01 1Gilead Alberta ULC
02 1LUPIN LIMITED.
01 2Emtricitabine
01 1India
02 1U.S.A
Registration Number : 229MF10061
Registrant's Address : 1021 Hayter Road Edmonton, Alberta T6S 1A1, Canada
Initial Date of Registration : 2017-03-07
Latest Date of Registration : 2020-07-01
Registration Number : 229MF10167
Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 4...
Initial Date of Registration : 2017-08-22
Latest Date of Registration : 2017-08-22
A Emtricitabine / Tenofovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Emtricitabine / Tenofovir, including repackagers and relabelers. The FDA regulates Emtricitabine / Tenofovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Emtricitabine / 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 Emtricitabine / Tenofovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Emtricitabine / Tenofovir supplier is an individual or a company that provides Emtricitabine / Tenofovir active pharmaceutical ingredient (API) or Emtricitabine / Tenofovir finished formulations upon request. The Emtricitabine / Tenofovir suppliers may include Emtricitabine / Tenofovir API manufacturers, exporters, distributors and traders.
click here to find a list of Emtricitabine / 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 Emtricitabine / Tenofovir Drug Master File in Japan (Emtricitabine / Tenofovir JDMF) empowers Emtricitabine / 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 Emtricitabine / Tenofovir JDMF during the approval evaluation for pharmaceutical products. At the time of Emtricitabine / 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 Emtricitabine / Tenofovir suppliers with JDMF on PharmaCompass.
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