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prospan, Diprolene, Diprosone, Diprolene AF, Betamethasone Dipropionate

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ACTIVE PHARMA INGREDIENTS

50 API Suppliers, 16 USDMF, 8 CEP/COS, 6 JDMF, 8 EU WC, 2 KDMF, 10 NDC API, 33 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

143 FDF Dossiers, 79 FDA Orange Book, 7 Europe, 3 Canada, 24 Australia, 9 South Africa, 21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT, AUGMENTED;TOPICAL - EQ 0.05% BASE, CREAM;TOPICAL - EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - EQ 0.05% BASE, OINTMENT;TOPICAL - EQ 0.05% BASE, CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, OINTMENT;TOPICAL - 0.064%;0.005%, SUSPENSION;TOPICAL - 0.064%;0.005%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 2 SPI Pharma, 3 DKSH, 1 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 1 Actylis, 1 Alcedo Pharmachem, 11 BASF, 1 Clariant, 4 Corel Pharma Chem, 2 Finar, 1 Kerry, 4 Lubrizol Life Science Health, 11 Roquette, 1 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Valens Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

27 Topical, 13 Film Formers & Plasticizers, 9 Emulsifying Agents, 8 Parenteral, 8 Solubilizers, 6 Lubricants & Glidants, 6 Thickeners and Stabilizers, 5 Fillers, Diluents & Binders, 5 Coating Systems & Additives, 4 Controlled & Modified Release, 4 Taste Masking, 3 Direct Compression, 3 Surfactant & Foaming Agents, 2 Chewable & Orodispersible Aids, 2 Granulation, 1 Rheology Modifiers, 1 Co-Processed Excipients, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 47 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 17 Finished Drug Prices, 9 Annual Reports

MARKET PLACE

18 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

20 US Patents

20 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 5 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
26/09/2024	Symbiotec Pharmalab	India	SYMBIOTEC PHARMALAB PRIVATE LTD	25798	BETAMETHASONE DIPROPIONATE	2012-02-16	Active	II	Complete	2016-06-02	2016-02-12
26/09/2024	Axplora	Germany	FARMABIOS SPA	23118	BETAMETHASONE DIPROPIONATE MICRONIZED	2009-09-16	Active	II	Complete	2013-10-07	2013-09-26

List of Drug Master Files (DMF) of prospan, Diprolene, Diprosone, Diprolene AF, Betamethasone Dipropionate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Prospan, Diprolene, Diprosone, Diprolene AF, Betamethasone Dipropionate

prospan, Diprolene, Diprosone, Diprolene AF, Betamethasone Dipropionate

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

50 API Suppliers

16 USDMF

8 CEP/COS

6 JDMF

8 EU WC

2 KDMF

10 NDC API

33 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

FINISHED DOSAGE FORMULATIONS

143 FDF Dossiers

79 FDA Orange Book

7 Europe

3 Canada

24 Australia

9 South Africa

21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT, AUGMENTED;TOPICAL - EQ 0.05% BASE

CREAM;TOPICAL - EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - EQ 0.05% BASE

OINTMENT;TOPICAL - EQ 0.05% BASE

CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

OINTMENT;TOPICAL - 0.064%;0.005%

SUSPENSION;TOPICAL - 0.064%;0.005%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

2 SPI Pharma

3 DKSH

1 Gangwal Healthcare

9 Nanjing Well Pharmaceutical

1 Actylis

1 Alcedo Pharmachem

11 BASF

1 Clariant

4 Corel Pharma Chem

2 Finar

1 Kerry

4 Lubrizol Life Science Health

11 Roquette

1 Seppic

2 Shandong Focus Biotechnology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

1 Valens Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

27 Topical

13 Film Formers & Plasticizers

9 Emulsifying Agents

8 Parenteral

8 Solubilizers

6 Lubricants & Glidants

6 Thickeners and Stabilizers

5 Fillers, Diluents & Binders

5 Coating Systems & Additives

4 Controlled & Modified Release

4 Taste Masking

3 Direct Compression

3 Surfactant & Foaming Agents

2 Chewable & Orodispersible Aids

2 Granulation

1 Rheology Modifiers

1 Co-Processed Excipients

CREAM;TOPICAL - EQ 0.05% BASE;1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons