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Drug Approvals by the Medicines Control Council in South Africa containing Buprenorphine. Original Data : South African Medicines Price Registry

Client Email

Product

Buprenorphine
ORP-101
CAS 52485-79-7
Buprenorphine Hydrochloride
3-O-Methyl Norbuprenorphine
CAS 78715-23-8
CAS 16196-70-6
South Africa

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SCI PHARMTECH Buprenorphine

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xyz-pharma-m-2024-09-09

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Buprenorphine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 12 USDMF, 11 CEP/COS, 2 JDMF, 4 EU WC, 13 NDC API, 23 Listed Suppliers, $ API Reference Price

33 API Suppliers
12 USDMF
11 CEP/COS
2 JDMF
4 EU WC
13 NDC API
23 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

28 Drugs in Development

28 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

13 API Suppliers

13 API Suppliers

FINISHED DOSAGE FORMULATIONS

268 FDF Dossiers, 39 FDA Orange Book, 117 Europe, 6 Canada, 63 Australia, 7 South Africa, 36 Listed Dossiers

268 FDF Dossiers
39 FDA Orange Book
117 Europe
6 Canada
63 Australia
7 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, 12 SPI Pharma, 2 Seqens, 1 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 18 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 28 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 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, 4 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 24 Direct Compression, 24 Controlled & Modified Release, 17 Taste Masking, 15 Granulation, 14 Thickeners and Stabilizers, 12 Solubilizers, 12 Chewable & Orodispersible Aids, 10 Parenteral, 10 Lubricants & Glidants, 9 Co-Processed Excipients, 8 Film Formers & Plasticizers, 7 Topical, 6 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 API Stability Enhancers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Rheology Modifiers

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

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 192 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
192 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 94 Finished Drug Prices

1 US Medicaid Prescriptions
94 Finished Drug Prices

MARKET PLACE

11 APIs, 5 FDF Dossiers

11 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

96 US Patents, 7 US Exclusivities, 7 Health Canada Patents

96 US Patents
7 US Exclusivities
7 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 20 Others

2 EDQM
1 USP
20 Others

$ API Ref.Price (USD/KG) : 15,127 Xls

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01 2Adcock Ingram Critical Care (Pty) Ltd

02 5Mundipharma (Pty) Ltd

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7 All

01 7Buprenorphine

filter Dosage Form Reset all filters

7 All

01 1INJ

02 5PTD

03 1TAB

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01 2Sovenor 10 Patch

02 2Sovenor 20 Patch

03 1Sovenor 5 Patch

04 1Temgesic 1ml

05 1Temgesic Sublingual Tablets

Temad Buprenorphine

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

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01

Adcock Ingram Critical Care (Pty) Ltd

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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

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02

Adcock Ingram Critical Care (Pty) Ltd

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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

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03

Mundipharma (Pty) Ltd

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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

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Mundipharma (Pty) Ltd

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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

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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

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Mundipharma (Pty) Ltd

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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

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Mundipharma (Pty) Ltd

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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

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