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 Emtriva manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Emtriva, including repackagers and relabelers. The FDA regulates Emtriva manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Emtriva 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 Emtriva manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Emtriva supplier is an individual or a company that provides Emtriva active pharmaceutical ingredient (API) or Emtriva finished formulations upon request. The Emtriva suppliers may include Emtriva API manufacturers, exporters, distributors and traders.
click here to find a list of Emtriva 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 Emtriva Drug Master File in Japan (Emtriva JDMF) empowers Emtriva 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 Emtriva JDMF during the approval evaluation for pharmaceutical products. At the time of Emtriva 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 Emtriva suppliers with JDMF on PharmaCompass.
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