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JDMF
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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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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
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USDMF
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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, ...
Century has been an API manufacturer for over 30 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...
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Drugs in Development
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 202276
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 202276
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 202276
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Avanafil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avanafil, including repackagers and relabelers. The FDA regulates Avanafil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avanafil 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 Avanafil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Avanafil supplier is an individual or a company that provides Avanafil active pharmaceutical ingredient (API) or Avanafil finished formulations upon request. The Avanafil suppliers may include Avanafil API manufacturers, exporters, distributors and traders.
click here to find a list of Avanafil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Avanafil DMF (Drug Master File) is a document detailing the whole manufacturing process of Avanafil active pharmaceutical ingredient (API) in detail. Different forms of Avanafil DMFs exist exist since differing nations have different regulations, such as Avanafil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Avanafil DMF submitted to regulatory agencies in the US is known as a USDMF. Avanafil USDMF includes data on Avanafil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Avanafil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Avanafil suppliers with USDMF 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 Avanafil Drug Master File in Korea (Avanafil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Avanafil. The MFDS reviews the Avanafil KDMF as part of the drug registration process and uses the information provided in the Avanafil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Avanafil 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 Avanafil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Avanafil suppliers with KDMF on PharmaCompass.
A Avanafil written confirmation (Avanafil WC) is an official document issued by a regulatory agency to a Avanafil manufacturer, verifying that the manufacturing facility of a Avanafil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Avanafil APIs or Avanafil finished pharmaceutical products to another nation, regulatory agencies frequently require a Avanafil WC (written confirmation) as part of the regulatory process.
click here to find a list of Avanafil 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 Avanafil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Avanafil 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 Avanafil 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 Avanafil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Avanafil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Avanafil suppliers with NDC on PharmaCompass.
Avanafil 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 Avanafil 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 Avanafil GMP manufacturer or Avanafil GMP API supplier for your needs.
A Avanafil CoA (Certificate of Analysis) is a formal document that attests to Avanafil's compliance with Avanafil specifications and serves as a tool for batch-level quality control.
Avanafil CoA mostly includes findings from lab analyses of a specific batch. For each Avanafil 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.
Avanafil may be tested according to a variety of international standards, such as European Pharmacopoeia (Avanafil EP), Avanafil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Avanafil USP).
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