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

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Pipeline Prospector 2025 highlights: FDA approves pill version of Novo’s Wegovy; BioMarin acquires Amicus for US$ 4.8 bn

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ACTIVE PHARMA INGREDIENTS

55 API Suppliers, 17 USDMF, 9 JDMF, 9 EU WC, 15 KDMF, 16 NDC API, 27 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

37 Drugs in Development

37 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

116 FDF Dossiers, 37 FDA Orange Book, 40 Europe, 11 Canada, 5 South Africa, 23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% BASE, SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% BASE, SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE, SPRAY, METERED;NASAL - 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 3 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 1 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 10 BASF, 1 Clariant, 10 Corel Pharma Chem, 1 Finar, 6 Gangwal Chemicals, 3 Ideal Cures, 1 Ingredion Pharma Solutions, 10 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 4 Microlex e.U, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 3 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

36 Coating Systems & Additives, 31 Fillers, Diluents & Binders, 14 Parenteral, 14 Direct Compression, 14 Controlled & Modified Release, 13 Chewable & Orodispersible Aids, 12 Taste Masking, 11 Solubilizers, 10 Granulation, 9 Disintegrants & Superdisintegrants, 7 Thickeners and Stabilizers, 6 Film Formers & Plasticizers, 5 Co-Processed Excipients, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Rheology Modifiers, 3 Topical, 2 Coloring Agents, 1 Lubricants & Glidants, 1 Surfactant & Foaming Agents, 1 Emulsifying Agents

DIGITAL CONTENT

55 News #PharmaBuzz

55 News #PharmaBuzz

GLOBAL SALES INFORMATION

10 US Medicaid Prescriptions, 4 Regulatory FDF Prices, 19 Annual Reports

MARKET PLACE

21 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 1 US Exclusivities, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 Others

5 Others

ANALYTICAL

3 Analytical Methods

3 Analytical Methods

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Registrant Name	Registration No.	Compound	Registration Date	Manufacturer	Manufacturer's Country	Manufacturer's Address
30/12/2025	Aurore Life Sciences	India	Kolon Life Science Co., Ltd.	20240911-209-J-1704	Olopatadine hydrochloride	2024-09-11	Aurore Pharmaceuticals Private Limited (Unit-1)@Kolon Life Science Co., Ltd.	India	Plot No. 35, 36, 38 to 40, 49 to 51 Phase IV, IDA, Jeedimetla, Hyderabad Telangana Jeedimetla Village, Quthbullapur Mandal, Medchal-Malkajgiri District Pincode 500055, Telangana State India@54, Gipyodosi 1-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do
30/12/2025	Chongqing Huapont Pharmaceutical	China	Ace Biopharm Co., Ltd.	20251229-209-J-2080	Olopatadine hydrochloride	2025-12-29	Chongqing Huapont Shengchem Pharmaceutical Co., Ltd.	China	No. 6, Huanan 1st Road, Yanjia Avenue, Changshou District, Chongqing 401221, China

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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.

Patanase

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ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

55 API Suppliers

17 USDMF

9 JDMF

9 EU WC

15 KDMF

16 NDC API

27 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

37 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

116 FDF Dossiers

37 FDA Orange Book

40 Europe

11 Canada

5 South Africa

23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% BASE

SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% BASE

SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE

SPRAY, METERED;NASAL - 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

13 SPI Pharma

3 DKSH

4 Boai NKY Pharmaceuticals Ltd

1 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Kirsch Pharma

1 ACG Worldwide

5 Actylis

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

10 BASF

1 Clariant

10 Corel Pharma Chem

1 Finar

6 Gangwal Chemicals

3 Ideal Cures

1 Ingredion Pharma Solutions

10 Kerry

3 Kima Chemical

6 Lonza Capsugel

4 Microlex e.U

2 Novo Excipients

1 Pharmatrans-Sanaq

2 Pluviaendo

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

3 Roquette

6 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

1 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

36 Coating Systems & Additives

31 Fillers, Diluents & Binders

14 Parenteral

14 Direct Compression

14 Controlled & Modified Release

13 Chewable & Orodispersible Aids

12 Taste Masking

11 Solubilizers

10 Granulation

9 Disintegrants & Superdisintegrants

7 Thickeners and Stabilizers

6 Film Formers & Plasticizers

SPRAY, METERED;NASAL - 0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons