Lupin Ltd.’s shares dropped 2% after the company provided an update on the U.S. FDA inspection at its Pithampur Unit-2 manufacturing facility. The inspection, which took place from July 8 to July 17, 2025, concluded with the issuance of a Form-483 containing four observations.
Following the inspection, the U.S. FDA has classified the facility’s inspection outcome as “Official Action Indicated (OAI),” indicating that the agency has identified compliance issues that require corrective action. Such a classification typically signals the need for the company to address deficiencies to ensure adherence to regulatory standards.
Lupin emphasized that it is actively engaging with the U.S. FDA to satisfactorily resolve the identified issues. The company reiterated its commitment to maintaining compliance with Current Good Manufacturing Practices (CGMP) at all its manufacturing facilities.
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