Zydus Lifesciences shares fell 3 percent on July 19 after the company's Jarod injectables manufacturing facility got classified as 'Official Action Indicated' (OAI) by the United States Food and Drug Administration (USFDA).
At 10.43 am, shares of Zydus Lifesciences were trading at Rs 1,162.90 apiece on the NSE.
This comes after the US drug regulator inspected the facility from April 15-23 this year. The inspection was followed by the US FDA issuing 10 observations for the facility under review. The observations issued by the US FDA were likely not rectified by the drugmaker, leading to the OAI classification of the facility.
The OAI classification is the most stringent among the three classifications issued by the drug regulator. The US FDA classifies a facility as OAI when it finds serious compliance issues, which, if not resolved, could lead to the unit facing export, regulatory, or administrative curbs.
To receive clearance, Zydus Life must address the observations raised by the drug regulator and have the unit re-inspected before it can launch or file new drugs from the facility.
Just last week, shares of the drugmaker soared to a 52-week high after it received the final nod from the US FDA to market a key drug used to treat chronic heart failure.
Sacubitril and Valsartan tablets are a combination used to treat chronic heart failure in adults, helping to reduce the risk of death and hospitalization. The drug will be manufactured at the group's formulation facility in Moraiya, Ahmedabad (India). With this, the group now has 399 approvals and has filed over 460 ANDAs since the process began in FY04.
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