Laurus Labs has received an approval from the US Food & Drug Administration (USFDA) under PEPFAR (President’s Emergency Plan for AIDS Relief) for two ANDAs (Abbreviated New Drug Application) TLE 400 (Tenofovir/ Lamivudine/ Efavirenz - 300/300/400mg) and TLE 600 (Tenofovir/ Lamivudine/ Efavirenz - 300/300/600mg) tablets.
Laurus Labs is one of the few players in the ARV segment to receive an approval for TLE 400 tablets. TLE 400 is one of the most preferred regimens in the ARV first line treatment. The company already received WHO Pre-Qualification for TLE 400 (Tenofovir/ Lamivudine/ Efavirenz - 300/300/400mg). These approvals enable Laurus Labs to launch both the products in several LMIC markets.
Laurus Labs is a leading research and development driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of APIs for anti-retroviral (ARV) and Hepatitis C. It also manufactures APIs in oncology and other therapeutic areas.
