FDA inspection of Natco's API site at Hyderabad

Natco Pharma announced the conclusion of the US FDA inspection at its Mekaguda, Hyderabad, Active Pharmaceutical Ingredients (API) Unit. The USFDA inspected the API manufacturing plant from June 9 to June 13, 2025. 

Upon conclusion of the inspection, the Company received one observation in Form 483. The company is confident in addressing the point raised by the USFDA in Form 483.


According to its website, the facility currently has a capacity of around 400 KL, and approximately 700 staff members work there.


Along with the USFDA, the facility has also been approved by the Australian TGA, the German Health Authority Hamburg, the Korean Health Authority, the PMDA in Japan, and Cofepris in Mexico.


It is possible that the names listed below are some of the important DMFs being manufactured at the site.

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