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Prednicarbate
USDMF
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Prednicarbate

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ACTIVE PHARMA INGREDIENTS

9 API Suppliers, 2 USDMF, 3 CEP/COS, 1 KDMF, 4 NDC API, 7 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

29 FDF Dossiers, 4 FDA Orange Book, 21 Europe, 1 Canada, 3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 DKSH, 1 Faran Shimi Pharmaceutical, 3 Nanjing Well Pharmaceutical, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 1 Finar, 5 Microlex e.U, 1 Pluviaendo, 1 Prachin Chemical, 1 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

14 Topical, 8 Lubricants & Glidants, 5 Fillers, Diluents & Binders, 4 Emulsifying Agents, 4 Thickeners and Stabilizers, 3 Solubilizers, 2 Film Formers & Plasticizers, 1 Parenteral, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 21 Regulatory FDF Prices

MARKET PLACE

1 APIs

1 APIs

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 4 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
28/03/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	17031	PREDNICARBATE DRUG SUBSTANCE	2003-12-19	Active	II	N/A
28/03/2025	Taro Pharmaceutical Industries	U.S.A	TARO PHARMACEUTICAL INDUSTRIES LTD	20510	PREDNICARBATE USP MICRONIZED	2007-05-07	Active	II	N/A

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Prednicarbate

Prednicarbate

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

9 API Suppliers

2 USDMF

3 CEP/COS

1 KDMF

4 NDC API

7 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

29 FDF Dossiers

4 FDA Orange Book

21 Europe

1 Canada

3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

1 DKSH

1 Faran Shimi Pharmaceutical

3 Nanjing Well Pharmaceutical

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

8 BASF

1 Finar

5 Microlex e.U

1 Pluviaendo

1 Prachin Chemical

1 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Valens Pharmachem

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

14 Topical

8 Lubricants & Glidants

5 Fillers, Diluents & Binders

4 Emulsifying Agents

4 Thickeners and Stabilizers

3 Solubilizers

2 Film Formers & Plasticizers

1 Parenteral

1 API Stability Enhancers

1 Surfactant & Foaming Agents

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

21 Regulatory FDF Prices

MARKET PLACE

1 APIs

REF. STANDARDS & IMPURITIES

2 EDQM

4 USP

4 Others

Filters

OINTMENT;TOPICAL - 0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CREAM;TOPICAL - 0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons