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Drug Approvals by the Medicines Control Council in South Africa containing NCGC00025000-03. Original Data : South African Medicines Price Registry

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NCGC00025000-03
South Africa

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NCGC00025000-03

ACCESS ALL DATA, CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 16 USDMF, 6 CEP/COS, 2 JDMF, 4 EU WC, 13 KDMF, 19 NDC API, 30 Listed Suppliers, $ API Reference Price

45 API Suppliers
16 USDMF
6 CEP/COS
2 JDMF
4 EU WC
13 KDMF
19 NDC API
30 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

18 API Suppliers

18 API Suppliers

FINISHED DOSAGE FORMULATIONS

122 FDF Dossiers, 25 FDA Orange Book, 37 Europe, 4 Canada, 10 South Africa, 46 Listed Dossiers

122 FDF Dossiers
25 FDA Orange Book
37 Europe
4 Canada
10 South Africa
46 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 1%, AEROSOL, FOAM;TOPICAL - 2%, GEL;TOPICAL - 2%

TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SHAMPOO;TOPICAL - 1%
AEROSOL, FOAM;TOPICAL - 2%
GEL;TOPICAL - 2%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 4 DKSH, 1 Jai Radhe Sales, 2 Nippon Fine Chemical, 1 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 11 Gangwal Healthcare, 11 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 13 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 34 BASF, 2 BioSpectra, 1 Clariant, 1 Corel Pharma Chem, 4 DFE Pharma, 3 Finar, 12 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 21 Kerry, 2 Lubrizol Life Science Health, 11 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 13 Roquette, 17 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 9 Sigachi Industries, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

62 Fillers, Diluents & Binders, 49 Topical, 40 Solubilizers, 34 Thickeners and Stabilizers, 32 Direct Compression, 28 Parenteral, 19 Co-Processed Excipients, 17 Granulation, 16 Emulsifying Agents, 14 Controlled & Modified Release, 14 Lubricants & Glidants, 14 Surfactant & Foaming Agents, 11 Disintegrants & Superdisintegrants, 9 Coating Systems & Additives, 9 Film Formers & Plasticizers, 6 Chewable & Orodispersible Aids, 6 Taste Masking, 5 Rheology Modifiers, 4 API Stability Enhancers

62 Fillers, Diluents & Binders
49 Topical
40 Solubilizers
34 Thickeners and Stabilizers
32 Direct Compression
28 Parenteral
19 Co-Processed Excipients
17 Granulation
16 Emulsifying Agents
14 Controlled & Modified Release
14 Lubricants & Glidants
14 Surfactant & Foaming Agents
11 Disintegrants & Superdisintegrants
9 Coating Systems & Additives
9 Film Formers & Plasticizers
6 Chewable & Orodispersible Aids
6 Taste Masking
5 Rheology Modifiers
4 API Stability Enhancers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 14 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 36 Finished Drug Prices

1 US Medicaid Prescriptions
36 Finished Drug Prices

MARKET PLACE

42 APIs, 2 FDF Dossiers

42 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 3 Others

3 EDQM
1 USP
3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 82 Xls

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10 All

01 3Pharmacare Limited, Woodmead

02 1Adcock Ingram Limited

03 3Janssen Pharmaceutica (Pty) Ltd

04 1Johnson & Johnson (Pty) Ltd

05 1Pharma Dynamics (Pty) Ltd

06 1Sandoz SA (Pty) Ltd

filter Active Ingredients Reset all filters

10 All

01 10Ketoconazole

filter Dosage Form Reset all filters

10 All

01 2CRE

02 3SHA

03 5TAB

filter Brand Name Reset all filters

10 All

01 1Adco-Dermed

02 2Ketazol

03 1Ketazol Cream

04 1Kez

05 1Niz Shampoo

06 1Nizcreme

07 1Nizoral 200 Mg

08 1Nizoral 200 mg

09 1Sandoz Ketoconazole 200 Tablets

Nuray Ketoconazole

FDF Dossiers
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South Africa
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01

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Ketoconazole

Brand Name : Ketazol

Dosage Form : TAB

Dosage Strength : 200mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Ketoconazole

Brand Name : Ketazol

Dosage Form : TAB

Dosage Strength : 200mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Pharmacare Limited, Woodmead

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Regulatory Info : Generic

Registration Country : South Africa

Ketoconazole

Brand Name : Ketazol Cream

Dosage Form : CRE

Dosage Strength : 20mg/g

Packaging : 20X1mg/g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Adcock Ingram Limited

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Adcock Ingram Limited

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Regulatory Info : Generic

Registration Country : South Africa

Ketoconazole

Brand Name : Adco-Dermed

Dosage Form : SHA

Dosage Strength : 20mg/ml

Packaging : 80X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

Johnson & Johnson (Pty) Ltd

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Johnson & Johnson (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Ketoconazole

Brand Name : Niz Shampoo

Dosage Form : SHA

Dosage Strength : 20mg/g

Packaging : 80X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Janssen Pharmaceutica (Pty) Ltd

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Janssen Pharmaceutica (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Ketoconazole

Brand Name : Nizcreme

Dosage Form : CRE

Dosage Strength : 20mg/g

Packaging : 20X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Janssen Pharmaceutica (Pty) Ltd

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Janssen Pharmaceutica (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Ketoconazole

Brand Name : Nizoral 200 mg

Dosage Form : TAB

Dosage Strength : 200mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Janssen Pharmaceutica (Pty) Ltd

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Janssen Pharmaceutica (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Ketoconazole

Brand Name : Nizoral 200 Mg

Dosage Form : TAB

Dosage Strength : 200mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Pharma Dynamics (Pty) Ltd

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Pharma Dynamics (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Ketoconazole

Brand Name : Kez

Dosage Form : SHA

Dosage Strength : 20mg/ml

Packaging : 80X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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10

Sandoz SA (Pty) Ltd

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Sandoz SA (Pty) Ltd

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Regulatory Info : Generic

Registration Country : South Africa

Ketoconazole

Brand Name : Sandoz Ketoconazole 200 Tablets

Dosage Form : TAB

Dosage Strength : 200mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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