The United States Food and Drug Administration (USFDA) has further classified the inspection as ‘Official Action Indicated’ (OAI).
The drug maker has responded to all the observations issued by the USFDA. Additionally, it has voluntarily undertaken a comprehensive evaluation of the facility for further enhancements that lead to improvement of the facility.
“The company will work with the US FDA on this activity and is confident that it will result in the US FDA approving the company’s facility at Gagillapur in compliance with its expectations within a short time,” Granules stated in a regulatory filing.
Granules India is primarily involved in the manufacturing and selling of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).
Granules India consolidated net profit fell 4.79% to Rs 97.23 crore on 18.74% decline in total revenue from operations to Rs 966.62 crore in Q2 FY25 over Q2 FY24.