[ad_1]
The US health regulator inspected Granules India’s Unit V facility located at Jawaharlal Nehru Pharma City (JNPC) in the Anakapalli District of Parawada Mandal, Andhra Pradesh between April 8 and April 12.
Following the inspection, the US FDA has classified the Unit V facility as ‘No Action Indicated’ (NAI), indicating compliance with current Good Manufacturing Practices (cGMP) standards.
The US FDA has also confirmed that no further regulatory action is required for the said facility.
Opening higher at ₹575.95 apiece on the BSE, shares of Granules India Ltd. rose further to touch an intraday high of ₹590.
The outcome of the inspection reflects the facility’s high standards in the production of Active Pharmaceutical Ingredients (APIs) and Finished Dosages(FDs) for both oncology and non-oncology therapeutic areas, Granules India Ltd said.
The US Food and Drug Administration also conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit during the inspection, which was concluded with zero Form 483 observations.
The company’s Chairman & Managing Director, Krishna Prasad Chigurupati said, “The successful completion of this US FDA inspection with zero observations and the subsequent receipt of the EIR with NAI status reflects our unwavering commitment to maintaining the highest quality standards in our manufacturing operations.”
Granules India reported a subdued performance in the second quarter of fiscal 2025, with revenues slipping 19% year-on-year to ₹966.6 crore from ₹1,189.5 crore a year ago. The decline in revenue was caused by a voluntary pause at the company’s Gagillapur facility due to the US FDA inspection. Profits slipped to 5% YoY to ₹97.2 crore in Q2 FY25 from ₹10.21 crore a year ago.
Shares of Granules India traded flat in the afternoon session on Friday, marginally up by 0.45% to ₹574 per piece on the BSE at 12:48 pm.
Also Read : SBI Q2 Results: Net profit aided by higher other income; Asset quality improves
(Edited by : Poonam Behura)
[ad_2]
Source link