The inspection was conducted from August 17 to August 21, 2026, at the company’s FDF manufacturing facility located in Parawada, Visakhapatnam.
At the conclusion of the inspection, the company was issued a Form 483 with four observations, NATCO Pharma said in a regulatory filing.
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The company said it believes the observations are procedural in nature and is confident of addressing them comprehensively within the stipulated timelines.
What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors post the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
Post Form 483 is issued, the company is given 15 days’ time to submit its response to the USFDA explaining what steps the company will take to resolve the observations made by the USFDA.
First Quarter Results
NATCO Pharma reported a 57% year-on-year decline in profit to ₹206.5 crore in the first quarter, compared with ₹480.7 crore in the year-ago period. Its revenue declined 44.7% to ₹735.2 crore from ₹1,328.9 crore in the June quarter last year.
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The company’s earnings before interest, taxes, depreciation and amortisation (EBITDA) declined 67.3% in the first quarter to ₹186.5 crore from ₹571 crore in the prior fiscal. Its margins also contracted sharply to 25.4% from 43% in the year-ago period.
Natco Pharma’s board of directors also approved the fund raise of up to ₹2,000 crore via issuance of shares and securities.
Shares of Natco Pharma Ltd ended at ₹883.80, up by ₹6.05, or 0.69%, on the BSE.
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First Published: Aug 21, 2026 5:32 PM IST
