Module 2

MODULE II
TECHNICAL SUMMARY
MODULE 2 TECHNICAL SUMMARY
2.1 TABLE OF CONTENT
Module 2 – SUMMARY
PP Overall table of contents of modules 2
2.2 Introduction
2.3 Overall Quality Summary
2.3.1 Overview Of Active Pharmaceutical Ingredient [API]/ Drug Substance
2.3.1.1 General Information
2.3.1.2 Manufacturer
2.3.1.3 Characterisation
2.3.1.4 Control of drug substance
2.3.1.5 Reference standards or materials
2.3.1.6 Container closure system
2.3.1.7 Stability
2.3.2 Overview of finished pharmaceutical product [FPP]/drug product
2.3.2.1 Description and composition of drug product
2.3.2.2 Pharmaceutical development
2.3.2.3 Manufacture
2.3.2.4 Control of excipients
2.3.2.5 Control of drug product
2.3.2.6 Reference standards or materials
2.3.2.7 Container closure system
2.3.2.8 Stability
2.4 Overview and summary of non clinical and clinical documentation
2.4.1 New chemical entities only
2.4.2 Generic drug applications only
2.4.2.1 Clinical overview and clinical summary
2.4.2.1.1 Product Development Rationale
2.4.2.1.2 Overview of Biopharmaceutics studies
2.4.2.1.3 Summary of Biopharmaceutic Studies and Associated Analytical
Methods
2.4.2.1.3.1 Background and Overview
2.4.2.1.3.2 Summary of Results of Individual Studies
2.4.2.1.3.3 Comparison and Analyses of Results Across Studies
2.4.2.1.4 Overview and summary of In vitro dissolution tests complementary
to bioequivalence studies
2.4.2.1.5 Overview and summary of In vitro dissolution tests in support of
biowaiver of strength
Module II Technical Summary
Product name: Fluconazole Tablets USP 150 mg
2.2 INTRODUCTION:
Proprietary Name of Drug Product:
Non-Proprietary Name of Drug Product:
Fluconazole Tablets USP 150 mg
Non-Proprietary Name of Drug Substances:
Fluconazole USP
Company Name: Hamax Pharmaceuticals
Dosage Form:
Uncoated Tablet
Strength(s):
Fluconazole USP 150 mg
Route of Administration: Oral
Proposed Indication (s):

Fluconazole Tablets USP 150 mg is indicated for the treatment of candidal vaginitis, acute
or recurrent. It should also be used for treatment of partners with associated candidal
balanitis.
2.3 QUALITY OVERALL SUMMARY (QOS):

2.3.1 OVERVIEW OF THE ACTIVE PHARMACEUTICAL INGREDIENT(S)

[API(S)] :
TABLE OF CONTENTS:
SECTION CONTENTS
APPLICANT’S PART QOS
2.3.1.1 GENERAL INFORMATION
2.3.1.2 MANUFACTURE
2.3.1.3 CHARACTERISATION
2.3.1.4 CONTROL OF DRUG SUBSTANCE
2.3.1.5 REFERENCE STANDARDS OR MATERIALS
2.3.1.6 CONTAINER CLOSURE SYSTEM
2.3.1.7 STABILITY
CONCLUSION
2.3.1.1 General Information:
2.3.1.1.1 Nomenclature:
Fluconazole USP
Internationally used name Fluconazole USP
Chemical Name 2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazole-1-yl)-2-

propan-2-ol
Compendial Name Fluconazole USP
Pharmacopoeial Name Fluconazole USP
C.A.S Registry Number 86386-73-4

2.3.1.1.2 Structure:
Fluconazole USP
Structural Formula
Fluconazole USP
Molecular formula
Fluconazole USP C13H12F2N6O
Molecular weight
Fluconazole USP 306.27
2.3.1.1.3 General properties of the API(s):
Fluconazole USP
Appearance A White or almost white powder
Solubility Freely soluble in methanol, soluble in alcohol and in

acetone, sparingly soluble in isopropanol and in
chloroform, slightly soluble in water, very slightly
soluble in toluene.
2.3.1.2 Manufacturer of API(s):
2.3.1.2.1 Name and address of API(s) manufacturer:
Fluconazole USP
SITE ADDRESS
Administrative Synergene Active Ingredients Private Limited.
Flat No. 302, Bhanu Enclavc,
Sunder Nagar, Erragadda,
Hyderabad- 500 038, A.P. INDIA.
Tel No: +91-40-23700421, 23813969, 23812317
Fax: +91-40-23705088
E-mail: sp@metroapi.com
www.metroapi.com
Production Synergene Active Ingredients Private Limited.
Plot No. 48/B, Sy. 337/P, S.V.C.I.E.
Banchupally (V), Quthbullapur (M),
R.R. Dist. , A.P. INDIA.
Tel No: +91-4032435806
Fax: +91-40-23705088
www.metroapi.com
Analysis Synergene Active Ingredients Private Limited.
Plot No. 48/B, Sy. 337/P, S.V.C.I.E.
Banchupally (V), Quthbullapur (M),
R.R. Dist. , A.P. INDIA.
Tel No: +91-4032435806
Fax: +91-40-23705088
www.metroapi.com
Contract
Nil
manufacturing
Other sites Nil

2.3.1.3 CHARACTERISATION
Fluconazole USP
The elucidation of structure of Fluconazole USP is based on appropriate

physical and chemical test results.
1. Infrared Spectroscopy
2. Nuclear Magnetic Resonance Spectroscopy
3. Mass spectrum
Refer Module 3 – 3.2.1.3

2.3.1.4 CONTROL OF DRUG SUBSTANCE
Fluconazole USP
Specification of FLUCONAZOLE USP

For Method and Certificate of Analysis, refer Module III -3.2.1.4

2.3.1.5 REFERENCE STANDARD OR MATERIALS
Fluconazole USP
Fluconazole USP
For detailed packing specification, please refer Module 3 -3.2.1.6

2.3.1.7 STABILITY
Fluconazole USP
STABILITY SUMMARY AND CONCLUSION

Stability Data
Enclosed in Module III in point no. 3.2.1.7 of dossier.

Finished Product
Proprietary Name of Drug Product:
Non-Proprietary Name of Drug Product: Fluconazole Tablets USP 150 mg
Non-Proprietary Name of Drug Substance: Fluconazole USP
Company Name:
Applicant:
Hamax Pharmaceuticals
Manufacturer:
Relax Bio Tech Pvt. Ltd.
862 / 1, GIDC, Makarpura,
Vadodara - 390010.
Gujarat, INDIA
Dosage Form: Uncoated Tablet
Strength(s):
Each uncoated tablet contains:
Fluconazole USP ……… 150 mg
Excipients ……….……….… q.s.
Route of Administration: Oral
Proposed Indication (s):

Fluconazole Tablets USP 150 mg is indicated for the treatment of candidal vaginitis, acute or
recurrent. It should also be used for treatment of partners with associated candidal balanitis.
2.3.2 OVERVIEW OF THE FINISHED PHARMACEUTICAL PRODUCT/ DRUG

PRODUCT:
TABLE OF CONTENTS
SECTION CONTENTS
APPLICANT’S PART QOS
2.3.2.1 DESCRIPTION AND COMPOSITION OF DRUG PRODUCT
2.3.2.2 PHARMACEUTICAL DEVELOPMENT
2.3.2.3 MANUFACTURER
2.3.2.4 CONTROL OF EXCIPIENTS
2.3.2.5 CONTROL OF DRUG PRODUCT
2.3.2.6 REFERENCE STANDARDS OR MATERIALS
2.3.2.8 STABILITY
CONCLUSION
2.3.2.1 Description and Composition of the Drug Product:
Description:
Pink coloured, round shape, biconvex uncoated tablet having plain on both sides.
Composition:
Fluconazole USP ……… 150 mg
Excipients ……….……….… q.s.
UNIT FORMULA
Quantity /
No. Ingredients Specification Reason For Inclusion
Tab. in mg
DRY MIXING
1. Fluconazole USP 150.00 Active
2. Maize Starch BP 65.00 Binder
3. Micro crystalline cellulose BP 54.00 Binder
BINDER PREPRATION
4. Maize Starch (Paste) BP 7.00 Binder
5. Povidone-30 BP 6.00 Binder
6. Purified Water BP q.s. Solvent
LUBRICATION
7 Purified Talc BP 3.80 Lubricant
8 Magnesium Stearate BP 3.72 Lubricant
9 Colloidal Anhydrous Silica BP 2.50 Glidant
10 Sodium Starch Glycollate BP 2.80 Disintegrant
11 Cross carmellose sodium BP 5.00 Disintegrant
Where, USP = United States Pharmacopoeia, BP = British Pharmacopoeia, IH: In-House,

q.s.: Quantity sufficient
2.3.2.2 PHARMACEUTICAL DEVELOPMENT:
We have enclosed the PDR in Module III in point no. 3.2.2.2 of dossier with following
points:
Literature survey
Active Ingredient
Excipients study
Physicochemical characteristics of active substance
Selection of excipients
Development of composition
Prototype freeze formula
Overages
Physicochemical and biological properties
Development of manufacturing process
Container closure system
Microbiological characteristics
Compatibility
2.3. 2.3 Manufacturer
Site Address
Administrative Hamax Pharmaceuticals
701 GIDC, Makarpura,
Vadodara - 390010.
Gujarat, INDIA
Production Relax Bio-tech Pvt. Ltd.
862 / 1, GIDC, Makarpura,
Vadodara - 390010.
Gujarat, INDIA
2.3.2.4 CONTROL OF EXCIPIENTS:
Detailed specification and method of analysis is enclosed in the Module 3 point no. 3.2.2.4 of
dossier.
2.3.2.5 CONTROL OF DRUG PRODUCT:
2.3.2.5.1 Specifications for the Finished Pharmaceutical Product
Enclosed Below
FINISHED PRODUCT SPECIFICATION

Department: PRODUCT – STP No.:
Quality Control FL/QC/FPS/053/01
(Fluconazole Tablets USP 150 mg)
Effective From: Revision No.:
May 2016 00
SPECIFICATION AS PER : USP
Review Before: Page No:
April 2018 Page 1 of 1
SR.
TESTS SPECIFICATION
NO.
1 Description White to off White coloured, round shape,
biconvex uncoated tablets plain on both sides.
2 Identification The retention time of the major peak of the
Sample solution corresponds to that of the
Standard solution, as obtained in the Assay.
3 Average weight 300 mg ± 3.0 % (291.00 mg to 309.00 mg)
4 Uniformity of weight ± 3 % of Average Weight
5 Disintegration Time NMT 15 minutes
6 Dissolution NLT 75% (Q) is dissolved in 45 min
7 Uniformity of Dosage Unit NMT 15
8 Assay:
Fluconazole USP 150 mg NLT 90.0% to NMT 110.0%
9 Microbial limit test
Total bacterial count NMT 1000 cfu/gm.
Yeast and mould count NMT 100 cfu/gm
Pathogens Absent
Prepared by: Approved by: Authorised by:
Executive – Q.C. Manager – Q.C. Manager – Q.A.

2.3.2.6 REFERENCE STANDARDS OR MATERIALS:
Reference working standards are prepared from the standard material of Fluconazole USP
RS.
The working standards prepared are used for further analysis of raw and finished products.
Certificate of Analysis for working standard is enclosed in Module III - 3.2.2.6.

