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

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Broncodil

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ACTIVE PHARMA INGREDIENTS

72 API Suppliers, 29 USDMF, 13 CEP/COS, 1 JDMF, 11 EU WC, 3 KDMF, 23 NDC API, 38 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

87 Drugs in Development

87 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

444 FDF Dossiers, 136 FDA Orange Book, 162 Europe, 20 Canada, 16 Australia, 43 South Africa, 67 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH, SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH, AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 6 SPI Pharma, 1 Pharm-RX Chemical, 5 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 6 Kirsch Pharma, 1 ACG Worldwide, 11 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 2 CD Formulation, 11 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 3 Finar, 6 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 23 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 26 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 26 Direct Compression, 25 Granulation, 24 Controlled & Modified Release, 23 Thickeners and Stabilizers, 18 Taste Masking, 18 Film Formers & Plasticizers, 17 Disintegrants & Superdisintegrants, 16 Lubricants & Glidants, 14 Topical, 13 Parenteral, 11 Co-Processed Excipients, 10 Solubilizers, 9 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 3 Rheology Modifiers, 2 Coloring Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 97 News #PharmaBuzz

GLOBAL SALES INFORMATION

38 US Medicaid Prescriptions, 53 Regulatory FDF Prices, 21 Annual Reports

MARKET PLACE

33 APIs, 14 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

4 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 31 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	Supriya Lifescience	India	SUPRIYA LIFESCIENCE LTD	30708	ALBUTEROL SULFATE USP	2016-06-27	Active	II	N/A
03/02/2026	Vamsi Labs	India	VAMSI LABS LTD	42593	ALBUTEROL SULFATE USP	2025-11-22	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.

Broncodil

Broncodil

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

72 API Suppliers

29 USDMF

13 CEP/COS

1 JDMF

11 EU WC

3 KDMF

23 NDC API

38 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

87 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

444 FDF Dossiers

136 FDA Orange Book

162 Europe

20 Canada

16 Australia

43 South Africa

67 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH

SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH

AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc

6 SPI Pharma

1 Pharm-RX Chemical

5 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

6 Kirsch Pharma

1 ACG Worldwide

11 Actylis

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

2 CD Formulation

11 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

3 Finar

6 Gangwal Chemicals

4 Ideal Cures

3 Ingredion Pharma Solutions

23 Kerry

2 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

4 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

26 Roquette

8 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

9 Sigachi Industries

3 Silverline Chemicals

3 The Dow Chemical Company

1 Valens Pharmachem

3 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders

43 Coating Systems & Additives

26 Direct Compression

25 Granulation

24 Controlled & Modified Release

SOLUTION;INHALATION - EQ 0.083% BASE;0.017% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons