Tenofovir Alafenamide Fumarate API and Tablet Process Transfer
Basic Information
Name: Tenofovir Alafenamide Fumarate
Aliases: TAF, GS-7340-02, Tenofovir Alafenamide Fumarate
Brand Name: Vemlidy
Dosage Form: Tablet
Specification: 25 mg (as Tenofovir Alafenamide), 28 mg (as Tenofovir Alafenamide Hemifumarate)
Indication: For the treatment of Hepatitis B Virus (HBV) infection and Acquired Immunodeficiency Syndrome (HIV)
Dosage and Administration: Once daily for the treatment of Hepatitis B Virus infection and related diseases
Chemical Structure:
[Structure not provided in text]
Molecular Formula: (C21H29N6O5P)2 · C4H4O4
Molecular Weight: 1069.00
Chemical Name: N-[(S)-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]phenoxyphosphinyl]-L-alanine 1-methylethyl ester
9-[(R)-2-[(S)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine hemifumarate
CAS Registry Number: 379270-37-8 (free base); 1392275-56-7 (hemifumarate)
BCS Classification: 3
Market Status:
This product was developed by Gilead Sciences and was approved by the U.S. FDA in November 2016, marketed as Vemlidy (30 tablets per bottle). It was launched in Japan in December 2016 (14 tablets per bottle) and in the EU in January 2017.
Registration Category: Chemical Drug Category 4
Domestic Status: Not yet marketed in China. The originator is undergoing Phase III clinical trials, and only Chia Tai Tianqing has applied for clinical trials under Category 2.1 for Alafenamide.
