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Darifenacin

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 15 USDMF, 9 EU WC, 7 NDC API, 14 Listed Suppliers, $ API Reference Price

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TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Faran Shimi Pharmaceutical, 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 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 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, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

50 Coating Systems & Additives, 47 Fillers, Diluents & Binders, 27 Controlled & Modified Release, 19 Thickeners and Stabilizers, 16 Lubricants & Glidants, 14 Topical, 13 Direct Compression, 11 Granulation, 11 Film Formers & Plasticizers, 9 Co-Processed Excipients, 8 Solubilizers, 6 Disintegrants & Superdisintegrants, 6 API Stability Enhancers, 5 Emulsifying Agents, 5 Rheology Modifiers, 5 Parenteral, 5 Empty Capsules, 4 Taste Masking, 4 Coloring Agents, 4 Vegetarian Capsules, 3 Chewable & Orodispersible Aids, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

12 News #PharmaBuzz

12 News #PharmaBuzz

GLOBAL SALES INFORMATION

10 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

2 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 Health Canada Patents

8 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP, 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
28/03/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	22206	DARIFENACIN HYDROBROMIDE	2008-11-21	Active	II	Complete	2013-08-28	2013-08-14
28/03/2025	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LTD	26138	DARIFENACIN HYDROBROMIDE	2012-06-27	Active	II	Complete	2014-04-18	2013-09-26

Darifenacin

Darifenacin

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers

15 USDMF

9 EU WC

7 NDC API

14 Listed Suppliers

$ API Reference Price

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

2 Faran Shimi Pharmaceutical

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 Finar

8 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

31 Kerry

3 Kima Chemical

6 Lonza Capsugel

10 Microlex e.U

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

10 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

50 Coating Systems & Additives

47 Fillers, Diluents & Binders

27 Controlled & Modified Release

19 Thickeners and Stabilizers

16 Lubricants & Glidants

14 Topical

13 Direct Compression

11 Granulation

11 Film Formers & Plasticizers

9 Co-Processed Excipients

8 Solubilizers

6 Disintegrants & Superdisintegrants

6 API Stability Enhancers

5 Emulsifying Agents

5 Rheology Modifiers

5 Parenteral

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