Fenofibric Acid

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ACTIVE PHARMA INGREDIENTS

71 API Suppliers, 27 USDMF, 16 CEP/COS, 4 JDMF, 17 EU WC, 28 KDMF, 18 NDC API, 44 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

281 FDF Dossiers, 129 FDA Orange Book, 52 Europe, 12 Canada, 28 Australia, 2 South Africa, 58 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 160MG, CAPSULE;ORAL - 150MG, CAPSULE;ORAL - 50MG, TABLET;ORAL - 145MG, TABLET;ORAL - 48MG, CAPSULE;ORAL - 130MG, CAPSULE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 43MG, CAPSULE;ORAL - 90MG, TABLET;ORAL - 105MG, TABLET;ORAL - 35MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 3 Rochem International Inc, 19 SPI Pharma, 3 Seqens, 11 DKSH, 1 PMC Isochem, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 2 Kewpie Corporation, 14 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 35 BASF, 1 Bioplus Life Sciences, 2 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 14 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 3 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 31 Roquette, 15 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

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USFDA APPLICATION NUMBER - 22418 / DOSAGE - TABLET;ORAL - 35MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Fenofibric Acid(UNII: BGF9MN2HU1) (Fenofibric Acid - UNII:BGF9MN2HU1)	Fenofibric Acid	35mg \| 105mg

Inactive Ingredients

Ingredient Name	Caraco Pharma, Inc.	Mutual Pharmaceutical Company, Inc.
cellulose, microcrystalline(OP1R32D61U)
Copovidone K25-31(D9C330MD8B)
crospovidone(68401960MK)
magnesium stearate(70097M6I30)

Drug Product Composition: Fenofibric Acid

Fenofibric Acid

Fenofibric Acid

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

71 API Suppliers

27 USDMF

16 CEP/COS

4 JDMF

17 EU WC

28 KDMF

18 NDC API

44 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

281 FDF Dossiers

129 FDA Orange Book

52 Europe

12 Canada

28 Australia

2 South Africa

58 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 160MG

CAPSULE;ORAL - 150MG

CAPSULE;ORAL - 50MG

TABLET;ORAL - 145MG

TABLET;ORAL - 48MG

CAPSULE;ORAL - 130MG

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

CAPSULE;ORAL - 43MG

CAPSULE;ORAL - 90MG

TABLET;ORAL - 105MG

TABLET;ORAL - 35MG

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Evonik

3 Rochem International Inc

19 SPI Pharma

3 Seqens

11 DKSH

1 PMC Isochem

1 Pharm-RX Chemical

8 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

15 Gangwal Healthcare

2 Kewpie Corporation

14 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

7 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

35 BASF

1 Bioplus Life Sciences

2 Clariant

14 Corel Pharma Chem

7 DFE Pharma

1 Doshion Polyscience

2 Finar

14 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

3 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

4 Novo Excipients

CAPSULE;ORAL - 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons