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Zydus lifesciences said that US Food and Drug Administration (USFDA) classified the inspection conducted at its injectables manufacturing facility located at Ahmedabad in March 2024 as OAI (Official Action Indicated).
Further, the regulatory agency has granted a teleconference Regulatory Meeting to discuss all the implemented and proposed actions.
The company said that it will work closely with the agency to resolve this regulatory status of this facility expeditiously.
The inspection was conducted from 18th March to 27th March 2024 located at Pharmez Special Economic Zone, Matoda, Gujarat, India.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The pharma major reported consolidated net profit of Rs 1,182.3 crore in Q4 FY24 steeply higher than Rs 296.6 crore recorded in Q4 FY23.
Revenue from operations jumped 10.44% to Rs 5,533.8 crore during the quarter as compared with Rs 5,010.6 crore posted in corresponding quarter last year.
The scrip rose 1.70% to end at Rs 1108.80 on Friday, 14, June 2024. The stock market is closed today on account of Bakri-Id.