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

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Buprenorphine
South Africa

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Buprenorphine

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Inke S.A: APIs manufacturing plant.

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SCI PHARMTECH Buprenorphine

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Buprenorphine

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 12 USDMF, 13 CEP/COS, 2 JDMF, 3 EU WC, 13 NDC API, 21 Listed Suppliers, $ API Reference Price

37 API Suppliers
12 USDMF
13 CEP/COS
2 JDMF
3 EU WC
13 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

128 Drugs in Development

128 Drugs in Development

INTERMEDIATES

11 Intermediate Suppliers

11 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

265 FDF Dossiers, 39 FDA Orange Book, 111 Europe, 6 Canada, 63 Australia, 10 South Africa, 36 Listed Dossiers

265 FDF Dossiers
39 FDA Orange Book
111 Europe
6 Canada
63 Australia
10 South Africa
36 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 10MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 15MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 20MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 5MCG/HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 7.5MCG/HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 10MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 15MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 20MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 5MCG/HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 7.5MCG/HR

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 13 SPI Pharma, 3 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 6 Actylis, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 18 BASF, 1 CD Formulation, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Esteem Industries, 1 Finar, 7 Gangwal Chemicals, 3 Ideal Cures, 1 Ingredion Pharma Solutions, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 3 Sigachi Industries, 1 Silverline Chemicals, 2 The Dow Chemical Company, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

46 Fillers, Diluents & Binders, 38 Coating Systems & Additives, 20 Direct Compression, 19 Taste Masking, 18 Granulation, 18 Thickeners and Stabilizers, 18 Controlled & Modified Release, 14 Chewable & Orodispersible Aids, 12 Solubilizers, 11 Parenteral, 10 Lubricants & Glidants, 9 Disintegrants & Superdisintegrants, 8 Topical, 7 Film Formers & Plasticizers, 6 Co-Processed Excipients, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Emulsifying Agents, 3 Rheology Modifiers, 2 Coloring Agents

46 Fillers, Diluents & Binders
38 Coating Systems & Additives
20 Direct Compression
19 Taste Masking
18 Granulation
18 Thickeners and Stabilizers
18 Controlled & Modified Release
14 Chewable & Orodispersible Aids
12 Solubilizers
11 Parenteral
10 Lubricants & Glidants
9 Disintegrants & Superdisintegrants
8 Topical
7 Film Formers & Plasticizers
6 Co-Processed Excipients
5 Empty Capsules
4 Vegetarian Capsules
4 API Stability Enhancers
4 Emulsifying Agents
3 Rheology Modifiers
2 Coloring Agents

DIGITAL CONTENT

203 News #PharmaBuzz

203 News #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 52 Regulatory FDF Prices

9 US Medicaid Prescriptions
52 Regulatory FDF Prices

MARKET PLACE

11 APIs, 5 FDF Dossiers

11 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

110 US Patents, 9 US Exclusivities, 7 Health Canada Patents

110 US Patents
9 US Exclusivities
7 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 24 Others

2 EDQM
24 Others

$ API Ref.Price (USD/KG) : 21,065 Xls

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filter Applicant Reset all filters

10 All

01 2Adcock Ingram Critical Care (Pty) Ltd

02 5Mundipharma (Pty) Ltd

03 3Trinity Pharma (Pty) Ltd

filter Active Ingredients Reset all filters

10 All

01 10Buprenorphine

filter Dosage Form Reset all filters

10 All

01 1INJ

02 8PTD

03 1TAB

filter Brand Name Reset all filters

10 All

01 1Bupremed 10

02 1Bupremed 20

03 1Bupremed 5

04 2Sovenor 10 Patch

05 2Sovenor 20 Patch

06 1Sovenor 5 Patch

07 1Temgesic 1ml

08 1Temgesic Sublingual Tablets

List of Suppliers

Product Main Page

01

Adcock Ingram Critical Care (Pty) Ltd

OTS 2025

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

OTS 2025

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine

Brand Name : Temgesic 1ml

Dosage Form : INJ

Dosage Strength : 0.3mg

Packaging : 1X5mg

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

OTS 2025

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

OTS 2025

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine

Brand Name : Temgesic Sublingual Tablets

Dosage Form : TAB

Dosage Strength : 0.2mg

Packaging : 50X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Mundipharma (Pty) Ltd

OTS 2025

Not Confirmed

Mundipharma (Pty) Ltd

OTS 2025

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine

Brand Name : Sovenor 5 Patch

Dosage Form : PTD

Dosage Strength : 5mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Mundipharma (Pty) Ltd

OTS 2025

Not Confirmed

Mundipharma (Pty) Ltd

OTS 2025

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine

Brand Name : Sovenor 10 Patch

Dosage Form : PTD

Dosage Strength : 10mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Mundipharma (Pty) Ltd

OTS 2025

Not Confirmed

Mundipharma (Pty) Ltd

OTS 2025

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine

Brand Name : Sovenor 10 Patch

Dosage Form : PTD

Dosage Strength : 10mg

Packaging : 2X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Mundipharma (Pty) Ltd

OTS 2025

Not Confirmed

Mundipharma (Pty) Ltd

OTS 2025

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine

Brand Name : Sovenor 20 Patch

Dosage Form : PTD

Dosage Strength : 20mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Mundipharma (Pty) Ltd

OTS 2025

Not Confirmed

Mundipharma (Pty) Ltd

OTS 2025

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Buprenorphine

Brand Name : Sovenor 20 Patch

Dosage Form : PTD

Dosage Strength : 20mg

Packaging : 2X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Trinity Pharma (Pty) Ltd

OTS 2025

Not Confirmed

Trinity Pharma (Pty) Ltd

OTS 2025

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Buprenorphine

Brand Name : Bupremed 5

Dosage Form : PTD

Dosage Strength : 5mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Trinity Pharma (Pty) Ltd

OTS 2025

Not Confirmed

Trinity Pharma (Pty) Ltd

OTS 2025

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Buprenorphine

Brand Name : Bupremed 10

Dosage Form : PTD

Dosage Strength : 10mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Trinity Pharma (Pty) Ltd

OTS 2025

Not Confirmed

Trinity Pharma (Pty) Ltd

OTS 2025

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 : Generic

Registration Country : South Africa

Buprenorphine

Brand Name : Bupremed 20

Dosage Form : PTD

Dosage Strength : 20mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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