NCGC00025000-10

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ACTIVE PHARMA INGREDIENTS

71 API Suppliers, 15 USDMF, 7 CEP/COS, 2 JDMF, 6 EU WC, 13 KDMF, 24 NDC API, 34 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

33 Intermediate Suppliers

33 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

115 FDF Dossiers, 28 FDA Orange Book, 21 Europe, 4 Canada, 10 South Africa, 52 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TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 1%, AEROSOL, FOAM;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TOPICAL - 2%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 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 10 Kirsch Pharma, 13 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 34 BASF, 2 BioSpectra, 3 CD Formulation, 1 Clariant, 1 Corel Pharma Chem, 4 DFE Pharma, 3 Esteem Industries, 3 Finar, 12 Gangwal Chemicals, 1 Ideal Cures, 2 Ingredion Pharma Solutions, 12 Kerry, 1 Keval Exports, 2 Lubrizol Life Science Health, 11 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nitika Pharmaceutical Specialities, 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, 8 Sigachi Industries, 2 Silverline Chemicals, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

52 Topical, 49 Fillers, Diluents & Binders, 41 Solubilizers, 40 Thickeners and Stabilizers, 34 Parenteral, 23 Direct Compression, 20 Granulation, 19 Emulsifying Agents, 16 Surfactant & Foaming Agents, 14 Co-Processed Excipients, 13 Lubricants & Glidants, 12 Controlled & Modified Release, 10 Film Formers & Plasticizers, 8 Chewable & Orodispersible Aids, 8 Disintegrants & Superdisintegrants, 7 Coating Systems & Additives, 7 Taste Masking, 7 Rheology Modifiers, 4 API Stability Enhancers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 15 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 12 Regulatory FDF Prices

MARKET PLACE

45 APIs, 3 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21946 / DOSAGE - GEL;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	Aqua Pharmaceuticals
ALCOHOL(3K9958V90M)
ASCORBIC ACID(PQ6CK8PD0R)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C YELLOW NO. 6(H77VEI93A8)
GLYCERIN(PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
PPG-15 STEARYL ETHER(1II18XLS1L)
PROPYLENE GLYCOL(6DC9Q167V3)

Drug Product Composition: NCGC00025000-10

NCGC00025000-10

NCGC00025000-10

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

71 API Suppliers

15 USDMF

7 CEP/COS

2 JDMF

6 EU WC

13 KDMF

24 NDC API

34 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

33 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

115 FDF Dossiers

28 FDA Orange Book

21 Europe

4 Canada

10 South Africa

52 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 Boai NKY Pharmaceuticals Ltd

3 Gangwal Healthcare

11 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

10 Kirsch Pharma

13 Actylis

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

34 BASF

2 BioSpectra

3 CD Formulation

1 Clariant

1 Corel Pharma Chem

4 DFE Pharma

3 Esteem Industries

3 Finar

12 Gangwal Chemicals

1 Ideal Cures

2 Ingredion Pharma Solutions

12 Kerry

1 Keval Exports

2 Lubrizol Life Science Health

11 Microlex e.U

2 Nanjing Bold Chemical

2 Nippon Fine Chemical

2 Nitika Pharmaceutical Specialities

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

8 Sigachi Industries

2 Silverline Chemicals

1 Ulanqab Kema New Material

1 Valens Pharmachem

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