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Approved Marketing Authorisations (MA) containing NCGC00025000-05 in Europe. Original Data : EMA Website

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Product

NCGC00025000-05
Europe

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FAMAR CDMO- From early development to commercial manufacturing.

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NCGC00025000-05

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TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SHAMPOO;TOPICAL - 1%, AEROSOL, FOAM;TOPICAL - 2%, GEL;TOPICAL - 2%

TABLET;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Filters

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FILTER :

filter Applicant Reset all filters

37 All

01 12care4

02 1Actavis Nordic A / S

03 1CCS Health Care AB

04 1Copyfarm A / S

05 2Drossapharm AG

06 1LABORATOIRE HRA PHARMA

07 1Laboratoire CONTENT, Pharma

08 1Laboratoire HRA Pharma,

09 2McNeil Sweden AB

10 2Mepha Pharma AG

11 1Nobel Ilac Sanayii Ve Ticaret A.S.

12 2Permamed AG Betriebsstandort Therwil

13 1Pinewood Laboratories Ltd

14 1STADA Arzneimittel AG

15 3Spirig HealthCare AG

16 1Teva Pharmaceutical Industries Ltd.

17 15Blank

filter Active Ingredients Reset all filters

37 All

01 29Ketoconazole

02 8ketoconazole

filter Dosage Form Reset all filters

37 All

01 1 Egg/Pill Vaginal

02 1Antic-calc Tablet

03 7Cream

04 9Gel

05 1Ketokonazolo 200Mg 60 Units Oral Use

06 7SHAMPOO

07 8Solution

08 1Suppositories

09 1TABLET

10 1Tablet

filter Country Reset all filters

37 All

01 1Italy

02 3Norway

03 15Spain

04 8Sweden

05 9Switzerland

06 1Turkey

filter Brand Name Reset all filters

37 All

01 12% Ketoconazole Cinfa 100Ml Gel Efg

02 12% Medezol 100Ml Gel

03 1Abamed Ketoconazole 2% 30G Cream

04 1Abamed Ketoconazole 2% Gel Bottle 100Ml Efg

05 1Fungarest 2% 100Ml Gel

06 1Fungarest Cream 2% 30G

07 3Fungoral

08 2Keto-med Shampoo

09 1Ketoconazole

10 1Ketoconazole 2% Pharmagenus 100Ml Gel Efg

11 1Ketoconazole Actavis

12 1Ketoconazole Alternova

13 1Ketoconazole CONTENT,

14 1Ketoconazole Copyfarm

15 1Ketoconazole Teva

16 1Ketoconazole Vir 20Mg/Ml Gel Efg 1 Bottle Of 100Ml

17 1Ketoisdin Cream 2% 30G

18 1Ketoisdin Ova 400Mg 5 Vaginal Suppositories

19 1Ketoson

20 2Ketozol-Mepha Shampoo

21 1Kezol

22 1Korhispana Ketoconazole 2% Gel 100Ml Efg

23 2Lur Shampoo

24 1Nizoral

25 2Nizoral Shampoo

26 1Panfungol 2% 30G Cream

27 1Panfungol 400Mg 5 Eggs

28 1Teknazol

29 1The Keto-Cure 20Mg/Ml Bottle 100Ml Gel

30 1The Sandoz Ketoconazole 2% 100Ml Gel Efg

31 1ketoconazole HRA

Nuray Ketoconazole

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Actavis Nordic A / S

BioProcess International

Not Confirmed

Actavis Nordic A / S

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Sweden

ketoconazole

Brand Name : Ketoconazole Actavis

Dosage Form : SHAMPOO

Dosage Strength : 20 MG / G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

McNeil Sweden AB

BioProcess International

Not Confirmed

McNeil Sweden AB

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Sweden

ketoconazole

Brand Name : Fungoral

Dosage Form : SHAMPOO

Dosage Strength : 20 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

03

Nobel Ilac Sanayii Ve Ticaret A.S.

BioProcess International

Not Confirmed

Nobel Ilac Sanayii Ve Ticaret A.S.

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Turkey

Ketoconazole

Brand Name : Teknazol

Dosage Form : Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

STADA Arzneimittel AG

BioProcess International

Not Confirmed

STADA Arzneimittel AG

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Sweden

ketoconazole

Brand Name : Kezol

Dosage Form : SHAMPOO

Dosage Strength : 20 MG / G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Teva Pharmaceutical Industries Ltd.

BioProcess International

Not Confirmed

Teva Pharmaceutical Industries Ltd.

BioProcess International

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Sweden

ketoconazole

Brand Name : Ketoconazole Teva

Dosage Form : SHAMPOO

Dosage Strength : 20 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Laboratoire HRA Pharma,

Country

BioProcess International

Not Confirmed

Laboratoire HRA Pharma,

Country

BioProcess International

Not Confirmed

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Virtual Booth

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Regulatory Info :

Registration Country : Sweden

ketoconazole

Brand Name : ketoconazole HRA

Dosage Form : TABLET

Dosage Strength : 200 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

07

Pinewood Laboratories Ltd

Country

BioProcess International

Not Confirmed

Pinewood Laboratories Ltd

Country

BioProcess International

Not Confirmed

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Country

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Sweden

ketoconazole

Brand Name : Ketoconazole Alternova

Dosage Form : SHAMPOO

Dosage Strength : 20 MG / G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

08

Copyfarm A / S

Country

BioProcess International

Not Confirmed

Copyfarm A / S

Country

BioProcess International

Not Confirmed

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Regulatory Info :

Registration Country : Sweden

ketoconazole

Brand Name : Ketoconazole Copyfarm

Dosage Form : SHAMPOO

Dosage Strength : 20 MG / G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

CCS Health Care AB

Country

BioProcess International

Not Confirmed

CCS Health Care AB

Country

BioProcess International

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Virtual Booth

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Regulatory Info :

Registration Country : Sweden

ketoconazole

Brand Name : Ketoson

Dosage Form : SHAMPOO

Dosage Strength : 20 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

LABORATOIRE HRA PHARMA

Country

BioProcess International

Not Confirmed

LABORATOIRE HRA PHARMA

Country

BioProcess International

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Country

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Italy

Ketoconazole

Brand Name : Ketoconazole

Dosage Form : Ketokonazolo 200Mg 60 Units Oral Use

Dosage Strength : 60 CPR 200 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

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