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NATCO Pharma's Hyderabad-based plant gets 'one' Form 483 observation post US FDA audit

NATCO Pharma's Hyderabad-based plant gets 'one' Form 483 observation post US FDA audit

Business Standard20 hours ago

NATCO Pharma said that the U.S. Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Mekaguda, Hyderabad, India, which was conducted from 09 to 13 of June 2025.
On conclusion of the inspection, the company received one observation in the Form-483.
The company believes that the observation is procedural in nature. The company is confident to address this observation comprehensively.
NATCO Pharma, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products.
The companys consolidated net profit increased 5.3% to Rs 406.60 crore on 14.3% jump in revenue from operations to Rs 1,221 crore in Q4 FY25 over Q4 FY24.
The scrip had declined 1.26% to end at Rs 912.55 on the BSE on Friday.

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