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

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Product

Methadone HCl
Levomethadone
Methadone
South Africa

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Parand Darou Pharma Methadone Hydrochloride

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2024-10-07

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Methadone HCl

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 10 USDMF, 8 CEP/COS, 1 JDMF, 6 EU WC, 11 NDC API, 12 Listed Suppliers, $ API Reference Price

26 API Suppliers
10 USDMF
8 CEP/COS
1 JDMF
6 EU WC
11 NDC API
12 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price, API Exports, FDF Exports

API Reference Price
API Exports
FDF Exports

FINISHED DOSAGE FORMULATIONS

149 FDF Dossiers, 51 FDA Orange Book, 57 Europe, 18 Canada, 6 South Africa, 17 Listed Dossiers

149 FDF Dossiers
51 FDA Orange Book
57 Europe
18 Canada
6 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CONCENTRATE;ORAL - 10MG/ML, TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CONCENTRATE;ORAL - 10MG/ML
TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 1 DKSH, 11 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 9 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 5 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 25 Kerry, 12 Microlex e.U, 2 Nanjing Bold Chemical, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 24 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

1 Rochem International Inc
6 SPI Pharma
1 DKSH
11 Gangwal Healthcare
5 Nanjing Well Pharmaceutical
1 Pfanstiehl
9 Actylis
1 Aeon Procare
4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
6 BASF
5 DFE Pharma
2 Finar
7 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
2 Ingredion Pharma Solutions
25 Kerry
12 Microlex e.U
2 Nanjing Bold Chemical
1 Pharmatrans-Sanaq
4 Pluviaendo
2 Prachin Chemical
24 Roquette
1 Seppic
3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
10 Sigachi Industries
1 Valens Pharmachem
2 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

61 Fillers, Diluents & Binders, 29 Direct Compression, 19 Thickeners and Stabilizers, 17 Lubricants & Glidants, 15 Co-Processed Excipients, 15 Film Formers & Plasticizers, 14 Parenteral, 13 Granulation, 11 Coating Systems & Additives, 11 Taste Masking, 9 Topical, 9 Controlled & Modified Release, 9 Disintegrants & Superdisintegrants, 8 Chewable & Orodispersible Aids, 6 Solubilizers, 5 Emulsifying Agents, 1 Soft Gelatin, 1 Rheology Modifiers, 1 API Stability Enhancers

61 Fillers, Diluents & Binders
29 Direct Compression
19 Thickeners and Stabilizers
17 Lubricants & Glidants
15 Co-Processed Excipients
15 Film Formers & Plasticizers
14 Parenteral
13 Granulation
11 Coating Systems & Additives
11 Taste Masking
9 Topical
9 Controlled & Modified Release
9 Disintegrants & Superdisintegrants
8 Chewable & Orodispersible Aids
6 Solubilizers
5 Emulsifying Agents
1 Soft Gelatin
1 Rheology Modifiers
1 API Stability Enhancers

DIGITAL CONTENT

9 NEWS #PharmaBuzz

9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

16 Finished Drug Prices

16 Finished Drug Prices

MARKET PLACE

7 APIs, 2 FDF Dossiers

7 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 2 Others

3 EDQM
1 USP
2 Others

$ API Ref.Price (USD/KG) : 398 Xls

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filter Applicant Reset all filters

6 All

01 2Adcock Ingram Critical Care (Pty) Ltd

02 1Arya Pharma (Pty) Ltd

03 1Equity Pharmaceuticals (Pty) Ltd

04 2Umsebe Healthcare

filter Active Ingredients Reset all filters

6 All

01 4Methadone Hydrochloride

02 2Methadone hydrochloride

filter Dosage Form Reset all filters

6 All

01 5SOL

02 1SYR

filter Brand Name Reset all filters

6 All

01 1Equity Methadone

02 2Methadone Adco 10mg

03 2Misyo 10 mg/ml

04 1Rutrex

Faran-Shini-Methadone-Hydrochlorid

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Adcock Ingram Critical Care (Pty) Ltd

AAPS 2024

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Methadone Hydrochloride

Brand Name : Methadone Adco 10mg

Dosage Form : SOL

Dosage Strength : 10mg/ml

Packaging : 100X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Adcock Ingram Critical Care (Pty) Ltd

AAPS 2024

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Methadone Hydrochloride

Brand Name : Methadone Adco 10mg

Dosage Form : SOL

Dosage Strength : 10mg/ml

Packaging : 1000X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Equity Pharmaceuticals (Pty) Ltd

AAPS 2024

Not Confirmed

Equity Pharmaceuticals (Pty) Ltd

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Methadone Hydrochloride

Brand Name : Equity Methadone

Dosage Form : SYR

Dosage Strength : 2mg/ml

Packaging : 60X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Umsebe Healthcare

AAPS 2024

Not Confirmed

Umsebe Healthcare

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Methadone hydrochloride

Brand Name : Misyo 10 mg/ml

Dosage Form : SOL

Dosage Strength : 10mg/ml

Packaging : 1000X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Umsebe Healthcare

AAPS 2024

Not Confirmed

Umsebe Healthcare

AAPS 2024

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Methadone hydrochloride

Brand Name : Misyo 10 mg/ml

Dosage Form : SOL

Dosage Strength : 10mg/ml

Packaging : 100X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Arya Pharma (Pty) Ltd

Country

AAPS 2024

Not Confirmed

Arya Pharma (Pty) Ltd

Country

AAPS 2024

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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Country

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Methadone Hydrochloride

Brand Name : Rutrex

Dosage Form : SOL

Dosage Strength : 10mg/ml

Packaging : 1000X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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