2.3.2.7 CONTAINER CLOSURE SYSTEM:
Alu-Alu blisters of 1 tablet packed in a mono carton along with the Pack Insert, 20 such
monocartons packed in an outer carton.
Sr. No. Items
1. Printed Aluminium Foil

2. Plain Aluminium Foil
3. Mono Carton
4. Outer Carton
5. Pack Insert
2.3.2.8 STABILITY DATA

2.3.2.8.1 STABILITY PROTOCOL
Name of the Product: (Fluconazole Tablets USP 150 mg)
Label Claim:
Fluconazole USP ……….… 150 mg
Excipients …………………….… q.s.
Approved colour used
Description: Pink coloured, round shape, biconvex uncoated tablet having plain on both
sides.
Packing and package Size:

Alu-Alu blisters of 1 tablet packed in a mono carton along with the Pack Insert, 20 such
monocartons packed in an outer carton.
Storage Condition:
Accelerated stability study: Temperature: 40 ± 2°C & Relative Humidity: 75 ± 5% RH
Real Time stability study : Temperature: 30± 2°C & Relative Humidity: 65% ± 5% RH
Study Duration:
Accelerated stability study: 6 months
Real Time stability study : up to the pre determined shelf life.
Frequency of Testing:
Accelerated stability study: Initial, 1 month, 2 months, 3 months & 6 months.
Real Time stability study :Initial, 3 months, 6 months, 9 months, 12 months,
18 months, 24 months & 36 months.
Test Method:
Reference
No Test Acceptance Criteria
Method
1 Description Pink coloured, round shape, biconvex In-House
uncoated tablet having plain on both
sides.
2 Identification The retention time of the major peak of USP
the Sample solution corresponds to that
of the Standard solution, as obtained in
the Assay.
3 Disintegration Time NMT 15 minutes In-House
4 Dissolution NLT 75% (Q) is dissolved in 45 min USP
5 Assay: USP
Fluconazole USP 150 mg NLT 90.0% to NMT 110.0%
6 Microbial limit test BP
Total bacterial count NMT 1000 cfu/gm.
Yeast and mould count NMT 100 cfu/gm
Pathogens Absent
Detail of Batches Tested:
Batch No. FL13001 FL13002 FL13003
Batch Size 1,00,000 Tablets 1,00,000 Tablets 1,00,000 Tablets

Date of July 2013 July 2013 July 2013
Manufacturing
Manufacturing 862 / 1, GIDC, Makarpura,
Site Vadodara - 390010.
Gujarat, INDIA
Conclusion: Fluconazole Tablets USP 150 mg is found to be Stable for accelerated stability
tests for 6 months & real time stability tests for 36 months.
Shelf Life of the product: 36 months

2.3.2.8.2 Post-approval stability protocol and stability commitment
Not Applicable
2.3.2. 8.3 Stability Data
Please refer Module III -3.2.2.8.3

2.4 OVERVIEW AND SUMMARY OF NON CLINICAL AND CLINICAL

DOCUMENTATION:
2.4.1 New Chemical entities only

Not applicable
2.4.2 GENERIC DRUG APPLICATIONS ONLY
2.4.2.1 CLINICAL OVERVIEW AND CLINICAL SUMMARY
Fluconazole USP
Recommended International Name : Fluconazole

Nonproprietary (rINN) Name : Fluconazole
Compendial Name : Fluconazole USP
National Approved Names : Fluconazole USP
BANM : --
Systematic Chemical Name : 2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-
triazole-1-yl)-2-propan-2-ol
Proprietary names : Fluconazole USP
Chemical abstracts service : 86386-73-4
ATC code : J02A C01
Pharmaopoeaial status : USP
FLUCONAZOLE USP
Molecular Formula : C13H12F2N6O

Molecular weight : 306.27
Therapeutic category : Antiinfectives for systemic use.
2.4.2.1.1 Product Development Rationale
Therapeutic category : Antiinfectives for systemic use.
Therapeutic indications
Fluconazole Tablets USP 150 mg is indicated for the treatment of candidal vaginitis, acute or
recurrent. It should also be used for treatment of partners with associated candidal balanitis.
2.4.2.1.2 Overview of Biopharmaceutics studies

Not applicable
2.4.2.1.3 Summary of Biopharmaceutic Studies and Associated Analytical Methods

Not applicable
2.4.2.1.3.1 Background and Overview

Not applicable.
2.4.2.1.3.2 Summary of Results of Individual Studies

Not applicable.
2.4.2.1.3.3 Comparison and Analyses of Results Across Studies

Not applicable.
2.4.2.1.4 Overview and summary of In vitro dissolution tests complementary to

bioequivalence studies
Not applicable.
2.4.2.1.5 Overview & summary In vitro dissolution tests in support of biowaiver of

strengths
Not applicable.

