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Approved Marketing Authorisations (MA) containing Vardenafil Hydrochloride in Europe. Original Data : EMA Website

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Product

Vardenafil Hydrochloride
Europe

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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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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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Vardenafil Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 6 USDMF, 5 CEP/COS, 2 JDMF, 8 EU WC, 2 KDMF, 9 NDC API, 21 Listed Suppliers, $ API Reference Price

27 API Suppliers
6 USDMF
5 CEP/COS
2 JDMF
8 EU WC
2 KDMF
9 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

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

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

102 FDF Dossiers, 32 FDA Orange Book, 39 Europe, 6 Canada, 5 South Africa, 20 Listed Dossiers

102 FDF Dossiers
32 FDA Orange Book
39 Europe
6 Canada
5 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 3 DKSH, 7 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 3 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 21 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 2 The Dow Chemical Company, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 42 Fillers, Diluents & Binders, 24 Controlled & Modified Release, 22 Direct Compression, 17 Thickeners and Stabilizers, 16 Taste Masking, 14 Chewable & Orodispersible Aids, 14 Film Formers & Plasticizers, 11 Lubricants & Glidants, 11 Co-Processed Excipients, 11 Granulation, 8 Parenteral, 7 Topical, 6 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 API Stability Enhancers, 5 Solubilizers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Rheology Modifiers, 1 Soft Gelatin

45 Coating Systems & Additives
42 Fillers, Diluents & Binders
24 Controlled & Modified Release
22 Direct Compression
17 Thickeners and Stabilizers
16 Taste Masking
14 Chewable & Orodispersible Aids
14 Film Formers & Plasticizers
11 Lubricants & Glidants
11 Co-Processed Excipients
11 Granulation
8 Parenteral
7 Topical
6 Disintegrants & Superdisintegrants
5 Empty Capsules
5 API Stability Enhancers
5 Solubilizers
4 Emulsifying Agents
4 Vegetarian Capsules
4 Coloring Agents
2 Rheology Modifiers
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 26 Finished Drug Prices, 2 Annual Reports

1 US Medicaid Prescriptions
26 Finished Drug Prices
2 Annual Reports

MARKET PLACE

12 APIs

12 APIs

PATENTS & EXCLUSIVITIES

5 US Patents, 5 Health Canada Patents

5 US Patents
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 11 Others

2 USP
11 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 2,164 Xls

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39 All

01 1BAYER PHARMA AG

02 6BAYER SpA

03 15Bayer Pharma AG

04 1DOC GENERICI SRL

05 2Farm Agon

06 7GLAXOSMITHKLINE SpA

07 1MYLAN SPA

08 5Macleods Pharmaceuticals Limited

09 1TEVA ITALIA SRL

filter Active Ingredients Reset all filters

39 All

01 31Vardenafil

02 8vardenafilhydrokloridtrihydrat

filter Dosage Form Reset all filters

39 All

01 8Antic-calc Tablet, Film Coated

02 3FILM COATED PILL

03 3FILMDRAGERAD TABLETT

04 4Film-Coated Tablets

05 4IR TABLET

06 1MUNSÖNDERFALLANDE TABLETT

07 1ODT TABLET

08 1ORODISPERSIBLE TABLET

09 1Smeltetablett

10 13Blank

filter Country Reset all filters

39 All

01 17Italy

02 9Norway

03 8Sweden

04 5United Kingdom

filter Brand Name Reset all filters

39 All

01 1LEVITRA

02 19Levitra

03 1VARDENAFIL DOC

04 1VARDENAFIL MYLAN

05 1VARDENAFIL TEVA ITALY

06 11Vivanza

07 5Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Bayer Pharma AG

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Regulatory Info :

Registration Country : Sweden

vardenafilhydrokloridtrihydrat

Brand Name : Levitra

Dosage Form : ORODISPERSIBLE TABLET

Dosage Strength : 10 MG

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Approval Date :

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Regulatory Info :

Registration Country : Sweden

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02

Bayer Pharma AG

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Regulatory Info :

Registration Country : Sweden

vardenafilhydrokloridtrihydrat

Brand Name : Levitra

Dosage Form : FILM COATED PILL

Dosage Strength : 10 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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03

Bayer Pharma AG

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Regulatory Info :

Registration Country : Sweden

vardenafilhydrokloridtrihydrat

Brand Name : Levitra

Dosage Form : FILM COATED PILL

Dosage Strength : 5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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04

Bayer Pharma AG

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Regulatory Info :

Registration Country : Sweden

vardenafilhydrokloridtrihydrat

Brand Name : Levitra

Dosage Form : FILM COATED PILL

Dosage Strength : 20 MG

Packaging :

Approval Date :

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Regulatory Info :

Registration Country : Sweden

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05

Bayer Pharma AG

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Regulatory Info :

Registration Country : Sweden

vardenafilhydrokloridtrihydrat

Brand Name : Vivanza

Dosage Form : MUNSÖNDERFALLANDE TABLETT

Dosage Strength : 10 MG

Packaging :

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Application Number :

Regulatory Info :

Registration Country : Sweden

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06

Macleods Pharmaceuticals Limited

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Regulatory Info : Generic US CTD

Registration Country : United Kingdom

Brand Name :

Dosage Form : IR TABLET

Dosage Strength : 2.5MG

Packaging :

Approval Date :

Application Number : 21400

Regulatory Info : Generic US CTD

Registration Country : United Kingdom

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07

Macleods Pharmaceuticals Limited

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Regulatory Info : Generic US CTD

Registration Country : United Kingdom

Brand Name :

Dosage Form : IR TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 21400

Regulatory Info : Generic US CTD

Registration Country : United Kingdom

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08

Macleods Pharmaceuticals Limited

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Macleods Pharmaceuticals Limited

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Regulatory Info : Generic US CTD

Registration Country : United Kingdom

Brand Name :

Dosage Form : IR TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 21400

Regulatory Info : Generic US CTD

Registration Country : United Kingdom

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09

Macleods Pharmaceuticals Limited

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Macleods Pharmaceuticals Limited

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Regulatory Info : Generic US CTD

Registration Country : United Kingdom

Brand Name :

Dosage Form : IR TABLET

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number : 21400

Regulatory Info : Generic US CTD

Registration Country : United Kingdom

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10

Macleods Pharmaceuticals Limited

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Macleods Pharmaceuticals Limited

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Regulatory Info : Generic US CTD

Registration Country : United Kingdom

Brand Name :

Dosage Form : ODT TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 21400

Regulatory Info : Generic US CTD

Registration Country : United Kingdom

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