Laurus Labs receives EIR from US FDA for Visakhapatnam units
The company has also received approval from the Global Fund (GF) expert review panel for its fixed dose combination, TLE 400, for supply in GF-funded projects
Drug firm Laurus Labs said that it has received an establishment inspection report from the US health regulator for two of its active pharmaceutical ingredients units at Visakhapatnam in Andhra Pradesh.
The establishment inspection report (EIR) from US Food and Drug Administration (US FDA) is for company’s active pharmaceutical ingredients units 1 and 3, at Visakhapatnam, for the inspection conducted in June 2019, Laurus Labs said in a filing to BSE.
The company has also received approval from the Global Fund (GF) expert review panel for its fixed dose combination, TLE 400, for supply in GF-funded projects, it added.
Laurus Labs is one among the three companies to receive the approval for this product in antiretroviral therapy, the company said.
TLE 400 is the alternative first line regimen for treatment of HIV/AIDS as per the World Health Organisation guidelines issued in July 2019, it added.