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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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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, 14 NDC API, 20 Listed Suppliers, $ API Reference Price

26 API Suppliers
6 USDMF
5 CEP/COS
2 JDMF
8 EU WC
2 KDMF
14 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

100 FDF Dossiers, 32 FDA Orange Book, 39 Europe, 6 Canada, 3 South Africa, 20 Listed Dossiers

100 FDF Dossiers
32 FDA Orange Book
39 Europe
6 Canada
3 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TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

media
1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

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

MARKET PLACE

12 APIs

marketPlace
12 APIs

PATENTS & EXCLUSIVITIES

5 US Patents, 5 Health Canada Patents

patents
5 US Patents
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP , 11 Others

otherSolutions
2 USP
11 Others

ANALYTICAL

2 BioAnalytical Methods

otherMethods
2 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 2,146

MARKET PLACE

API

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

100

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

1,118,918

Annual Reports (USD Million)

255

Finished Drug Prices

167 RELATED EXCIPIENT COMPANIES

279EXCIPIENTS BY APPLICATIONS

Chemistry

Click the arrow to open the dropdown

Click the button for full data set

Also known as:

Molecular Formula

C₂₃H₃₃ClN₆O₄S

Molecular Weight

525.1 g/mol

InChI Key

XCMULUAPJXCOHI-UHFFFAOYSA-N

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 Formula	C₂₃H₃₃ClN₆O₄S
Molecular Weight	525.1 g/mol
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

4 Drug and Medication Information

4.1 Drug Information

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

API SUPPLIERS

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USDMF

01

Zaklady Farmaceutyczne Polpharma Sa

Poland

DCAT Week

Attending

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

Contact Supplier

Poland

Virtual Booth

Digital Content

VARDENAFIL HYDROCHLORIDE TRIHYDRATE

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

02

Alembic Pharmaceuticals Ltd

India

BIO Partnering at JPM

Not Confirmed

03

Chromo Laboratories India Private Lt...

India

BIO Partnering at JPM

Not Confirmed

04

Macleods Pharmaceuticals Ltd

India

BIO Partnering at JPM

Not Confirmed

05

Raks Pharma Pvt Ltd

India

BIO Partnering at JPM

Not Confirmed

06

Sms Pharmaceuticals Ltd

India

BIO Partnering at JPM

Not Confirmed

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CEP/COS

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JDMF

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1640543400,"product":"CHEMICAL : VARDENAFIL HYDROCHLORIDE TRIHYDRATE","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.60","actualQuantity":"1.6","unit":"KGS","unitRateFc":"5940","totalValueFC":"11050.6","currency":"EUR","unitRateINR":"520938","date":"27-Dec-2021","totalValueINR":"833500.8","totalValueInUsd":"11050.6","indian_port":"AHMEDABAD AIR","hs_no":"29359090","bill_no":"6851577","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666981800,"product":"CHEMICAL : VARDENAFIL HYDROCHLORIDE TRIHYDRATE EP\/BP\/IP\/USP\/PH.EUR.","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"5940","totalValueFC":"5962.8","currency":"EUR","unitRateINR":"490644","date":"29-Oct-2022","totalValueINR":"490644","totalValueInUsd":"5962.8","indian_port":"AHMEDABAD AIR","hs_no":"29359090","bill_no":"3088575","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695321000,"product":"VARDENAFIL HYDROCHLORIDE TRIHYDRATE EP\/BP\/IP\/USP\/PH. EUR (VARDENAFIL HYDROCHLORIDE TRIHYDRATE PH. EUR.)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"5940","totalValueFC":"6443.9","currency":"EUR","unitRateINR":"534897","date":"22-Sep-2023","totalValueINR":"534897","totalValueInUsd":"6443.9","indian_port":"Ahmedabad Air","hs_no":"29359090","bill_no":"7945703","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":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.20","actualQuantity":"1.2","unit":"KGS","unitRateFc":"5940","totalValueFC":"7940.4","currency":"EUR","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":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.44","actualQuantity":"2.44","unit":"KGS","unitRateFc":"5940","totalValueFC":"16145.5","currency":"EUR","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":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":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"3.36","actualQuantity":"3.36","unit":"KGS","unitRateFc":"5940","totalValueFC":"22233.2","currency":"EUR","unitRateINR":"549450","date":"30-Mar-2024","totalValueINR":"1846152","totalValueInUsd":"22233.2","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,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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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

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

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

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

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

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.

Find Vardenafil Hydrochloride manufacturers, exporters & distributors on PharmaCompass

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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**

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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