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Buprenorphine Hydrochloride

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ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 21 USDMF, 16 CEP/COS, 2 JDMF, 6 EU WC, 27 NDC API, 23 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

176 FDF Dossiers, 95 FDA Orange Book, 37 Europe, 22 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INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE,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, 7 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 8 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 1 ACG Worldwide, 11 Actylis, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 6 DFE Pharma, 3 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 19 Microlex e.U, 1 NEWEDGE Overseas, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 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, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

90 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 37 Thickeners and Stabilizers, 36 Disintegrants & Superdisintegrants, 36 Direct Compression, 29 Controlled & Modified Release, 28 Taste Masking, 26 Granulation, 22 Solubilizers, 20 Chewable & Orodispersible Aids, 18 Co-Processed Excipients, 16 Lubricants & Glidants, 13 Topical, 13 Parenteral, 13 Film Formers & Plasticizers, 9 Rheology Modifiers, 6 Emulsifying Agents, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 54 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Regulatory FDF Prices

MARKET PLACE

8 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

97 US Patents

97 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 4 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Certificate Holder	Certificate No.	Substance	Issue Date	Status	Type	End Date	Substance No.
28/03/2025	Noramco	U.S.A	NORAMCO, LLC. Wilmington US	R1-CEP 2010-142 - Rev 05	Buprenorphine hydrochloride	2023-08-23	Valid	Chemical		1181
28/03/2025	Sanofi	France	SANOFI CHIMIE Gentilly FR	R1-CEP 2010-291 - Rev 00	Buprenorphine hydrochloride	2016-04-11	Withdrawn by Holder	Chemical	2021-07-05	1181

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

40 API Suppliers

21 USDMF

16 CEP/COS

2 JDMF

6 EU WC

27 NDC API

23 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

176 FDF Dossiers

95 FDA Orange Book

37 Europe

22 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

7 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

8 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 Pramukh Pharmachem

1 Zeal MediPharma

1 ACG Worldwide

11 Actylis

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

23 BASF

1 Bioplus Life Sciences

10 Corel Pharma Chem

6 DFE Pharma

3 Finar

8 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

37 Kerry

4 Kima Chemical

6 Lonza Capsugel

1 Lubrizol Life Science Health

19 Microlex e.U

1 NEWEDGE Overseas

2 Nippon Fine Chemical

2 Nomisma Healthcare

3 Novo Excipients

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