-3285 (Eporon) was
investigated for 13 weeks in beagle dogs intravenously.
v. The mutagenic potential of DA-3285 (Eporon) was
evaluated using the short-term genotoxicity tests
including Ames, chromosome aberration and micronuclei
tests.
vi. The local irritation studies of DA-3285 (Eporon) were
carried out in rabbits.
vii. Antigenecity of DA-3285 (Eporon) was examined in
guinea pigs and mice.
Clinical Comparison i. A randomized, double-blind, active control, single
dosing, crossover clinical trial to investigate the
pharmacokinetics of Eporon® and Eprex® after
subcutaneous administration in healthy volunteers (n=42)
ii. A Randomized, Active Comparator-Controlled, Parallel-
Group, Single-Blind, Multicenter, Phase III Study to
Evaluate the Efficacy, Safety and Immunogenicity of
Subcutaneous Eporon versus Epoetin Alfa (Eprex) in the
Treatment of Anemia Associated with Chronic Renal
Failure in Pre-dialysis Patients (n=214).
iii. A Post Marketing Surveillance to monitor the efficacy
and safety of Eporon® Inj.
The last renewal application submission of above products is confirmed by RRR section.
Decision: Keeping in view the biosimilarity data and valid legalized CoPP provided by
the firm; Registration Board cancelled the registrations of Eporon vial
2000IU (Reg. No. 023638) and Eporon Vial 4000IU (Reg. No. 023637) in
name of M/s Century Pharmaceuticals (Pvt) Ltd, Karachiand granted in
name of M/s Shamco Traders (Pvt) Ltd. Lahoresubject to the compliance of
current Import Policy for Finished Drugs, verification of cold storage facility
and comments on the price of the product from Pricing division

g. Transfer of Registration of Imported Human biologicals from M/s
Century Pharmaceuticals (Pvt) Ltd, Karachi to M/s Helix Pharma (Pvt.)
Ltd, Karachi deferred in 269th meeting of Registration Board.(Evaluator:
Sarfaraz Nawaz)
M/s Helix Pharma (Pvt.) Ltd, Karachi has requested for transfer of following
registered imported drugs from the name of M/s Century Pharmaceuticals (Pvt) Ltd, Karachi
to their name. The products detail is as under:
Sr. Reg. No. Manufacturer Brand Name and Date of application / Fee
No. Composition status / Packing / MRP
1 031337 M/s Dong-A ST Co., Ltd. Leucostim 75ug Form – 5A
(Dong-A Pharmaceutical Co., Injection. Dy.No. 1856 R&I
Ltd. Before Split-Off on Each 0.3ml vial DRAP
March 5th 2013) contains: Filgrastim dated 17-02-2017
(N-dong, B-dong Section 2) 250ug/ml
493 Nongong-ro, Nongong- Fee deposited
eup, Dalseong-gun, Daegu, Shelf life. 02years Rs.100,000/-
Republic of Korea dated 08-02-2017

Decision of 269th meeting of RB:

“Registration Board deferred the products for verification of renewal
status of the products”
The last renewal application submission of above products is confirmed by RRR section.
Decision: Registration Board referred the application to the working group/committee
constituted in 273rd meeting of Registration Board.

h. Transfer of Registration of Imported Human Biologicals from M/s
Seignior Pharma Karachi to M/s Searle Company Ltd, Karachi deferred
in 270th meeting of Registration Board.(Evaluator: Sarfaraz Nawaz)
M/s Searle Company Ltd, Karachi has requested for transfer of following
registered imported drugs from the name of M/s Seignior Pharma Karachi to their name. The
products are detailed as under:
Sr. Reg. Manufacturer Brand Name and Date of application / Decision of
No. No. Composition Fee status / Packing / 270th meeting
MRP of RB
1 021935 M/s Biosidus S.A Hemax Form – 5A Registration
Av de los Quilmes (Freeze Dried Power Dy.No. 84 R&I Board
137, Bernal Oeste, for Injection) DRAP24-04-2017 deferred the
Quilmes, Province Each unit dose above
of Buenos Aires, contains: Rs.100,000/- 24-4-2017 products for
Argentina Recombinant confirmation/
Human Pack Size: verification of
Erythropoietin 1 vial containing freeze submission of
2000IU dried powder, 1 solvent renewal by
ampoule with 2ml the firm.
Shelf life. 02years solvent for injection, 1
disposable syringe and
2 disposable needles.
Price: As per registered
price.
Av de los Quilmes (Freeze Dried Power Dy.No. 86 R&I DRAP Board
137, Bernal Oeste, for Injection) 24-04-2017 deferred the
price.
Av de los Quilmes (Freeze Dried Power Dy.No. 79 R&I Board
137, Bernal Oeste, for Injection) DRAP24-04-2017 deferred the
price.

The firm has submitted last renewal application in Biological division in time.

i. Transfer of Registration of Imported Human Biologicals from M/s

Seignior Pharma Karachi to M/s Searle Company Ltd,
Karachi.(Evaluator: Muhammad Sarfraz Nawaz)
M/s the Searle Company (Pvt) Limited Karachi has submitted an application
for transfer of registration of below mentioned registered products in name of M/s Seignior
Pharma Karachi to their name. Details of the products provided by the firm are given below:
Sr. Reg. Brand Name and Date of Initial Last CoPP details
No. No. Composition application / Fee Reg. renewal
status / Packing / date application
MRP submission
date
1 031321 Neutromax Form – 5A 11-11- 29-10-2013 Valid legalized
Injection 300mcg Dy.No. 83 R&I 2003 CoPP No.
(Solution for DRAP 24-04-2017 20132020-
injection) Rs. 100,000/- Pack 00003317
Each unit dose Size: 1 vial dated:
contains: Price: As per 12-01-2017
Filgrastim 300mcg registered price
2 031322 Neutromax Form – 5A 11-11- 29-10-2013 Valid legalized

Injection 480mcg Dy.No. 81 R&I 2003 CoPP dated:
(Solution for DRAP 24-04-2017 12-01-2017
injection) Rs. 100,000/- No on
Each unit dose 24-04-2017 proceeding
contains: Pack Size: 1 vial 00003217
Filgrastim 480mcg Price: As per
registered price
The firm has submitted following documents: -
The renewal application submission within due date is confirmed by RRR section.

j. Change of name of principal manufacturer applied by M/s Majeed Sons,
Rawalpindi deferred in 271st meeting of Registration Board.(Evaluator:
Sarfraz Nawaz)
M/s Majeed Sons, Rawalpindi, have informed that their product/vaccine

Euvax-B (recombinant) Hep-B vaccines (0.5ml & 1ml) are registered under registration No.
027389 & 017479. They have further informed that these products are manufactured by LG
Life Science South Korea and pre-qualified by WHO (World Health Organization) for
purchase by UNICEF or UN Agency.
The firm has submitted that their principle has changed its name from LG Life Science to LG
Chem South Korea. The changed name is already implemented in South Korea and at
International level. This vaccine is WHO prequalified as per 17.10.2017 WHO data.The
details of the products are as under:
S. Reg. No. Product Name and Previous Name of New Name of
No. composition Manufacturer Manufacturer as per
CoPP
1. 027389 Euvax-B Injection M/s LG Life Science M/s LG Chem, Ltd.,
0.5ml Limited Korea 129, Seokam-ro,
Each 0.5ml inj. Iksan-si, Jeollabuk-do,
Contains…. Purified Republic of Korea.
hepatitis B surface
antigen (Rdna) [Host:
Saccharomyces
cerevisiae AB110,
Vector: pYLBC-A/G-
UB-HBs…10µg
2. 017479 Euvax-B Injection 1ml M/s LG Life Science M/s LG Chem, Ltd.,
Each ml inj. Limited Korea 129, Seokam-ro,
Contains…. Purified Iksan-si, Jeollabuk-do,
hepatitis B surface Republic of Korea.
antigen (Rdna) [Host:
Saccharomyces
cerevisiae AB110,
Vector: pYLBC-A/G-
UB-HBs…20µg
The firm has submitted following documents

i. Fee Rs. 5000/- for change of name for above products.
ii. Legalized FSC and CoPP indicating LG Chem, Ltd., formerly named as LG
Life Sciences Ltd
iii. Form 5A.
iv. Copy of Registration letter dated 01-03-2011.
v. Copy of submission of renewal Rs. 40000/- each dated 27-04-2016.
vi. Copy of letter of explanation on merger with LG Life Sciences, Ltd.
vii. Production Process & Analytical Procedures.
After securitization of above submitted documents it is evident that firm has submitted the
renewal application after the expiry of due renewal date but within 60 days of the expiry of
registration. Therefore, as per rule 27 of Drug (LR&A) Rules 1976, when an application is

made as aforesaid the registration shall subject to the orders passed on the application by
registration board for renewal continuing in force for the next period of five years.
Decision of 271st meeting of RB:
“Registration Board deferred the product for following:
i. Verification of last renewal submission.
ii. Submission of legalized document indicating that only name is changed while the
address of manufacturer is same, issued by the concerned authority of country of
origin”
Renewal is verified by RRR section and CoPP indicatesthat former name was LG Life
Sciences, Ltd. with same address.
Decision: Registration Board approved the change in name of manufacturer of Euvax-

