Laurus Labs gets EIR from USFDA for API Units 1& 3 at Visakhapatnam

05 Sep 2019

Laurus Labs 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.

In FDF segment, the company also 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. The company is one among the three companies to receive the approval for this product in ART (Anti Retro Viral Therapy).

This approval enables company to participate directly in GF and also In-Country tenders based on GF funding across Sub-Saharan African region along with our other ARV portfolio comprising of TLD (Tenofovir/Lamivudine/Dolutegravir 300/300/50mg), DTG (Dolutegravir 50mg) and ET (Emtricitabine/Tenofovir 200/300mg). 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 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.

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