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MODULE II

2.1 TABLE OF CONTENT

Proprietary Name of Drug Product:

Non-Proprietary Name of Drug Product:

Fluconazole Tablets USP 150 mg

Non-Proprietary Name of Drug Substances:

Company Name: Hamax Pharmaceuticals

Route of Administration: Oral

Proposed Indication (s):

2.3 QUALITY OVERALL SUMMARY (QOS):

2.3.1 OVERVIEW OF THE ACTIVE PHARMACEUTICAL INGREDIENT(S)

APPLICANT’S PART QOS

2.3.1.1 GENERAL INFORMATION

2.3.1.4 CONTROL OF DRUG SUBSTANCE

2.3.1.5 REFERENCE STANDARDS OR MATERIALS

2.3.1.6 CONTAINER CLOSURE SYSTEM

2.3.1.1 General Information:

Internationally used name Fluconazole USP

Chemical Name 2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazole-1-yl)-2-

Compendial Name Fluconazole USP

Pharmacopoeial Name Fluconazole USP

C.A.S Registry Number 86386-73-4

2.3.1.1.3 General properties of the API(s):

Appearance A White or almost white powder

Solubility Freely soluble in methanol, soluble in alcohol and in

2.3.1.2 Manufacturer of API(s):

2.3.1.2.1 Name and address of API(s) manufacturer:

Other sites Nil

The elucidation of structure of Fluconazole USP is based on appropriate

Refer Module 3 – 3.2.1.3

2.3.1.4 CONTROL OF DRUG SUBSTANCE

Specification of FLUCONAZOLE USP

For Method and Certificate of Analysis, refer Module III -3.2.1.4

2.3.1.5 REFERENCE STANDARD OR MATERIALS

2.3.1.6 CONTAINER CLOSURE SYSTEM

For detailed packing specification, please refer Module 3 -3.2.1.6

STABILITY SUMMARY AND CONCLUSION

Enclosed in Module III in point no. 3.2.1.7 of dossier.

Proprietary Name of Drug Product:

Non-Proprietary Name of Drug Product: Fluconazole Tablets USP 150 mg

Non-Proprietary Name of Drug Substance: Fluconazole USP

Dosage Form: Uncoated Tablet

Route of Administration: Oral

Proposed Indication (s):

2.3.2 OVERVIEW OF THE FINISHED PHARMACEUTICAL PRODUCT/ DRUG

APPLICANT’S PART QOS

2.3.2.1 DESCRIPTION AND COMPOSITION OF DRUG PRODUCT

2.3.2.2 PHARMACEUTICAL DEVELOPMENT

2.3.2.4 CONTROL OF EXCIPIENTS

2.3.2.5 CONTROL OF DRUG PRODUCT

2.3.2.6 REFERENCE STANDARDS OR MATERIALS

2.3.2.7 CONTAINER CLOSURE SYSTEM

2.3.2.1 Description and Composition of the Drug Product:

Where, USP = United States Pharmacopoeia, BP = British Pharmacopoeia, IH: In-House,

2.3.2.2 PHARMACEUTICAL DEVELOPMENT:

2.3. 2.3 Manufacturer

2.3.2.4 CONTROL OF EXCIPIENTS:

2.3.2.5 CONTROL OF DRUG PRODUCT:

2.3.2.5.1 Specifications for the Finished Pharmaceutical Product

FINISHED PRODUCT SPECIFICATION

Prepared by: Approved by: Authorised by:

Executive – Q.C. Manager – Q.C. Manager – Q.A.

2.3.2.6 REFERENCE STANDARDS OR MATERIALS: