Natco Pharma gets seven FDA observations at Manali API unit

Natco Pharma on Friday, November 21, said the US Food and Drug Administration (FDA) has concluded its inspection of the company’s active pharmaceutical ingredient (API) manufacturing facility in Manali, Chennai.

The inspection, carried on November 17-21, resulted in seven Form 483 observations.

The company said the observations are procedural in nature and that it is confident of addressing them comprehensively.

Natco added that it remains committed to maintaining cGMP compliance and supplying high-quality

products to global markets.

Q2 Results

The company announced its September quarter results on November 14. Natco Pharma reported a 23.5% year-on-year drop in net profit at ₹518 crore, compared to ₹677.3 crore a year ago.

Quarterly revenue slipped marginally to ₹1,363 crore, while EBITDA declined 28% to ₹579 crore.

The EBITDA margin contracted sharply to 42.5% from 58.6% last year.

The board also declared an interim dividend of ₹1.50 per share for FY26. The record date was November 20, with payouts scheduled to begin on November 28.

Shares of Natco Pharma Ltd ended marginally lower on Friday, November 21, by 0.84% at ₹862 on the NSE.

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