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NCGC00024983-01

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ACTIVE PHARMA INGREDIENTS

73 API Suppliers, 38 USDMF, 11 CEP/COS, 7 JDMF, 7 EU WC, 6 KDMF, 17 NDC API, 23 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

305 FDF Dossiers, 75 FDA Orange Book, 129 Europe, 17 Canada, 4 Australia, 32 South Africa, 48 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 90MG, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 7 Evonik, 2 Rochem International Inc, 6 SPI Pharma, 14 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 3 Kirsch Pharma, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 26 BASF, 1 CD Formulation, 1 Clariant, 12 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 1 Esteem Industries, 3 Finar, 8 Gangwal Chemicals, 9 Ideal Cures, 2 Ingredion Pharma Solutions, 26 Kerry, 1 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 24 Roquette, 10 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 Silverline Chemicals, 1 Symrise, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 58 Coating Systems & Additives, 34 Controlled & Modified Release, 28 Thickeners and Stabilizers, 28 Granulation, 28 Direct Compression, 24 Solubilizers, 23 Topical, 22 Parenteral, 22 Film Formers & Plasticizers, 20 Taste Masking, 16 Lubricants & Glidants, 13 Co-Processed Excipients, 10 Chewable & Orodispersible Aids, 10 Disintegrants & Superdisintegrants, 9 Empty Capsules, 8 Rheology Modifiers, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

20 News #PharmaBuzz

20 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 98 Regulatory FDF Prices, 11 Annual Reports

MARKET PLACE

22 APIs, 17 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 14 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	Moehs Iberica	Spain	MOEHS IBERICA SL	7504	NIFEDIPINE	1988-06-03	Active	II	Complete	2013-04-02	2013-03-25
31/10/2025	TAPI Technology & API Services	Israel	TAPI NL BV	6197	NIFEDIPINE	1985-12-03	Active	II	Complete	2012-11-30	2012-11-09

NCGC00024983-01

NCGC00024983-01

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

73 API Suppliers

38 USDMF

11 CEP/COS

7 JDMF

7 EU WC

6 KDMF

17 NDC API

23 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

305 FDF Dossiers

75 FDA Orange Book

129 Europe

17 Canada

4 Australia

32 South Africa

48 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 10MG

CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 30MG

TABLET, EXTENDED RELEASE;ORAL - 60MG

TABLET, EXTENDED RELEASE;ORAL - 90MG

TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

7 Evonik

2 Rochem International Inc

6 SPI Pharma

14 DKSH

4 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

3 Kirsch Pharma

4 ACG Worldwide

8 Actylis

1 Aeon Procare

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

26 BASF

1 CD Formulation

1 Clariant

12 Corel Pharma Chem

5 DFE Pharma

3 Doshion Polyscience

1 Esteem Industries

3 Finar

8 Gangwal Chemicals

9 Ideal Cures

2 Ingredion Pharma Solutions

26 Kerry

1 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

2 Pharmatrans-Sanaq

7 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

24 Roquette

10 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

CAPSULE;ORAL - 20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons