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

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Trandolapril
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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Trandolapril

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ACTIVE PHARMA INGREDIENTS

15 API Suppliers, 8 USDMF, 6 CEP/COS, 3 JDMF, 3 EU WC, 4 NDC API, 6 Listed Suppliers, $ API Reference Price

15 API Suppliers
8 USDMF
6 CEP/COS
3 JDMF
3 EU WC
4 NDC API
6 Listed Suppliers
$ API Reference Price

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

106 FDF Dossiers, 33 FDA Orange Book, 8 Europe, 29 Canada, 24 Australia, 8 South Africa, 4 Listed Dossiers

106 FDF Dossiers
33 FDA Orange Book
8 Europe
29 Canada
24 Australia
8 South Africa
4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 5 SPI Pharma, 2 Seqens, 4 DKSH, 5 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 13 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 6 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 16 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

71 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 32 Direct Compression, 29 Controlled & Modified Release, 23 Disintegrants & Superdisintegrants, 20 Thickeners and Stabilizers, 20 Lubricants & Glidants, 20 Granulation, 18 Co-Processed Excipients, 12 Solubilizers, 9 Film Formers & Plasticizers, 8 Topical, 8 Chewable & Orodispersible Aids, 7 Taste Masking, 6 Parenteral, 5 Empty Capsules, 5 API Stability Enhancers, 5 Coloring Agents, 4 Emulsifying Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 1 Surfactant & Foaming Agents

71 Fillers, Diluents & Binders
47 Coating Systems & Additives
32 Direct Compression
29 Controlled & Modified Release
23 Disintegrants & Superdisintegrants
20 Thickeners and Stabilizers
20 Lubricants & Glidants
20 Granulation
18 Co-Processed Excipients
12 Solubilizers
9 Film Formers & Plasticizers
8 Topical
8 Chewable & Orodispersible Aids
7 Taste Masking
6 Parenteral
5 Empty Capsules
5 API Stability Enhancers
5 Coloring Agents
4 Emulsifying Agents
4 Rheology Modifiers
4 Vegetarian Capsules
1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 NEWS #PharmaBuzz

3 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 17 Finished Drug Prices

1 US Medicaid Prescriptions
17 Finished Drug Prices

MARKET PLACE

2 APIs

2 APIs

PATENTS & EXCLUSIVITIES

7 Health Canada Patents

7 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 6 Others

3 EDQM
2 USP
6 Others

$ API Ref.Price (USD/KG) : 4,920 Xls

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filter Applicant Reset all filters

8 All

01 1AbbVie (Pty) Ltd

02 7Abbott Laboratories SA (Pty) Ltd

filter Active Ingredients Reset all filters

8 All

01 8Trandolapril

filter Dosage Form Reset all filters

8 All

01 3CAP

02 1INJ

03 4TAB

filter Brand Name Reset all filters

8 All

01 3Mavik (was Gopten)

02 1Synagis 100 mg

03 2Tarka 180/2

04 2Tarka 240/4

List of Suppliers

Product Main Page

01

AbbVie (Pty) Ltd

PharmaVenue

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Trandolapril

Brand Name : Synagis 100 mg

Dosage Form : INJ

Dosage Strength : 2mg

Packaging : 1X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Abbvie Company Banner

Product Web Link

Digital Content

Corporate PDF

02

Abbott Laboratories SA (Pty) Ltd

PharmaVenue

Not Confirmed

Abbott Laboratories SA (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Trandolapril

Brand Name : Mavik (was Gopten)

Dosage Form : CAP

Dosage Strength : 4mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Abbott Laboratories SA (Pty) Ltd

PharmaVenue

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Abbott Laboratories SA (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Trandolapril

Brand Name : Tarka 180/2

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Abbott Laboratories SA (Pty) Ltd

PharmaVenue

Not Confirmed

Abbott Laboratories SA (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Trandolapril

Brand Name : Tarka 180/2

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Abbott Laboratories SA (Pty) Ltd

PharmaVenue

Not Confirmed

Abbott Laboratories SA (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Trandolapril

Brand Name : Tarka 240/4

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Abbott Laboratories SA (Pty) Ltd

PharmaVenue

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Abbott Laboratories SA (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Trandolapril

Brand Name : Tarka 240/4

Dosage Form : TAB

Dosage Strength : 4mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Abbott Laboratories SA (Pty) Ltd

PharmaVenue

Not Confirmed

Abbott Laboratories SA (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Trandolapril

Brand Name : Mavik (was Gopten)

Dosage Form : CAP

Dosage Strength : 10mg/ml

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Abbott Laboratories SA (Pty) Ltd

PharmaVenue

Not Confirmed

Abbott Laboratories SA (Pty) Ltd

PharmaVenue

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Trandolapril

Brand Name : Mavik (was Gopten)

Dosage Form : CAP

Dosage Strength : 2mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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