L-Tyrosine API | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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L-Tyrosine API
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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L-Tyrosine API

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 7 USDMF, 4 CEP/COS, 6 JDMF, 2 NDC API, 5 Listed Suppliers

17 API Suppliers
7 USDMF
4 CEP/COS
6 JDMF
2 NDC API
5 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

22 FDF Dossiers, 1 FDA Orange Book, 12 Canada, 1 Australia, 8 South Africa

22 FDF Dossiers
1 FDA Orange Book
12 Canada
1 Australia
8 South Africa

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 3 Rochem International Inc, 2 DKSH, 2 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 1 Gangwal Healthcare, 2 Kewpie Corporation, 1 Nanjing Well Pharmaceutical, 3 Actylis, 1 Bioplus Life Sciences, 1 Kerry, 2 Pluviaendo

2 EUROAPI
3 Rochem International Inc
2 DKSH
2 Pharm-RX Chemical
1 Faran Shimi Pharmaceutical
1 Gangwal Healthcare
2 Kewpie Corporation
1 Nanjing Well Pharmaceutical
3 Actylis
1 Bioplus Life Sciences
1 Kerry
2 Pluviaendo

EXCIPIENTS BY APPLICATIONS

6 Parenteral, 4 Topical, 3 Taste Masking, 3 Emulsifying Agents, 3 Thickeners and Stabilizers, 2 Rheology Modifiers, 1 Coating Systems & Additives, 1 API Stability Enhancers, 1 Solubilizers, 1 Controlled & Modified Release, 1 Film Formers & Plasticizers, 1 Fillers, Diluents & Binders

6 Parenteral
4 Topical
3 Taste Masking
3 Emulsifying Agents
3 Thickeners and Stabilizers
2 Rheology Modifiers
1 Coating Systems & Additives
1 API Stability Enhancers
1 Solubilizers
1 Controlled & Modified Release
1 Film Formers & Plasticizers
1 Fillers, Diluents & Binders

DIGITAL CONTENT

8 News #PharmaBuzz

8 News #PharmaBuzz

MARKET PLACE

15 APIs, 1 Intermediates

15 APIs
1 Intermediates

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 2 JP, 21 Others

1 EDQM
1 USP
2 JP
21 Others

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filter Applicant Reset all filters

8 All

01 1Adcock Ingram Critical Care (Pty) Ltd

02 2Baxter Healthcare South Africa (Pty) Ltd

03 5Fresenius Kabi South Africa (Pty) Ltd

filter Active Ingredients Reset all filters

8 All

01 8Tyrosine

filter Dosage Form Reset all filters

8 All

01 7INF

02 1SOL

filter Brand Name Reset all filters

8 All

01 1Numeta G13E

02 1Numeta G16E

03 1Nutrineal PD4 with 1.1% amino acids

04 4SMOFKABIVEN

05 1SMOFKABIVEN PERIPHERAL

List of Suppliers

Product Main Page

01

Adcock Ingram Critical Care (Pty) Ltd

ELCC

Not Confirmed

Adcock Ingram Critical Care (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Nutrineal PD4 with 1.1% amino acids

Dosage Form : SOL

Dosage Strength : 152mg/1000ml

Packaging : 2500X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Fresenius Kabi South Africa (Pty) Ltd

ELCC

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

ELCC

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : SMOFKABIVEN PERIPHERAL

Dosage Form : INF

Dosage Strength : 0.12g/1000ml

Packaging : 1206X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Fresenius Kabi South Africa (Pty) Ltd

ELCC

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : SMOFKABIVEN

Dosage Form : INF

Dosage Strength : 0.2g/1000ml

Packaging : 493X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Fresenius Kabi South Africa (Pty) Ltd

ELCC

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : SMOFKABIVEN

Dosage Form : INF

Dosage Strength : 0.2g/1000ml

Packaging : 986X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Fresenius Kabi South Africa (Pty) Ltd

ELCC

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : SMOFKABIVEN

Dosage Form : INF

Dosage Strength : 0.2g/1000ml

Packaging : 1477X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Fresenius Kabi South Africa (Pty) Ltd

ELCC

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : SMOFKABIVEN

Dosage Form : INF

Dosage Strength : 0.2g/1000ml

Packaging : 1970X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Baxter Healthcare South Africa (Pty) Ltd

Country

ELCC

Not Confirmed

Baxter Healthcare South Africa (Pty) Ltd

Country

ELCC

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Numeta G16E

Dosage Form : INF

Dosage Strength : 0.1g/500ml

Packaging : 500X6g/500ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

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08

Baxter Healthcare South Africa (Pty) Ltd

Country

ELCC

Not Confirmed

Baxter Healthcare South Africa (Pty) Ltd

Country

ELCC

Not Confirmed

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Country

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Numeta G13E

Dosage Form : INF

Dosage Strength : 0.07g/300ml

Packaging : 300X10g/300ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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