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

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Flumazenil
South Africa

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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Flumazenil

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ACTIVE PHARMA INGREDIENTS

15 API Suppliers, 4 USDMF, 4 CEP/COS, 3 JDMF, 9 KDMF, 4 NDC API, 11 Listed Suppliers, $ API Reference Price

15 API Suppliers
4 USDMF
4 CEP/COS
3 JDMF
9 KDMF
4 NDC API
11 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INJECTABLE;INJECTION - 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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1 US Medicaid Prescriptions, 17 Finished Drug Prices

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4 APIs, 1 FDF Dossiers

4 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 8 Others

2 EDQM
2 USP
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

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01 3Flumazenil

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01 3INJ

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01 1Anexate 0,5 mg

02 1Anexate 1,0 mg

03 1Flumazenil 0.5mg/5ml Fresenius

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01

Fresenius Kabi South Africa (Pty) Ltd

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Fresenius Kabi South Africa (Pty) Ltd

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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

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02

Pharmaco Distribution (Pty) Ltd

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Pharmaco Distribution (Pty) Ltd

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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

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03

Pharmaco Distribution (Pty) Ltd

Antibody Engineering

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Pharmaco Distribution (Pty) Ltd

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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

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