GenRx Pharmaceuticals Pvt. Ltd.

PHARMACEUTICAL FORMULATION MANUFACTURING UNIT

A Brief Summary

A company in the name and style of M/s GenRx Pharmaceuticals Pvt. Ltd. has been
incorporated and registered in year 2009 in Mumbai. The company’s Registered Office is
at LG1, Hill Palace, Raunak Park, Konkanipada, Pokharan Road No. 2, Thane – 400 610
Maharashtra, India.

GenRx Pharmaceuticals Pvt. Ltd has purchased the asset from M/s. Liva Healthcare
Ltd which is a winner of IDMA’s QUALITY EXCELLENCE AWARDS, and FIRST PRIZE from
District Industries Corporation for good manufacturing practices. This unit is cGMP
Certified.

GenRx is promoted by Mr. Rameshchandra Shankarbhai Patel. This unit is located at

A-52, MIDC, Sinnar, Dist. Nashik, about 180 Kms from Mumbai and 20 Kms from Nashik
city.

M/s. Liva Healthcare Ltd. was an associate company of the world wide famous Zydus
Cadilla group. The building is RCC structure with ground plus two floors. Total
constructed area is 2800 Sq.mtrs on a plot of 7200 Sq.mtrs with lush green
surroundings.

GenRx premise is having MIDC roads on west and south sides and vacant plot on
remaining sides and non-polluting other units around the factory. The climate is very
pleasant, cool and less humid, with plenty of trees in the vicinity.

GenRx Pharmaceuticals Pvt. Ltd is equipped with facility to manufacture the following
allopathic pharmaceuticals formulations, Nutraceuticals and natural products to national
and international standards.
The Facility has manufacturing licences namely Form No 25, 28, 32.

GenRx Pharmaceuticals Pvt. Ltd has fully functional capabilities to manufacture

Allopathic formulations, Nutraceuticals and Natural products in the form of solid and
semi-solid dosages such as Tablets, Capsules (hard gelatin); External preparations and
Cosmetic preparations. We also cater to Nasal preparations like sprays and drops to
national and international standards. The total capacity of various departments to
manufacture for major formulations in a day, for Tablets is 3.5 million Tabs
(2000Kg bulk capacity), for Encapsulation it is 1.6 million Caps. Blister Packing
Capacity is 0.75 Million Blisters and Strip Packing capacity is 0.15 Million Strips.
For External preparation the filling capacity is 100,000 aluminium tubes
(1200Kg bulk capacity) and for Cosmetics it is 70,000 lamitubes, whereas the
Nasal preparation is 50,000 units. The storage capacity for Raw Materials (RM),
Packaging Materials (PM) and Finished Goods (FG) is adequate to cater the
needs of production.

The company is reconditioned and upgraded to comply with requirements of ScheduleM,

cGMP and WHO standards as defined by the Government.

The company has an F&D laboratory of 4000 sq.ft area at their registered office premises
at Thane for the development of new products and technical support to the company.
Our clients include the following reputed companies such as;
1. Ajanta Pharma Ltd., Mumbai.
2. Meyer Organics Ltd., Mumbai.
3. Puneet Laboratories. Mumbai.
4. Gajali Cosmetics. Mumbai.
5. Intellect Lifesciences Pvt. Ltd. Pune.

Prospective clients of the companies are as follows.

1. Zydus Cadilla health care Ltd., Ahmedabad.
2. Bayer Healthcare P. Ltd., Thane.
3. Merck India Ltd., Mumbai.
4. Nexgen Healthcare Pvt. Ltd. Mumbai.

The products would be manufactured and packed in blister packing – 10 Numbers to each
strip for Capsules and Tablets and 1 per carton for ointment.

The weight of Capsules inclusive of the packaging varies from 100 mg to 1.5 grams. The
average weight has been considered at 500 mg. 10 numbers of capsules are packed in 1
strip.

Tablets weigh between 150 and 1500 milligrams. The average weight has been assumed
as 600 mg. 10 numbers are packed per strip.

Ointments are packed individually in tubes. Tube content weight varies between 15 and
100 grams. The average weight of content in a tube is assumed at 15 grams or 15000
milligrams. The production facility as below

1) Ground Floor:
a) Two Granulation areas.
b) Four Compression areas.
c) Four Coating areas.
d) One Drying area.
e) Five packing Lines.
f) Three Ancillary areas.

2) First Floor:
a) Two Ointment Manufacturing areas.
b) One Cosmetic area.
c) One Nasal Preparation area.
d) Six filling Lines.
e) Six Packing Lines.
f) Two Ancillary areas.
g) Primary Packaging Stores.

3) Second Floor:
a) One Capsule Manufacturing area.
b) Two Capsule Filling areas.
c) One Ancillary area.
d) Two dispensing Booths.
e) One Sampling Booth.
f) Thermo labile Area.
g) QA and QC Departments.
h) Thermo stable Raw Material Stores.
Utilities
GenRx has provided high quality infrastructure in terms of utilities. All the utilities are
among the best available and compliant to national and international regulatory

requirements.
QUALITY CONTROL: Department monitors all systems like environment, Water,
materials, Product-in process and finished products. The Instrumentation Laboratory is
equipped with sophisticated instruments.

MICROBIOLOGY: The Microbiological laboratory has all requisite testing facilities.

Safety features and communication

Safety systems including Fire Extinguishers, Fire blankets, first aid box, Emergency exits,
Personnel Protective Equipment’s and Safety representative takes care of fire drills,
awareness programs and other safety related activities. We also follow proper Hygiene as
per cGMP Standards.

All the operating points in the facility are provided with intercom and the computers are
equipped with ERP Software and are connected through (LAN) local area network and
(WAN) Wide area network.

Quality Assurance
The Quality Assurance team functions alongside the Management and works with clear
policies and procedures for recruitment, schedules for medical examination, training
programs, internal audits and all other requirements of GMP.

Validation plans for equipment’s; process and cleaning are written down and
implemented. Calibration Schedules are drawn for all equipment’s and monitored for
effective implementation.

Policies for safety and control of occupational hazards are made and implemented
strictly. An In Process – Quality Control team functioning under the Q.A. continuously
monitors all the process activities.

The Q.A. Department ensures that all the recommendations of national and international
regulations and guidelines are implemented and effectively practiced as per the
requirements of the Customers and as per the regulatory norms that are being followed.
Finished products are released into market only after approval from Q.A. Department.
 GenRx LIST OF APPROVED PRODUCTS UNDER BRAND NAME COMING
UNDER SCHEDULE OTHER THAN C & C1
Sr. Pack
No
Name of products Composition Remark
size
1 Tramagen 100 Capsules Each Capsule contains
1 x 10’ Prescription
(Tramadol Tramadol HCl BP…………………… 100 mg
Blister Rx
CapsulesI.P.100mg) Excipients…………………… Q. S
2 L-CetrigenX Tablets Each Film coated tablet contains
(Levo-Cetrizine HCL Levo-Cetrizine Hydrochloride IP……….5 mg 1 x 10’ Prescription
Tablets IP) Colours:Titanium dioxideI.P. Blister Rx
Excipients ………………… Q. S.
3 Nasovent0.65%Nasal SodiumChlorideI.P ………….. 0.65 % w/v
Drop/Spray (Nasal Saline Benzalkonium Chloride ..……. 0.01 % w/v
10 ml OTC
Solution 0.65% w/v) (As Benzalkonium Chloride Solution IP)
Purified Water I.P………………………..Q.S.
4 Nasovent 2.0%Nasal SodiumChlorideI.P ……………….. 2.0% w/v
Drop/Spray (Nasal Saline Benzalkonium Chloride ………….0.01 % w/v
10 ml OTC
Solution 2.0% w/v) (As Benzalkonium Chloride Solution IP)
Purified Water I.P………………………..Q.S.
5 Olinex Gel Diclofenac Sodium 1.0 % w/w
(Diclofenac Sodium + (as Diclofenac Diethylamine BP... 1.16 % w/w)
Oleum Lini + Methyl Oleum Lini ( containing predominantly a
Salicylate + Menthol Linoenic acid.)……………………3.0 % w/w
15g
Gel) Methyl Salicylate IP ……………10.0 % w/w Prescription
and
Menthol IP ………………………..5.0 % w/w Rx
30g
Preservative added
tubes
Methyl Paraben IP ……………… 0.15 % w/w
Propyl Paraben IP …………… 0.10 % w/w
Gel Base …………………………… q. s.
6 Nasovent-OX 0.05 % Oxymetazoline Hydrochloride USP 0.05 % w/v
Drops/Spray Benzalkonium Chloride ………….0.01 % w/v
(Oxymetazoline (As Benzalkonium Chloride Solution IP) 10 ml OTC
Hydrochloride Nasal Purified Water I.P………………………..Q.S.
solution USP )
7 No Feel Ointment Lignocaine Hydrochloride BP equivalent to
5g Prescription
(Lignocaine Ointment Lignocane……………………………2% w/w
tubes Rx
B.P. 2% w/w) Water miscible hydrophilic base……….q.s
8 GMS Flexi Tablets Each Film coated tablet contains
(Glucosamine Tablets Glucosamine………………..500mg 1 x 10’ Prescription
USP) (as Glucosamine Sulfate Potassium Chloride Blister Rx
USP)
9 NJOYGRA 50 Each Film Coated Tablet Contains: Prescription
1 x 4’
Sildenafil Citrate I.P. equi. to Sildenafil 50mg Rx
Blister
colour :Erythrosine Lake
10 NJOYGRA 100 Each Film Coated Tablet Contains:
1 x 4’ Prescription
Sildenafil Citrate I.P. equi. to Sildenafil 100mg
Blister Rx
colour :Erythrosine Lake
11 MVITAGEN (Chewable Each uncoated Flavoured Chewable Tablet
Tablets) Contains:
(For Prophylactic use) Vitamin A acetate IP……………….1600 IU
Vitamin D3 IP……………………….100 IU
Thiamine Mononitrate IP………….1.0 mg 1 x 10’
OTC
Riboflavin IP……………………….1.0 mg Blister
Pyridoxine Hydrochloride IP…….1.0 mg
Niacinamide IP……………………….15 mg
Vitamin C IP………….25 mg
12 B- GEN TABLETS Each Film Coated Tablet Contains:
(For Prophylactic use) Vitamin B1 Mononitrate IP………….2.0 mg
Vitamin B2 IP……………………….3.0 mg
Niacinamide IP……………………….20 mg
Vitamin B6 IP……………………….1.0 mg
1 x 10’
Calcium Pantothenate IP………...4.0 mg OTC
Blister
Methylcobalamin IP……………….0.5 mcg
Vitamin C IP…………………………..50 mg
Folic Acid IP…………………………..0.3 mg
Biotin USP……………………………300 mcg
13 VITAPENE CAPSULES Each Hard Gelatin Capsules Contains:
(For Prophylactic use) Lycopene 10%......................2000 mcg
Vitamin A acetate IP…………………2000 IU
Vitamin E acetate IP………………….….5 IU
Ascorbic Acid IP (coated)……………...40 mg
Zinc Sulphate Monohydrate USP. Eqv. to
Elemental Zinc ……………………….....5 mg 1 x 10’
OTC
Copper Sulphate IP. Eqv. to Elemental Copper Blister
………………………………………....0.5 mg
Manganese Sulphate IP. Eqv. to Elemental
Manganese……………………………..0.6 mg
Selenium Dioxide USP. Eqv. to Elemental
Selenium………………………………26 mcg

GenRx LIST OF APPROVED PRODUCTS UNDER ( COSMETIC )

Sr.
No
Name of products Composition Pack size
1 GenRish sun Screen lotion 100 ml OTC
2 GenRish Face Wash 100 ml OTC
3 GenRish baby Oil 100 ml OTC
4 GenRish Baby Lotion 100 ml OTC
5 GenRish Hair Gel 50 g OTC
6 GenRish Moisturising Cream 50g OTC
7 GenRish Hand sanitiser 100 ml OTC
8 GenRish Mosquito Repellent Spray 40 ml OTC
9 Mosjet Mosquito Repellent Spray 40 ml OTC
 GenRx LIST OF PRODUCTS COMING UNDER SCHEDULE C & C1 (Generic)
Sr.
No
Name of products Composition Pack size Remark
1 Clobetasol Propionate Clobetasol Propinate cream USP….0.05% w/w
cream USP Preservative added 15g and
Chlorocresol IP …………………….0.1 % w/w Prescription
Ceram Base …………………….………Q. S. 30g tubes Rx
2 Erythromycin Each Capsule contains
Estolate IP Capsules Erythromycin Estolate IP e. q. to 1 x 10’
Erythromycin………………………..250 mg Prescription
Blister
Excipients……….……………………Q. S. Rx
3 Azithromycin Tablet Each uncoated tablet contains
IP 500 mg Azithromycin IP ……………………500 mg 1 x 10’
Prescription
Excipients………..……………………Q. S. Blister
Rx

LIST OF PRODUCTS COMING UNDER SCHEDULE OTHER THAN C & C1

(Generic)
Sr. Pack
Name of products Composition Remark
No size
1 Omeprazole Capsule Each Capsule contains
1 x 10’
IP 20 mg Omeprazole IP (As enteric coated granules) 20mg Prescription
Blister
Excipients …………………… Q. S. Rx
2 Piroxicam Capsules IP Each Capsule contains
1 x 10’
20 mg Piroxicam IP…………………………….. 20 mg Prescription
Blister
Excipients …………………… Q. S. Rx
3 Tramadol Each Capsule contains
1 x 10’
Hydrochloride Tramadol HCl BP……………………… 100 mg Prescription
Blister
Capsules BP 100 mg Excipient…….…………………… Q. S. Rx
4 Triamterene Capsules Each Capsule contains
1 x 10’
IP Triamterene IP………………………… 50 mg Prescription
Blister
Excipients………………………… Q. S. Rx
5 Diclofenac Gel BP Diclofenac Diethylamine BP( e. q. to 15 g
Diclofenac Sodium 1.0 % w/w …… 1.16 % w/w and
Prescription
Gel Base ………………………………… Q. S. 30g
Rx
tubes
6 Diclofenac Diclofenac Diethylamine BP e. q. to
Diethylamine + Oleum Diclofenac Sodium 1.0 % w/w )… 1.16 % w/w
15 g
Lini +Methyl Salicylate Oleum Lini ( containing predominantly a
and
+ Menthol Gel Linoenic acid. )………………………3.0 % w/w Prescription
30g
Methyl Salicylate IP ………….…. 10.0 % w/w Rx
tubes
Menthol IP ………………………….5.0 % w/w
Gel Base……………………………….q. s.
7 Miconazole Nitrate Miconazole Nitrate IP…………….2.00 % w/w 15 g Prescription
Cream IP Ceram Base ……………………….……… q.s. tubes Rx
8 Silver Sulphadiazine & Silver Sulphadiazine USP …………1.00 % w/w
Chlorhexidine Chlorhexidine Gluconate Solutin 20 % IP 15 g Prescription
Gluconate Cream e. q. to Chlorhexidine Gluconate …. 0.20 %w/w tubes Rx
Cream Base …………………………q. s.
9 Oxymetazoline Oxymetazoline Hydrochloride USP...0.05 % w/v
Hydrochloride Nasal Preservative added
10 ml Prescription
Drops USP Benzalkonium Chloride Soln IP e. q. to
Rx
Benzalkonium Chloride ……………0.01 % w/v
10 Cetrizine Each Film coated tablet contains
1 x 10’
Hydrochloride Tablet Cetrizine Hydrochloride IP……………10 mg Prescription
Blister
IP 10 mg Excipients…………………… Q. S. Rx
11 Diclofenac Potassium Each Film coated tablet contains
1 x 10’
Tablet USP 50 mg Diclofenac Potassium USP……………….50 mg Prescription
Blister
Excipients…………………… Q. S. Rx
12 Famotidine Tablet USP Each Film coated tablet contains
1 x 10’ Prescription
20 mg Famotidine USP…………………….20 mg
Blister Rx
Excipients…………………… Q. S.
13 Fluconazole Tablet 150 Each Uncoated tablet contains
1 x 10’ Prescription
mg Fluconazole USP……………………150 mg
Blister Rx
Excipients…………………… Q. S.
14 Paracetamol Tablet IP Each Uncoated tablet contains
1 x 10’
500 mg Paracetamol IP……………………500 mg
Blister OTC
Excipients….…..…………… Q. S.
15 Pseudoephedrine Each Film coated tablet contains
1 x 10’ Prescription
Tablet IP Pseudoephedrine HCl IP…..………….30 mg
Blister Rx
Excipients…………………… Q. S.
16 Dexamethasone Tablets Each uncoated Tablet contains
1 x 10’ Prescription
BP Dexamethasone B.P…..……………….. 0.5mg
Blister Rx
Excipients …………………… Q. S.

LIST OF PRODUCTS COMING UNDER COSMETICS (Generic)

Sr.
Name of products Pack size Remark
No
1 Moisturising Cream with Vitamin E. 50 g OTC
2 Sunscreen Lotion. 50 g OTC

Contd……
A bird eye view of GenRx Pharmaceuticals Pvt Ltd manufacturing unit
Spacious Lobbies for easy movements
 Large RM storage spaces

BSR with large storage capacity.

R.O. Water Plant having 1000Ltrs. capacity per hour.

Distilled Water Plant

A} TABLET SECTION .
GRANULATION 1 area.
 GRANULATION 2 area.

COMPRESSION AREAS -1(20stn), 2(27stn), 3(29stn), 4(35stn)

COATING AREAS
Sugar Coating area

3 Film coating areas

 Proposed Auto Coater Area

PACKING HALL 2 (For Tablets and Capsules)

3 BLISTER Machines
2 STRIP Packing Machines
B} CAPSULE SECTION .
2 Capsule Filling areas

Blending Area
Filling and Polishing Area 1

Filling and Polishing Area 2

C} External Preparations (Ointment, Creams, Nasal Drops/ Spray)
OINTMENT SECTION 1

OINTMENT SECTION 2
 FILLING PACKING 2

Nasal Drops Departmen t

D} COSMETICS
Filling Packing 1
D} QUALITY CONTROL AND QUALITY ASSURANCE
DEPARTMENT