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

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Flecainide
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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Flecainide

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 12 USDMF, 14 CEP/COS, 1 JDMF, 6 EU WC, 1 KDMF, 8 NDC API, 15 Listed Suppliers, $ API Reference Price

26 API Suppliers
12 USDMF
14 CEP/COS
1 JDMF
6 EU WC
1 KDMF
8 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

127 FDF Dossiers, 31 FDA Orange Book, 66 Europe, 12 Canada, 8 Australia, 6 South Africa, 4 Listed Dossiers

127 FDF Dossiers
31 FDA Orange Book
66 Europe
12 Canada
8 Australia
6 South Africa
4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 SPI Pharma, 2 DKSH, 3 Faran Shimi Pharmaceutical, 1 Chynops Pharma, 5 Gangwal Healthcare, 1 Pramukh Pharmachem, 1 Zeal MediPharma, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 3 DFE Pharma, 4 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 4 Kerry, 9 Microlex e.U, 1 NEWEDGE Overseas, 2 Pharmatrans-Sanaq, 3 Pluviaendo, 4 Prachin Chemical, 18 Roquette, 1 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 3 Vasa Pharmachem

1 Minakem
5 SPI Pharma
2 DKSH
3 Faran Shimi Pharmaceutical
1 Chynops Pharma
5 Gangwal Healthcare
1 Pramukh Pharmachem
1 Zeal MediPharma
1 Alcedo Pharmachem
7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
2 BASF
3 DFE Pharma
4 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
3 Ingredion Pharma Solutions
4 Kerry
9 Microlex e.U
1 NEWEDGE Overseas
2 Pharmatrans-Sanaq
3 Pluviaendo
4 Prachin Chemical
18 Roquette
1 Seppic
4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
9 Sigachi Industries
3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

35 Fillers, Diluents & Binders, 19 Lubricants & Glidants, 18 Disintegrants & Superdisintegrants, 14 Direct Compression, 13 Thickeners and Stabilizers, 9 Granulation, 8 Co-Processed Excipients, 8 Coating Systems & Additives, 6 Chewable & Orodispersible Aids, 5 Film Formers & Plasticizers, 5 Taste Masking, 4 Controlled & Modified Release, 3 Emulsifying Agents, 2 Rheology Modifiers, 1 API Stability Enhancers, 1 Topical

35 Fillers, Diluents & Binders
19 Lubricants & Glidants
18 Disintegrants & Superdisintegrants
14 Direct Compression
13 Thickeners and Stabilizers
9 Granulation
8 Co-Processed Excipients
8 Coating Systems & Additives
6 Chewable & Orodispersible Aids
5 Film Formers & Plasticizers
5 Taste Masking
4 Controlled & Modified Release
3 Emulsifying Agents
2 Rheology Modifiers
1 API Stability Enhancers
1 Topical

DIGITAL CONTENT

6 News #PharmaBuzz

6 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 53 Regulatory FDF Prices

1 US Medicaid Prescriptions
53 Regulatory FDF Prices

MARKET PLACE

15 APIs, 4 FDF Dossiers

15 APIs
4 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM, 2 USP, 5 Others

4 EDQM
2 USP
5 Others

$ API Ref.Price (USD/KG) : 349 Xls

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6 All

01 2Forrester Pharma (Pty) Ltd

02 4iNova Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

6 All

01 6Flecainide acetate

filter Dosage Form Reset all filters

6 All

01 4CAP

02 1INJ

03 1TAB

filter Brand Name Reset all filters

6 All

01 2Tambocor

02 1Tambocor CR 100

03 1Tambocor CR 200

04 1Tempacin 100 CR

05 1Tempacin 200 CR

List of Suppliers

Product Main Page

01

Forrester Pharma (Pty) Ltd

ELCC

Not Confirmed

Forrester 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

Flecainide acetate

Brand Name : Tempacin 100 CR

Dosage Form : CAP

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Forrester Pharma (Pty) Ltd

ELCC

Not Confirmed

Forrester Pharma (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Flecainide acetate

Brand Name : Tempacin 200 CR

Dosage Form : CAP

Dosage Strength : 200mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

iNova Pharmaceuticals (Pty) Ltd

ELCC

Not Confirmed

iNova Pharmaceuticals (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Flecainide acetate

Brand Name : Tambocor CR 100

Dosage Form : CAP

Dosage Strength : 100mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

iNova Pharmaceuticals (Pty) Ltd

ELCC

Not Confirmed

iNova Pharmaceuticals (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Flecainide acetate

Brand Name : Tambocor CR 200

Dosage Form : CAP

Dosage Strength : 200mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

iNova Pharmaceuticals (Pty) Ltd

ELCC

Not Confirmed

iNova Pharmaceuticals (Pty) Ltd

ELCC

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Flecainide acetate

Brand Name : Tambocor

Dosage Form : INJ

Dosage Strength : 10mg/ml

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

iNova Pharmaceuticals (Pty) Ltd

ELCC

Not Confirmed

iNova 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 : Originator

Registration Country : South Africa

Flecainide acetate

Brand Name : Tambocor

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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