B Injection 0.5ml (Reg. No. 027389) and 0.1ml (Reg. No. 017479) from M/s
LG Life Science Limited, Korea to M/s LG Chem, Ltd., Korea as per valid
legalized CoPP. The renewal of the product is regularized up to 28-02-2021.
k: Imported Human Biologicals applied by M/s Shamco Traders (Pvt) Ltd.,

Lahore deferred in 273rd meeting of Registration Board.(Evaluator: sarfraz
Nawaz)
Following products of M/s Shamco Traders (Pvt.) Ltd., Lahore were deferred
rd
in 273 meeting of Registration Board as per following details:
1. Name of Importer M/s Shamco Traders (Pvt) Ltd. 174-A Ahmed Block, New
Garden Town, Lahore Pakistan
Name of Manufacturer M/s Dong-A ST Co., Ltd. (Dong-A Pharmaceutical Co., Ltd.
Before Split-Off on March 5th, 2013)
(N-dong, B-dong Section 2) 493 Nongong-ro, Nongong-eup,
Dalseong-gun, Daegu, Republic of Korea
Brand Name +Dosage Form + Eporon PFS 2000IU/0.5ml
Strength
Recombinant human erythropoietin…….2000IU
Finished product EP Specs
specifications
Pharmacological Group Antianemic
Approval status in Reference EPREX 2,000 IU/mL solution for injection in pre-filled syringe
countries (EMC)
International availability of Korea, Brazil, Bolivia, Chile, Colombia, Georgia, Mexico,
this product Peru, Thailand, Turkey, Vietnam, Mongolia, Philippines, Syria
(as perform-5A)
Similar Product already Eporon® Injection 2000/1.0ml
registered in Pakistan by M/s Century Pharmaceuticals (Pvt) Ltd, Karachi
Demanded Price / Pack size As per SRO
General documentation FSC No : 2016-AI-1708, GMP Issue date 2017.07.032017-EI-
0087 GMP date of expiration 2018.08.23
Decision of RB in 273rd “Registration Board decided to defer the application and
meeting advised the firm to submit the following documents.
i. Labeling and prescribing information.
ii. Accelerated stability data.
iii. Valid Legalize CoPP.”
Remarks of Evaluator Firm has submitted required documents.
Decision of Registration Board
2. Name of Importer M/s Shamco Traders (Pvt) Ltd. 174-A Ahmed Block, New
Garden Town, Lahore Pakistan
Name of Manufacturer M/s Dong-A ST Co., Ltd. (Dong-A Pharmaceutical Co., Ltd.
Before Split-Off on March 5th, 2013)
(N-dong, B-dong Section 2) 493 Nongong-ro, Nongong-eup,
Dalseong-gun, Daegu, Republic of Korea
Brand Name +Dosage Form + Eporon PFS 4000IU/0.4ml

Strength
(Recombinant human erythropoietin…….4000IU
Finished product EP Specs
specifications
Pharmacological Group Antianemic
Approval status in Reference EPREX 4,000 IU/mL solution for injection in pre-filled syringe
countries (EMC)
International availability of Korea, Brazil, Bolivia, Chile, Colombia, Georgia, Mexico,

this product Peru, Thailand, Turkey, Vietnam, Mongolia, Philippines, Syria
(as per Form-5A)
Similar Products already Eporon® Injection 4000/1.0ml

registered in Pakistan by M/s Century Pharmaceuticals (Pvt) Ltd, Karachi

Dy No & Date of application Dy. No. 297(R&I) Date: 15-03-2017
Demanded Price /Pack size As per SRO
General documentation FSC No : 2016-AI-1707, GMP Issue date 2017.07.032017-EI-
0087 GMP date of expiration 2018.08.23
Decision of RB in 273rd Decision of 273rd meeting of RB:
meeting “Registration Board decided to defer the application and
advised the firm to submit the following documents.
i. Labeling and prescribing information.
ii. Accelerated stability data.
iii. Valid Legalize CoPP.”
Remarks of Evaluator Firm has submitted required documents.
Decision

The firm has provided biosimilarity data as per following details:
WHO Biosimilarity Guidelines Data Submitted by the firm
Quality Comparison Elucidation of Chemical Structure
i. Peptide Map by RP-HPLC.
Physicochemical Characterization ii. Amino acid Composition by Acid hydrolysis and HPLC.
iii. Amino acid sequence and Disulfide bond by Trypsin
digestion and RP-HPLC
iv. Higher order structure by CD spectroscopy.
v. Capillary zone electrophoresis for patterns of Eporon.
vi. Monosaccharide analysis by Acid hydrolysis and Bio-LC
(HPAEC-PAD)
vii. N-glycan structure by Deglycosylation and HPLC
viii. UV spectra by UV spectroscopy
ix. Molecular weight by SDS-PAGE
x. Isoelectric focusing
Biological Activity Biological activity in vivo potency test by using PLA (Parallel
line assay).
Immunochemical properties Polyacrylamide gel electrophoresis and immunoblotting

test/Western blot
Impurities Product related impurities by SE-HPLC/RP-HPLC (Non-

comparative)
Stability Studies Stability study is provided.

Non-clinical Comparison Pre-clinical Studies
i. In-vitro Studies i. Pharmacokinetics study in rat for bioequalence.
ii. In-vivo Studies ii. Pharmacokinetics study in beagle dog for bioequalence.
a. Biological/ Pharmacodynamic Toxicology
activity i. Acute intravenous toxicities of DA-3285 (Eporon) were
b. Non- clinical toxicity as investigated in Sprague-Dawley rats.
determined in one repeat dose ii. The acute toxicity of DA-3285 (Eporon) was tested in
toxicity study beagle dogs.
iii. The study was conducted to investigate the subacute
intravenous toxicity of DA-3285
(Eporon) in Sprague-Dawley rats.
iv. The subchronic toxicity study of DA-3285 (Eporon) was
investigated for 13 weeks in beagle dogs intravenously.
v. The mutagenic potential of DA-3285 (Eporon) was
evaluated using the short-term genotoxicity tests including
Ames, chromosome aberration and micronuclei tests.
vi. The local irritation studies of DA-3285 (Eporon) were
carried out in rabbits.
vii. Antigenecity of DA-3285 (Eporon) was examined in guinea
pigs and mice.
Clinical Comparison i. A randomized, double-blind, active control, single dosing,
crossover clinical trial to investigate the pharmacokinetics
of Eporon® and Eprex® after subcutaneous administration
in healthy volunteers (n=42)
ii. A Randomized, Active Comparator-Controlled, Parallel-
Group, Single-Blind, Multicenter, Phase III Study to
Evaluate the Efficacy, Safety and Immunogenicity of
Subcutaneous Eporon versus Epoetin Alfa (Eprex) in the
Treatment of Anemia Associated with Chronic Renal
Failure in Pre-dialysis Patients (n=214).
iii. A Post Marketing Surveillance to monitor the efficacy and
safety of Eporon® Inj.

Decision: Keeping in view the biosimilarity data and valid legalized CoPP provided
by the firm; Registration Board approved the product subject to price
fixation by the Federal Government and compliance of current Import
Policy for Finished Drugs
l: Request for Change of Corporate Name of Manufacturing Site of

Registered Drug by M/s Sanofi-Aventis Pakistan, Karachideferred in
273rd meeting of Registration Board..(Evaluator: Saadat Ali Khan)
M/s Sanofi-Aventis Pakistan has applied for change of corporate name of
manufacturer of their following already registered product, as per details given below:-
Reg. Brand Name & Composition Pack Existing Name New Proposed
No. Size Name
069588 Enterogermina Oral 10‟s M/s Sanofi- M/s
Suspension 20‟s Aventis S.p.A, SanofiS.p.AViale
Each 5ml bottle contains: - Viale Europe 11, Europe 11, 21040
21040 Origgio Origgio (VA),
Spores of Poly-antibiotic (VA), Italy. Italy.
resistant Bacillus clausii ….
2 billion
Purified water q.s 5ml.
The case was taken up in 270th meeting of Registration Board and the Board decided as under;
“The above product is probiotic, therefore referred to HOTC division for processing at their
end”
The case was forwarded to Health & OTC division as per above decision of the Board but the
division is of opinion that the product is already registered one so could not be enlisted as
Health & OTC product.
The Registration Board in its 273rd meeting deferred the application for evaluation by the
Biological division.
The evaluation is as under:

The firm categorically mentioned that there is no change in location of the plant. The
following documents are submitted by the firm.
 Original Challan of Rs.5000/-
 Original Legalized CoPP (C. No.IT/54-4/H/2015)
 Original Legalized GMP Certificate of the Manufacturing Site (C.No. IT/54-
4/H/2015)
 Copy of Registration Letter and last renewal status
 NOC for CRF clearance
Decision: Registration Board approved the change in name of manufacturer of

Enterogermina Oral Suspension (Reg. No. 069588) from M/s Sanofi-
Aventis S.p.A, Viale Europe 11, 21040 Origgio (VA), Italy to M/s
SanofiS.p.AViale Europe 11, 21040 Origgio (VA), Italy as per valid
legalized CoPP.

m: Request of M/s Sanofi-Aventis Pakistan, Karachi for Registration of new
strength of his already registered product Enterogerminadeferred in 274th
meeting of Registration Board..(Evaluator: Saadat Ali Khan)
M/s Sanofi-Aventis Pakistan applied for Registration of a new strength of his

already registered product and the Board in its 268th meeting referred the product to Health &
OTC division.
Manufacturer Brand Name & Type of Form, Documents Details Decision of

th
Composition Fee submitted, 268 meeting
Pack Size/Price of RB
M/s Sanofi- Enterogermina Form-5A Legalized CoPP As the applied
aventisS.p.AV 4 billion / 5ml oral Dy. No. 645 No.CPP/2016/504 product is a
ialeEurope,11- suspension dated 04-07-16 &CPP/2016/181 pro-biotic,
Origgio (VA), Fee Rs.100000 dated 14-03-2016 GMP hence
Italy One vial of 4 billion dated 22-06-16 No.IT/54-4/h/2015 dated Registration
contains: Pack size: 1x20 03/06/2015 Board referred
4 billion spores of Vials 1x10 Vials the product to
multi-antibiotic- Price: As per Health & OTC
resistant Bacillus DPC Division.
clausiiPurified water
qs 5ml.
Shelf life: 2 years
It is worth noting that the same product in different strength (2 billion) is registered vide
Registration No.069588. The firm applied for Change of Corporate Name of Manufacturing
Site and the Board in its 270th meeting referred the case to Health & OTC division. The Health
and OTC division referred the case back to this division with remarks that the product is
already registered once so could not be enlisted as Health & OTC product. The case was again
taken up in 274th meeting of Registration Board and the Board deferred the case to this division
for evaluation.
The current application was not referred to the H&OTC Division and has been evaluated by the
Biological division.
Decision: Registration Board decided to refer the matter to DRAP's authority with
complete background of case inlight of its earlier decision in 39 th meeting
held on 03rd November, 2016.
n: Exemption of labeling text on the following Registered Vaccines applied by M/s

Sanofi Aventis Pakistan Limited, Karachi.(Evaluator: saadat Ali Khan)
M/s Sanofi Aventis Pakistan Limited requested for the grant of exemption in labeling text
(Urdu Text, MRP and Registration Letter) for the following vaccines at the time of
importation into Pakistan.
S.No. Manufacturer Reg. No Product
1. Sanofi Pasteur Parc Industrial 082506 Dengvaxia,
Incarville, 27100 Val de Reuil (Dengue tetravalent vaccine) Powder and
France. solvent for suspension for injection
2. -do- 082507 Dengvaxia MD,
(Dengue tetravalent vaccine) Powder and
solvent for suspension for injection

The firm informed that the said vaccines are manufactured at a single source to fulfill the
requirements of whole world and generally have low volume sales. Therefore, it is not
possible to follow the packaging and labeling of every country at the time of export plus
production, packaging, quality controls of these sterile and temperature sensitive products
required specialized methods and techniques of handling under high controlled environment.
Therefore, their repackaging or over printing is generally avoided so as not to compromise on
the change process.
The firm further submitted that World Health Organization has also issued guidelines on
describing principles of packaging/labeling and shipping of vaccines to which their
compliant.
The firm also submitted that in order to be compliant to the Pakistan Drugs Labeling and
Packaging rules once the vaccines are released customs and come into their warehouse, they
are giving the undertaking that they will print name in Urdu text along with the Registration
number and maximum retail price on each pack under Cold Chain Process before releasing
the goods in the market.
Decision: Registration Board acceded to the request of the firm for import of
Dengvaxia (Powder and solvent for suspension for injection) Reg. No.
082506 and Dengvaxia MD (Powder and solvent for suspension for
injection) Reg. No. 082507 without MRP, registration number and urdu
text and printing the same at licensed premises of M/s Sanofi Aventis, plot
23, sector 22, Korangi Industrial area, Karachi before sale. Other terms
and conditions shall remain same.
o: Requirement of published safety and efficacy datadeferred in 274th meeting of

Registration Board.
As per DRAP Act, 2012 Schedule-I 1(8):Pharmaceutical dossier includes a set of
document submitted by a Person for the registration of a therapeutic good, containing
complete information about: …(e)clinical trial data and published reports about the safety and
efficacy of the drug.
Division of Biological Evaluation & Research in 274th meeting requested guidance
from the Registration Board in this matter so as to have across the board fair application of
these statutory requirements.
Registration Board advised DBER to prepare a proposal on the requirement of
published safety and efficacy data of the drug as per DRAP Act, 2012 for next Registration
Board meeting as to have across the board fair application of these statutory requirements.
It is submitted that the most of the time published safety and efficacy data of Human
biological products is available for products applied from reference countries while it is not
available generally from non reference countries. Furthermore, in majority of cases the
published safety and efficacy data of veterinary biological products is not available from
reference, non reference countries and locally manufactured drugs.
Decision: Registration Board referred the caseto the working group/ committee

p: Local manufacturing of Biologicals deferred in different meetings.
Registration Board in its 270th meeting while discussing local manufacturing of Biologicals
decided as follows:
“Registration Board advised Division of Biological Evaluation & Research to come up with
working paper in the next meeting, keeping in view the existing policy for registration of
human biological as decided in 246th meeting of Registration Board, status of biosimilarity
data requirement by the existing registration holders as decided in aforesaid meeting and
proposals for registration of future biological products.
In the 271st meeting, the Division of biological evaluation and registration apprised the
Board that the Division is in process of making a consolidated working paper to ensure the
safety of patients as well as to facilitate industry. The Board acknowledged the above
information.
The Division of biological evaluation and registration prepared a working paper for
biosimilarity data requirement for recombinant rDNA-derived therapeutic proteins
(localmanufacturing of biological products). The working paper was referred to the Director
NCL for his opinion and the final draft as forwarded was placed before the Board for
consideration and Board decided as follows:
“Registration Board deliberated the matter and constituted following committee to make
guidelines for the evaluation of different classes/categories of Biological Drugs (Human &
Veterinary) keeping in view the statutory requirements as well as the current scenario
ofPakistan.
a. Maj.Gen. TahirMukhtar Commandant AFIRM. (Chairman)
b. Dr. Noor Us Saba, Director Biological Drugs (Member)
c. Dr. Qurban Ali, DG NVL (Member)
d. M. Akhtar Abbas Khan, Dy. Director Biological (Secretary)
e. Representative of Pharma Bureau, PPMA and PCDA (Observer)
f. The committee can co-opt any expert as a member for its technical assistance.”
Following are the cases of locally manufactured Biologicals deferred in 273rd meeting of
Registration Board due to paucity of time.
M/s Macter International Limited, Karachi(Evaluator: Muhammad ZubairMasood)
a. Application for registration of Redimab (Rituximab) 100mg/10ml Vial (M/s

Macter International Limited, Karachi).
Brand Name, Type of Form, Dy. Documentary Remarks
Composition, No & date of details (CoPP etc.)
Pharmacological group, application, Fee Reference
Shelf life status, Packing & agencies status,
demanded MRP Me too
Redimab 100mg CTD GMP certificate M/s Roche international has
(Concentrate for solution 1861/2014(R&I) No. CN20110019 filed a suit against Reditux of
for infusion) 22-04-2014 dated 09-10-2011 M/s Macter International
Each vial (10ml) contains: Rs. 20000 Karachi having Rituximab.
Rituximab ………10mg. 20-04-2014
Pack of 1‟s (Vial) Mabthera by Roche
Monoclonal antibody Price: Products Ltd, UK
As per PRC
Shelf Life: 2 years Ristova of Roche
Pakistan Limited.
Evaluation report as per decision of 246th meeting of Registration Board.

Sr. Documents and data required as Documents and data submitted by M/s Macter Remarks
No per 246th meeting International Karachi
1 Legalized GMP certificate of Legalized GMP Certificate No. CN20110019
biological drug as an evidence that DATED 09-10-2011 valid until 08-10-2016
the manufacturer is an authorized M/s Shanghai CP Guojian Pharmaceutical co.,
manufacturer of that particular Ltd. China.
biological drug in its country of
origin.
2 Structural similarity of subject Characterization of Primary and secondary
biological drug product structure of redimab and its comparability
(concentrate/ ready to fill bulk for analysis with innovator retuximab sold under
further processing) with reference brand name of Rituxan by M/s Shanghai CP
biological product (innovator) Guojian Pharmaceutical co., Ltd. China
following methods:
 N-terminal amino acid sequenced analysis,
 C-terminal Lys truncation by mass peptide
mapping by sequence coverage.
 Molecule weight by reducing SDS PAGE.
 MALDI-TOF Mass spectrum performed
the test results demonstrate that the main
components of basically identical, and the
molecular weight of relative to each other
 Peptide Mapping by RP-HPLC
This demonstrates that our products are
homogeneous and stable.
 Comparison of Methionine Oxidation for
Anti-CD20 innovator.
 Biological Characterization was done by
bioactivity determination and affinity
comparison by immumofluorescence
method.
 Impurities by SEC-HPLC, SDS-PAGE
3 Manufacturer to manufacture the Not provided.
finished biological product for trial
studies
4 Bio-comparability studies including Comparative analysis of finished drug
identity testing to parent molecule, (Redimab) with Ristova of Roche:
purity testing, in vitro biological Identity by SDS Page
activity, potency and toxicity with Purity by:
support of iso-electro focusing data, SDS Page (Silver staining)
gel electrophoresis, Western-Blot Gel Filtration HPLC
and other analytical techniques) and Protein content by UV (280nm)
stability studies of finished Biological activity
biological product General safety tests :
BET and sterility
Stability data of locally manufactured finished

product (accelerated and real time) is provided.
5 Others Certificate of analysis of Rituximab bulk is
submitted.
Clinical Data has also been submitted.

b. Application for registration of Redimab (Rituximab) 500mg/50ml Vial (M/s Macter
International Limited, Karachi)
Brand Name, Composition, Type of Form, Dy. No & Documentary Remarks

Pharmacological group, date of application, Fee details (CoPP etc.)
Shelf life status, Packing & Reference agencies
demanded MRP status,
Me too
Redimab 500mg/50ml Form-5 GMP certificate M/s Roche
(Concentrate for solution 1860/2014(R&I) No. CN20110019 international has filed a
for infusion) 22-04-2014 dated 09-10-2011. suit against Reditux of
Each vial (50ml) contains: Rs. 20000 01-04-2014 Mabthera by M/s Macter
Rituximab ………500mg. Pack of 1‟s (Vial) Roche Products International Karachi
Price: Ltd, UK having Rituximab.
Monoclonal antibody As per PRC
Ristova of Roche
Shelf Life: 2 years Pakistan Limited.
Sr. Documents and data required as per Documents and data submitted by M/s Remarks
No 246th meeting Macter International Karachi
1 Legalized GMP certificate of biological Legalized GMP Certificate No.
drug as an evidence that the manufacturer CN20110019 DATED 09-10-2011 valid
is an authorized manufacturer of that until 08-10-2016 M/s Shanghai CP
particular biological drug in its country of Guojian Pharmaceutical co., Ltd. China.
origin.
2 Structural similarity of subject biological Characterization of Primary and
drug product (concentrate/ ready to fill secondary structure of redimab and its
bulk for further processing) with comparability analysis with innovator
reference biological product (innovator) retuximab sold under brand name of
Rituxan by M/s Shanghai CP Guojian
Pharmaceutical co., Ltd. China following
methods:
 N-terminal amino acid sequenced
analysis,
 C-terminal Lys truncation by mass
peptide mapping by sequence
coverage.
 Molecule weight by reducing SDS
PAGE.
 MALDI-TOF Mass spectrum
performed the test results
demonstrate that the main
components of basically identical,
and the molecular weight of relative
to each other
 Peptide Mapping by RP-HPLC
This demonstrates that our products
are homogeneous and stable.
 Comparison of Methionine Oxidation
for Anti-CD20 innovator.
 Biological Characterization was done
by bioactivity determination and
affinity comparison by
immumofluorescence method.
 Impurities by SEC-HPLC, SDS-
PAGE
3 Manufacturer to manufacture the finished Not provided.
biological product for trial studies
4 Bio-comparability studies including Comparative analysis of finished drug
identity testing to parent molecule, purity (Redimab) with Ristova of Roche:
testing, in vitro biological activity, Identity by SDS Page
potency and toxicity with support of iso- Purity by:
electro focusing data, gel electrophoresis, SDS Page (Silver staining)
Western-Blot and other analytical Gel Filtration HPLC
techniques) and stability studies of Protein content by UV (280nm)
finished biological product Biological activity
General safety tests :
BET and sterility
Stability data of locally manufactured
finished product (accelerated and real
time ) is provided.
5 Others Certificate of analysis of Rituximab bulk
is submitted.
Clinical Data has also been submitted.
c. Application for registration of Epocan (Epoietin Alfa) 2000IU/ml Vial (M/s Macter
Brand Name, Composition, Type of Form, Dy. No Documentary details (CoPP etc.)
Pharmacological group, & date of application, Reference agencies status,
Shelf life Fee status, Packing & Me too
demanded MRP
Epocan 2000IU/ml Form-5 Legalized CoPP no. WHO-CPP-
(Solution for injection) 1626/2014(R&I) CERT-JN-130801 dated 01-08-
Each vial (ml) contains: 15-04-2014 2013
Epoietinalfa………2000IU(0.0135mg) Rs. 20000 31-03-2014 Legalized Free Sale Certificate no.
Pack of 1‟s (Vial) 2013-107 dated 26-08-2013
Hematopoiettic agent. Price: Legalized GMP certificate No.
As per PRC K5087 dated 25-11-2009
Shelf Life: 3 years
Epogen by Amgen, USA
EPO by Nexpharm

Sr. Documents and data Documents and data submitted by Remarks
No required as per 246th M/s Macter International Karachi
meeting
1 Legalized GMP certificate of Legalized GMP Certificate No.
biological drug as an CN20140140 date of issuance 17-3-
evidence that the 2014 valid upto 16-03-2019 M/s
manufacturer is an authorized Shandong Kexing Bio – Products co.,
manufacturer of that Ltd. Tangwangshan Road, Mingshui
particular biological drug in Development Zone, Zhangqiu,
its country of origin. Shandong, China submitted.
Legalized Free Sale Certificate No.

2015-157 date of issuance 16-11-2015
valid for two year for date of issuance
for Erythropoietin injection submitted.
Legalized COPP No. WHO. CPP-
CERT-ZQ-151116 date of issuance
16-11-2015.
3 Structural similarity of Comparative analysis of Recombinant Only comparative studies
subject biological drug Human Erythropoietin (Drug conducted locally are
product (concentrate/ ready substance) Vs RMP Recormon Roche submitted.
to fill bulk for further is submitted and following tests are According to the firm
processing) with reference carried out by M/s Macter they have conducted
biological product International, Karachi. comparative analysis with
(innovator)  SDS-PAGE (Silver staining) natural recombinant
 SDS-PAGE (Coomassie staining) human erythropoietin as
 Isoelectric focusing firm is of the opinion that
 Purity (By Gel filtration API from innovator is not
chromatography) extractable for
 Sialic Acid (by Resorcinol comparative studies.
Method)
 Protein content (By ELISA) Bioequivalence study is
provided by the firm with
Eprex.
4 Manufacturer to manufacture
the finished biological
product for trial studies
5 Bio-comparability studies Comparitive analysis of Finished Comparative analysis of
including identity testing to product VS BRP Erythropoetin Alfa Finished product VS BRP
parent molecule, purity EDQM is also submitted and Erythropoetin Alfa
testing, in vitro biological following test are carried out: EDQM is provided
activity, potency and toxicity instead of RMP
with support of iso-electro Identity by ELISA, Potency by Elisa, Recormon Roche.
focusing data, gel Total Protein content (By Lowry
electrophoresis, Western-Blot Assay), General Safety Test (By
and other analytical Bacterial endotixin test by gel Clot
techniques) and stability Method (LAL Test), Sterility Test by
studies of finished biological membrane filtration method.
product
The firm has also submitted
accelerated and real time stability
studies
6 Others Specification of ready to fill bulk of
M/s Shandong Kexingbioproducts Co.,
Ltd, China
Identification test, Physical tests
(Appearance Visible particles),
Chemical tests (pH, Content of sodium
ion content of citrate ion content of
protein Osmolality, Activity tests
(Activity in vitro , Activity in vivo),
Sterility and BET , Abnormal toxicity
test.
Finished products specification of M/s
Macter International Karachi as under:
Physical Appearance,
ParticulateMater, Extractable volume,
pH, Osmaolality, Immuno-
identification, Potency, Content of
Protein, BET, Sterility, Abnormal
Toxicity.

d. Application for registration of Epocan (Epoietin Alfa) 4000IU/ml Vial (M/s Macter
Brand Name, Composition, Type of Form, Dy. No & Documentary details (CoPP etc.)
Pharmacological group, date of application, Fee Reference agencies status,
Shelf life status, Packing & Me too
demanded MRP
(Solution for injection) 1626/2014(R&I) CERT-JN-130801 dated 01-08-2013
Each vial (ml) contains: 15-04-2014 Legalized Free Sale Certificate no.
Epoietinalfa…4000IU(0.027mg) Rs. 20000 31-03-2014 2013-107 dated 26-08-2013
Pack of 1‟s (Vial) Legalized GMP certificate No. K5087
Price: dated 25-11-2009
Hematopoiettic agent. As per PRC
Shelf Life: 3 years
Erithromax by Pharmatec Pakistan
(Pvt.) Ltd.
Evaluation report as per decision of 246th meeting of Registration Board
Sr. Documents and data required Documents and data submitted by Remarks
No as per 246thmeeting M/s Macter International Karachi
1 Legalized GMP certificate of Legalized GMP Certificate No. GMP submitted reflects
biological drug as an evidence CN20140140 date of issuance 17- that manufacturer is
that the manufacturer is an 3-2014 valid upto 16-03-2019 M/s authorized to
authorized manufacturer of that Shandong Kexing Bio – Products manufacturer
particular biological drug in its co., Ltd. Tangwangshan Road, Recombinant Human
country of origin. Mingshui Development Zone, Erythropoietin injection.
Zhangqiu, Shandong, China
submitted.
Legalized Free Sale Certificate

