Buprenorphine Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Buprenorphine Hydrochloride
South Africa

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Noramco Buprenorphine Hydrochloride

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Buprenorphine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 21 USDMF, 16 CEP/COS, 2 JDMF, 6 EU WC, 25 NDC API, 20 Listed Suppliers, $ API Reference Price

36 API Suppliers
21 USDMF
16 CEP/COS
2 JDMF
6 EU WC
25 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

177 FDF Dossiers, 99 FDA Orange Book, 37 Europe, 22 Canada, 4 South Africa, 15 Listed Dossiers

177 FDF Dossiers
99 FDA Orange Book
37 Europe
22 Canada
4 South Africa
15 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INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT, FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE, FILM;BUCCAL - EQ 4.2MG BASE;EQ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TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM;BUCCAL - EQ 0.075MG BASE, FILM;BUCCAL - EQ 0.15MG BASE, FILM;BUCCAL - EQ 0.3MG BASE, FILM;BUCCAL - EQ 0.45MG BASE,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

INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 17 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 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

96 Fillers, Diluents & Binders, 51 Coating Systems & Additives, 45 Direct Compression, 35 Disintegrants & Superdisintegrants, 35 Thickeners and Stabilizers, 30 Controlled & Modified Release, 27 Taste Masking, 26 Granulation, 22 Co-Processed Excipients, 21 Solubilizers, 20 Chewable & Orodispersible Aids, 18 Lubricants & Glidants, 15 Parenteral, 13 Film Formers & Plasticizers, 13 Topical, 6 API Stability Enhancers, 6 Emulsifying Agents, 6 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Surfactant & Foaming Agents

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 54 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
54 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Finished Drug Prices

3 US Medicaid Prescriptions
8 Finished Drug Prices

MARKET PLACE

8 APIs, 4 FDF Dossiers

8 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

102 US Patents

102 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 4 Others

2 EDQM
1 USP
4 Others

$ API Ref.Price (USD/KG) : 21,460 Xls

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01 4Adcock Ingram Critical Care (Pty) Ltd

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01 4Buprenorphine Hydrochloride

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01 4SLT

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01 1Suboxone 2 mg

02 1Suboxone 8 mg

03 1Subutex sublingual 2 mg

04 1Subutex sublingual 8 mg

Temad Buprenorphine Hydrochloride

List of Suppliers

Product Main Page

01

Adcock Ingram Critical Care (Pty) Ltd

Pharmtech & Ingredients

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Adcock Ingram Critical Care (Pty) Ltd

Pharmtech & Ingredients

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine Hydrochloride

Brand Name : Subutex sublingual 2 mg

Dosage Form : SLT

Dosage Strength : 2mg

Packaging : 7X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Adcock Ingram Critical Care (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine Hydrochloride

Brand Name : Subutex sublingual 8 mg

Dosage Form : SLT

Dosage Strength : 8mg

Packaging : 7X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Adcock Ingram Critical Care (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine Hydrochloride

Brand Name : Suboxone 2 mg

Dosage Form : SLT

Dosage Strength : 2mg

Packaging : 7X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Adcock Ingram Critical Care (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

Pharmtech & Ingredients

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine Hydrochloride

Brand Name : Suboxone 8 mg

Dosage Form : SLT

Dosage Strength : 8mg

Packaging : 7X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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