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API SUPPLIERS
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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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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- TABLET, ORALLY DISINTEGRATING;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal...DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federa...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal...DOSAGE - TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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ANALYTICAL
ABOUT THIS PAGE
95
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).
click here to find a list of Vardenafil suppliers with KDMF on PharmaCompass.
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.
click here to find a list of Vardenafil 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 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).
