SUBOXONE

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ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 21 USDMF, 17 CEP/COS, 2 JDMF, 4 EU WC, 26 NDC API, 22 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

24 Drugs in Development

24 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

254 FDF Dossiers, 95 FDA Orange Book, 114 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INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE,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 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, 54 News #PharmaBuzz

GLOBAL SALES INFORMATION

27 US Medicaid Prescriptions, 8 Regulatory FDF Prices

MARKET PLACE

9 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

97 US Patents, 23 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 Others

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USFDA APPLICATION NUMBER - 204442 / DOSAGE - IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
buprenorphine hydrochloride(UNII: 56W8MW3EN1) (buprenorphine - UNII:40D3SCR4GZ)	buprenorphine	80mg

Setid 10fd7088 Cc4a 4bda A5e3 A82563540a9a Applno 204442 Form Implant Implantation Dosage Eq 80mg Base Implant - Drug Product Composition: SUBOXONE

SUBOXONE

SUBOXONE

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

52 API Suppliers

21 USDMF

17 CEP/COS

2 JDMF

4 EU WC

26 NDC API

22 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

24 Drugs in Development

INTERMEDIATES

6 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

254 FDF Dossiers

95 FDA Orange Book

114 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 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

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