01 1Aurisco Pharmaceutical
02 1MSN Laboratories
01 1"TENOFOVIR ALAFENAMIDE MONOFUMARATE"
02 1TENOFOVIR ALAFENAMIDE MONOFUMARATE
01 1China
02 1India
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37711
Submission : 2022-12-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38509
Submission : 2023-09-07
Status : Active
Type : II
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.
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