Strides Shasun receives USFDA tentative approval for Efavirenz

Product approval has been granted for the oral dosage produced at the company facility based out of Bangalore


Mumbai: Strides Shasun Limited on May 26, 2016 announced that it has received tentative approval from the United States Food & Drug Administration (USFDA) for Efavirenz Tablet USP, 600 mg.

The final approval will be received after Patent Expiry in August 2018.

According to IMS data, the US market for Efavirenz 600 mg Tablet is approximately USD 150 Million. The product will be manufactured at the Company’s Oral dosage facility at Bangalore and marketed by Strides in the US Market.

Efavirenz Tablet is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults and adolescents.

Strides Shasun, listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR), is a vertically integrated global pharmaceutical Company headquartered in Bangalore.  The company has four business verticals, viz., Regulated Markets, Emerging Markets, Institutional Business and Pharmaceutical Services and Active Ingredients.