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

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ACTIVE PHARMA INGREDIENTS

88 API Suppliers, 33 USDMF, 17 CEP/COS, 10 JDMF, 17 EU WC, 31 KDMF, 17 NDC API, 41 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

40 Drugs in Development

40 Drugs in Development

INTERMEDIATES

25 Intermediate Suppliers

25 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

909 FDF Dossiers, 84 FDA Orange Book, 567 Europe, 55 Canada, 78 Australia, 41 South Africa, 84 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 20MG BASE, TABLET;ORAL - EQ 5MG BASE, SOLUTION;ORAL - EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 3 Rochem International Inc, 18 SPI Pharma, 2 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 21 BASF, 1 CD Formulation, 2 Clariant, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 2 Finar, 10 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 44 Coating Systems & Additives, 31 Direct Compression, 30 Thickeners and Stabilizers, 28 Solubilizers, 25 Granulation, 24 Controlled & Modified Release, 24 Parenteral, 23 Disintegrants & Superdisintegrants, 23 Film Formers & Plasticizers, 20 Taste Masking, 19 Topical, 19 Chewable & Orodispersible Aids, 13 Lubricants & Glidants, 13 Co-Processed Excipients, 8 Rheology Modifiers, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

9 News #PharmaBuzz

9 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 73 Regulatory FDF Prices, 6 Annual Reports

MARKET PLACE

16 APIs, 2 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

4 US Exclusivities, 8 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 4 USP, 5 Others

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Registrant Name	MF Registration No.	Classification	Initial Date of Reg.	Latest Date of Reg.	Registrant's Address
29/01/2026	H. Lundbeck AS	Denmark	H. Lundbeck A/S	222MF10216	Escitalopram oxalate	2010-08-10	2020-06-11	Ottiliavej 9, DK-2500, Valby, Copenhagen, Denmark
29/01/2026	Hetero Drugs	India	Hetero Labs Limited	230MF10141	Escitalopram oxalate [D]	2018-10-12	2018-10-12	7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA

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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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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

88 API Suppliers

33 USDMF

17 CEP/COS

10 JDMF

17 EU WC

31 KDMF

17 NDC API

41 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

40 Drugs in Development

INTERMEDIATES

25 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

909 FDF Dossiers

84 FDA Orange Book

567 Europe

55 Canada

78 Australia

41 South Africa

84 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 20MG BASE

TABLET;ORAL - EQ 5MG BASE

SOLUTION;ORAL - EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Minakem

3 Rochem International Inc

18 SPI Pharma

2 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Kirsch Pharma

1 ACG Worldwide

9 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

21 BASF

1 CD Formulation

2 Clariant

10 Corel Pharma Chem

5 DFE Pharma

1 Esteem Industries

2 Finar

10 Gangwal Chemicals

4 Ideal Cures

4 Ingredion Pharma Solutions

20 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

16 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

2 Novo Excipients

2 Pharmatrans-Sanaq

7 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

27 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

3 Silverline Chemicals

3 The Dow Chemical Company

1 Valens Pharmachem

3 Vasa Pharmachem

SOLUTION;ORAL - EQ 5MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons