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

Data Compilation
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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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ALEVE-D COMPONENT NAPROXEN SODIUM

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

60 API Suppliers, 22 USDMF, 7 CEP/COS, 3 EU WC, 35 KDMF, 10 NDC API, 11 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

34 Drugs in Development

34 Drugs in Development

FINISHED DOSAGE FORMULATIONS

164 FDF Dossiers, 85 FDA Orange Book, 23 Europe, 18 Canada, 4 South Africa, 34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 500MG BASE, TABLET;ORAL - 220MG, TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE, CAPSULE;ORAL - EQ 200MG BASE, TABLET;ORAL - 500MG;EQ 85MG BASE, TABLET;ORAL - 60MG;EQ 10MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 11 Evonik, 3 Rochem International Inc, 20 SPI Pharma, 12 DKSH, 11 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 7 Kirsch Pharma, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 33 BASF, 1 CD Formulation, 3 Clariant, 17 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 9 Ideal Cures, 5 Ingredion Pharma Solutions, 22 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 38 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 64 Coating Systems & Additives, 50 Thickeners and Stabilizers, 45 Disintegrants & Superdisintegrants, 44 Controlled & Modified Release, 40 Solubilizers, 40 Direct Compression, 34 Parenteral, 34 Granulation, 29 Film Formers & Plasticizers, 26 Taste Masking, 26 Topical, 23 Lubricants & Glidants, 21 Chewable & Orodispersible Aids, 16 Co-Processed Excipients, 12 Rheology Modifiers, 10 Emulsifying Agents, 9 Empty Capsules, 8 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

44 News #PharmaBuzz

44 News #PharmaBuzz

GLOBAL SALES INFORMATION

14 US Medicaid Prescriptions, 4 Regulatory FDF Prices

MARKET PLACE

40 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

12 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Registrant Name	Registration No.	Compound	Registration Date	Manufacturer	Manufacturer's Country	Manufacturer's Address
29/01/2026	Dr. Reddy\'s Laboratories	India	SK Chemical Co., Ltd.	20140318-143-I-360-09(3)	naproxen sodium	2022-01-12	Industrialas Quimicas Falcon de Mexico, SA De CV	Mexico	Km. 4.5, Carretera Federal Cuernavaca-Cuautla Col. CIVAC CP 62578 Mpio. Jiutepec, Morelos, Mexico
29/01/2026	Dr. Reddy\'s Laboratories	India	Pamirae Co., Ltd.	20140318-143-I-360-09	naproxen sodium	2014-03-18	Industrialas Quimicas Falcon de Mexico, SA De CV	Mexico	Km. 4.5, Carretera Federal Cuernavaca-Cuautla Col. CIVAC CP 62578 Mpio. Jiutepec, Morelos, Mexico

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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.

ALEVE-D COMPONENT NAPROXEN SODIUM

ALEVE-D COMPONENT NAPROXEN SODIUM

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

60 API Suppliers

22 USDMF

7 CEP/COS

3 EU WC

35 KDMF

10 NDC API

11 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

34 Drugs in Development

FINISHED DOSAGE FORMULATIONS

164 FDF Dossiers

85 FDA Orange Book

23 Europe

18 Canada

4 South Africa

34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 500MG BASE

TABLET;ORAL - 220MG

TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE

CAPSULE;ORAL - EQ 200MG BASE

TABLET;ORAL - 500MG;EQ 85MG BASE

TABLET;ORAL - 60MG;EQ 10MG BASE

RELATED EXCIPIENT COMPANIES

2 EUROAPI

11 Evonik

3 Rochem International Inc

20 SPI Pharma

12 DKSH

11 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

11 Nanjing Well Pharmaceutical

2 Pfanstiehl

7 Kirsch Pharma

4 ACG Worldwide

11 Actylis

2 Aeon Procare

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

33 BASF

1 CD Formulation

3 Clariant

17 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

2 Finar

13 Gangwal Chemicals

9 Ideal Cures

5 Ingredion Pharma Solutions

22 Kerry

4 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

20 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

8 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

38 Roquette

13 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

TABLET;ORAL - EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons