Synopsis
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Molecular Weight | 525.1 g/mol |
---|---|
Molecular Formula | C23H33ClN6O4S |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 8 |
Exact Mass | 524.1972524 g/mol |
Monoisotopic Mass | 524.1972524 g/mol |
Topological Polar Surface Area | 118 A^2 |
Heavy Atom Count | 35 |
Formal Charge | 0 |
Complexity | 854 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Vardenafil hydrochloride |
Drug Label | LEVITRA 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 Ingredient | Vardenafil hydrochloride |
Dosage Form | Tablet |
Route | Oral |
Strength | 2.5mg; 5mg; 10mg; 20mg |
Market Status | Prescription |
Company | Teva Pharms |
2 of 2 | |
---|---|
Drug Name | Vardenafil hydrochloride |
Drug Label | LEVITRA 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 Ingredient | Vardenafil hydrochloride |
Dosage Form | Tablet |
Route | Oral |
Strength | 2.5mg; 5mg; 10mg; 20mg |
Market Status | Prescription |
Company | Teva Pharms |
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-15
Pay. Date : 2015-08-21
DMF Number : 25174
Submission : 2011-08-02
Status : Active
Type : II
Certificate Number : CEP 2014-106 - Rev 02
Issue Date : 2024-05-29
Type : Chemical
Substance Number : 2782
Status : Valid
Registration Number : 231MF10080
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2019-04-03
Latest Date of Registration :
NDC Package Code : 12658-0463
Start Marketing Date : 2003-08-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2018-10-28
Registration Number : 20181028-211-J-269
Manufacturer Name : Zakłady Farmaceutyczne Polpharma SA
Manufacturer Address : ul. Peplińska 19, 83-200 Starogard Gdański, Poland
Available Reg Filing : ASMF, CN, CA |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32908
Submission : 2018-09-20
Status : Active
Type : II
Certificate Number : CEP 2018-202 - Rev 02
Issue Date : 2025-05-13
Type : Chemical
Substance Number : 2782
Status : Valid
NDC Package Code : 67835-0014
Start Marketing Date : 2018-03-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-13
Pay. Date : 2013-07-10
DMF Number : 25795
Submission : 2012-04-09
Status : Active
Type : II
Certificate Number : R1-CEP 2015-207 - Rev 00
Issue Date : 2021-09-21
Type : Chemical
Substance Number : 2782
Status : Valid
Date of Issue : 2022-09-07
Valid Till : 2025-07-02
Written Confirmation Number : WC-0079
Address of the Firm :
NDC Package Code : 33342-504
Start Marketing Date : 2016-02-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-20
Pay. Date : 2014-12-24
DMF Number : 28900
Submission : 2014-12-31
Status : Active
Type : II
Certificate Number : R1-CEP 2015-095 - Rev 01
Issue Date : 2023-06-26
Type : Chemical
Substance Number : 2782
Status : Valid
Registration Number : 301MF10002
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2019-05-08
Latest Date of Registration :
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2018-02-22
Registration Number : 20180222-211-J-181
Manufacturer Name : Alembic Pharmaceuticals Limited (API Unit-III)
Manufacturer Address : Plot No. 842-843, Taluka-Padra, City : Karakhadi - 391 450, District-Vadodara Gujarat State, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33220
Submission : 2019-03-07
Status : Active
Type : II
Date of Issue : 2022-02-02
Valid Till : 2024-07-06
Written Confirmation Number : WC-0317
Address of the Firm :
NDC Package Code : 52562-004
Start Marketing Date : 2020-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-05
Pay. Date : 2016-10-03
DMF Number : 30804
Submission : 2016-10-27
Status : Active
Type : II
NDC Package Code : 47621-303
Start Marketing Date : 2017-06-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-15
Pay. Date : 2015-08-21
DMF Number : 25174
Submission : 2011-08-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-20
Pay. Date : 2014-12-24
DMF Number : 28900
Submission : 2014-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33220
Submission : 2019-03-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-13
Pay. Date : 2013-07-10
DMF Number : 25795
Submission : 2012-04-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-05
Pay. Date : 2016-10-03
DMF Number : 30804
Submission : 2016-10-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32908
Submission : 2018-09-20
Status : Active
Type : II
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Vardenafil Hydrochloride Trihydrate, Standard, M...
Certificate Number : CEP 2014-106 - Rev 02
Status : Valid
Issue Date : 2024-05-29
Type : Chemical
Substance Number : 2782
Vardenafil Hydrochloride Trihydrate
Certificate Number : R1-CEP 2015-095 - Rev 01
Status : Valid
Issue Date : 2023-06-26
Type : Chemical
Substance Number : 2782
Vardenafil Hydrochloride Trihydrate
Certificate Number : R1-CEP 2015-207 - Rev 00
Status : Valid
Issue Date : 2021-09-21
Type : Chemical
Substance Number : 2782
Vardenafil Hydrochloride Trihydrate
Certificate Number : CEP 2018-202 - Rev 02
Status : Valid
Issue Date : 2025-05-13
Type : Chemical
Substance Number : 2782
Vardenafil Hydrochloride Trihydrate
Certificate Number : CEP 2015-329 - Rev 01
Status : Valid
Issue Date : 2024-07-30
Type : Chemical
Substance Number : 2782
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Vardenafil hydrochloride hydrate
Registration Number : 231MF10080
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2019-04-03
Latest Date of Registration : 2019-04-03
Vardenafil Hydrochloride Trihydrate
Registration Number : 301MF10002
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2019-05-08
Latest Date of Registration : 2019-05-08
Date of Issue : 2022-02-02
Valid Till : 2024-07-06
Written Confirmation Number : WC-0317
Address of the Firm : Plot No. 43 & 44, IDA Phase-ll, Pashamylaram, Pashamylaram(V), Patancheru (M), S...
Date of Issue : 2022-09-07
Valid Till : 2025-07-02
Written Confirmation Number : WC-0079
Address of the Firm : Plot No. - 2209, G.I.D.C., Sarigam - 396 155, Dist - Valsad, Gujarat, India
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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, ...
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 ...
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
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...
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...
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...
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...
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...
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...
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...
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
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RLD : No
TE Code : AB
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
RLD : Yes
TE Code :
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 :
RLD : No
TE Code : AB
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
RLD : No
TE Code : AB
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
RLD : No
TE Code : AB
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
RLD : No
TE Code : AB
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
RLD : No
TE Code : AB
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
RLD : No
TE Code : AB
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
RLD : No
TE Code : AB
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
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
Portfolio PDF
Product Web Link
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Website
Corporate PDF
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
Regulatory Info :
Registration Country : Sweden
vardenafilhydrokloridtrihydrat
Brand Name : Vivanza
Dosage Form : MUNSÖNDERFALLANDE TABLETT
Dosage Strength : 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
vardenafilhydrokloridtrihydrat
Brand Name : Vivanza
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 20 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Levitra
Dosage Form :
Dosage Strength : 2 Cpr Riv 10 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Levitra
Dosage Form :
Dosage Strength : 4 Cpr Riv 20 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Levitra
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 20 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Levitra
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : Vivanza
Dosage Form :
Dosage Strength : 2 Cpr Riv 10 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Italy
Brand Name : VARDENAFIL MYLAN
Dosage Form : Film-Coated Tablets
Dosage Strength : 20 mg
Packaging : 12 UNITS 20 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Category : Fillers, Diluents & Binders, Granulation, Solubilizers
Brand Name : AFFINISOL HPMC HME
Application : Solubilizers
Excipient Details : Solubility enhancement, Spray-Dried Dispersion (SDD), Hot Melt Extrusion (HME)
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Solution, Tablet
Grade : Not Available
Category : Solubilizers
Brand Name : Kollisolv PEG 400
Application : Solubilizers
Excipient Details : Liquid plasticizer, Solvent for oral and topical applications, Hydrophilic fill for solubilization of hydrophilic APIs.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Polyethylene Glycol 400
Dosage Form : Solution, Tablet, Topical Film, Transdermal Patch
Grade : Not Available
Category : Controlled & Modified Release, Granulation, Solubilizers
Application : Controlled & Modified Release, Granulation, Solubilizers
Excipient Details : Solubility and bioavailability enhancement, ideal for hot melt extrusion (HME)
Pharmacopoeia Ref : Polyvinyl caprolactam – poly...
Technical Specs : Not Available
Ingredient(s) : polyethylene glycol
Brand Name : Kollisolv PEG 300
Application : Solubilizers
Excipient Details : Liquid plasticizer, solvent for oral and topical applications, hydrophilic fill for solubilization of hydrophilic APIs.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Polyethylene Glycol 300
Brand Name : Kollisolv PEG 600
Application : Solubilizers
Excipient Details : Hydrophilic fill for solubilization of hydrophilic APIs.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Polyethylene Glycol 600
Global Sales Information
Company : Alembic Pharmac
Vardenafil HCl
Drug Cost (USD) : 52,778
Year : 2023
Prescribers : 194
Prescriptions : 497
Portfolio PDF
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Corporate PDF
Company : Lannett Co. Inc
Vardenafil HCl
Drug Cost (USD) : 189,121
Year : 2023
Prescribers : 528
Prescriptions : 1587
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Macleods Pharma
Vardenafil HCl
Drug Cost (USD) : 69,592
Year : 2023
Prescribers : 261
Prescriptions : 730
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Teva USA
Vardenafil HCl
Drug Cost (USD) : 37,252
Year : 2023
Prescribers : 115
Prescriptions : 263
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Zydus Pharmaceu
Vardenafil HCl
Drug Cost (USD) : 276,748
Year : 2023
Prescribers : 832
Prescriptions : 2450
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Alembic Pharmac
Vardenafil HCl
Drug Cost (USD) : 130,256
Year : 2022
Prescribers : 274
Prescriptions : 729
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Zydus Pharmaceu
Vardenafil HCl
Drug Cost (USD) : 493,765
Year : 2022
Prescribers : 989
Prescriptions : 2684
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Lannett Co. Inc
Vardenafil HCl
Drug Cost (USD) : 310,969
Year : 2022
Prescribers : 676
Prescriptions : 1839
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Macleods Pharma
Vardenafil HCl
Drug Cost (USD) : 134,886
Year : 2022
Prescribers : 303
Prescriptions : 808
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Teva USA
Vardenafil HCl
Drug Cost (USD) : 49,042
Year : 2022
Prescribers : 129
Prescriptions : 294
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Dosage Form :
Dosage Strength : 4 Cpr Riv 5 Mg
Price Per Pack (Euro) : 37.7
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 12 Cpr Riv 10 Mg
Price Per Pack (Euro) : 122
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 8 Cpr Riv 10 Mg
Price Per Pack (Euro) : 86
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 4 Cpr Riv 10 Mg
Price Per Pack (Euro) : 43.8
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 2 Cpr Riv 10 Mg
Price Per Pack (Euro) : 23
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 4 Cpr Riv 20 Mg
Price Per Pack (Euro) : 50.9
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 4 Cpr Riv 5 Mg
Price Per Pack (Euro) : 35.1
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 2 Cpr Riv 5 Mg
Price Per Pack (Euro) : 19
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 8 Cpr Riv 10 Mg
Price Per Pack (Euro) : 78.5
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 4 Cpr Riv 10 Mg
Price Per Pack (Euro) : 39.5
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Main Therapeutic Indication : Sexual Health
Currency : USD
2015 Revenue in Millions : 270
2014 Revenue in Millions : 249
Growth (%) : -8%
Main Therapeutic Indication : Sexual Health
Currency : USD
2014 Revenue in Millions : -15.50%
2013 Revenue in Millions :
Growth (%) :
Market Place
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Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
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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.
A Vardenafil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vardenafil, including repackagers and relabelers. The FDA regulates Vardenafil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vardenafil 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vardenafil supplier is an individual or a company that provides Vardenafil active pharmaceutical ingredient (API) or Vardenafil finished formulations upon request. The Vardenafil suppliers may include Vardenafil API manufacturers, exporters, distributors and traders.
click here to find a list of Vardenafil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vardenafil DMF (Drug Master File) is a document detailing the whole manufacturing process of Vardenafil active pharmaceutical ingredient (API) in detail. Different forms of Vardenafil DMFs exist exist since differing nations have different regulations, such as Vardenafil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vardenafil DMF submitted to regulatory agencies in the US is known as a USDMF. Vardenafil USDMF includes data on Vardenafil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vardenafil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vardenafil suppliers with USDMF on PharmaCompass.
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 Drug Master File in Japan (Vardenafil JDMF) empowers Vardenafil 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Vardenafil 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 suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Vardenafil Drug Master File in Korea (Vardenafil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vardenafil. The MFDS reviews the Vardenafil KDMF as part of the drug registration process and uses the information provided in the Vardenafil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vardenafil 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 API can apply through the Korea Drug Master File (KDMF).
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A Vardenafil CEP of the European Pharmacopoeia monograph is often referred to as a Vardenafil Certificate of Suitability (COS). The purpose of a Vardenafil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vardenafil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vardenafil to their clients by showing that a Vardenafil CEP has been issued for it. The manufacturer submits a Vardenafil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vardenafil CEP holder for the record. Additionally, the data presented in the Vardenafil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vardenafil DMF.
A Vardenafil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vardenafil 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 suppliers with CEP (COS) on PharmaCompass.
A Vardenafil written confirmation (Vardenafil WC) is an official document issued by a regulatory agency to a Vardenafil manufacturer, verifying that the manufacturing facility of a Vardenafil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vardenafil APIs or Vardenafil finished pharmaceutical products to another nation, regulatory agencies frequently require a Vardenafil WC (written confirmation) as part of the regulatory process.
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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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vardenafil API and other APIs are published in this directory by the FDA.
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 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.
The NDC directory also contains data on finished compounded human drug products that contain Vardenafil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vardenafil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vardenafil suppliers with NDC on PharmaCompass.
Vardenafil 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 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 GMP manufacturer or Vardenafil GMP API supplier for your needs.
A Vardenafil CoA (Certificate of Analysis) is a formal document that attests to Vardenafil's compliance with Vardenafil specifications and serves as a tool for batch-level quality control.
Vardenafil CoA mostly includes findings from lab analyses of a specific batch. For each Vardenafil 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Vardenafil EP), Vardenafil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vardenafil USP).