Natco Pharma's Division In Hyderabad Gets Seven FDA Observations

Natco Pharma Ltd.'s pharma division in Kothur, Hyderabad, received seven observations from the US Food and Drugs Administration under Form 483, an exchange filing on Thursday said.

Observations are made when in the investigator's judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic have been adulterated or are being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health, the US FDA website said.

The FDA Form 483 does not however constitute a final ruling from the agency on whether the conditions are violating any of their regulations.

"The company is confident it will address the observations within the stipulated timeline. Company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally," the firm said in its filing.

The firm's active pharmaceutical ingredient manufacturing facility in Mekaguda, Hyderabad, also received an observation from the USFDA under Form 483. The US FDA conducted an investigation from June 9 to June 13, 2025. The company deemed the observation "procedural in nature".

Natco Pharma reported slower-than-expected earnings growth in the final quarter of Fiscal 2025.

Shares of Natco Pharma closed 0.39% higher at Rs 881.60 apiece on the NSE, compared to a 1.1% fall in the benchmark Nifty. The stock has fallen 24.81% in the last 12 months and 36.45% on a year-to-date basis.

Out of 12 analysts tracking the company, five have a 'buy' rating on the stock, three recommend 'hold' and four suggest 'sell', according to Bloomberg data. The average of 12-month analysts' price target implies a potential upside of 10.2%.