Nifedipine

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ACTIVE PHARMA INGREDIENTS

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

DEVELOPMENTS

28 Drugs in Development

28 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

306 FDF Dossiers, 75 FDA Orange Book, 130 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CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 90MG, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Direct Compression, 28 Thickeners and Stabilizers, 28 Granulation, 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

Filters

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USFDA APPLICATION NUMBER - 18482 / DOSAGE - CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NIFEDIPINE(UNII: I9ZF7L6G2L) (NIFEDIPINE - UNII:I9ZF7L6G2L)	NIFEDIPINE	10mg

Inactive Ingredients

Ingredient Name	Pfizer Laboratories Div Pfizer Inc	REMEDYREPACK INC.
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
GLYCERIN(PDC6A3C0OX)
PEPPERMINT OIL(AV092KU4JH)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SACCHARIN SODIUM ANHYDROUS(I4807BK602)
SACCHARIN SODIUM(SB8ZUX40TY)
WATER BUFFALO, COOKED(RM3G76I0A1)
WATER(059QF0KO0R)

Setid 7dec6ce7 Cd5f 43be B050 B8103d35f0bc Applno 18482 Form Capsule Oral Dosage 20mg - Drug Product Composition: Nifedipine

Nifedipine

Nifedipine

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

72 API Suppliers

38 USDMF

11 CEP/COS

7 JDMF

7 EU WC

6 KDMF

17 NDC API

23 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

28 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

306 FDF Dossiers

75 FDA Orange Book

130 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

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