“We acknowledge that several investors have sought clarification, and we want to reassure them that we are actively addressing the observations and are fully committed to resolving the issues raised. We will work with the USFDA to address the issues raised in the observations,” the company stated in regulatory filing.
On 7 September 2024, the company announced the completion of the US Food and Drug Administration (USFDA) inspection at its Gagillapur facility in Hyderabad, Telangana. The inspection was conducted from 26th August to 6th September 2024, concluded with six observations.
The inspection covered both current good manufacturing practice (cGMP) and pre-approval inspection (PAI) processes.
Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).
The pharma company reported a consolidated net profit of Rs 134.65 crore in Q1 FY25, steeply higher than Rs 47.89 crore posted in Q1 FY24. Revenue from operations in first quarter of FY25 was at Rs 1,179.87 crore, up 19.72% from Rs 985.52 crore reported in the same period a year ago.