No. 2015-157 date of issuance 16-
11-2015 valid for two year for
date of issuance for Erythropoietin
injection submitted.
CERT-ZQ-151116 date of
issuance 16-11-2015
3 Structural similarity of subject Comparative analysis of Only comparative
biological drug product Recombinant Human studies conducted
(concentrate/ ready to fill bulk Erythropoietin Vs RMP Recormon locally are submitted.
for further processing) with Roche is submitted and following According to the firm
reference biological product test are carried out by M/s Macter they have conducted
(innovator) International, Karachi comparative analysis
 SDS-PAGE (Silver staining) with natural
 SDS-PAGE (Coomassie recombinant human
staining) erythropoietin as firm is
 Isoelectric focusing of the opinion that API
 Purity(By Gel filtration from innovator is not
chromatography) extractable for
 Sialic Acid (by Resorcinol comparative studies.
Method)
 Protein content (By ELISA) Bioequivalence study is
provided by the firm
with Eprex.
4 Authorization to manufacture Not provided Not provided

the finished biological product
for trial studies
5 Bio-comparability studies Comparative analysis of Finished Comparative analysis of
including identity testing to product VS BRP Erythropoeitin Finished product VS
parent molecule, purity testing, Alfa EDQM is also submitted and BRP Erythropoeitin
in vitro biological activity, following test are carried out: Alfa EDQM is provided
potency and toxicity with Identity by ELISA, Potency by instead of RMP.
support of iso-electro focusing Elisa, Total Protein content (By
data, gel electrophoresis, Lowry Assay), General Safety
Western-Blot and other Test (By Bacterial endotoxin test
analytical techniques) and by gel Clot Method (LAL Test),
stability studies of finished Sterility Test by membrane
biological product filtration method.

studies
6 Others Specification of ready to fill bulk
of M/s Shandong
Kexingbioproducts Co.,Ltd, China
Chemical tests (pH, Content of
sodium ion content of citrate ion
content of protein Osmolality,
Activity tests (Activity in vitro ,
Activity in vivo), Sterility and
BET , Abnormal toxicity test.
Finished products specification of

M/s Macter International Karachi
as under:
Physical Appearance, Particulate
Matter, Extractable volume, pH,
Osmaolality, Immuno-
identification, Potency, Content of
Protein, BET, Sterility, Abnormal
Toxicity.

e. Application for registration of Epocan (Epoietin Alfa) 10000IU/ml Vial (M/s Macter
International Limited, Karachi).
Brand Name, Composition, Type of Form, Dy. No Documentary details (CoPP

Pharmacological group, & date of application, etc.)
Shelf life Fee status, Packing & Reference agencies status,
demanded MRP Me too
(Solution for injection) 1627/2014(R&I) CERT-JN-130801 dated 01-08-
Each vial (ml) contains: 15-04-2014 2013
Epoietinalfa………10000IU(0.0675mg) Rs. 20000 31-03-2014 Legalized Free Sale Certificate
Pack of 1‟s (Vial) no. 2013-107 dated 26-08-2013
Hematopoietic agent. Price: Legalized GMP certificate No.
As per PRC K5087 dated 25-11-2009
Shelf Life: 3 years
PDpoetin by NextarPharma,
Karachi.
Sr. Documents and data Documents and data submitted by M/s Remarks
No required as per 246th Macter International Karachi
meeting
1 Legalized GMP certificate Legalized GMP Certificate No. GMP submitted reflects
of biological drug as an CN20140140 date of issuance 17-3- that manufacturer is
evidence that the 2014 valid upto 16-03-2019 M/s authorized to
manufacturer is an Shandong Kexing Bio – Products co., manufacture.
authorized manufacturer of Ltd. Tangwangshan Road, Mingshui
that particular biological Development Zone, Zhangqiu, Recombinant Human
drug in its country of origin. Shandong, China submitted. Erythropoietin injection.
Legalized Free Sale Certificate No.

2015-157 date of issuance 16-11-2015
valid for two year for date of issuance
for Erythropoietin injection submitted.
CERT-ZQ-151116 date of issuance 16-
11-2015
3 Structural similarity of Comparative analysis of Recombinant Only comparative studies
subject biological drug Human Erythropoietin Vs RMP conducted locally is
product (concentrate/ ready Recormon Roche is submitted and submitted
to fill bulk for further following test are carried out by M/s According to the firm
processing) with reference Macter International, Karachi they have conducted
biological product  SDS-PAGE (Silver staining) comparative analysis with
(innovator)  SDS-PAGE (Coomassie staining) natural recombinant
 Isoelectric focusing human erythropoietin as
 Purity (By Gel filtration firm is of the opinion that
chromatography) API from innovator is not
 Sialic Acid (by Resorcinol extractable for
Method) comparative studies.
 Protein content (By ELISA)
Bioequivalence study is
provided by the firm with
Eprex.
4 Authorization to Not provided Not provided
manufacture the finished

biological product for trial
studies
5 Bio-comparability studies Comparative analysis of Finished Comparative analysis of
including identity testing to product VS BRP Erythropoietin Alfa Finished product VS BRP
parent molecule, purity EDQM is also submitted and Erythropoeitin Alfa
testing, in vitro biological following test are carried out: EDQM is provided
activity, potency and instead of RMP.
toxicity with support of iso- Identity by ELISA, Potency by Elisa,
electro focusing data, gel Total Protein content (By Lowry
electrophoresis, Western- Assay), General Safety Test (By
Blot and other analytical Bacterial endotoxin test by gel Clot
techniques) and stability Method (LAL Test), Sterility Test by
studies of finished membrane filtration method.
biological product
studies.
6 Others Specification of ready to fill bulk of
M/s Shandong Kexingbioproducts Co.,
Ltd, China
Chemical tests (pH, Content of sodium
ion content of citrate ion content of
protein Osmolality, Activity tests
(Activity in vitro , Activity in vivo),
Sterility and BET , Abnormal toxicity
test.
Finished products specification of M/s

Macter International Karachi as under:
Physical Appearance, Particulate
Matter, Extractable volume, pH,
Osmolality, Immuno-identification,
Potency, Content of Protein, BET,
Sterility, Abnormal Toxicity.

f. Application for registration of T-Mab (Trastuzumab) 150mg Vial (M/s Macter
Brand Name, Composition, Type of Form, Dy. Documentary details Remarks
Pharmacological group, No & date of (CoPP etc.)
Shelf life application, Fee Reference agencies
status, Packing & status,
demanded MRP Me too
T-Mab Form-5 Legalized GMP Locally 150mg
(Powder for concentrate for solution 930/2014(R&I) Certificate No. Trastuzumab is
for infusion) 17-04-2014 CN20110019 dated not available.
Each vial contains: Rs. 20000/- 09-10-2011 valid until
Trastuzumab………..150mg 13-01-2014 08-10-2016
Pack of 1‟s (Vial)
Antineoplastic monoclonal antibody Price: Herceptin 150mg by
As per PRC Roche Products
Shelf life: 2 years Limited, UK

Sr. Documents and data required as Documents and data submitted by M/s Macter Remarks
No per 246th meeting International Karachi
1 Legalized GMP certificate of Legalized GMP Certificate No. CN20110019 dated
biological drug as an evidence 09-10-2011 valid until 08-10-2016 M/s Shanghai
that the manufacturer is an CP Guojian Pharmaceutical co., Ltd. China.
authorized manufacturer of that
particular biological drug in its
country of origin.
2 Structural similarity of subject Characterization of Primary and secondary
biological drug product structure of anti-HER2 rh.MAb and its
(concentrate/ ready to fill bulk comparability analysis with innovator Herceptin by
for further processing) with M/s Shanghai CP Guojian Pharmaceutical co., Ltd.
reference biological product China following methods:
(innovator)  The primary structure of anti-HER2 rhMAb.
Similarity in secondary structure by circular
Dichorism (CD) and Spectra.
 Similarity in IEF profile.
 Similarity in molecular weight by reducing
SDS-PAGE.
 MALDI-TOF Mass spectrum performed the
test results demonstrate that the main
components of basically identical, and the
molecular weight of relative to each other.
 Peptides Mapping by RP-HPLC which
demonstrates that our products are
homogeneous and stable.
 N-Glycosylation Analtysis.
 SDS-PAGE Purity
 SEC-HPLC Purity
 Similarity in Biological Activities and
Immunological Properties
 Biological Characterization was done by
bioactivity determination and affinity
comparison by immumofluorescence method.
 Impurities by SEC-HPLC, SDS-PAGE
3 Authorization to manufacture the Not provided.
finished biological product for
trial studies
4 Bio-comparability studies Biocomparability of finished drug the firm has
including identity testing to submitted following data are as under:
parent molecule, purity testing, Comparative Analysis of Locally Manufactured
in vitro biological activity, Drug Product of T-Mab 150 mg with Reference
potency and toxicity with Medicinal Product Harceptin, Materials,
support of iso-electro focusing Identification (By SDS-PAGE& By Isoelectric
data, gel electrophoresis, focusing), Purity (By SDS-PAGE& By Gel
Western-Blot and other Filtration Chromatography), Biological activity,
analytical techniques) and General Safety Tests By Bacterial Endotoxin Test
stability studies of finished (By Gel Clot Method), Sterility Test.
biological product Stability Studies of Locally Manufactured Drug
Product of T-Mab 150mg.Real Time stability
studies, Accelerated stability studies
5 Others Non-clinical study The firm submitted data are as
under:
1. Pharmacology
(Primary pharmacology, Secondary Pharmacology,
Safety Pharmacology, Pharmacodynamic drug
interactions).
2. Pharmacokinetics
(Absorption, distribution, Metabolism, Excretion,
Pharmacokinetics Drug Interaction)
3. Single-Dose Toxicity
(Acute Single-Dose toxicity for intravenous
injection anti-HER2 rh MAB of CPGJ into mice)
4. Repeat-Dose toxicity
(Repeat-Dose toxicity for intravenous injection
anti-HER2 rh MAB of CPGJ into rhesus)
5. Genotoxicity
(Genotoxicity of –HER2 rh MAB of CPGJ)
6. Hemolytic Study
(Hemolytic Study of –HER2 rh MAB of CPGJ)

g. Application for registration of T-Mab (Trastuzumab) 440mg Vial (M/s Macter International
Limited, Karachi).
Brand Name, Composition, Type of Form, Dy. No & Documentary details (CoPP
Pharmacological group, date of application, Fee etc.)
Shelf life status, Packing & Reference agencies status,
demanded MRP Me too
T-Mab Form-5 Legalized GMP Certificate No.
(Powder for concentrate for solution 927/2014(R&I) CN20110019 dated 09-10-2011
for infusion) 17-04-2014 valid until 08-10-2016
Each vial contains: Rs. 20000 13-01-2014
Trastuzumab………..440mg Pack of 1‟s (Vial) Herceptin by Roche Pakistan
Price:
Antineoplastic monoclonal antibody As per PRC
Shelf life: 2 years

No required as per 246th meeting Macter International Karachi
1 Legalized GMP certificate of Legalized GMP Certificate No. The application of
biological drug as an evidence CN20110019 dated 09-10-2011 valid the firm is
that the manufacturer is an until 08-10-2016 M/s Shanghai CP considered in
authorized manufacturer of that Guojian Pharmaceutical co., Ltd. China 257thmeeting of
particular biological drug in its RB wherein it was
country of origin. deferred for
evaluation by the
division.
2 Structural similarity of subject Characterization of Primary and
biological drug product secondary structure of anti-HER2
(concentrate/ ready to fill bulk rh.MAb and its comparability analysis
for further processing) with with innovator Herceptin by M/s
reference biological product Shanghai CP Guojian Pharmaceutical
(innovator) co., Ltd. China following methods:
 The primary structure of anti-HER2
rhMAb. Similarity in secondary
structure by circular Dichorism (CD)
and Spectra.
 Similarity in IEF profile.
 Similarity in molecular weight by
reducing SDS-PAGE.
 MALDI-TOF Mass spectrum
performed the test results
demonstrate that the main
components of basically identical,
and the molecular weight of relative
to each other.
 Peptides Mapping by RP-HPLC
which demonstrates that our
products are homogeneous and
stable.
 N-Glycosylation Analtysis.
 SDS-PAGE purity.
 SEC-HPLC Purity
 Biological Characterization was
done by bioactivity determination
and affinity comparison by
immumofluorescence method.
 Impurities by SEC-HPLC, SDS-
PAGE
3 Manufacturer to manufacture Not provided.
the finished biological product
for trial studies
4 Bio-comparability studies Biocomparability of finished drug the

including identity testing to firm has submitted following data are as
parent molecule, purity testing, under:
in vitro biological activity,
potency and toxicity with Comparative Analysis of Locally
support of iso-electro focusing Manufactured Drug Product of T-Mab
data, gel electrophoresis, 440mg WITH Reference Medicinal
Western-Blot and other Product Harceptin, Materials,
analytical techniques) and Identification (By SDS-PAGE&
stability studies of finished Isoelectric focusing), Purity (By SDS-
biological product PAGE& By Gel Filtration
Chromatography), Protein Content (By
UV), Biological Activity, General Safety
Tests By Bacterial Endotoxin Test (By
Gel Clot Method), Sterility Test.
Stability Studies of Locally
Manufactured Drug Product of T-Mab
440.
Real Time stability studies, Accelerated
stability studies
5 Others Animal Toxicology study The firm

submitted data are as under:
1. Pharmacology
(Primary pharmacology, Secondary
Pharmacology, Safety Pharmacology,
Pharmacodynamic drug interactions).
2. Pharmacokinetics
(Absorption, distribution, Metabolism,
Excretion, Pharmacokinetics Drug
Interaction)
3. Single-Dose Toxicity
(Acute Single-Dose toxicity for
intravenous injection anti-HER2 rh
MAB of CPGJ into mice)
4. Repeat-Dose toxicity
(Repeat-Dose toxicity for intravenous
injection anti-HER2 rh MAB of CPGJ
into rhesus)
5. Genotoxicity
(Genotoxicity of –HER2 rh MAB of
CPGJ)
6. Hemolytic Study
(Hemolytic Study of –HER2 rh MAB of
CPGJ)

h. Application for registration of Macgrastim (Filgrastim (rhGCSF) 300mcg/ 1.2 ml) vial (M/s
Brand Name, Composition, Type of Form, Dy. No & Documentary details (CoPP etc.)
Pharmacological group, date of application, Fee Reference agencies status,
Shelf life status, Packing & Me too
demanded MRP
Macgrastim (Filgrastim) Form-5 Legalized CoPP no. 2013-039
Each vial contains: 1118/2014(R&I) dated 16-08-2013
Filgrastim…..300mcg/1.2ml 10-10-2014 Legalized GMP certificate no.
Rs. 20000 16-09-2014 CN20130269 dated 30-09-2013
Colony Stimulating Factor Pack of 1‟s (Vial)
Shelf Life: 2 years Price: As per PRC Grastim by CCL Pharma,
Lahore.

Sr. Documents and data required Documents and data submitted by M/s Macter Remarks
th
No as per 246 meeting International Karachi
1 Legalized GMP certificate of Legalized CoPP No: CN20130269 dated
biological drug as an evidence 30.09.2013 valid upto 29.09.2018 of M/s
that the manufacturer is an Hangzhou Jiuyuan Gene Engeineering Co., Ltd,
authorized manufacturer of that China indication that the manufacturer has
particular biological drug in its approval to manufacture the rhGCSF injection
country of origin.
2 Structural similarity of subject Physicochemical and biosimilarity analysis of
biological drug product rhGSCF with Filgrastim produced by Kirin
(concentrate/ ready to fill bulk Brewery Co., Japan:
for further processing) with rhGSCF Formula/ chemical structure.
reference biological product  Molecular weight:
(innovator) SDS reducing Page
HPLC
 Purity:
Gel electrophoresis
Isoelectric focusing
RP HPLC
SEC HPLC
Capillary electrophoresis
 Assay for chemical structure:
Sequencing of rDNA
UV spectrum
Composition of amino acids
Peptide mapping
N- terminal sequencing
 Immunology:
Identification by western blot
ELISA
 Biological activity:
In vitro
In vivo
3 Manufacturer to manufacture the Not provided.
finished biological product for
trial studies
4 Bio-comparability studies Comparative Analysis of Locally Manufactured
including identity testing to Product Macgrastim Liquid Solution for Injection
parent molecule, purity testing, (300 mcg/ 1.2 ml ) VS Neupogen (Innovator):
in vitro biological activity,  Immunoidentification by western blot
potency and toxicity with  Purity by SDS Page
support of iso-electro focusing  Purity by gel filtration
data, gel electrophoresis,  Potency protein by Bradford assay
Western-Blot and other  Biological activity by cell proliferation
analytical techniques) and assay
stability studies of finished  General safety tests: BET and sterility
biological product Stability data of finished product (accelerated and
real time is provided)
5 Others Certificate of analysis of bulk material to be
supplied is submitted.
Clinical data submitted.
i. Applications for registration of Biovac HB (Hepatitis B Vaccine) 10mcg/0.5ml, 20mcg/ml (M/s

S. Name of Brand Name Date of Documentary Remarks

#. Importer/Manu /Composition application/Fee details
factruer status/price
1. Macter Biovac HB Form-5 Legalized a. Firm has
International 10mcg/0.5ml 182/2014(R&I) CoPP No. submitted the
Ltd. 216, SITE, (Recombinant 10-03-2014 2015-A1-0917 CoPP FSC and
Karachi, Hepatitis B Dy No.40 DDC Dated GMP of bulk
Pakistan (Local Vaccine) (BD) Dated 16-7-2015 material issued
Manufacturer) Each 100ml of 17-3-2014 Legalized from regulatory
vaccine contains: GMP No. body of Korea.
Bulk material Purified hepatitis B Fee Rs. 20000/- 2015-F1-0102 b. Under finished
source: surface antigen Dated dated 9-4-2015 product
LG Life (rDNA) (Host: 21-8-2013 Engerix B by specifications firm
Sciences Korea. Saccharomyces Pack Size: 1‟s & GSK, UK has provided, tests
cerevisiae AB 110, 10‟s (vial) Engerix B by of Physical
Vector: pYLBC- Price: As per GSK, Pakistan appearance,
A/G-UB- PRC aluminum content,
HBs)…2mg Potency by Elisa,
identification and
Prevention of purity by SDS-
Hepatitis B Page, endotoxin
Shelf Life: 2 years bioburden and
sterility tests.
2. Macter Biovac HB Out Dy No. 184 Legalized a. Firm has
International 20mcg/ml dated 10.3.2014 CoPP No. 2- submitted the
Ltd. 216, SITE, (Recombinant 13-A1-1023 CoPP FSC and
Karachi, Hepatitis-B 20000/- dated Republic of GMP of bulk
Pakistan (Local Vaccine) 21-8-2013 Korea dated material issued
Manufacturer) Each 100ml of Pack Size: 1‟s & 08-05-2013 from regulatory
vaccine contains: 10‟s (vial) Legalized Free body of Korea.
Bulk material Purified hepatitis B Price. As per sale certificate b. Under finished
source: surface antigen PRC No. 2013-A1- product
LG Life (rDNA) (Host: 1022 dated specifications firm
Sciences Korea. Saccharomyces 08-5-2013 has provided, tests
cerevisiae AB 110, Legalized of Physical
Vector: pYLBC- GMP appearance,
A/G-UB- certificate aluminum content,
HBs)……2mg Dated 15-3-13 Potency by Elisa,
Prevention of enclosed. identification and
Hepatitis B Engerix B by purity by SDS-
Shelf Life: 2 years GSK, UK Page, endotoxin
Engerix B by bioburden and
GSK, Pakistan sterility tests.

Sr. Documents/ data as per Documents / data submitted by Remarks
no. requirement of DRB 246 Macter
1. Legalized GMP Legalized GMP certificate by KFDA Notarized and legalized (by
certificate of biological issued on March 15, 2013. Pakistan embassy Soule,
drug as evidence that South Korea) GMP
manufacturer is an certificate Issued by Korea
authorized manufacturer Food & Drug
of that particular Administration on March
biological drug in its 15, 2013 is submitted.
country of origin
WHO pre-qualification
letter
WHO prequalification certificate and Issued by Coordinator
Web link of WHO website link quality, safety and standard
https://extranet.who.int/gavi/PQ_We is submitted.
b/  This product &
for WHO prequalified vaccine manufacturer are included
manufacturers included in GAVI in the list of prequalified
program is provided. vaccines & manufacturer at
WHO web link
Legalized COPP certificate no. https://extranet.who.int/gav
2013-A1-1023 issued on May 08, i/PQ_Web/.
2013 is provided.
Notarized and legalized (by
Pakistan embassy Soule,
South Korea) COPP
certificate no. 2013-A1-
1023 issued on May 08,
2013 is provided.
2. Structural similarity of Product characterization is Studies are performed by
subject biological drug performed for comparability with LG life Sciences South
product (ready to fill WHO reference standard of NIBSC Korea are available in
bulk) with reference Hep B antigen &innovators product provided CTD dossier.
biological product Engerix B of GSK by SDS PAGE
(innovator). (mol. Wt.), UV spectrophotometery
(identification), Circular Dichorism
(secondary structure), electron
microscopy (particle morphology),
gradient centrifugation (density),
gradient Centrifugation
(homogeneity), Tryptic digestion &
SDS Page, N Terminal sequence
(identity), C terminal sequencing
(identity), Amino acid composition,
thin layer chromatography
(phospholipids composition),
Antigenicity by ELISA (efficacy),
Size Exclusion Chromatography and
SDS page for purity,
3. Bio comparability studies Comparative analysis of locally Comparative studies of local
including identity testing produced drug product with batches with innovators
to parent molecule, purity Reference medicinal product product Engerix B of
testing, in vitro (Engerix B). GSK are provided.
biological activity / Identity: SDS PAGE
potency testing and Purity: SDS PAGE
toxicity with support of Potency: ELISA
IEF data, gel General safety tests
electrophoresis, western Bacterial Endotoxin test, Sterility
blot and other analytical test and abnormal toxicity test.
methods and stability Stability data is provided by the firm.
studies of finished (Long term and accelerated stability
drug. data)
4. Others Animal toxicity studies and clinical Pharmacokinetics and
trial studies are submitted toxicological studies are
provided.
Decision of RB in 260th meeting:

“Registration Board deliberated and deferred these applications that manufacturing and
quality control of biological products require specialized facilities and approval from the
Licensing Division, DRAP. The Board discussed that these manufacturing units have already
been granted registrations of various biological products for local manufacturing (mostly
therapeutic proteins). As these firms have applied for registration for local manufacturing of
various biological products including rDNA products, Therapeutic protein, Monoclonal
antibodies, Vaccines (Live, Attenuated, rDNA vaccines, so the Board decided to have opinion
of licensing division DRAP regarding approved manufacturing facilities (categories of
biological products) of these firms and status of already registered biological drugs from
these firms.”
j. Application for registration of Neupeg (Peg-Filgrastim) 6mg/ml vial (M/s Macter

Brand Name, Composition, Type of Form, Dy. No Documentary details (CoPP etc.) Remarks
Pharmacological group, & date of application, Reference agencies status,
Shelf life Fee status, Packing & Me too
demanded MRP
Neupeg 6mg/ml Form-5 Legalized CoPP No. MFG/WHO-
(Pegfilgrastim) Out Dy. No. 163 COPP/INTAS/2016/128492
Each vial contains: 10-03-2014
Pegfilgrastim……..6mg/ml Rs. 8000/-31-10-2011 Legalized GMP certificate no.
Rs. 12000/- 16091293 dated 19-09-2016
Immunomodulator 09-10-2012
Pack of 1‟s (Vial)
Shelf Life: 2 years Price: Rs. 53730/-

No required as per 246th Macter International Karachi
meeting
1 Legalized GMP certificate GMP certificate No. 16091293 dated 19-
of biological drug as an 09-2016 valid upto 18-09-2018 issued by
evidence that the Food & Drug Control Administration,
manufacturer is an Gujrat state, India to Intas
authorized manufacturer of Biopharmaceuticals Ltd., Plot No.
that particular biological 423/P/A, SarkheiBavla Highway, Village
drug in its country of origin. Moraiya, TalikaSanand, Gujrat.
2 Structural similarity of Physicochemical and biosimilarity
subject biological drug analysis of Intas‟ Pegfilgrastim with
product (concentrate/ ready RMP Neulasta of Roche Products:
to fill bulk for further Primary sequence/structure
processing) with reference analysis(includes sequence correctness,
biological product and position of disulphide linkage)
(innovator)  N terminal sequence
 GCSF DNA sequence
 Amino acid composition
 Peptide map analysis
 Western Blot
pI determination
 Isoelectric focusing
Identity (pegylation)
 SDS-PAGE(non-reducing;iodine
stain)
Tertiary structure analysis
 UV Spectroscopy
 Fluorescence Spectroscopy
Molecular weight determination
 Mass Spectrophotometry (MALDI)
Product related variants, differing in
molecular weight
 SDS-PAGE (Non-reducing; silver
stain)
 SE HPLC
Charge/Hydrophobicity related variants
 RP HPLC
Charge related variants
 Cation Exchange Chromatography
HPLC (CEx-HPLC)
Biological activity
 In-vitro biological activity
3 Manufacturer to Not provided.
manufacture the finished
biological product for trial
studies
4 Bio-comparability studies Biocomparability studies provided by the Biocomparability
including identity testing to firm for Neupeg with Neulastim of studies are
parent molecule, purity Roche, Switzerland. performed with
testing, in vitro biological Physicochemical comparison of Neupeg Neulastim of Roche,
activity, potency and with RMP Neulastim: Switzerland which is
toxicity with support of iso-  Expression host available as Pre-
electro focusing data, gel  Molecular size of free Filgrastim filled syringe and its
electrophoresis, Western- molecule composition is
Blot and other analytical  Pegylation chemistry 6mg/0.6ml, While
techniques) and stability  Molecular size of Pegylated Conjugate Neupeg of Macter,
studies of finished biological  Concentration of Pegfilgrastim Pakistan is a vial and
product  Route of administration its composition is
 Peptide map 6mg/ml.
 Non-reducing SDS-PAGE
 Immunoblot
 Size exclusion chromatography
 RP HPLC Chromatogram
Stability data is provided by the firm.
(Long term & accelerated stability data.)
5 Others Animal Studies
Comparative safety, efficacy clinical
trials
Decision: Registration Board referred the applicationsto the working group/

committee constituted in 273rd meeting of Registration Board

Item No.V: Additional Agenda.
A. Phamaceutical Evaluation & Registration Division
Case No.01: Pricing of Veterinary Drugs.
Registration Board again took up the matter of fixation or otherwise, the price of
veterinary drugs. In order to recap the case details, the Board was apprised of the relevant
portion of minutes of 274th meeting as under:-
The Board discussed the issue of pricing of veterinary drugs with reference to a letter
issue by the Pricing Division in June, 2017, wherein it was clarified that the Drug Price
Policy, 2015 does not cover veterinary products. The Board was informed that the price
of veterinary products, as per previous practices, are given as de-controlled. The Board
deliberated upon the question that whether it is in public interest to bring the prices of
veterinary drugs under control or otherwise. The representative of PPMA Mr. Ahsan
Awan presented following facts with regard to this issue.
(i) Majority of the veterinary drugs and user are commercial enterprises including
commercial poultry farmer, dairy farmer, livestock‟s feeds mill etc. The
veterinary medicines are one of the many inputs for these commercial
enterprises and constitute only 2-5% of total input cost. Controlling prices of
these medicines, therefore, would not likely to have significant effects on
production cost of end products like egg, meat, skin and hide etc.
(ii) There is no price regulatory mechanism for the livestock products like egg,
meat, milk etc so the benefit, if any, of controlling the prices veterinary drugs
may not be transferred to the general public rather it would benefit the
commercial enterprises.
(iii) In Europe and USA there is no control over prices of veterinary drugs.
(iv) The B-2-B relationship between veterinary drugs manufacturer and
commercial enterprises, the prices of such drugs vary considerably depending
on the requirements, which in turn depend on size of commercial
enterprises/stocks.
(v) The veterinary drugs are used not only to combat disease but also used for
growth promotion to increase production of end products like eggs, meat, milk
etc, therefore, their prices cannot be regulated under one regime.
The Board while noting the above facts also requested the veterinary expert Dr. Qurban Ali to
give his views on the issue.
Dr.Qurban Ali expressed his views as under:-
There is no direct control on prices of livestock products like poultry, meat, milk etc.
Though, sometimes the prices of these products are controlled at the district level from
profiteering point of view, otherwise their prices are decontrolled and determined by
demand and supply situation. He further informed that at present use of veterinary
medicines by livestock farmers has been a routine practice and this sector is growing
with rapid pace. Almost 80% of the livestock holdings are small which are more
vulnerable to the price of inputs including medicines. Therefore, the matter of control of
prices of veterinary medicinesneed to be thoroughly evaluated by considering all pros
and cons.
Decision: Registration Board after considering views explained above observed that
the Registration Board’s jurisdiction primarily relates to the technical
aspects of veterinary medicines and it is not appropriate forum to
consider and decide upon pricing aspects of the veterinary drugs. The
Board, therefore, decided to refer the matter to be Costing & Pricing
Division/ Drug Pricing Committee for further necessary action.

Case No.02: Amendments in Rule-27 of Drugs (Licensing, Registering and
Advertising) Rules, 1976.
Registration Board in its 252nd meeting recommended the authority for amendment in
Rule 27 of Drugs (Licensing, Registering and Advertising) Rules, 1976.The
recommendations of the Registration Board were considered by Drug Regulatory Authority
in its 34th meeting held on 29th April, 2016.The Authority refer these amendments in Rule27of
(Drugs Licensing, Registering &Advertising Rules1976) for approval of Federal Government
after the opinion of Law and Justice Division. The amendment in Rule 27 of (Licensing,
Registering &Advertising) Rules 1976, has been approved by the Federal Government and
notified in the Official Gazette vide S.R.O. 1005(I)/2017.
DRAP has uploaded the notification on its website.
(http://www.dra.gov.pk/userfiles1/file/Rule27ofLRARules1976RenewalGazette vide
S.R.O No. 1005/I (2017) 05_10_2017.pdf)and is reproduced as under:
S.R.O. 1005(I)/2017. – In exercise of the powers conferred by section 23 of the Drug

Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), read with clause (a) of section 7
thereof and section 43 of the Drugs Act, 1976 (XXXI of 1976), the Drug Regulatory
Authority of Pakistan, with the approval of the Federal Government, is pleased to direct that
in the Drugs (Licensing, Registering and Advertising) Rules, 1976, the following further
amendments shall be made, the same having been previously published as required by sub-
section (3) of the said section 43, namely:--
In the aforesaid Rules, in rule 27.--
(i) in the first proviso, for the words “for the renewal of registration shall not be
entertained unless it has been”, the words “shall be” shall be substituted; and
(ii) after the first proviso, the following proviso shall be added, namely:-
“Provided further that one time opportunity shall be given to those firms who have
not complied with the first proviso since 1st January, 2010 till the issuance of this
notification and those within sixty days after issuance of this notification shall deposit
three times of their applicable renewal fee for their registration to continue to be
valid until explicit orders are passed on the request by the Registration Board. After
the expiry of sixty days of issuance of this notification, the registration of the product
shall be considered as cancelled and any manufacturing shall be penalized under the
provision of the Act.
Provided also that those firms who do not fulfill the first proviso, an additional fee
shall be charged equivalent to applicable renewal fee for each month till one year of
the expiry of registration and after one year the registration shall be cancelled.
Furthermore regarding the consideration of fee as per SRO 1005(I)/2017, opinion of Legal
Affair Division was sorted with reference to following queries;
i. Letter submitted with differential fee according to S.R.O 1005(I) / 2017 with
reference to previously submitted application with fee.
ii. Renewal application submitted with three times of their application renewal fee.
Accordingly reply of Legal Affair Division is as under;
This recent amendment in Rule 27 of the Drugs (Licensing, Registering and Advertising)
Rules, 1976 vide S.R.O. 1005(I) / 2017 provide that “[…] and those within sixty days after
issuance of this notification shall deposit three times of their applicable renewal fee […]”.

Hence three times of applicable renewal fee has to be deposited within sixty days after
issuance of notification (i.e. after 05th October, 2017).
Furthermore following popup notification has been uploaded by Legal Affair Division.
IMPORTANT NOTIFICATION
“The Firms who could not submit applications for renewal of drug registration
since 01stJanuary, 2010 are hereby informed that one time opportunity has been
given to apply for renewal of their drug registration with 03 times of applicable
fee by 03rdDecember, 2017. After that, the registration of product shall be
considered as cancelled and any manufacturing shall be penalized under the
provision of Drugs Act, 1976.
[Authority: S.R.O 1005(I)/2017 dated 05thOctober, 2017]”
Decision: Registration Board noted the information, and advised to process the case
in the light of this S.R.O and clarification by Legal Affair Division.
Case No.03: Time line for scrutinization of Registration applications

Registration Board in its 270th meeting decided to adopt timeline for a judicious
disposal of registration applications. On request of PPMA, Registration Board again
discussed the matter and decided to adopt following procedure.
a. In case of registration applications for local manufacturing and cases already
deferred by Registration Board, where documents other than stability study
data, formulation development data and analytical method validation data is
required, initial letter of shortcomings (if any)/decision of R.B (for deferred
cases) shall be issued/conveyed by P E& R Division to the applicant with
advice to respond within 15 working days of letter issuance. In case, reply by
the firm is still deficient, or not responded by applicant another letter will be
issued with advice to respond within 15 working days. Then case shall be
placed before Registration Board for its consideration.
b. The cases which were deferred for latest (within one year) GMP inspection
report will be conveyed to the firm but will not be presented until submission
of same by applicant.
c. In case of registration applications of imported pharmaceutical products,
where original, legalized CoPP/GMP/Free sale is required a time period of
upto 120 days shall be provided to the firm. Then the case shall be placed
before Registration Board for its consideration.
d. In case of registration applications for local manufacturing, where stability
study data, formulation development data and analytical method validation
data is required, a time period upto 12 months shall be provided to the firm.
Then case shall be placed before Registration Board for its consideration.
e. All correspondence shall be delivered by registered post. However, authorized
representative can also receive letter on behalf of the firm.
Meeting ended with a vote of thanks to and from the chair.

End of Document
__________________________________________________________________________

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Minutes for 275thRegistration Board Meeting held on 25-27th October, 2017.

Item No. Detail of Item Page No.

Item No.I Confirmation for minutes of 274thRegistration Board meeting 03 – 05

Item No.II Pharmacy Services Division 06 – 16

Item No.III Pharmaceutical Evaluation & Registration Division 17 –744

Item No.IV Biological Evaluation & Registration Division 745–792

Item No.V Additional agenda

Minutes for 275th Registration Board Meeting 1

Minutes for 275th Registration Board Meeting 2

Observations / Reservations Discussion in Registration Board

Director DTL, Quetta, Government of Baluchistan.

After above discussions, Registration Board confirmed / approved circulated draft

Minutes for 275th Registration Board Meeting 5

Minutes for 275th Registration Board Meeting 6

3. A - Request by the Applicant:

Minutes for 275th Registration Board Meeting 7

Case No.02: Request for approval of amendment in protocol, of already approved

Minutes for 275th Registration Board Meeting 9

Minutes for 275th Registration Board Meeting 10

Case No.03: Request for approval of amendment in protocol of alreacdy approved

Minutes for 275th Registration Board Meeting 11

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5. Request of the Applicant:

6. Whereas the record reveals that;

Minutes for 275th Registration Board Meeting 16

A. Pharmaceutical Evaluation Cell.

Minutes for 275th Registration Board Meeting 17

12. Mst. Mehwish Javed Khan Evaluator PEC-XIII

Minutes for 275th Registration Board Meeting 18

1. USA Food & Drug Yes https://www.accessdata.fda.gov/scripts/c

2. Canada Health Canada Yes https://health-products.canada.ca/dpd-

3. Australia Therapeutic Goods Yes http://tga-

8. Netherland Medicines Evaluation Yes http://www.geneesmiddeleninformatieba

Minutes for 275th Registration Board Meeting 19

10. Austria Austrian Agency for Yes https://aspregister.basg.gv.at/aspregister/f

14. Europe European Medicines Yes http://www.ema.europa.eu/ema/index.jsp

Minutes for 275th Registration Board Meeting 20

Minutes for 275th Registration Board Meeting 21

B. Reference Regulatory Authorities for Veterinary Drugs

Case No.02: On site investigation of submitted data.

In 254th meeting Registration Board, Registration Board considered recommendations /

During various inspections carried out for verification of authenticity of submitted

Minutes for 275th Registration Board Meeting 23

Case No. 03: Previously deferred cases of Letrozole

Minutes for 275th Registration Board Meeting 26

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