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Australia
DRUG PRODUCT COMPOSITIONS0
FDF
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API SUPPLIERS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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JDMF
NDC
KDMF
ASMF, CN...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
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USDMF
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 :
Type : II
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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, ...
Jai Radhe Sales is your partner for all your sourcing needs.
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...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
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...
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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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REF. STANDARDS & IMPURITIES
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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 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.
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.
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for STAXYN 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 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.
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 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.
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).
