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

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Repaglinide
South Africa

Evonik

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Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

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xyz-pharma-m-2025-04-21

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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xyz-pharma-m-2025-04-14

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Repaglinide

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 12 USDMF, 11 CEP/COS, 3 JDMF, 8 EU WC, 2 KDMF, 6 NDC API, 17 Listed Suppliers, $ API Reference Price

29 API Suppliers
12 USDMF
11 CEP/COS
3 JDMF
8 EU WC
2 KDMF
6 NDC API
17 Listed Suppliers
$ API Reference Price

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

268 FDF Dossiers, 31 FDA Orange Book, 191 Europe, 15 Canada, 6 South Africa, 25 Listed Dossiers

268 FDF Dossiers
31 FDA Orange Book
191 Europe
15 Canada
6 South Africa
25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;1MG, TABLET;ORAL - 500MG;2MG

TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 - 500MG;1MG
TABLET;ORAL - 500MG;2MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 6 SPI Pharma, 3 DKSH, 5 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 5 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 27 BASF, 1 Corel Pharma Chem, 3 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 9 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 5 Kerry, 8 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 25 Roquette, 1 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

46 Fillers, Diluents & Binders, 22 Direct Compression, 20 Granulation, 20 Thickeners and Stabilizers, 20 Disintegrants & Superdisintegrants, 19 Solubilizers, 16 Topical, 16 Lubricants & Glidants, 16 Film Formers & Plasticizers, 15 Taste Masking, 15 Coating Systems & Additives, 14 Controlled & Modified Release, 11 Parenteral, 11 Co-Processed Excipients, 8 Chewable & Orodispersible Aids, 5 Emulsifying Agents, 2 Coloring Agents, 2 Rheology Modifiers, 2 API Stability Enhancers, 1 Surfactant & Foaming Agents, 1 Soft Gelatin

46 Fillers, Diluents & Binders
22 Direct Compression
20 Granulation
20 Thickeners and Stabilizers
20 Disintegrants & Superdisintegrants
19 Solubilizers
16 Topical
16 Lubricants & Glidants
16 Film Formers & Plasticizers
15 Taste Masking
15 Coating Systems & Additives
14 Controlled & Modified Release
11 Parenteral
11 Co-Processed Excipients
8 Chewable & Orodispersible Aids
5 Emulsifying Agents
2 Coloring Agents
2 Rheology Modifiers
2 API Stability Enhancers
1 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

8 News #PharmaBuzz

8 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 155 Regulatory FDF Prices, 5 Annual Reports

1 US Medicaid Prescriptions
155 Regulatory FDF Prices
5 Annual Reports

MARKET PLACE

7 APIs, 2 FDF Dossiers

7 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 5 Others

3 EDQM
5 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 2,526 Xls

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filter Applicant Reset all filters

6 All

01 3Macleods Pharmaceuticals SA (Pty) Ltd

02 3Novo Nordisk (Pty) Ltd

filter Active Ingredients Reset all filters

6 All

01 3Repaglinide

02 3repaglinide

filter Dosage Form Reset all filters

6 All

01 6TAB

filter Brand Name Reset all filters

6 All

01 1Normidab 0,5 MG

02 1Normidab 1 MG

03 1Normidab 2 MG

04 1Novonorm 0.5 mg

05 1Novonorm 1.0 mg

06 1Novonorm 2.0 mg

List of Suppliers

Product Main Page

01

Macleods Pharmaceuticals SA (Pty) Ltd

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Macleods Pharmaceuticals SA (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

repaglinide

Brand Name : Normidab 0,5 MG

Dosage Form : TAB

Dosage Strength : 0.5mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

02

Macleods Pharmaceuticals SA (Pty) Ltd

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Macleods Pharmaceuticals SA (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

repaglinide

Brand Name : Normidab 1 MG

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

03

Macleods Pharmaceuticals SA (Pty) Ltd

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Macleods Pharmaceuticals SA (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

repaglinide

Brand Name : Normidab 2 MG

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

04

Novo Nordisk (Pty) Ltd

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Novo Nordisk (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Repaglinide

Brand Name : Novonorm 0.5 mg

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 90X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Novo Nordisk (Pty) Ltd

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Novo Nordisk (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Repaglinide

Brand Name : Novonorm 1.0 mg

Dosage Form : TAB

Dosage Strength : 1mg

Packaging : 90X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Novo Nordisk (Pty) Ltd

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Novo Nordisk (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Repaglinide

Brand Name : Novonorm 2.0 mg

Dosage Form : TAB

Dosage Strength : 2mg

Packaging : 90X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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