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Darifenacin Hydrobromide

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 14 USDMF, 7 EU WC, 7 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

55 FDF Dossiers, 20 FDA Orange Book, 14 Europe, 6 Canada, 5 South Africa, 10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 5 DKSH, 3 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 9 BASF, 3 Clariant, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Esteem Industries, 1 Finar, 8 Gangwal Chemicals, 5 Ideal Cures, 21 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 38 Fillers, Diluents & Binders, 22 Controlled & Modified Release, 18 Thickeners and Stabilizers, 16 Lubricants & Glidants, 15 Topical, 14 Granulation, 14 Direct Compression, 10 Film Formers & Plasticizers, 10 Co-Processed Excipients, 8 Solubilizers, 6 Disintegrants & Superdisintegrants, 6 API Stability Enhancers, 5 Empty Capsules, 5 Emulsifying Agents, 5 Rheology Modifiers, 5 Parenteral, 4 Vegetarian Capsules, 4 Taste Masking, 4 Coloring Agents, 4 Chewable & Orodispersible Aids, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

12 News #PharmaBuzz

12 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 6 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

2 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 Others

4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
31/10/2025	TAPI Technology & API Services	Israel	TAPI NL BV	22206	DARIFENACIN HYDROBROMIDE	2008-11-21	Active	II	Complete	2013-08-28	2013-08-14
31/10/2025	Unimark Remedies	India	UNIMARK REMEDIES LTD	26419	DARIFENACIN HYDROBROMIDE	2012-09-27	Inactive	II	N/A

Darifenacin Hydrobromide

Darifenacin Hydrobromide

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

24 API Suppliers

14 USDMF

7 EU WC

7 NDC API

12 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

55 FDF Dossiers

20 FDA Orange Book

14 Europe

6 Canada

5 South Africa

10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

5 DKSH

3 Boai NKY Pharmaceuticals Ltd

3 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 ACG Worldwide

3 Actylis

1 Aeon Procare

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

9 BASF

3 Clariant

10 Corel Pharma Chem

4 DFE Pharma

1 Esteem Industries

1 Finar

8 Gangwal Chemicals

5 Ideal Cures

21 Kerry

1 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

10 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

1 Pharmatrans-Sanaq

2 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

9 Roquette

6 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

9 Sigachi Industries

2 Silverline Chemicals

2 The Dow Chemical Company

1 Ulanqab Kema New Material

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives

38 Fillers, Diluents & Binders

22 Controlled & Modified Release

18 Thickeners and Stabilizers

16 Lubricants & Glidants

15 Topical

14 Granulation

14 Direct Compression

10 Film Formers & Plasticizers

10 Co-Processed Excipients

8 Solubilizers

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons