India, Hyderabad, 27th February 2018: : Hetero, one of India’s leading generic pharmaceutical companies and world’s largest producer of anti-retroviral drugs, today announces the launch of the first generic fixed-dose combination (FDC) of ‘Emtricitabine (200mg) and Tenofovir Alafenamide (25mg) in India. The product has been approved by Drug Controller General of India (DCGI) and will be marketed and distributed under the brand name ‘TAFERO-EM’ by Hetero Healthcare Ltd.
The FDC drug ‘Emtricitabine and Tenofovir Alafenamide’ is an anti-retroviral medication which is indicated in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 12 years of age and older. The FDC drug ‘Emtricitabine and Tenofovir Alafenamide’ helps to control HIV infection, decreasing the amount of HIV in the patient’s body. This lowers the chances of getting other HIV complications and thereby improves their quality of life.
Studies suggests that Emtricitabine and Tenofovir Alafenamide are key anti-retroviral agents which has shown high antiviral efficacy and better safety profile in HIV patients. This combination represents the new generation HIV treatment and is recommended by various international guidelines as a preferred dual-NRTI backbone along with a third agent1.
TAFERO-EM is the first generic version of Gilead’s Descovy®.
The buyer and seller were advised by Crowe and Deloitte respectively.
Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. Established by Dr. B.P.S. Reddy in 1993, Hetero is in the business of development, manufacturing and marketing of drug intermediates, active pharmaceutical ingredients (APIs), and finished dosages. Hetero has over 25 state-of-the-art manufacturing facilities which has been approved by various regulatory authorities like US FDA, EU, TGA – Australia, MCC – South Africa among others. With more than 200 products in its portfolio across various therapeutic areas, Hetero has a strong global presence in 120+ countries. The company focuses on making affordable medicines accessible to patients worldwide. For more information on Hetero, please visit www.heteroworld.com.
References: 1. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV; Department of Health and Human Services (DHHS) 2017; European AIDS Clinical Society (EACS) Guidelines; Version 9; October 2017