Strides Pharma gets EIR from US FDA for Bangalore facility

Strides Pharma Science on Friday said that it has received establishment inspection report (EIR) from US Food and Drug Administration (USFDA) for its Bangalore facility, indicating closure of the inspection.

The US drug regulator had inspected the company's Bangalore facility from 5 December 2022 to 9 December 2022 and issued form 483 with 3 inspectional observations.

Based on the company's response to the observations and subsequent commitments, the USFDA had classified the inspection as VAI (voluntary action indicated).

The Bangalore-based facility is the company's largest manufacturing facility. The facility services the key regulated markets of the US, Europe, and Australia.

Strides Pharma Science is engaged in develops and manufactures a wide range of IP-led niche pharmaceutical products.

On consolidated basis, the company reported net loss of Rs 80.03 crore in Q3 FY23 as compared with net loss of Rs 121.67 crore in Q3 FY22. Net sales rose 8.9% year on year to Rs 864.85 crore in Q3 FY23.

Shares of Strides Pharma Science were down 0.13% to Rs 298.40 on the BSE.

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