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Laurus Labs gets approval from FDA
Pharma major Laurus Labs received an 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.
Hyderabad: Pharma major Laurus Labs received an 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 the FDF segment, the company 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.
Laurus Labs is one among the three companies to receive the approval for this product in ART (Anti Retro Viral Therapy).
This approval enables Laurus Labs 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).
