Laurus Labs gets USFDA Establishment Inspection Report for Visakhapatnam units

The establishment inspection report (EIR) from US Food and Drug Administration (USFDA) is for company's active pharmaceutical ingredients units 1 and 3, at Visakhapatnam, for the inspection conducted on June 2019, Laurus Labs said in a filing to BSE.

New Delhi: Drug firm Laurus Labs on Thursday said 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 (USFDA) is for company's active pharmaceutical ingredients units 1 and 3, at Visakhapatnam, for the inspection conducted on 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.

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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 Organization guidelines issued in July 2019, it added.

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