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

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Pethidine Hydrochloride
South Africa

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2025-03-24

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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xyz-pharma-m-2025-03-17

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Pethidine Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

14 API Suppliers, 5 USDMF, 3 CEP/COS, 2 JDMF, 2 EU WC, 6 NDC API, 6 Listed Suppliers, $ API Reference Price

14 API Suppliers
5 USDMF
3 CEP/COS
2 JDMF
2 EU WC
6 NDC API
6 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

104 FDF Dossiers, 79 FDA Orange Book, 5 Europe, 1 Canada, 5 South Africa, 14 Listed Dossiers

104 FDF Dossiers
79 FDA Orange Book
5 Europe
1 Canada
5 South Africa
14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 100MG/ML, INJECTABLE;INJECTION - 25MG/ML, INJECTABLE;INJECTION - 50MG/ML, INJECTABLE;INJECTION - 75MG/ML, TABLET;ORAL - 100MG, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML

INJECTABLE;INJECTION - 100MG/ML
INJECTABLE;INJECTION - 25MG/ML
INJECTABLE;INJECTION - 50MG/ML
INJECTABLE;INJECTION - 75MG/ML
TABLET;ORAL - 100MG
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 10MG/ML

DIGITAL CONTENT

2 News #PharmaBuzz

2 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 14 Regulatory FDF Prices

2 US Medicaid Prescriptions
14 Regulatory FDF Prices

MARKET PLACE

6 APIs

6 APIs

REF. STANDARDS & IMPURITIES

2 Others

2 Others

$ API Ref.Price (USD/KG) : 488 Xls

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5 All

01 3Fresenius Kabi Manufacturing SA (Pty) Ltd

02 2Mylan (Pty) Ltd

filter Active Ingredients Reset all filters

5 All

01 3Pethidine Hydrochloride

02 2Pethidine hydrochloride

filter Dosage Form Reset all filters

5 All

01 5INJ

filter Brand Name Reset all filters

5 All

01 2Mylan Penthindine

02 1Pethidine HCI 100mg/2ml Fresenius

03 1Pethidine HCl 25mg/1ml Fresenius

04 1Pethidine HCl 50mg/1ml Fresenius

List of Suppliers

Product Main Page

01

Fresenius Kabi Manufacturing SA (Pty) Lt...

ELCC

Not Confirmed

Fresenius Kabi Manufacturing SA (Pty) Lt...

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pethidine Hydrochloride

Brand Name : Pethidine HCl 25mg/1ml Fresenius

Dosage Form : INJ

Dosage Strength : 25mg/ml

Packaging : 1X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Fresenius Kabi Manufacturing SA (Pty) Lt...

ELCC

Not Confirmed

Fresenius Kabi Manufacturing SA (Pty) Lt...

ELCC

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

Pethidine Hydrochloride

Brand Name : Pethidine HCl 50mg/1ml Fresenius

Dosage Form : INJ

Dosage Strength : 50mg/ml

Packaging : 1X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Fresenius Kabi Manufacturing SA (Pty) Lt...

ELCC

Not Confirmed

Fresenius Kabi Manufacturing SA (Pty) Lt...

ELCC

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

Pethidine Hydrochloride

Brand Name : Pethidine HCI 100mg/2ml Fresenius

Dosage Form : INJ

Dosage Strength : 100mg/2ml

Packaging : 2X10mg/2ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Mylan (Pty) Ltd

ELCC

Not Confirmed

Mylan (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pethidine hydrochloride

Brand Name : Mylan Penthindine

Dosage Form : INJ

Dosage Strength : 50mg/ml

Packaging : 1X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Mylan (Pty) Ltd

ELCC

Not Confirmed

Mylan (Pty) Ltd

ELCC

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

Pethidine hydrochloride

Brand Name : Mylan Penthindine

Dosage Form : INJ

Dosage Strength : 100mg/2ml

Packaging : 2X10mg/2ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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