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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 Reference Price

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PLC","customerCountry":"BANGLADESH","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"925","totalValueFC":"9080.7","currency":"USD","unitRateINR":77732.5,"date":"10-Apr-2025","totalValueINR":"777325","totalValueInUsd":"9080.7","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"9832664","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3 RT D NO 7-1-621\/328,, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745951400,"product":"VARDENAFIL HCL TRIHYDRATE (TAX INV# MH2511600046 DT:30.04.2025)","address":"407\/408,SHARDA CHAMBERS,","city":"MUMBAI, MAHARASHTRA.","supplier":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE 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PLC","customerCountry":"BANGLADESH","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"900","totalValueFC":"8763.4","currency":"USD","unitRateINR":74665,"date":"09-May-2025","totalValueINR":"746650","totalValueInUsd":"8763.4","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"1644684","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3 RT D NO 7-1-621\/328,, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748025000,"product":"VARDENAFIL HYDROCHLORIDE TRIHYDRATE BP","address":"425\/3 RT D NO 7-1-621\/328,","city":"HYDERABAD.AP","supplier":"RAKSHIT PHARMACEUTICALS LTD","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"PRIME BANK PLC,,","customerCountry":"BANGLADESH","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"925","totalValueFC":"13652.6","currency":"USD","unitRateINR":77547.5,"date":"24-May-2025","totalValueINR":"1163212.5","totalValueInUsd":"13652.6","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"2110614","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"425\/3 RT D NO 7-1-621\/328,, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748629800,"product":"VARDENAFIL HCL TRIHYDRATE (TAX INV# MH2511600119 DT:30.05.2025)","address":"407\/408,SHARDA CHAMBERS,","city":"MUMBAI, MAHARASHTRA.","supplier":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE 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SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"PHARMACEUTICAL WORKS POLPHARMA S A","supplierCountry":"POLAND","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"5940","totalValueFC":"11925.6","currency":"EURO","unitRateINR":"490644","date":"29-Oct-2022","totalValueINR":"981288","totalValueInUsd":"11925.6","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":"2022","qtr":"Q4","strtotime":1666981800,"product":"CHEMICAL : VARDENAFIL HYDROCHLORIDE TRIHYDRATE EP\/BP\/IP\/USP\/PH.EUR.","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. 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POLAND, , PolandSDNF Poland","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"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":"PHARMACEUTICAL WORKS POLPHARMASA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"INTAS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"5940","totalValueFC":"16109.8","currency":"EURO","unitRateINR":"534897","date":"22-Sep-2023","totalValueINR":"1337242.5","totalValueInUsd":"16109.8","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":1706553000,"product":"VARDENAFIL HCL TRIHYDRATE (AS PER INVOICE AND PACKING LIST)(REJECTED AND RETURNT FOR REPLACEMENT)","address":"304,ATLANTA ARCADE,","city":"MUMBAI MAHARASHTRA","supplier":"JAMJOOM PHARMACEUTICALS CO","supplierCountry":"INDIA","foreign_port":"JEDDAH","customer":"MACLEODS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"18.89","actualQuantity":"18.89","unit":"KGS","unitRateFc":"3100","totalValueFC":"60296","currency":"USD","unitRateINR":"265288.7","date":"30-Jan-2024","totalValueINR":"5011302.9","totalValueInUsd":"60296","indian_port":"Bombay Air","hs_no":"29331999","bill_no":"9901347","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"JEDDAH","supplierAddress":"P.O.BOX 6267 PLOT NO ME 1-3 PHASE VINDUSTRIAL CITY JEEDAH 21442 SAUDI ARABIA 966-12-6081111 SAUDI ARABIA","customerAddress":"304,ATLANTA ARCADE,"},{"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"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743791400,"product":"VARDENAFIL HYDROCHLORIDE TRIHYDRATE. 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04-Jan-2022
31-May-2025
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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

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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.

API | Excipient name

Vardenafil Hydrochloride

STAXYN Manufacturers

A STAXYN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of STAXYN, including repackagers and relabelers. The FDA regulates STAXYN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. STAXYN 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 STAXYN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

STAXYN Suppliers

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

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

STAXYN USDMF

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

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

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

STAXYN 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 STAXYN Drug Master File in Japan (STAXYN JDMF) empowers STAXYN 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 STAXYN JDMF during the approval evaluation for pharmaceutical products. At the time of STAXYN 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 STAXYN suppliers with JDMF on PharmaCompass.

STAXYN KDMF

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

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

After submitting a STAXYN 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 STAXYN API can apply through the Korea Drug Master File (KDMF).

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

STAXYN CEP

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

A STAXYN CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. STAXYN 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 STAXYN suppliers with CEP (COS) on PharmaCompass.

STAXYN WC

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

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

STAXYN 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 STAXYN as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for STAXYN 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 STAXYN 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 STAXYN and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a STAXYN NDC to their finished compounded human drug products, they may choose to do so.

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

STAXYN GMP

STAXYN 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 STAXYN 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 STAXYN GMP manufacturer or STAXYN GMP API supplier for your needs.

STAXYN CoA

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

STAXYN CoA mostly includes findings from lab analyses of a specific batch. For each STAXYN 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.

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