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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Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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xyz-pharma-m-2025-01-06

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Pethidine Hydrochloride

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ACTIVE PHARMA INGREDIENTS

15 API Suppliers, 5 USDMF, 4 CEP/COS, 2 JDMF, 2 EU WC, 6 NDC API, 6 Listed Suppliers, $ API Reference Price

15 API Suppliers
5 USDMF
4 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75MG/ML, TABLET;ORAL - 100MG, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML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TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Finished Drug Prices

2 US Medicaid Prescriptions
14 Finished Drug Prices

MARKET PLACE

6 APIs

6 APIs

REF. STANDARDS & IMPURITIES

2 Others

2 Others

$ API Ref.Price (USD/KG) : 553 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 Hcl

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 Hcl Fresenius Pf 100Mg/2Ml

03 1Pethidine Hcl Fresenius Pf 25Mg/1Ml

04 1Pethidine Hcl Fresenius Pf 50Mg/1Ml

List of Suppliers

Product Main Page

01

Fresenius Kabi Manufacturing SA (Pty) Lt...

PharmaVenue

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Fresenius Kabi Manufacturing SA (Pty) Lt...

PharmaVenue

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pethidine Hcl

Brand Name : Pethidine Hcl Fresenius Pf 25Mg/1Ml

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...

PharmaVenue

Not Confirmed

Fresenius Kabi Manufacturing SA (Pty) Lt...

PharmaVenue

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pethidine Hcl

Brand Name : Pethidine Hcl Fresenius Pf 50Mg/1Ml

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...

PharmaVenue

Not Confirmed

Fresenius Kabi Manufacturing SA (Pty) Lt...

PharmaVenue

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Pethidine Hcl

Brand Name : Pethidine Hcl Fresenius Pf 100Mg/2Ml

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

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Mylan (Pty) Ltd

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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

PharmaVenue

Not Confirmed

Mylan (Pty) Ltd

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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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