Hetero, a leading generic pharmaceutical company, has announced the launch of the first ever generic fixed dose combination (FDC) drug -- Darunavir+Ritanovair in India.

The drug has been cleared by the Drug Controller-General of India. The product will be marketed and distributed under the brand name ‘DANAVIR-R’ in India by Hetero Healthcare Ltd. It It will be made available in three strengths - 800/100 mg, 600/100 mg and 400/50 mg.

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 said Hetero, one of the world’s leading producers of anti-retroviral drugs, in a press release.

The 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, said B P S Reddy, CMD, Hetero Group of Companies.

“Hetero will continue to invest in R&D capabilities and will develop such world-class anti-retroviral drug combinations in future.”

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

The Hyderabad-based Hetero is into the development, manufacturing and marketing of drug intermediates, active pharmaceutical ingredients (APIs), and finished dosages. It has over 25 modern manufacturing facilities, which have been approved by various regulatory authorities such as the USFDA, EU, TGA – Australia and MCC – South Africa, among others.

With more than 200 products in its portfolio across various therapeutic areas, Hetero has a strong presence in 120+ countries.

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