USFDA inspection: Natco Pharma gets 7 observations for Kothur Pharma Division
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-06-20 06:01 GMT | Update On 2025-06-20 06:01 GMT
Hyderabad: Natco Pharma Limited has announced that the U.S. Food and Drug Administration (FDA) has concluded an inspection with seven observations at the company's Pharma Division located at Kothur, Hyderabad, India.
The inspection was conducted from June 9th – June 19th, 2025.
"On conclusion of the inspection, the Company received 7 (Seven) observations in the Form-483. The Company is confident it will address the observations within the stipulated timeline," Natco informed in a BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
NATCO Pharma Limited, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharma ingredients and crop protection products. Natco is a R&D oriented, and a science driven, Oncology company in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company’s manufacturing facilities are approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.
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