Fluorouracil Cream | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Fluorouracil Cream
South Africa

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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LEBSA- Your strategic API source for niche molecules.

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Fluorouracil Cream

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 15 USDMF, 4 CEP/COS, 2 JDMF, 13 NDC API, 15 Listed Suppliers, $ API Reference Price

41 API Suppliers
15 USDMF
4 CEP/COS
2 JDMF
13 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

107 Drugs in Development

107 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

170 FDF Dossiers, 69 FDA Orange Book, 42 Europe, 6 Canada, 28 Australia, 11 South Africa, 14 Listed Dossiers

170 FDF Dossiers
69 FDA Orange Book
42 Europe
6 Canada
28 Australia
11 South Africa
14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;TOPICAL - 2%, SOLUTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.5%, CREAM;TOPICAL - 4%

SOLUTION;TOPICAL - 2%
SOLUTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CREAM;TOPICAL - 0.5%
CREAM;TOPICAL - 4%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 SPI Pharma, 10 DKSH, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 5 Actylis, 1 Ashland, 10 BASF, 1 BioSpectra, 1 Clariant, 2 Corel Pharma Chem, 2 Finar, 6 Gangwal Chemicals, 7 Kerry, 2 Lubrizol Life Science Health, 3 Microlex e.U, 2 Nanjing Bold Chemical, 1 Pluviaendo, 4 Roquette, 9 Seppic, 1 Valens Pharmachem

2 EUROAPI
1 SPI Pharma
10 DKSH
6 Nanjing Well Pharmaceutical
1 Pfanstiehl
5 Actylis
1 Ashland
10 BASF
1 BioSpectra
1 Clariant
2 Corel Pharma Chem
2 Finar
6 Gangwal Chemicals
7 Kerry
2 Lubrizol Life Science Health
3 Microlex e.U
2 Nanjing Bold Chemical
1 Pluviaendo
4 Roquette
9 Seppic
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

29 Topical, 22 Solubilizers, 15 Parenteral, 11 Film Formers & Plasticizers, 11 Thickeners and Stabilizers, 10 Emulsifying Agents, 10 Fillers, Diluents & Binders, 9 Coating Systems & Additives, 7 Surfactant & Foaming Agents, 6 Co-Processed Excipients, 4 Direct Compression, 4 Lubricants & Glidants, 3 Rheology Modifiers, 2 Granulation, 2 Controlled & Modified Release, 1 API Stability Enhancers

29 Topical
22 Solubilizers
15 Parenteral
11 Film Formers & Plasticizers
11 Thickeners and Stabilizers
10 Emulsifying Agents
10 Fillers, Diluents & Binders
9 Coating Systems & Additives
7 Surfactant & Foaming Agents
6 Co-Processed Excipients
4 Direct Compression
4 Lubricants & Glidants
3 Rheology Modifiers
2 Granulation
2 Controlled & Modified Release
1 API Stability Enhancers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 41 News #PharmaBuzz

1 Data Compilation #PharmaFlow
41 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 46 Regulatory FDF Prices, 1 Annual Reports

2 US Medicaid Prescriptions
46 Regulatory FDF Prices
1 Annual Reports

MARKET PLACE

16 APIs, 15 FDF Dossiers

16 APIs
15 FDF Dossiers

REF. STANDARDS & IMPURITIES

6 EDQM, 1 USP, 6 Others

6 EDQM
1 USP
6 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 337 Xls

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11 All

01 2Accord Healthcare (Pty) Ltd

02 1Mylan (Pty) Ltd

03 1Pfizer Laboratories (Pty) Ltd

04 2Pharmachemie

05 1Pharmaplan (Pty) Ltd

06 4Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

11 All

01 65 Fluorouracil

02 15-Fluorouracil

03 4Fluorouracil

filter Dosage Form Reset all filters

11 All

01 10INJ

02 1OIN

filter Brand Name Reset all filters

11 All

01 15-Fluorouracil-Faulding 10ml

02 1Abic Fluorouracil 250Mg

03 1Abic Fluorouracil 500Mg

04 1Efudix

05 2Floracor 50mg/ml Injection

06 1Fluracedyl 1000 Mg

07 1Fluracedyl 250 Mg

08 1Fluracedyl 500 Mg

09 1Fluracedyl 5000 Mg

10 1Fluroblastin

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

Pharmacy Expo

Not Confirmed

Accord Healthcare (Pty) Ltd

Pharmacy Expo

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluorouracil

Brand Name : Floracor 50mg/ml Injection

Dosage Form : INJ

Dosage Strength : 50mg/ml

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Accord Healthcare (Pty) Ltd

Pharmacy Expo

Not Confirmed

Accord Healthcare (Pty) Ltd

Pharmacy Expo

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluorouracil

Brand Name : Floracor 50mg/ml Injection

Dosage Form : INJ

Dosage Strength : 50mg/ml

Packaging : 10X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Pfizer Laboratories (Pty) Ltd

Pharmacy Expo

Not Confirmed

Pfizer Laboratories (Pty) Ltd

Pharmacy Expo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

5-Fluorouracil

Brand Name : Fluroblastin

Dosage Form : INJ

Dosage Strength : 500mg/10ml

Packaging : 10X10mg/10ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

04

Pharmachemie

Pharmacy Expo

Not Confirmed

Pharmachemie

Pharmacy Expo

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

5 Fluorouracil

Brand Name : Abic Fluorouracil 250Mg

Dosage Form : INJ

Dosage Strength : 250mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Pharmachemie

Pharmacy Expo

Not Confirmed

Pharmachemie

Pharmacy Expo

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

5 Fluorouracil

Brand Name : Abic Fluorouracil 500Mg

Dosage Form : INJ

Dosage Strength : 500mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Pharmaplan (Pty) Ltd

Pharmacy Expo

Not Confirmed

Pharmaplan (Pty) Ltd

Pharmacy Expo

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Fluorouracil

Brand Name : 5-Fluorouracil-Faulding 10ml

Dosage Form : INJ

Dosage Strength : 50mg/ml

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Teva Pharmaceuticals (Pty) Ltd

Pharmacy Expo

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

Pharmacy Expo

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

5 Fluorouracil

Brand Name : Fluracedyl 250 Mg

Dosage Form : INJ

Dosage Strength : 250mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Teva Pharmaceuticals (Pty) Ltd

Pharmacy Expo

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

Pharmacy Expo

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

5 Fluorouracil

Brand Name : Fluracedyl 500 Mg

Dosage Form : INJ

Dosage Strength : 500mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Teva Pharmaceuticals (Pty) Ltd

Pharmacy Expo

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

Pharmacy Expo

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

5 Fluorouracil

Brand Name : Fluracedyl 1000 Mg

Dosage Form : INJ

Dosage Strength : 1000mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Mylan (Pty) Ltd

Pharmacy Expo

Not Confirmed

Mylan (Pty) Ltd

Pharmacy Expo

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Fluorouracil

Brand Name : Efudix

Dosage Form : OIN

Dosage Strength : 5%

Packaging : 20X1%

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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