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The said facility underwent for-cause current good manufacturing practice (cGMP) surveillance and pre-approval inspection for manufacturing of the drug substance Enzylutamide from 14 to 22 December 2023.
Post inspection, the company has now received post application action letter from the United States Food and Drug Administration (USFDA), confirming that the inspected facility has been considered as ready to commercially manufacture and supply the API.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The pharmaceutical company reported 26.76% increase in consolidated net profit of Rs 789.6 crore on 5.83% rise in revenue from operations to Rs 4,343.70 crore in Q3 FY24 over Q3 FY23.
The counter hit an all time high of Rs 973.80 in today’s intraday session.
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