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Ketoconazole

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ACTIVE PHARMA INGREDIENTS

46 API Suppliers, 15 USDMF, 6 CEP/COS, 2 JDMF, 4 EU WC, 13 KDMF, 21 NDC API, 31 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

23 Intermediate Suppliers

23 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

131 FDF Dossiers, 27 FDA Orange Book, 37 Europe, 4 Canada, 10 South Africa, 53 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TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 1%, AEROSOL, FOAM;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 2%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 5 SPI Pharma, 5 DKSH, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 13 Actylis, 4 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 Nippon Fine 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, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders, 51 Topical, 39 Solubilizers, 35 Thickeners and Stabilizers, 26 Parenteral, 22 Direct Compression, 17 Granulation, 16 Emulsifying Agents, 14 Co-Processed Excipients, 14 Surfactant & Foaming Agents, 13 Lubricants & Glidants, 13 Controlled & Modified Release, 10 Film Formers & Plasticizers, 9 Coating Systems & Additives, 8 Disintegrants & Superdisintegrants, 6 Taste Masking, 6 Rheology Modifiers, 6 Chewable & Orodispersible Aids, 4 API Stability Enhancers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 14 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 36 Regulatory FDF Prices

MARKET PLACE

43 APIs, 2 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 3 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	Nuray Chemicals Private Limited	India	SS PHARMA LLC	38417	KETOCONAZOLE USP	2023-07-15	Active	II	Complete	2023-08-23	2023-05-26
28/03/2025	Albemarle Corporation	U.S.A	ALBEMARLE CORP	12171	KETOCONAZOLE	1996-10-11	Inactive	II	N/A

Ketoconazole

Ketoconazole

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

46 API Suppliers

15 USDMF

6 CEP/COS

2 JDMF

4 EU WC

13 KDMF

21 NDC API

31 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

23 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

131 FDF Dossiers

27 FDA Orange Book

37 Europe

4 Canada

10 South Africa

53 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% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;TOPICAL - 2%

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

5 SPI Pharma

5 DKSH

1 Pharm-RX Chemical

4 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

3 Gangwal Healthcare

11 Nanjing Well Pharmaceutical

2 Pfanstiehl

13 Actylis

4 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 Nippon Fine 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

1 Ulanqab Kema New Material

1 Valens Pharmachem

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders

51 Topical

39 Solubilizers

35 Thickeners and Stabilizers

26 Parenteral

22 Direct Compression

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

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