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Nifedipine

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ACTIVE PHARMA INGREDIENTS

60 API Suppliers, 38 USDMF, 11 CEP/COS, 7 JDMF, 6 EU WC, 5 KDMF, 18 NDC API, 19 Listed Suppliers, $ API Reference Price

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

276 FDF Dossiers, 75 FDA Orange Book, 100 Europe, 18 Canada, 4 Australia, 32 South Africa, 47 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CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 90MG, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 6 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 26 BASF, 1 Clariant, 12 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 8 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 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, 10 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

77 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 40 Controlled & Modified Release, 29 Thickeners and Stabilizers, 24 Solubilizers, 23 Granulation, 23 Direct Compression, 23 Film Formers & Plasticizers, 21 Topical, 20 Taste Masking, 20 Parenteral, 16 Lubricants & Glidants, 14 Co-Processed Excipients, 10 Disintegrants & Superdisintegrants, 9 Empty Capsules, 8 Rheology Modifiers, 8 Chewable & Orodispersible Aids, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

19 News #PharmaBuzz

19 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 106 Regulatory FDF Prices, 10 Annual Reports

MARKET PLACE

20 APIs, 17 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 15 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	Moehs Iberica	Spain	MOEHS IBERICA SL	7504	NIFEDIPINE	1988-06-03	Active	II	Complete	2013-04-02	2013-03-25
28/03/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	6197	NIFEDIPINE	1985-12-03	Active	II	Complete	2012-11-30	2012-11-09

Nifedipine

Nifedipine

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

60 API Suppliers

38 USDMF

11 CEP/COS

7 JDMF

6 EU WC

5 KDMF

18 NDC API

19 Listed Suppliers

$ API Reference Price

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

276 FDF Dossiers

75 FDA Orange Book

100 Europe

18 Canada

4 Australia

32 South Africa

47 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

6 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

4 ACG Worldwide

8 Actylis

1 Aeon Procare

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

26 BASF

1 Clariant

12 Corel Pharma Chem

5 DFE Pharma

3 Doshion Polyscience

3 Finar

8 Gangwal Chemicals

11 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

39 Kerry

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

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

10 Sigachi Industries

3 The Dow Chemical Company

1 Ulanqab Kema New Material

1 Valens Pharmachem

2 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

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