01 1Gilead Alberta ULC
01 1Tenofovir Ara Fe Nami de fumarate
01 1U.S.A
Tenofovir alafenamide fumarate
Registration Number : 227MF10232
Registrant's Address : 1021 Hayter Road Edmonton, Alberta T6S 1A1, Canada
Initial Date of Registration : 2015-09-24
Latest Date of Registration : 2021-12-22
A Tenofovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tenofovir, including repackagers and relabelers. The FDA regulates Tenofovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tenofovir 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tenofovir supplier is an individual or a company that provides Tenofovir active pharmaceutical ingredient (API) or Tenofovir finished formulations upon request. The Tenofovir suppliers may include Tenofovir API manufacturers, exporters, distributors and traders.
click here to find a list of Tenofovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Tenofovir Drug Master File in Japan (Tenofovir JDMF) empowers Tenofovir 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 Tenofovir JDMF during the approval evaluation for pharmaceutical products. At the time of Tenofovir 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 Tenofovir suppliers with JDMF on PharmaCompass.
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