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

Data Compilation
#PharmaFlow

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

Stock Recap
#PipelineProspector

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

49 API Suppliers, 20 USDMF, 17 CEP/COS, 2 JDMF, 4 EU WC, 27 NDC API, 22 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

26 Drugs in Development

26 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

300 FDF Dossiers, 105 FDA Orange Book, 150 Europe, 23 Canada, 4 South Africa, 18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE, FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE, TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE, FILM;BUCCAL - EQ 0.6MG BASE, FILM;BUCCAL - EQ 0.75MG BASE, FILM;BUCCAL - EQ 0.9MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE, FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 6 Rochem International Inc, 18 SPI Pharma, 8 DKSH, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Shanghai Minbiotech, 2 Pfanstiehl, 6 Kirsch Pharma, 1 Panvo Organics, 1 ACG Worldwide, 11 Actylis, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 23 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 3 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 19 Microlex e.U, 2 Nippon Fine Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 26 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Silverline Chemicals, 1 Symrise, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

76 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 41 Direct Compression, 40 Thickeners and Stabilizers, 36 Disintegrants & Superdisintegrants, 31 Granulation, 29 Taste Masking, 24 Controlled & Modified Release, 23 Solubilizers, 22 Chewable & Orodispersible Aids, 18 Parenteral, 17 Lubricants & Glidants, 15 Topical, 15 Co-Processed Excipients, 12 Film Formers & Plasticizers, 9 Rheology Modifiers, 7 Emulsifying Agents, 5 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 57 News #PharmaBuzz

GLOBAL SALES INFORMATION

27 US Medicaid Prescriptions, 4 Regulatory FDF Prices

MARKET PLACE

10 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

96 US Patents, 23 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 Others

$ Xls download

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	MACFARLAN SMITH LTD	19109	BUPRENORPHINE HYDROCHLORIDE	2006-01-12	Active	II	Complete	2012-12-26	2012-11-30
29/01/2026	Noramco	U.S.A	NORAMCO LLC	23683	BUPRENORPHINE HYDROCHLORIDE (R036869) DRUG SUBSTANCE	2010-04-05	Active	II	Complete	2012-11-23	2012-11-23

Privacy policy
Terms and conditions
Disclaimers
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.

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

49 API Suppliers

20 USDMF

17 CEP/COS

2 JDMF

4 EU WC

27 NDC API

22 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

26 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

300 FDF Dossiers

105 FDA Orange Book

150 Europe

23 Canada

4 South Africa

18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT

FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE

FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE

FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE

TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FILM;BUCCAL - EQ 0.075MG BASE

FILM;BUCCAL - EQ 0.15MG BASE

FILM;BUCCAL - EQ 0.3MG BASE

FILM;BUCCAL - EQ 0.45MG BASE

FILM;BUCCAL - EQ 0.6MG BASE

FILM;BUCCAL - EQ 0.75MG BASE

FILM;BUCCAL - EQ 0.9MG BASE

FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE

FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE

FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE

FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

RELATED EXCIPIENT COMPANIES

1 Minakem

6 Rochem International Inc

18 SPI Pharma

8 DKSH

1 Pharm-RX Chemical

8 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

2 Shanghai Minbiotech

2 Pfanstiehl

6 Kirsch Pharma

1 Panvo Organics

1 ACG Worldwide

11 Actylis

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

23 BASF

1 Bioplus Life Sciences

1 CD Formulation

10 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

3 Finar

8 Gangwal Chemicals

4 Ideal Cures

4 Ingredion Pharma Solutions

24 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

1 Lubrizol Life Science Health

19 Microlex e.U

2 Nippon Fine Chemical

3 Nitika Pharmaceutical Specialities

INJECTABLE;INJECTION - EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons