Module 2

MILLENNIUM LIFESCIENCE LIMITED
12 B NIRMAL, 241/242 BACKBAY RECLAMATION

NARIMAN POINT, MUMBAI
DOSSIER FOR ALBENDAZOLE CHEWABLE
TABLETS 400 MG
MODULE – 2
SUMMARY OF QUALITY
INFORMATION,
PRE CLINICAL AND CLINICAL
REPORTS
TABLETS 400 MG
2.1 CTD TABLE OF CONTENTS
Sr.No. CONTENTS
2.2 Introduction
2.3 Quality Overall Summary – Introduction
2.3.S Quality Overall Summary – Drug Substance / Active Pharmaceutical
Ingredient
2.3.S.1 General Information
2.3.S.2 Manufacture
2.3.S.3 Characterisation
2.3.S.4 Control of Drug Substance / Active Pharmaceutical Ingredient
2.3.S.5 Reference Standard or Materials
2.3.S.6 Container Closure System
2.3.S.7 Stability
2.3.P Quality Overall Summary – Drug Product / Finished Pharmaceutical
Product
2.3.P.1 Description and Composition of the Drug Product / Pharmaceutical Product
2.3.P.2 Pharmaceutical Development
2.3.P.3 Manufacture
2.3.P.4 Control of Excipients
2.3.P.5 Control of Drug Product / Pharmaceutical Product
2.3.P.6 Reference Standard or Materials
2.3.P.7 Container Closure System
2.3.P.8 Stability
2.3.A Quality Overall Summary – Appendices
2.3.A.1 Facilities and equipment
2.3.A.2 Adventitious agents safety evaluation
2.3.A.3 Excipients
2.4 Non – Clinical Overview
2.5 Clinical Overview
2.5.1 Product Development Rationale
TABLETS 400 MG
2.5.2 Overview of BIO Pharmaceutics
2.5.3 Overview of Clinical Pharmacology
2.5.4 Overview of Efficacy
2.5.5 Overview of Safety
2.5.6 Benefits and Risk Conclusions
2.5.7 Literature Reference
2.6 Non – Clinical Written and Tabulated Summaries
2.6.1 Introduction
2.6.2 Pharmacology Written Summary
2.6.2.1 Brief Summary
2.6.2.2 Primary Pharmacodynamics
2.6.2.3 Secondary Pharmacodynamics
2.6.2.4 Safety Pharmacology
2.6.2.5 Pharmacodynamics Medicine Interactions
2.6.2.6 Discussion and Conclusions
2.6.2.7 Tables and Figures (See Appendix A)
2.6.3 Pharmacology Tabulated Summary (See Appendix B)
2.6.4 Pharmacokinetics Written Summary
2.6.4.2 Method of Analysis
2.6.4.3 Absorption
2.6.4.4 Distribution
2.6.4.5 Metabolism (interspecies comparison)
2.6.4.6 Excretion
2.6.4.7 Pharmacokinetic Medicine Interactions
2.6.4.8 Other Pharmacokinetic Studies
2.6.4.10 Tables and Figures
2.6.5 Pharmacokinetics Tabulated Summary (See Appendix B)
2.6.6 Toxicology Written Summary
TABLETS 400 MG
2.6.6.2 Single – Dose Toxicity
2.6.6.3 Repeat – Dose Toxicity (Including Supportive toxicokinetics evaluations)
2.6.6.4 Genotoxicity
2.6.6.5 Carcinogenicity (including supportive toxicokinetics evaluations)
2.6.6.6 Reproductive and Development Toxicity (including range – finding studies
and supportive toxicokinetics evaluations)
2.6.6.7 Local Tolerance
2.6.6.8 Other Toxicity Studies (if available)
2.6.6.10 Tables and Figures (See Appendix A)
2.6.7 Toxicology Tabulated Summary (See Appendix B)
2.7 Clinical Summary
2.7.1 Summary of Biopharmaceutical Studies and Associated Analytical Methods
2.7.1.1 Background and Overview
2.7.1.2 Summary of Results of Individual Studies
2.7.1.3 Comparison and Analyses of Results Across Studies
2.7.1.4 Appendix
2.7.2 Summary of Clinical Pharmacology Studies
2.7.2.1 Background and Overview
2.7.2.3 Comparison and Analysis of Results Across Studies
2.7.2.4 Special Studies
2.7.2.5 Appendix
2.7.3 Summary of Clinical Efficacy – Indication
2.7.3.1 Background and Overview of Clinical Efficacy
2.7.3.3 Comparison and Analyses of Results Across Studies
2.7.3.3.1 Study Populations
2.7.3.3.2 Comparison of Efficacy Results of All Studies
TABLETS 400 MG
2.7.3.3.3 Comparison of Results in Sub – populations
2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations
2.7.3.5 Persistence of Efficacy and / or Tolerance Effects
2.7.3.6 Appendix
2.7.4 Summary of Clinical Safety
2.7.4.1 Exposure to the Medicine
2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies
2.7.4.1.2 Overall Extent of Exposure
2.7.4.1.3 Demographic and other Characteristics of Study Population
2.7.4.2 Adverse Events
2.7.4.2.1 Analysis of Adverse Events
2.7.4.2.1.1 Common Adverse Events
2.7.4.2.1.2 Deaths
2.7.4.2.1.3 Other Serious Adverse Events
2.7.4.2.1.4 Other Significant Adverse Events
2.7.4.2.1.5 Analysis of Adverse Events by Organ System or Syndrome
2.7.4.2.2 Narratives
2.7.4.3 Clinical Laboratory Evaluations
2.7.4.4 Vital Signs, Physical Findings and other Observations related to Safety
2.7.4.5 Safety in Special Groups and Situations
2.7.4.5.1 Intrinsic Factors
2.7.4.5.2 Extrinsic Factors
2.7.4.5.3 Medicine Interactions
2.7.4.5.4 Use in Pregnancy and Lactation
2.7.4.5.5 Overdose
2.7.4.5.6 Medicine Abuse
2.7.4.5.7 Withdrawal and Rebound
2.7.4.5.8 Effects on Ability to Drive of Operate Machinery or Impairment of Mental
Ability
2.7.4.6 Post – Marketing Data
TABLETS 400 MG
2.7.4.7 Appendix
2.7.5 Literature References
2.7.6 Synopses of Individual Studies
TABLETS 400 MG
2.2 INTRODUCTION
Proprietary Name of the Medicinal Product
ALBENDAZOLE
Non – Proprietary Name of the Medicinal Product

ALBENDAZOLE
Company Name
MILLENNIUM LIFESCINCE LIMITED
12 B Nirmal, 241/242 Backbay Reclamination
Nariman Point Mumbai
Dosage Form
Uncoated chewable Tablet
Strength
400 MG
Route of Administration
Oral Administration
Proposed Indication
Alzel-400 Tablet is indicated in the treatment of single or mixed invasion caused by
threadworm human whipworms human, human worm, hookworm duodenal,
American hookworm, tapeworm and nematode intestinal tapeworm unarmed and
armed.
TABLETS 400 MG
2.3.S QUALITY OVERALL SUMMARY : - DRUG SUBSTANCE / ACTIVE
PHARMACEUTICAL INGREDIENT
2.3.S.1 GENERAL INFORMATION
A) Nomenclature
 International Non – Proprietary Name (INN)
Albendazole
 International Union of Pure and Applied Chemistry Name (IUPAC)

Methyl {5 – (propylthio) – 1 H – benzoimidazol – 2 - yl} Carbamate
 United sates Adopted Name / USAN or European Approved Name Modified

Albendazole
 CAS No.
54965 – 21 – 8
 Chemical Name
Carbamic acid, {5 – (propylthio) – 1H – benzimidazol – 2 - yl} -, methyl ester
 Brazilian Common Denomination (DBC No.)

00458
 Action and Use

Anthelminthic
TABLETS 400 MG
b) STRUCTURE
 Molecular Structure
 Molecular Formula
C12H15N3O2S
 Molecular Weight
265.33
 Percentage Composition
Carbon 54.33%
Hydrogen 5.70%
Nitrogen 15.84%
Oxygen 12.06%
Sulphur 12.08%
TABLETS 400 MG
c) GENERAL PROPERTIES
 Physical State
Solid
 Physical form
Powder
 Appearance
White to faintly yellowish powder
 Solubility
Feely soluble in anhydrous formic acid, very slightly soluble in ether, and in
methylene chlorides, practically insoluble in alcohol and in water.
 PH
6.3 (at 1% Suspension)
 PKa
6.9 (double bond nitrogen)
 Partition coefficient log P (n – octanol /water)

2.7
 Melting Point
208°C to 210°C (406 to 410°F)
 Odor
Odorless
TABLETS 400 MG
 Chemical Formula
C12H15N3O2S
 Particle Size
90% less than 50 microns
 Chirality
Not available
 Category
Anthelmintic
 Storage
Preserve in a tight container, and store at controlled room temperature
TABLETS 400 MG
2.3.S.2 MANUFACUTRE
Name of Manufacturer
Established In
2000
Corporate Office
IPCA Laboratories LTD
Regd. Off:
48, Kandivli Ind. Estate,
Mumbai 400 067
Manufacturer Site
At: Plot No A – 328/329/330,
T.T.C. Indl. Area, MIDC,
Navi Mumbai, Mahape,
District: Thane 400 710
TABLETS 400 MG
2.3.S.3 CHARACTERIZATION
Elucidation of Structure and other Characteristics
Albendazole BP is a well-known and an established pharmaceutical active ingredient
having therapeutic function as antibiotics.
 Evidence from NMR spectrum
 Evidence from DSC spectrum
 Evidence from HPLC spectrum
 Evidence from IR spectrum
 Evidence from XRD spectrum
Details are enclosed in Module – 3

TABLETS 400 MG
2.3.S.4 CONTROL OF DRUG SUBSTANCE
 STANDARD TEST SPECIFICATION
Sr.No. Test Specification Reference
01 Description An orange elongated, biconvex, scored on one In house
side uncoated chewable tablets.
02 Identification
A.By HPLC The retention time of the major peak for USP43NF38
Albendazole in the chromatogram of the In house
assay preparation shall corresponds to that in
the chromatogram of the standard prepration
as obtained in assay
03 Average weight 800.0 mg ± (760.0 mg to 840.0 mg) USP43NF38
04 Uniformity of Acceptance value (AV) of the 10 dosage units USP43NF38
Dosage Unit (by is L1≤15; for n = 10 units
Mass variation)
05 Organic NMT 0.05% (No spot, other than the principal USP43NF38
Impurities spot of the sample solution, is larger or more
intense than the principal spot of the standard
preparation)

TABLETS 400 MG
 ANALYTICAL VALIDATION
The Test Method or related substances and assay are described in BP method
validation of substances and assay analytical procedure performed by manufacturer.
Details are enclosed in Module - 3

TABLETS 400 MG
 SUMMARY OF BATCH ANALYSIS
Albendazole is analysed as per BP specifications. The Certificate of analysis shows
results of all parameters as per the specifications described by the manufacturer.
Certificate of analysis for each of these three validation batches are also provided in
DMF.

TABLETS 400 MG
2.3.S.5 REFERNCE STANDARD OR MATERIALS

TABLETS 400 MG
2.3.S.6 PACKING SYSTEM
The primary packing components are food grade and non – toxic having prime virgin
properties.
Following are the list of packing material used for the packing of finished product.
All packing materials are received by stores Department. Each consignment of the
Packing material is tested by Quality Control.
Department as per the laid down specifications. Packaging materials after approval of
Quality Control Department are issued to Packing Department.
Reconciliation record of labels is maintained.
The specifications and test methods of packaging material are enclosed on next pages.
Packing Procedure: The material is placed in food grade double polyethylene bags
Storage Conditions: Store in an airtight container. Protect from light

TABLETS 400 MG
2.3.S.7 STABILITY
Long term stability was initiated on marketable production batches samples. The
samples were packed in double polyethylene bags and then preserved in sealed HDPE
drums in a manner that is stimulates the marketed packing in sealed HDPE drums in a
manner that is simulates the marketed packing at storage condition.

TABLETS 400 MG
2.3.P QUALITY OVERALL SUMMARY – DRUG PRODUCT / FINISHED
PHARMACEUTICAL PRODUCT
2.3.P.1 DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT
Description of Product
An orange, elongated, biconvex, scored on one side uncoated chewable tablets.
Composition
Each uncoated chewable tablet contains:
Albendazole USP 400 mg

TABLETS 400 MG
2.3.P.2 PHARMACEUTICAL DEVELOPMENT
Formulation and the process development activities of “Albendazole Tablets 400 mg”
was carried out for evaluating Quality. Efficacy and Stability of the product:
thereafter product registration in Global Markets.
As the formulation for “Albendazole Tablets 400 mg” is developed and development
of the product and pre – formulation studies were commenced simultaneously. At this
stage more importance was given for testing of API and preservatives, which play
predominant role in formulation development.
During the development process a brief study on reference product characterization
manufactured by millennium was carried out to have a comparison with that of
formulation under development.
Details are enclosed in module – 3

TABLETS 400 MG
2.3.P.3 MANUFACTURER
NAME OF MANUFACTURER
MILLENNIUM LIFESCINCE LIMITED
Plot No A – 328/329/330 T.T.C. Indl
Area, MIDC, Navi Mumbai, Mahape,
District: Thane 400 710.

TABLETS 400 MG
2.3.P.4 CONTROL OF EXCIPIENTS
Specification
S.No. Name of Ingredient Pharmacopoeia Status
01 Lactose Monohydrate BP
02 Mannitol USP
03 Microcrystalline Cellulose BP
04 Sodium Starch Glycolate BP
05 Maize Starch BP
06 Sucrose BP
07 Sodium Saccharine BP
08 Purified Talc BP
09 Magnesium Stearate BP
10 Aspartame BP
11 Colloidal Silicon Dioxide BP
For In – House Excipients:

S.No. Name of Ingredient Pharmacopoeia Status
01 Colour Sunset Yellow Supra IHS
02 Orange Flavour Dry IHS
Details enclosed in Module- 3

TABLETS 400 MG
2.3.P.5 CONTROL OF DRUG PRODUCT
Standard Test Specification {At release + End of shelf life}:
Attached
S.No. Product Reference
01 Albendazole Chewable Tablets 400 mg IHS
Details enclosed in Module – 3.

TABLETS 400 MG
2.3.P.6 REFERENCE STANDARD OR MATERIALS
Albendazole BP
Working standard has been prepared against the reference standards stated above and
all tests for the finished product were conducted against the working standard.
Working Standard no. : QC/WS -96/17
Assay: 99.96% w/w
Working Standard COA enclosed in module – 3
Details enclosed in Module – 3.

TABLETS 400 MG
2.3.P.7 CONTAINER CLOSURE SYSTEM
The Finished Product, Albendazole Tablet 400 mg has been packed in 1 Tablets in a
Blister Further 1 blister packed in a unit Carton along with pack insert.
The Packaging Material Details are enclosed in Module – 3

TABLETS 400 MG
2.3.P.8 STABILITY
Albendazole Tablets 400 mg
The Stability data of 3 production batches initiated at our plant for Albendazole
Tablet 400 mg are provided. The data contains 36 months of stability data stored at
long term conditions and 6 months stability data at accelerated Conditions.
Container Closure System

The stability study was conducted on the dosage form packed in the container closure
system proposed for marketing.
Post – approval Stability Protocol and Stability Commitment

Stability Study Data up to 36 months for “Albendazole Tablet 400 mg” are enclosed
in Module – 3.
Stability Data
Albendazole Tablet 400 mg are enclosed in Module – 3
TABLETS 400 MG
2.3.A QUALITY OVERALL SUMMARY – APPENDICES
2.3.A.1FACILITIES AND EQUIPMENT
TABLETS 400 MG
2.3.A.2ADVENTITIOUS AGENTS SAFETY EVALUATION
TABLETS 400 MG
2.3.A.3EXCPIENTS
TABLETS 400 MG
2.4 NON – CLINICAL OVERVIEW
TABLETS 400 MG
2.5 CLINICAL OVERVIEW
2.5.1 PRODUCT DEVELOPMENT TRATIONALE
TABLETS 400 MG
2.5.2 OVERVIEW OF BIO PHARMACEUTICS
TABLETS 400 MG
2.5.3 OVERVIEW OF CLINICAL PHARMACOLOGY
TABLETS 400 MG
2.5.4 OVERVIEW OF EFFICACY
TABLETS 400 MG
2.5.5. OVERVIEW OF SAFETY
TABLETS 400 MG
2.5.6 BENEFITS AND RISKS CONCLUSIONS
TABLETS 400 MG
2.5.7 LITERATURE REFERENCES
TABLETS 400 MG
2.6 NON – CLINICAL WRITTEN AND TABULATED SUMMARIES
2.6.1 INTRODUCTION
TABLETS 400 MG
2.6.2 PHARMACOLOGY WRITTEN SUMMARY
2.6.2.1 BRIEF SUMMARY
TABLETS 400 MG
2.6.2.2 PRIMARY PHARMACODYNAMICS
TABLETS 400 MG
2.6.2.3 SECONDARY PHARMACODYNAMICS
TABLETS 400 MG
2.6.2.4 SAFETY PHARMACOLOGY
TABLETS 400 MG
2.6.2.5 PHARMACODYNAMIC MEDICINE INTERACTIONS
TABLETS 400 MG
2.6.2.6 DISCUSSION AND CONCLUSION
TABLETS 400 MG
2.6.2.7 TABLES AND FIGURES (See Appendix A)
TABLETS 400 MG
2.6.3 PHARMACOLOGY TABULATED SUMMARY (See Appendix B)
TABLETS 400 MG
2.6.4 PHARMACOKINETICS WRITTEN SUMMARY
TABLETS 400 MG
2.6.4.2 METHOD OF ANALYSIS
TABLETS 400 MG
2.6.4.3 ABSORPTION
TABLETS 400 MG
2.6.4.4 DISTRIBUTION
TABLETS 400 MG
2.6.4.5 METABOLISM (Interspecies Comparison)
TABLETS 400 MG
2.6.4.6 EXCRETION
TABLETS 400 MG
2.6.4.7 PHARMACOKINETIC MEDICINE INTERACTIONS
TABLETS 400 MG
2.6.4.8 OTHER PHARMACOKINETIC STUDIES
TABLETS 400 MG
2.6.4.9 DISCUSSION AND CONCLUSIONS
TABLETS 400 MG
2.6.4.10 TABLES AND FIGURES (See Appendix - A)
TABLETS 400 MG
2.6.5 PHARMACOKIBETICS TABULATED SUMMARY (See Appendix B)
TABLETS 400 MG
2.6.6 TOXICOLOGY WRITTEN SUMMARY
TABLETS 400 MG
2.6.6.2 SINGLE – DOSE TOXICITY
TABLETS 400 MG
2.6.6.3 REPEAT – DOSE TOXICITY (Including Supportive toxic kinetics evaluations)
TABLETS 400 MG
2.6.6.4 GENOTOXICITY
TABLETS 400 MG
2.6.6.5 CARCINOGENICITY (including supportive toxic kinetics evaluations)
TABLETS 400 MG
2.6.6.6 REPRODUCTIVE AND DEVELOPMENTAL TOXICITY (including range –
fining studies and supportive toxic kinetics evaluations)
TABLETS 400 MG
2.6.6.7 LOCAL TOLERANCE
TABLETS 400 MG
2.6.6.8 OTHER TOXICITY STUDIES (if available)
TABLETS 400 MG
2.6.6.9 DISCUSSION AND CONCLUSIONS
TABLETS 400 MG
2.6.6.10 TABLES AND FIGURES (see Appendix A)
TABLETS 400 MG
2.6.7 TOXICOLOGY TABULATED SUMMARY (See Appendix B)
TABLETS 400 MG
2.7 CLINICAL SUMMARY
2.7.1 SUMMARY OF BIOPHARMACEUTICAL STUDIES AND ASSOCIATED
ANALYTICAL METHODS
2.7.1.1 BACKGROUND AND OVERVIEW
TABLETS 400 MG
2.7.1.2 SUMMARY OF RESULTS OF INDIVIDUAL STUDIES
TABLETS 400 MG
2.7.1.3COMPARISON AND ANALYSES OF RESULTS ACROSS STUDIES
TABLETS 400 MG
2.7.1.4APPENDIX
TABLETS 400 MG
2.7.2 SUMMARY OF CLINICAL PHARMACOLOGY STUDIES
2.7.2.1BACKGROUND AND OVERIVIEW
TABLETS 400 MG
2.7.2.2SUMMARY OF RESULTS OF INDIVIDUAL STUDIES
TABLETS 400 MG
TABLETS 400 MG
2.7.2.4SPECIAL STUDIES
TABLETS 400 MG
2.7.2.5APPENDIX
TABLETS 400 MG
2.7.3 SUMMARY OF CLINICAL EFFICACY
2.7.3.1BACKGROUND AND OVERVIEW OF CLINICAL EFFICACY
TABLETS 400 MG
TABLETS 400 MG
TABLETS 400 MG
2.7.2.4SPECIAL SATUDIES
TABLETS 400 MG
2.7.2.5APPENDIX
TABLETS 400 MG
2.7.3 SUMMARY OF CLINICAL EFFICACY
2.7.3.1BACKGROUND AND OVERVIEW OF CLINICAL EFFICACY
TABLETS 400 MG
TABLETS 400 MG
2.7.3.3.1 STUDY POPULATIONS
TABLETS 400 MG
2.7.3.3.2 COMPARISON OF EFFICACY RESULTS OF ALL STUDIES
TABLETS 400 MG
2.7.3.3.3 COMPARISON OF RESULTS IN SUB – POPULATIONS
TABLETS 400 MG
2.7.3.4ANALYSIS OF CLINICAL INFORMATION RELEVANT TO DOSING
RECOMMENDATIONS
TABLETS 400 MG
2.7.3.5PERSISTENCE OF EFFICACY AND / OR TOLERANCE EFFECTS
TABLETS 400 MG
2.7.3.6APPEDNDIX
TABLETS 400 MG
2.7.4 SUMMARY OF CLINICAL SAFETY
2.7.4.1EXPOSURE TO THE MEDICINE
2.7.4.1.1OVERALL SAFETY EVALUATION PLAN AND NARRATIVES OF
SAFETY STUDIES
TABLETS 400 MG
2.7.4.1.2 OVERALL EXTENT OF EXPOSURE
TABLETS 400 MG
2.7.4.1.3 DEMOGRAPHIC AND OTHER CHARACTERISTICS OF STUDY
POPULATION
TABLETS 400 MG
2.7.4.2ADVERSE EVENTS
2.7.4.2.1 ANALYSIS OF ADVERSE EVENTS
2.7.4.2.1.1 COMMON ADVERSE EVENTS
TABLETS 400 MG
2.7.4.2.1.2 DEATHS
TABLETS 400 MG
2.7.4.2.1.3 OTHER SERIOUS ADVERSE EVENTS
TABLETS 400 MG
2.7.4.2.1.4 OTHER SIGNIFICANT ADVERSE EVENTS
TABLETS 400 MG
2.7.4.2.1.5 ANALYSIS OF ADVERSE EVENTS BY ORGAN SYSTEM OR
SYNDROME
TABLETS 400 MG
2.7.4.2.2 NARRATIVES
TABLETS 400 MG
2.7.4.3 CLINICAL LABORATORY EVALUATIONS
TABLETS 400 MG
2.7.4.4 VITAL SIGNS, PHYSICAL FINDINGS AND OTHER OBSERVATIONS
RELEATED TO SAFETY
TABLETS 400 MG
2.7.4.5SAFETY IN SPECIAL GROUPS AND SITUATIONS
2.7.4.5.1 INTRINSIC FACTORS
TABLETS 400 MG
2.7.4.5.2 EXTRINSIC FACTORS
TABLETS 400 MG
2.7.4.5.3 MEDICINE INTERACTIONS
TABLETS 400 MG
2.7.4.5.4 USE IN PREGNANCY AND LACTATION
TABLETS 400 MG
2.7.4.5.5 OVERDOSE
TABLETS 400 MG
2.7.4.5.6 MEDICINE ABUSE
TABLETS 400 MG
2.7.4.5.7 WITHDRAWAL AND REBOUND
TABLETS 400 MG
2.7.4.5.8 EFFECTS ON ABILITY TO DRIVE OF OPERATE MACHINERY OR
IMPAIRMENT OF MENTAL ABILITY
TABLETS 400 MG
2.7.4.6POST – MARKETING DATA
TABLETS 400 MG
2.7.4.7 APPENDIX
TABLETS 400 MG
2.7.5 LITERATURE REFERENCES
TABLETS 400 MG
2.7.6 SYNOPSES OF INDIVIDUAL STUDIES

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MILLENNIUM LIFESCIENCE LIMITED

12 B NIRMAL, 241/242 BACKBAY RECLAMATION

Non – Proprietary Name of the Medicinal Product

 International Union of Pure and Applied Chemistry Name (IUPAC)

 United sates Adopted Name / USAN or European Approved Name Modified

 Brazilian Common Denomination (DBC No.)

 Action and Use

 Partition coefficient log P (n – octanol /water)

Details are enclosed in Module – 3

Details are enclosed in Module – 3

Details are enclosed in Module - 3

Details are enclosed in Module – 3

Details are enclosed in Module – 3

Details are enclosed in Module – 3

Details are enclosed in Module – 3

Details are enclosed in Module – 3

Details are enclosed in module – 3

Details are enclosed in Module – 3

For In – House Excipients:

Details enclosed in Module- 3

Details enclosed in Module – 3.

Working Standard COA enclosed in module – 3

Details enclosed in Module – 3.

The Packaging Material Details are enclosed in Module – 3

Container Closure System

Post – approval Stability Protocol and Stability Commitment

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