NCGC00024928-23 | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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NCGC00024928-23
South Africa

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

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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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pharmacompass-1-m-2026-01-12

Evonik Health Care is the innovation hub for leading life science companies

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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pharmacompass-2-2026-02-09

NCGC00024928-23

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 12 USDMF, 5 CEP/COS, 4 JDMF, 4 KDMF, 11 NDC API, 21 Listed Suppliers, $ API Reference Price

40 API Suppliers
12 USDMF
5 CEP/COS
4 JDMF
4 KDMF
11 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

30 Drugs in Development

30 Drugs in Development

INTERMEDIATES

8 Intermediate Suppliers

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

138 FDF Dossiers, 26 FDA Orange Book, 62 Europe, 6 Canada, 14 Australia, 10 South Africa, 20 Listed Dossiers

138 FDF Dossiers
26 FDA Orange Book
62 Europe
6 Canada
14 Australia
10 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 20MG BASE/10ML

TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - EQ 20MG BASE/10ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 3 Rochem International Inc, 18 SPI Pharma, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 24 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 7 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 24 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 28 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders, 45 Coating Systems & Additives, 37 Direct Compression, 31 Granulation, 26 Disintegrants & Superdisintegrants, 25 Thickeners and Stabilizers, 22 Taste Masking, 22 Controlled & Modified Release, 19 Chewable & Orodispersible Aids, 19 Film Formers & Plasticizers, 18 Solubilizers, 15 Topical, 15 Parenteral, 14 Co-Processed Excipients, 13 Lubricants & Glidants, 6 Rheology Modifiers, 5 API Stability Enhancers, 5 Empty Capsules, 4 Emulsifying Agents, 4 Vegetarian Capsules, 2 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

73 Fillers, Diluents & Binders
45 Coating Systems & Additives
37 Direct Compression
31 Granulation
26 Disintegrants & Superdisintegrants
25 Thickeners and Stabilizers
22 Taste Masking
22 Controlled & Modified Release
19 Chewable & Orodispersible Aids
19 Film Formers & Plasticizers
18 Solubilizers
15 Topical
15 Parenteral
14 Co-Processed Excipients
13 Lubricants & Glidants
6 Rheology Modifiers
5 API Stability Enhancers
5 Empty Capsules
4 Emulsifying Agents
4 Vegetarian Capsules
2 Surfactant & Foaming Agents
2 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 26 News #PharmaBuzz

2 Data Compilation #PharmaFlow
26 News #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 28 Regulatory FDF Prices

7 US Medicaid Prescriptions
28 Regulatory FDF Prices

MARKET PLACE

6 APIs, 9 FDF Dossiers

6 APIs
9 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 2 Others

3 EDQM
2 Others

$ API Ref.Price (USD/KG) : 332 Xls

Filters

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filter Applicant Reset all filters

10 All

01 3Pharmacare Limited, Woodmead

02 1Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

03 1Aurogen South Africa (Pty) Ltd

04 2Pfizer Laboratories (Pty) Ltd

05 2Teva Pharmaceuticals (Pty) Ltd

06 1Trinity Pharma (Pty) Ltd

filter Active Ingredients Reset all filters

10 All

01 9Tamoxifen

02 1Tamoxifen Citrate

filter Dosage Form Reset all filters

10 All

01 1FCT

02 9TAB

filter Brand Name Reset all filters

10 All

01 1Kessar 10

02 1Kessar 20

03 2Neophedan

04 1Neophedan 20

05 1Nolvadex- D

06 2Tamoplex 20mg

07 1Tamoxal 20

08 1Tremofid

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

International Sweetener Colloquium

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Neophedan

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Pharmacare Limited, Woodmead

International Sweetener Colloquium

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Neophedan 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

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03

Pharmacare Limited, Woodmead

International Sweetener Colloquium

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Neophedan

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 250X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

International Sweetener Colloquium

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

International Sweetener Colloquium

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 : Originator

Registration Country : South Africa

Brand Name : Nolvadex- D

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Pfizer Laboratories (Pty) Ltd

International Sweetener Colloquium

Not Confirmed

Pfizer Laboratories (Pty) Ltd

International Sweetener Colloquium

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Kessar 10

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

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06

Pfizer Laboratories (Pty) Ltd

International Sweetener Colloquium

Not Confirmed

Pfizer Laboratories (Pty) Ltd

International Sweetener Colloquium

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Kessar 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Teva Pharmaceuticals (Pty) Ltd

International Sweetener Colloquium

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

International Sweetener Colloquium

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Tamoplex 20mg

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Teva Pharmaceuticals (Pty) Ltd

International Sweetener Colloquium

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

International Sweetener Colloquium

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 : Tamoplex 20mg

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 250X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Trinity Pharma (Pty) Ltd

International Sweetener Colloquium

Not Confirmed

Trinity Pharma (Pty) Ltd

International Sweetener Colloquium

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Tamoxifen Citrate

Brand Name : Tamoxal 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

10

Aurogen South Africa (Pty) Ltd

Country

International Sweetener Colloquium

Not Confirmed

Aurogen South Africa (Pty) Ltd

Country

International Sweetener Colloquium

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

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Tremofid

Dosage Form : FCT

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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Digital Content

Website

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