Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

Data Compilation
#PharmaFlow

Pipeline Prospector Oct 2024: Lundbeck acquires Longboard for US$ 2.6 bn; molecular glue degrader tech witnesses dealmaking

Stock Recap
#PipelineProspector

Darifenacin Hydrobromide

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

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

INTERMEDIATES

8 Intermediates Suppliers

8 Intermediates 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TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Seqens, 3 DKSH, 2 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 8 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 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 28 Controlled & Modified Release, 20 Direct Compression, 18 Thickeners and Stabilizers, 17 Lubricants & Glidants, 14 Topical, 13 Co-Processed Excipients, 11 Film Formers & Plasticizers, 11 Granulation, 8 Solubilizers, 7 Disintegrants & Superdisintegrants, 7 Parenteral, 6 API Stability Enhancers, 5 Empty Capsules, 5 Emulsifying Agents, 4 Vegetarian Capsules, 4 Taste Masking, 4 Coloring Agents, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

12 NEWS #PharmaBuzz

12 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

10 Finished Drug 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

Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LTD	26138	DARIFENACIN HYDROBROMIDE	2012-06-27	Active	II	Complete	2014-04-18	2013-09-26
28/10/2024	Apotex Pharmachem	Canada	APOTEX PHARMACHEM INC	26824	DARIFENACIN HYDROBROMIDE	2013-08-23	Active	II	Complete	2014-01-14	2013-03-26

Darifenacin Hydrobromide

Darifenacin Hydrobromide

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers

15 USDMF

9 EU WC

7 NDC API

15 Listed Suppliers

$ API Reference Price

INTERMEDIATES

8 Intermediates 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

2 Seqens

3 DKSH

2 Faran Shimi Pharmaceutical

3 Boai NKY Pharmaceuticals Ltd

8 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 Fillers, Diluents & Binders

50 Coating Systems & Additives

28 Controlled & Modified Release

20 Direct Compression

18 Thickeners and Stabilizers

17 Lubricants & Glidants

14 Topical

13 Co-Processed Excipients

11 Film Formers & Plasticizers

11 Granulation

8 Solubilizers

7 Disintegrants & Superdisintegrants

7 Parenteral

6 API Stability Enhancers

5 Empty Capsules

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