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

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Romazicon
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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Romazicon

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 4 USDMF, 4 CEP/COS, 3 JDMF, 9 KDMF, 3 NDC API, 12 Listed Suppliers, $ API Reference Price

21 API Suppliers
4 USDMF
4 CEP/COS
3 JDMF
9 KDMF
3 NDC API
12 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

62 FDF Dossiers, 20 FDA Orange Book, 26 Europe, 2 Canada, 3 South Africa, 11 Listed Dossiers

62 FDF Dossiers
20 FDA Orange Book
26 Europe
2 Canada
3 South Africa
11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Actylis

3 Actylis

DIGITAL CONTENT

4 News #PharmaBuzz

4 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 17 Regulatory FDF Prices

1 US Medicaid Prescriptions
17 Regulatory FDF Prices

MARKET PLACE

4 APIs, 1 FDF Dossiers

4 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 8 Others

2 EDQM
8 Others

$ API Ref.Price (USD/KG) : 526,208 Xls

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01 1Fresenius Kabi South Africa (Pty) Ltd

02 2Pharmaco Distribution (Pty) Ltd

filter Active Ingredients Reset all filters

3 All

01 3Flumazenil

filter Dosage Form Reset all filters

3 All

01 3INJ

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3 All

01 1Anexate 0,5 mg

02 1Anexate 1,0 mg

03 1Flumazenil 0.5mg/5ml Fresenius

List of Suppliers

Product Main Page

01

Fresenius Kabi South Africa (Pty) Ltd

AACR Annual meeting

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

AACR Annual meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Flumazenil 0.5mg/5ml Fresenius

Dosage Form : INJ

Dosage Strength : 0.5mg/5ml

Packaging : 5X5mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Pharmaco Distribution (Pty) Ltd

AACR Annual meeting

Not Confirmed

Pharmaco Distribution (Pty) Ltd

AACR Annual meeting

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Anexate 0,5 mg

Dosage Form : INJ

Dosage Strength : 25mg

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Pharmaco Distribution (Pty) Ltd

AACR Annual meeting

Not Confirmed

Pharmaco Distribution (Pty) Ltd

AACR Annual meeting

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Anexate 1,0 mg

Dosage Form : INJ

Dosage Strength : 1mg/10ml

Packaging : 10X1mg/10ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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