Natco Pharma Limited has informed the Exchange about the U.S. Food and Drug Administration (FDA) inspection at the API manufacturing plant located in Mekaguda, Hyderabad
NATCOPHARM · price
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The US FDA conducted a five-day inspection (June 9–13, 2025) at Natco Pharma's Active Pharmaceutical Ingredients (API) manufacturing facility in Mekaguda, Hyderabad. At the close of the inspection, the company received 1 observation in the Form-483, which the company describes as procedural in nature. Natco has stated it is confident of addressing the observation comprehensively and remains committed to current Good Manufacturing Practice (cGMP) compliance. The filing was made under SEBI Listing Regulations to keep the exchanges informed of the development.
A single procedural Form-483 observation is generally viewed as a minor regulatory outcome and is unlikely to materially affect operations or stock price in the short term. Investors should watch for the company's response to the US FDA, as any escalation to a Warning Letter could become a negative catalyst.