Ketoconazole

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 16 USDMF, 6 CEP/COS, 2 JDMF, 4 EU WC, 13 KDMF, 19 NDC API, 30 Listed Suppliers, $ API Reference Price

INTERMEDIATES

18 API Suppliers

18 API Suppliers

FINISHED DOSAGE FORMULATIONS

122 FDF Dossiers, 25 FDA Orange Book, 37 Europe, 4 Canada, 10 South Africa, 46 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 1%, AEROSOL, FOAM;TOPICAL - 2%, GEL;TOPICAL - 2%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 4 DKSH, 1 Jai Radhe Sales, 2 Nippon Fine Chemical, 1 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 13 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 34 BASF, 2 BioSpectra, 1 Clariant, 1 Corel Pharma Chem, 4 DFE Pharma, 3 Finar, 12 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 21 Kerry, 2 Lubrizol Life Science Health, 11 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 13 Roquette, 17 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 9 Sigachi Industries, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

62 Fillers, Diluents & Binders, 49 Topical, 40 Solubilizers, 34 Thickeners and Stabilizers, 32 Direct Compression, 28 Parenteral, 19 Co-Processed Excipients, 17 Granulation, 16 Emulsifying Agents, 14 Controlled & Modified Release, 14 Lubricants & Glidants, 14 Surfactant & Foaming Agents, 11 Disintegrants & Superdisintegrants, 9 Coating Systems & Additives, 9 Film Formers & Plasticizers, 6 Chewable & Orodispersible Aids, 6 Taste Masking, 5 Rheology Modifiers, 4 API Stability Enhancers

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1 US Medicaid Prescriptions, 36 Finished Drug Prices

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42 APIs, 2 FDF Dossiers

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3 EDQM, 1 USP, 3 Others

ANALYTICAL

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1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21738 / DOSAGE - AEROSOL, FOAM;TOPICAL - 2%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
KETOCONAZOLE(UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	20mg in 1

Inactive Ingredients

Ingredient Name	Mylan Pharmaceuticals Inc.	Prestium Pharma, Inc.
ALCOHOL(3K9958V90M)
CETYL ALCOHOL(936JST6JCN)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
POLYSORBATE 60(CAL22UVI4M)
POTASSIUM CITRATE(EE90ONI6FF)
PROPYLENE GLYCOL(6DC9Q167V3)
STEARYL ALCOHOL(2KR89I4H1Y)
WATER(059QF0KO0R)

Drug Product Composition: Ketoconazole

Ketoconazole

Ketoconazole

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers

16 USDMF

6 CEP/COS

2 JDMF

4 EU WC

13 KDMF

19 NDC API

30 Listed Suppliers

$ API Reference Price

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

18 API Suppliers

FINISHED DOSAGE FORMULATIONS

122 FDF Dossiers

25 FDA Orange Book

37 Europe

4 Canada

10 South Africa

46 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SHAMPOO;TOPICAL - 1%

AEROSOL, FOAM;TOPICAL - 2%

GEL;TOPICAL - 2%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

5 SPI Pharma

2 Seqens

4 DKSH

1 Jai Radhe Sales

2 Nippon Fine Chemical

1 Pharm-RX Chemical

4 Boai NKY Pharmaceuticals Ltd

11 Gangwal Healthcare

11 Nanjing Well Pharmaceutical

2 Pfanstiehl

13 Actylis

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

34 BASF

2 BioSpectra

1 Clariant

1 Corel Pharma Chem

4 DFE Pharma

3 Finar

12 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

21 Kerry

2 Lubrizol Life Science Health

11 Microlex e.U

2 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

2 Prachin Chemical

13 Roquette

17 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

9 Sigachi Industries

2 Ulanqab Kema New Material

1 Valens Pharmachem

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

62 Fillers, Diluents & Binders

TABLET;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SHAMPOO;TOPICAL - 2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons