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