Laurus Labs receives EIR from USFDA, stock shines
Laurus Labs informed the bourses, on Thursday, that the company has received the Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for its API Units 1 & 3, located at Parawada, Visakhapatnam, for the inspection conducted in June 2019. The EIR is prepare by FDA's investigator after the inspection.
Further, in FDF segment, the company has received Global Fund (GF) ERP (Expert Review Panel) approval for FDC (Fixed Dose Combination) TLE 400 (Tenofovir/Lamivudine/Efavirenz 300/300/400mg) for supply in GF funded projects. TLE 400 is the alternative first line regimen for treatment of HIV/AIDS as per the WHO guidelines issued in July 2019.
Laurus Labs is one among the three companies to receive the approval for this product in ART (Anti Retro Viral Therapy). This approval will help the company to participate directly in global fund and also in-country tenders based on GF funding across Sub-Saharan African region along with our other ARV portfolio.
In response to this positive development, the stock of Laurus Lab surged 3.20 per cent to touch an intraday high of Rs. 337.00 per share on BSE. At 12.09 hours, the stock was trading at Rs. 331.30, up by 1.47 per cent from previous close.