Melatonin | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Melatonin
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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Melatonin

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

15 API Suppliers, 7 USDMF, 2 CEP/COS, 2 EU WC, 4 KDMF, 5 NDC API, 1 VMF, 8 Listed Suppliers, $ API Reference Price

15 API Suppliers
7 USDMF
2 CEP/COS
2 EU WC
4 KDMF
5 NDC API
1 VMF
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

FINISHED DOSAGE FORMULATIONS

57 FDF Dossiers, 31 Europe, 2 Australia, 5 South Africa, 19 Listed Dossiers

57 FDF Dossiers
31 Europe
2 Australia
5 South Africa
19 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 1 SPI Pharma, 15 DKSH, 1 Pharm-RX Chemical, 3 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 3 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 1 Bioplus Life Sciences, 3 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 7 Kerry, 3 Lonza Capsugel, 10 Microlex e.U, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 13 Roquette, 1 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 9 Sigachi Industries, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

37 Fillers, Diluents & Binders, 18 Thickeners and Stabilizers, 15 Lubricants & Glidants, 14 Coating Systems & Additives, 13 Direct Compression, 13 Disintegrants & Superdisintegrants, 10 Granulation, 9 Co-Processed Excipients, 9 Film Formers & Plasticizers, 8 Topical, 8 Empty Capsules, 6 Taste Masking, 6 Controlled & Modified Release, 6 Parenteral, 5 Solubilizers, 5 Emulsifying Agents, 3 Coloring Agents, 2 Rheology Modifiers, 2 Chewable & Orodispersible Aids, 2 API Stability Enhancers, 1 Surfactant & Foaming Agents

37 Fillers, Diluents & Binders
18 Thickeners and Stabilizers
15 Lubricants & Glidants
14 Coating Systems & Additives
13 Direct Compression
13 Disintegrants & Superdisintegrants
10 Granulation
9 Co-Processed Excipients
9 Film Formers & Plasticizers
8 Topical
8 Empty Capsules
6 Taste Masking
6 Controlled & Modified Release
6 Parenteral
5 Solubilizers
5 Emulsifying Agents
3 Coloring Agents
2 Rheology Modifiers
2 Chewable & Orodispersible Aids
2 API Stability Enhancers
1 Surfactant & Foaming Agents

DIGITAL CONTENT

17 News #PharmaBuzz

17 News #PharmaBuzz

GLOBAL SALES INFORMATION

29 Regulatory FDF Prices

29 Regulatory FDF Prices

MARKET PLACE

42 APIs, 5 FDF Dossiers

42 APIs
5 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 USP, 2 Others

2 USP
2 Others

$ API Ref.Price (USD/KG) : 1,870 Xls

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filter Applicant Reset all filters

5 All

01 2Acino Pharma (Pty) Ltd

02 1Teva Pharmaceuticals (Pty) Ltd

03 2Trinity Pharma (Pty) Ltd

filter Active Ingredients Reset all filters

5 All

01 5Melatonin

filter Dosage Form Reset all filters

5 All

01 5TAB

filter Brand Name Reset all filters

5 All

01 1Cadiatev

02 1Circadin 2 mg

03 1Melnoc XR 2 mg

04 1Noctrin XR 2 mg

05 1VIGISOM

List of Suppliers

Product Main Page

01

Teva Pharmaceuticals (Pty) Ltd

ELCC

Not Confirmed

Teva Pharmaceuticals (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

Brand Name : Cadiatev

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Trinity Pharma (Pty) Ltd

ELCC

Not Confirmed

Trinity Pharma (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

Brand Name : Noctrin XR 2 mg

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Trinity Pharma (Pty) Ltd

ELCC

Not Confirmed

Trinity Pharma (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Melnoc XR 2 mg

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Acino Pharma (Pty) Ltd

Country

ELCC

Not Confirmed

Acino Pharma (Pty) Ltd

Country

ELCC

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : VIGISOM

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

05

Acino Pharma (Pty) Ltd

Country

ELCC

Not Confirmed

Acino Pharma (Pty) Ltd

Country

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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Country

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Circadin 2 mg

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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