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Vardenafil

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 6 USDMF, 5 CEP/COS, 2 JDMF, 8 EU WC, 2 KDMF, 13 NDC API, 20 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

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TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 14 SPI Pharma, 2 Seqens, 3 DKSH, 2 Faran Shimi Pharmaceutical, 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, 12 Co-Processed Excipients, 11 Granulation, 11 Lubricants & Glidants, 8 Parenteral, 7 Topical, 6 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 API Stability Enhancers, 5 Solubilizers, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 2 Rheology Modifiers, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

REF. STANDARDS & IMPURITIES

2 USP, 11 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/11/2024	Polpharma	Poland	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	25174	VARDENAFIL HYDROCHLORIDE TRIHYDRATE	2011-08-02	Active	II	Complete	2015-09-15	2015-08-21
28/11/2024	Alembic Pharmaceuticals Limited	India	ALEMBIC PHARMACEUTICALS LTD	28900	VARDENAFIL HYDROCHLORIDE USP	2014-12-31	Active	II	Complete	2015-02-20	2014-12-24

Vardenafil

Vardenafil

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers

6 USDMF

5 CEP/COS

2 JDMF

8 EU WC

2 KDMF

13 NDC API

20 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

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**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc

14 SPI Pharma

2 Seqens

3 DKSH

2 Faran Shimi Pharmaceutical

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

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