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Chemistry

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Also known as:
Molecular Formula
C23H33ClN6O4S
Molecular Weight
525.1  g/mol
InChI Key
XCMULUAPJXCOHI-UHFFFAOYSA-N

Vardenafil Hydrochloride
1 2D Structure

Vardenafil Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one;hydrochloride
2.1.2 InChI
InChI=1S/C23H32N6O4S.ClH/c1-5-8-20-24-16(4)21-23(30)25-22(26-29(20)21)18-15-17(9-10-19(18)33-7-3)34(31,32)28-13-11-27(6-2)12-14-28;/h9-10,15H,5-8,11-14H2,1-4H3,(H,25,26,30);1H
2.1.3 InChI Key
XCMULUAPJXCOHI-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCC1=NC(=C2N1NC(=NC2=O)C3=C(C=CC(=C3)S(=O)(=O)N4CCN(CC4)CC)OCC)C.Cl
2.1.5 Isomeric SMILES
CCCC1=NC(=C2N1NC(=NC2=O)C3=C(C=CC(=C3)S(=O)(=O)N4CCN(CC4)CC)OCC)C.Cl
2.2 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 525.1 g/mol
Molecular Formula C23H33ClN6O4S
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count8
Exact Mass524.1972524 g/mol
Monoisotopic Mass524.1972524 g/mol
Topological Polar Surface Area118 A^2
Heavy Atom Count35
Formal Charge0
Complexity854
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameVardenafil hydrochloride
Drug LabelLEVITRA is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Vardenafil HCl is designated...
Active IngredientVardenafil hydrochloride
Dosage FormTablet
RouteOral
Strength2.5mg; 5mg; 10mg; 20mg
Market StatusPrescription
CompanyTeva Pharms

2 of 2  
Drug NameVardenafil hydrochloride
Drug LabelLEVITRA is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).Vardenafil HCl is designated...
Active IngredientVardenafil hydrochloride
Dosage FormTablet
RouteOral
Strength2.5mg; 5mg; 10mg; 20mg
Market StatusPrescription
CompanyTeva Pharms

API SUPPLIERS

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01

Polpharma

Poland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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

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02

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

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

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LGM Pharma CB

03

Jai Radhe Sales

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Jai Radhe Sales

04

Century Pharmaceuticals

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentury has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.

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05

Shandong Loncom Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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06

SMS Pharmaceuticals

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharmex
Not Confirmed
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SMS Pharmaceuticals

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Pharmex
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07

Macleods Pharmaceuticals Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharmex
Not Confirmed
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Macleods Pharmaceuticals Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Pharmex
Not Confirmed
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08

Alembic Pharmaceuticals Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharmex
Not Confirmed
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Alembic Pharmaceuticals Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Pharmex
Not Confirmed
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09

Chromo Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharmex
Not Confirmed
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Chromo Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Not Confirmed
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10

Raks Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Pharmex
Not Confirmed
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Raks Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Listed Suppliers

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01

Polpharma

Poland
  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content

Vardenafil Hydrochloride

About the Company : Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API...

Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API development to scale-up, at our FDA-approved plant in Central Europe. Our expert team provides high-quality, tailor-made services for small molecule API clinical candidates, with strong regulatory support and world-class facilities. Trusted by global partners, we specialize in complex chemical processes and deliver exceptional customer experiences. Polpharma API – Your reliable European CDMO partner.
Polpharma CB

02

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

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

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Vardenafil Hydrochloride

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Digital Content Digital Content

Vardenafil Hydrochloride

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
Jai Radhe Sales

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentury has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.

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Digital Content Digital Content

Vardenafil Hydrochloride

About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...

Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in India and abroad. Its APIs are manufactured in accordance with cGMP, 21CFR part 10 and ICH guidelines. It also produces intermediates and develops new APIs as per the needs of its clients. Century conducts biotechnological research that focuses on human therapeutic proteins. Currently, research is underway to find treatments for asthma, mastocytosis and basophilic leukemia. Century supplies research-grade biotech products and a wide range of animal health products.
Century Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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Digital Content Digital Content

Vardenafil Hydrochloride

About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...

Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.
Shandong Loncom Pharmaceutical company banner

06

Pharmex
Not Confirmed
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Pharmex
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Vardenafil Hydrochloride

About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...

Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.
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07

Pharmex
Not Confirmed
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Vardenafil Hydrochloride

About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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08

Phalanx Labs

India
Pharmex
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Phalanx Labs

India
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Vardenafil Hydrochloride

About the Company : Phalanx Labs Pvt Ltd has incorporated as per the company‘s act in the year 2011 on 8th march. The company was started to manufacture pharmaceutical products with cGMP appropriate...

Phalanx Labs Pvt Ltd has incorporated as per the company‘s act in the year 2011 on 8th march. The company was started to manufacture pharmaceutical products with cGMP appropriate to US FDA, European etc. The company has acquired lands in Jawaharlal Nehru Pharma city, Vizag and Atchutapuram (APIIC) Ranasthalam. As the Jawaharlal Nehru Pharma city, Vizag is already in operation, Phalanx constructed its first unit in pharma city. The facility was created on Quality by Design (QbD) for the manufacture of APIs for regulatory standards.
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09

Pharmex
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Vardenafil Hydrochloride

About the Company : Rakshit is an integrated API manufacturing company. Established in 2000. Today Rakshit has emerged a dependable and strong manufacturer of key APIs & intermediates for global marke...

Rakshit is an integrated API manufacturing company. Established in 2000. Today Rakshit has emerged a dependable and strong manufacturer of key APIs & intermediates for global markets. Focusing on its activities in R&D as well as building up newer facilities/ capacities to catch up with increasing demand year after year. Rakshit group has 4 cGMP compliance Manufacturing Facilities spread over Andhra Pradesh & Telangana states of India. Supplying its products to all over the globe from US, Europe, Japan, Asia & to Latin America. Rakshit facilities are approved by the regulatory authorities like, USFDA, Japan PMDA, Korea-MFDS, CDSCO-India.
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10

Pharmex
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Vardenafil Hydrochloride

About the Company : SMS Pharmaceuticals Ltd. is a global player in API manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a sin...

SMS Pharmaceuticals Ltd. is a global player in API manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a single facility - single product manufacturing company in 1990 grew to be a multi-location group having product list spreading across an array of therapeutic segments. SMS was given the export house status in the year 1997-98. SMS is currently a listed company having ever appreciating international and domestic customer base.
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API Reference Price

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POLAND, , PolandSDNF Poland","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696444200,"product":"VARDENAFIL HYDROCHLORIDE TRIHYDRATE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"POLPHARMA S A","supplierCountry":"POLAND","foreign_port":"N\/A","customer":"ZYDUS LIFESCIENCES LTD","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"4520","totalValueFC":"182582.8","currency":"USD","unitRateINR":"379906","date":"05-Oct-2023","totalValueINR":"15196240","totalValueInUsd":"182582.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29359090","bill_no":"1004102","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"19 PELPLINSKA STR 83-200 STAROGARD GD. WARSAW POLAND , POLAND","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711737000,"product":"VARDENAFIL HYDROCHLORIDE TRIHYDRATE EP\/BP\/IP\/USP\/PH.EUR (VARDENAFIL HYDROCHLORIDE TRIHYDRATE PH.EUR)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"PHARMACEUTICAL WORKS POLPHARMASA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"1.20","actualQuantity":"1.2","unit":"KGS","unitRateFc":"5940","totalValueFC":"7940.4","currency":"EURO","unitRateINR":"549450","date":"30-Mar-2024","totalValueINR":"659340","totalValueInUsd":"7940.4","indian_port":"Ahmedabad Air","hs_no":"29359090","bill_no":"2817481","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"83-200 Starogard Gdanski 19 Pelplinska STR. POLAND, , PolandSDNF Poland","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711737000,"product":"VARDENAFIL HYDROCHLORIDE TRIHYDRATE EP\/BP\/IP\/USP\/PH.EUR (VARDENAFIL HYDROCHLORIDE TRIHYDRATE PH.EUR)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"PHARMACEUTICAL WORKS POLPHARMASA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"2.44","actualQuantity":"2.44","unit":"KGS","unitRateFc":"5940","totalValueFC":"16145.5","currency":"EURO","unitRateINR":"549450","date":"30-Mar-2024","totalValueINR":"1340658","totalValueInUsd":"16145.5","indian_port":"Ahmedabad Air","hs_no":"29359090","bill_no":"2817481","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"83-200 Starogard Gdanski 19 Pelplinska STR. POLAND, , PolandSDNF Poland","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711823400,"product":"VARDENAFIL HYDROCHLORIDE TRIHYDTATE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ZAKLADY FARMACEUTYCZNE POLPHARMA S A","supplierCountry":"POLAND","foreign_port":"N\/A","customer":"ZYDUS LIFESCIENCES LTD","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"4497.4","totalValueFC":"181985","currency":"USD","unitRateINR":"377781.6","date":"31-Mar-2024","totalValueINR":"15111264","totalValueInUsd":"181985","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29359090","bill_no":"1001220","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"UL PELPLINSKA 19 83-200 STSROGARD GDANSKI PL","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"VARDENAFIL HYDROCHLORIDE TRIHYDRATE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"ZAKLADY FARMACEUTYCZNE POLPHARMA S A","supplierCountry":"POLAND","foreign_port":"WARSZAWA","customer":"ZYDUS LIFESCIENCES LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"4520","totalValueFC":"45715.2","currency":"USD","unitRateINR":"385782","date":"25-Nov-2024","totalValueINR":"3857820","totalValueInUsd":"45715.2","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29359090","bill_no":"6872054","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSZAWA","supplierAddress":"PELPINSKA 19, 83-200 STAROGARD DGANSKI SDNF Poland","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"}]
04-Jan-2022
26-May-2025
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FDA Orange Book

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01

ALEMBIC

India
Pharmex
Not Confirmed
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ALEMBIC

India
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Pharmex
Not Confirmed

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2020-08-04

Application Number : 214031

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

BAYER HLTHCARE

Germany
Pharmex
Not Confirmed
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BAYER HLTHCARE

Germany
arrow
Pharmex
Not Confirmed

VARDENAFIL HYDROCHLORIDE

Brand Name : LEVITRA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2003-08-19

Application Number : 21400

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

Pharmex
Not Confirmed
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Pharmex
Not Confirmed

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Approval Date : 2019-10-22

Application Number : 204632

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

Pharmex
Not Confirmed
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arrow
Pharmex
Not Confirmed

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2019-10-22

Application Number : 204632

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

Pharmex
Not Confirmed
arrow
arrow
Pharmex
Not Confirmed

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2019-10-22

Application Number : 204632

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

TEVA PHARMS

Israel
Pharmex
Not Confirmed
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TEVA PHARMS

Israel
arrow
Pharmex
Not Confirmed

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Approval Date : 2012-05-03

Application Number : 91347

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

ZYDUS PHARMS

U.S.A
Pharmex
Not Confirmed
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ZYDUS PHARMS

U.S.A
arrow
Pharmex
Not Confirmed

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2018-10-31

Application Number : 208960

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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08

ZYDUS PHARMS

U.S.A
Pharmex
Not Confirmed
arrow

ZYDUS PHARMS

U.S.A
arrow
Pharmex
Not Confirmed

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2018-10-31

Application Number : 208960

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

ZYDUS PHARMS

U.S.A
Pharmex
Not Confirmed
arrow

ZYDUS PHARMS

U.S.A
arrow
Pharmex
Not Confirmed

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2018-10-31

Application Number : 208960

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

CROSSMEDIKA SA

Country
Pharmex
Not Confirmed
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CROSSMEDIKA SA

Country
arrow
Pharmex
Not Confirmed

VARDENAFIL HYDROCHLORIDE

Brand Name : VARDENAFIL HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2018-10-31

Application Number : 209057

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 200179

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DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21400

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DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21400

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DOSAGE - TABLET;ORAL - EQ 20MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21400

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DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21400

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ABOUT THIS PAGE

Looking for / Vardenafil Hydrochloride API manufacturers, exporters & distributors?

Vardenafil Hydrochloride manufacturers, exporters & distributors 1

90

PharmaCompass offers a list of Vardenafil Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Vardenafil Hydrochloride manufacturer or Vardenafil Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vardenafil Hydrochloride manufacturer or Vardenafil Hydrochloride supplier.

PharmaCompass also assists you with knowing the Vardenafil Hydrochloride API Price utilized in the formulation of products. Vardenafil Hydrochloride API Price is not always fixed or binding as the Vardenafil Hydrochloride Price is obtained through a variety of data sources. The Vardenafil Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Vardenafil Hydrochloride

Vardenafil Hydrochloride Manufacturers

A Vardenafil Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vardenafil Hydrochloride, including repackagers and relabelers. The FDA regulates Vardenafil Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vardenafil Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Vardenafil Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Vardenafil Hydrochloride Suppliers

A Vardenafil Hydrochloride supplier is an individual or a company that provides Vardenafil Hydrochloride active pharmaceutical ingredient (API) or Vardenafil Hydrochloride finished formulations upon request. The Vardenafil Hydrochloride suppliers may include Vardenafil Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Vardenafil Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Vardenafil Hydrochloride USDMF

A Vardenafil Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Vardenafil Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Vardenafil Hydrochloride DMFs exist exist since differing nations have different regulations, such as Vardenafil Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Vardenafil Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Vardenafil Hydrochloride USDMF includes data on Vardenafil Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vardenafil Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Vardenafil Hydrochloride suppliers with USDMF on PharmaCompass.

Vardenafil Hydrochloride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Vardenafil Hydrochloride Drug Master File in Japan (Vardenafil Hydrochloride JDMF) empowers Vardenafil Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Vardenafil Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Vardenafil Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Vardenafil Hydrochloride suppliers with JDMF on PharmaCompass.

Vardenafil Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Vardenafil Hydrochloride Drug Master File in Korea (Vardenafil Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vardenafil Hydrochloride. The MFDS reviews the Vardenafil Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Vardenafil Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Vardenafil Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Vardenafil Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Vardenafil Hydrochloride suppliers with KDMF on PharmaCompass.

Vardenafil Hydrochloride CEP

A Vardenafil Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Vardenafil Hydrochloride Certificate of Suitability (COS). The purpose of a Vardenafil Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vardenafil Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vardenafil Hydrochloride to their clients by showing that a Vardenafil Hydrochloride CEP has been issued for it. The manufacturer submits a Vardenafil Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vardenafil Hydrochloride CEP holder for the record. Additionally, the data presented in the Vardenafil Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vardenafil Hydrochloride DMF.

A Vardenafil Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vardenafil Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Vardenafil Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Vardenafil Hydrochloride WC

A Vardenafil Hydrochloride written confirmation (Vardenafil Hydrochloride WC) is an official document issued by a regulatory agency to a Vardenafil Hydrochloride manufacturer, verifying that the manufacturing facility of a Vardenafil Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vardenafil Hydrochloride APIs or Vardenafil Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Vardenafil Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Vardenafil Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Vardenafil Hydrochloride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Vardenafil Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Vardenafil Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Vardenafil Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Vardenafil Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vardenafil Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Vardenafil Hydrochloride suppliers with NDC on PharmaCompass.

Vardenafil Hydrochloride GMP

Vardenafil Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Vardenafil Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Vardenafil Hydrochloride GMP manufacturer or Vardenafil Hydrochloride GMP API supplier for your needs.

Vardenafil Hydrochloride CoA

A Vardenafil Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Vardenafil Hydrochloride's compliance with Vardenafil Hydrochloride specifications and serves as a tool for batch-level quality control.

Vardenafil Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Vardenafil Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Vardenafil Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Vardenafil Hydrochloride EP), Vardenafil Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vardenafil Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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