NATCO Pharma gets 7 observations from FDA for Hyderabad manufacturing unit

NATCO Pharma Limited on Thursday (June 19) announced the completion of a US Food and Drug Administration (FDA) inspection at its pharmaceutical manufacturing division located in Kothur, Hyderabad. The inspection was conducted over 10 days, from June 9-19, 2025. Following the conclusion, the company received seven observations in Form 483 from the FDA.

“The U.S. Food and Drug Administration (FDA) had conducted an inspection at our Pharma Division located in Kothur, Hyderabad, India, which was conducted from June 9th – June 19th, 2025. On conclusion of the inspection, the Company received 7 (Seven) observations in the Form-483,” according to a stock exchange filing.

In a statement, NATCO Pharma said it is confident of addressing all the observations within the stipulated timeline. The company added that it remains committed to current Good Manufacturing Practices (cGMP) compliance and to delivering high-quality products to its global customer and patient base.

Fourth quarter

Natco Pharma reported a consolidated net profit of ₹406 crore for the quarter ending March 31, 2025, up 5% year-on-year from ₹386.3 crore in the same period last year. Revenue for the quarter grew 16% to ₹1,287.3 crore compared to ₹1,110.3 crore in Q4 FY24.

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Earnings before interest, taxes, depreciation, and amortisation (EBITDA) for the quarter stood at ₹548 crore, up 10.2% YoY, while operating margins came in at 44.89%, slightly lower than 46.55% in the year-ago quarter.

The quarter included an impairment charge of ₹50 crore in the crop health science division and a ₹25 crore chargeback adjustment in the company’s US subsidiary, alongside increased R&D spending.

For the full year FY25, Natco reported its highest recorded revenue and profit. Consolidated revenue rose 16% to ₹4,784 crore, while net profit surged 36% to ₹1,883.4 crore.

Shares of NATCO Pharma Ltd ended at ₹881.35, up by ₹3.75, or 0.43%, on the BSE.

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