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India, Hyderabad, 14th November 2017: Hetero, one of Indiaās leading generic pharmaceutical companies and one of the worldās 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 āDarunavir + Ritonavirā in India. The product will be marketed and distributed under the brand name āDANAVIR-Rā in India by Hetero Healthcare Ltd. It will be made available in three strengths - 800/100mg, 600/100mg and 400/50mg
The FDC drug āDarunavir+Ritonavirā 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 patientās treatment with one tablet taken every day along with other anti-retroviral agents, ensuring that the drugs are taken in correct proportions. This ā2-in-1ā combination therapy improves the patientās adherence to treatment, while improving the quality of life.
Commenting on the approval, Dr. B.P.S. Reddy, CMD, Hetero Group of Companies said, āHetero is proud to extend its latest offering āDarunavir+Ritonavirā 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.ā
In line with Heteroās 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 Indiaās leading generic pharmaceutical companies and the worldās 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 ā Australia, MCC ā 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.
Media Contact:
Jeyasingh Balakrishnan Head ā Corporate Communications Hetero Labs Limited, India Mobile: +91 9989626541/ +91 9833836185 Email: Jeyasingh.b@heterodrugs.com