Natco Pharma shares decline after USFDA issues 7 observations for Chennai unit

Shares of Natco Pharma Ltd. were trading under pressure on Friday, February 13, after the company said the US drug regulator issued seven observations under Form 483 for the company’s Chennai API unit.The company, in an exchange filing, said that the US Food and Drug Administration (USFDA) issued these observations after it inspected the active pharmaceutical ingredient (API) division unit in Manali, Chennai, from November 17 to November 21, 2025.

Natco Pharma said the USFDA issued the establishment inspection report (EIR), classifying the inspection as voluntary action indicated (VAI).
This development comes a day after the company reported its results. Its consolidated net profit increased 14.3% to ₹152 crore from ₹133 crore in the same period last year.
Its revenue increased 36.3% to 647.3 crore from 474.8 crore in the previous year. The company reported EBITDA of 158.7 crore rising from 39 crore in the previous year. Its EBITDA margin also improved to 24.5% from 8.2% in the year-ago period.

Shares of Natco Pharma declined over over 2% in early trade. The stock was down 1.6% at ₹826.25 apiece. It has declined over 15% in the past year.

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