FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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ACTIVE PHARMA INGREDIENTS

80 API Suppliers, 31 USDMF, 30 CEP/COS, 6 JDMF, 6 EU WC, 2 KDMF, 28 NDC API, 47 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

165 Drugs in Development

165 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1271 FDF Dossiers, 75 FDA Orange Book, 980 Europe, 33 Canada, 76 Australia, 53 South Africa, 54 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SPRAY, METERED;NASAL - 0.05MG/SPRAY, POWDER;INHALATION - 0.05MG/INH, POWDER;INHALATION - 0.1MG/INH, POWDER;INHALATION - 0.25MG/INH, POWDER;INHALATION - 0.03MG/INH, POWDER;INHALATION - 0.055MG/INH, POWDER;INHALATION - 0.113MG/INH, POWDER;INHALATION - 0.232MG/INH, POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH, POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH, POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH, POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH, POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH, POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH, LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH, AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH, AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH, AEROSOL, METERED;INHALATION - 0.044MG/INH, AEROSOL, METERED;INHALATION - 0.11MG/INH, AEROSOL, METERED;INHALATION - 0.22MG/INH

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 2 SPI Pharma, 4 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 6 Kirsch Pharma, 10 Actylis, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 11 BASF, 1 CD Formulation, 5 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 1 Ideal Cures, 1 Ingredion Pharma Solutions, 12 Kerry, 3 Keval Exports, 1 Kima Chemical, 10 Microlex e.U, 1 Nanjing Bold Chemical, 1 Nitika Pharmaceutical Specialities, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 10 Roquette, 8 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 1 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

28 Fillers, Diluents & Binders, 22 Thickeners and Stabilizers, 21 Solubilizers, 19 Parenteral, 19 Topical, 17 Direct Compression, 15 Granulation, 14 Disintegrants & Superdisintegrants, 10 Co-Processed Excipients, 10 Emulsifying Agents, 8 Controlled & Modified Release, 7 Film Formers & Plasticizers, 7 Surfactant & Foaming Agents, 5 Coating Systems & Additives, 5 Rheology Modifiers, 4 Taste Masking, 4 Chewable & Orodispersible Aids, 1 API Stability Enhancers, 1 Lubricants & Glidants

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 144 News #PharmaBuzz

GLOBAL SALES INFORMATION

30 US Medicaid Prescriptions, 96 Regulatory FDF Prices, 14 Annual Reports

MARKET PLACE

18 APIs, 5 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

162 US Patents, 11 US Exclusivities, 97 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 8 USP, 19 Others

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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
29/01/2026	Coral Drugs Private Limited	India	CORAL DRUGS PVT LTD	21879	FLUTICASONE PROPIONATE	2008-08-12	Active	II	Complete	2018-05-11	2018-04-10
03/02/2026	Vamsi Labs	India	VAMSI LABS LTD	42812	FLUTICASONE PROPIONATE USP	2025-11-25	Active	II	N/A

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

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Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

80 API Suppliers

31 USDMF

30 CEP/COS

6 JDMF

6 EU WC

2 KDMF

28 NDC API

47 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

165 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1271 FDF Dossiers

75 FDA Orange Book

980 Europe

33 Canada

76 Australia

53 South Africa

54 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY

SPRAY, METERED;NASAL - 0.05MG/SPRAY

POWDER;INHALATION - 0.05MG/INH

POWDER;INHALATION - 0.1MG/INH

POWDER;INHALATION - 0.25MG/INH

POWDER;INHALATION - 0.03MG/INH

POWDER;INHALATION - 0.055MG/INH

POWDER;INHALATION - 0.113MG/INH

POWDER;INHALATION - 0.232MG/INH

POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH

POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH

POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH

POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH

POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH

POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH

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

AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH

AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH

AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH

AEROSOL, METERED;INHALATION - 0.044MG/INH

AEROSOL, METERED;INHALATION - 0.11MG/INH

AEROSOL, METERED;INHALATION - 0.22MG/INH

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

2 SPI Pharma

4 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

6 Kirsch Pharma

10 Actylis

3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

11 BASF

1 CD Formulation

5 DFE Pharma

2 Finar

7 Gangwal Chemicals

1 Ideal Cures

1 Ingredion Pharma Solutions

12 Kerry

3 Keval Exports

1 Kima Chemical

10 Microlex e.U

1 Nanjing Bold Chemical

1 Nitika Pharmaceutical Specialities

1 Pharmatrans-Sanaq

4 Pluviaendo

2 Prachin Chemical

10 Roquette

8 Seppic

OINTMENT;TOPICAL - 0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - 0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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