Nifedipine

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ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 38 USDMF, 11 CEP/COS, 7 JDMF, 6 EU WC, 7 KDMF, 19 NDC API, 17 Listed Suppliers, $ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

275 FDF Dossiers, 75 FDA Orange Book, 100 Europe, 18 Canada, 8 Australia, 32 South Africa, 42 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CAPSULE;ORAL - 10MG, CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 90MG, TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Evonik, 2 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 12 DKSH, 6 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 12 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

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NUMBER - 18482 / DOSAGE - CAPSULE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Drug Product Composition: Nifedipine

Nifedipine

Nifedipine

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

58 API Suppliers

38 USDMF

11 CEP/COS

7 JDMF

6 EU WC

7 KDMF

19 NDC API

17 Listed Suppliers

$ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

275 FDF Dossiers

75 FDA Orange Book

100 Europe

18 Canada

8 Australia

32 South Africa

42 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 Evonik

2 Rochem International Inc

6 SPI Pharma

2 Seqens

12 DKSH

6 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

12 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

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