Laurus Labs receives USFDA tentative approval for Tenofovir/Lamivudine/Dolutegravir (TLD) 300/300/50mg Tablets.
Also received an EIR from USFDA for its Unit 6
Deepthi | Myequity news | Date : 03-02-2019 11:45:00 IST
Laurus Labs Ltd is has received tentative approval from United States Food and Drug Administration (US FDA) under PEPFAR for Tenofovir/Lamivudine/Dolutegravir (TLD) 300/300/50mg fixed dose combination (FDC).
The TLD product will be available in the Generic form in low and middle income countries (LMIC). TLD is the preferred treatment recommended by US department of Health and Human Services Panel and also WHO has recommended TLD as one of the preferred first line regimen for the treatment of people living with HIV.
Laurus Labs expects to commercialise this important medicine in the access markets and the product will be manufactured from the company’s Unit 2 located at APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
Laurus Labs also received an Establishment Inspection Report (EIR) from USFDA for its Unit 6 on February 2, 2019. The manufacturing unit 6 was inspected by the regulatory agency in the month of November 2018 and is located at APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
Commenting on the USFDA approval, Dr.Satyanarayana Chava, Founder and CEO, Laurus Labs
said “it is a significant approval for Laurus Labs which has forayed into finished dosage forms recently. This product would demonstrate the company’s capability to develop fixed dose combinations of ARVs. And we are also happy to announce that we have received an EIR from the USFDA for our unit 6 which was inspected by the agency in the month of November 2018.” About Laurus Labs Limited:
Laurus Labs is a leading research & development driven and fully integrated pharmaceutical company in India. The Company has grown consistently to become one of the leading manufacturers of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus also manufactures APIs in Oncology and other therapeutic areas.