Press Releases

Press Releases

Hetero receives approval to launch the first-ever generic fixed-dose combination of ‘Darunavir + Ritonavir’ from DCGI

India, Hyderabad, 14th November 2017: Hetero, one of India’s leading generic pharmaceutical companies and one of the world’s largest producer of anti-retroviral drugs, today announced that it has received the approval from Drug Controller General of India (DCGI) to launch the first-ever generic fixed-dose combination (FDC) drug ‘Darunavir + Ritonavir’ in India. The product will be marketed and distributed under the brand name ‘DANAVIR-R’ in India by Hetero Healthcare Ltd. It will be made available in three strengths - 800/100mg, 600/100mg and 400/50mg

The FDC drug ‘Darunavir+Ritonavir’ is an anti-retroviral medication indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients. This firstever drug combination, a once-daily dose, simplifies the patient’s treatment with one tablet taken every day along with other anti-retroviral agents, ensuring that the drugs are taken in correct proportions. This ‘2-in-1’ combination therapy improves the patient’s adherence to treatment, while improving the quality of life.

Commenting on the approval, Dr. B.P.S. Reddy, CMD, Hetero Group of Companies said, “Hetero is proud to extend its latest offering ‘Darunavir+Ritonavir’ FDC in three strengths for HIV/AIDS patients. We will continue to invest in R&D capabilities and will develop such worldclass anti-retroviral drug combinations in future.”

In line with Hetero’s commitment in making HIV/AIDS drugs affordable and accessible to patients globally, the company also looks forward to make this product available in other countries, subject to approvals from respective regulatory authorities.

About Hetero

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

Media Contact:

Jeyasingh Balakrishnan
Head – Corporate Communications
Hetero Labs Limited, India
Mobile: +91 9989626541/ +91 9833836185