FDA issues EIR to Laurus Labs' API plants in AP

: Laurus Labs Limited has received the Establishment Inspection Report (EIR) from US Food and Drug Administration (US FDA) for its API (active pharmaceutical ingredients) Units 1 and 3, located at Parawada, Visakhapatnam in Andhra Pradesh.

According to a press release issued by the city-based drug maker, FDA authorities conducted the inspection in June 2019.

The company also said it 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), it said.

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 TLD (Tenofovir/Lamivudine/Dolutegravir 300/300/50mg), DTG (Dolutegravir 50mg) and ET (Emtricitabine/Tenofovir 200/300mg), Laurus Labs said.

TLE 400 is the alternative first line therapy for treatment of HIV/AIDS as per the WHO guidelines issued in July 2019.