Granules India announced that its facility in Gagillapur, Hyderabad, Telangana was inspected by US Food & Drug Administration (USFDA) from 26 August 2024 to 5 September 2024.
The Gagillapur facility is responsible for manufacturing Finished Dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs).The inspection was concluded with six observations. The recent inspection covered both current good manufacturing practice (cGMP) and pre-approval inspection (PAI) processes.
The company said that it is committed to addressing the observations promptly and will submit its response to the USFDA within the stipulated timeframe. The Gagillapur facility continues to play a vital role in the companys global operations, ensuring the supply of high-quality pharmaceutical products to markets worldwide.
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.
Shares of Granules India fell 2.25% to currently trade at Rs 672.35 on the BSE.
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