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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Oxycontin (TN)

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ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 10 USDMF, 10 CEP/COS, 1 JDMF, 1 EU WC, 7 KDMF, 15 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

80 Drugs in Development

80 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1098 FDF Dossiers, 293 FDA Orange Book, 596 Europe, 49 Canada, 88 Australia, 21 South Africa, 51 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 5MG, SOLUTION;ORAL - 100MG/5ML, SOLUTION;ORAL - 5MG/5ML, SOLUTION;ORAL - 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG, TABLET;ORAL - 7.5MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG, CAPSULE, EXTENDED RELEASE;ORAL - 18MG, CAPSULE, EXTENDED RELEASE;ORAL - 27MG, CAPSULE, EXTENDED RELEASE;ORAL - 36MG, CAPSULE, EXTENDED RELEASE;ORAL - 9MG, TABLET, EXTENDED RELEASE;ORAL - 10MG, TABLET, EXTENDED RELEASE;ORAL - 15MG, TABLET, EXTENDED RELEASE;ORAL - 20MG, TABLET, EXTENDED RELEASE;ORAL - 30MG, TABLET, EXTENDED RELEASE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 80MG, TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 15 Evonik, 7 Rochem International Inc, 23 SPI Pharma, 2 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 8 Kirsch Pharma, 4 ACG Worldwide, 14 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 38 BASF, 1 Bioplus Life Sciences, 3 CD Formulation, 1 Clariant, 22 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 13 Gangwal Chemicals, 10 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 40 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 5 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Valens Pharmachem, 5 Vasa Pharmachem, 1 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

83 Fillers, Diluents & Binders, 78 Coating Systems & Additives, 56 Controlled & Modified Release, 46 Direct Compression, 45 Disintegrants & Superdisintegrants, 45 Taste Masking, 42 Thickeners and Stabilizers, 41 Granulation, 34 Solubilizers, 33 Film Formers & Plasticizers, 32 Parenteral, 25 Chewable & Orodispersible Aids, 25 Lubricants & Glidants, 23 Topical, 17 Co-Processed Excipients, 9 Empty Capsules, 9 Emulsifying Agents, 8 API Stability Enhancers, 6 Surfactant & Foaming Agents, 6 Rheology Modifiers, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

296 News #PharmaBuzz

296 News #PharmaBuzz

GLOBAL SALES INFORMATION

59 US Medicaid Prescriptions, 87 Regulatory FDF Prices, 20 Annual Reports

MARKET PLACE

13 APIs, 9 FDF Dossiers

PATENTS & EXCLUSIVITIES

237 US Patents, 71 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 7 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	Veranova	U.S.A	VERANOVA LP	18472	OXYCODONE HYDROCHLORIDE	2005-06-30	Active	II	Complete	2014-06-21	2014-06-13
29/01/2026	Noramco	U.S.A	NORAMCO LLC	16399	OXYCODONE HYDROCHLORIDE	2003-02-03	Active	II	Complete	2013-04-16	2013-04-05

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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.

Oxycontin (TN)

Oxycontin (TN)

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

35 API Suppliers

10 USDMF

10 CEP/COS

1 JDMF

1 EU WC

7 KDMF

15 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

80 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1098 FDF Dossiers

293 FDA Orange Book

596 Europe

49 Canada

88 Australia

21 South Africa

51 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 5MG

SOLUTION;ORAL - 100MG/5ML

SOLUTION;ORAL - 5MG/5ML

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

TABLET;ORAL - 5MG

TABLET;ORAL - 7.5MG

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG

CAPSULE, EXTENDED RELEASE;ORAL - 18MG

CAPSULE, EXTENDED RELEASE;ORAL - 27MG

CAPSULE, EXTENDED RELEASE;ORAL - 36MG

CAPSULE, EXTENDED RELEASE;ORAL - 9MG

TABLET, EXTENDED RELEASE;ORAL - 10MG

TABLET, EXTENDED RELEASE;ORAL - 15MG

TABLET, EXTENDED RELEASE;ORAL - 20MG

TABLET, EXTENDED RELEASE;ORAL - 30MG

TABLET, EXTENDED RELEASE;ORAL - 40MG

TABLET, EXTENDED RELEASE;ORAL - 60MG

TABLET, EXTENDED RELEASE;ORAL - 80MG

TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

15 Evonik

7 Rochem International Inc

23 SPI Pharma

2 Pharm-RX Chemical

8 Boai NKY Pharmaceuticals Ltd

9 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

3 Pfanstiehl

8 Kirsch Pharma

4 ACG Worldwide

14 Actylis

1 Aeon Procare

3 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

38 BASF

1 Bioplus Life Sciences

3 CD Formulation

1 Clariant

22 Corel Pharma Chem

7 DFE Pharma

1 Esteem Industries

2 Finar

13 Gangwal Chemicals

10 Ideal Cures

5 Ingredion Pharma Solutions

26 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

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

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 325MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons