Natco Pharma receives USFDA EIR for Hyderabad API facility
Natco Pharma informed that the U.S. Food and Drug Administration (US FDA) has issued an EIR for its active pharmaceutical ingredient (API) division located in Mekaguda, Hyderabad, Telangana.
The US FDA had conducted an inspection at the companys aforementioned unit from 9 June to 13 June 2025.
Post the inspection, the company received one observation in Form-483, which was classified as voluntary action indicated (VAI).
In a regulatory filing made during market hours today, Natco Pharma announced that it has received an establishment inspection report (EIR) for its API facility located in Mekaguda.
NATCO Pharma, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products.
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The companys consolidated net profit increased 5.3% to Rs 406.60 crore on a 14.3% jump in revenue from operations to Rs 1,221 crore in Q4 FY25 over Q4 FY24.
Shares of Natco Pharma slipped 3% to Rs 1,003.75 on the BSE.
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First Published: Jul 24 2025 | 3:09 PM IST