Strides Arcolab Limited has received tentative approval from the United States Food and Drug Administration for one new drug application (ANDA) for fixed dose combination of Lamivudine and Zidovudine tablets 150 mg/300 mg under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR). The company has so far received 16 PEPFAR approvals.
The company supplies ARV products to global procurement agencies and this approval adds to the overall basket of medicines available.
Strides Arcolab, is a global pharmaceutical company which is engaged in the development and manufactures of a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables. The company has 14 manufacturing facilities across 6 countries and has a marketing presence in more than 60 countries in developed and emerging markets.