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Strides Arcolab receives ANDA approval from US FDA for Efavirenz tablets
Our Bureau, Bangalore | Wednesday, March 28, 2007, 08:00 Hrs  [IST]

Strides Arcolab received tentative approval from the United States Food and Drug Administration for Efavirenz tablets under the expedited review provisions of the President's Emergency Plan for Aids Relief (PEPFAR) programme.

Efavirenz, the generic version of Bristol Myers Squibb's Sustiva, is a non- nucleoside reverse transcriptase inhibitor, which prevents the AIDS virus from reproducing in cells. Efavirenz is used in combination with other anti-retroviral agents for the treatment of HIV-infections and is a key component of drug regimens for patients who are on concurrent treatment for tuberculosis.

Arun Kumar, vice chairman and managing director, Strides Arcolab, said, "We now have ANDA/ NDA approvals for all first line anti-retroviral drugs. This will give major boost to our AIDS, TB and Malaria (ATM) initiative particularly in Africa and South Asian countries."

The company also partners the Clinton Foundation to ensure availability of affordable quality generic ARVs in least developed countries.

Strides is one of India's largest exporters of branded generic pharmaceutical products. The company manufactures pharmaceuticals formulations in various dosage forms, including capsules, tablets, liquid injectables and is one of the world's top five manufacturers of soft gel capsules.

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