USFDA issues one observation for Natco Pharma Mekaguda unit

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-06-14 04:30 GMT   |   Update On 2025-06-14 04:30 GMT

Hyderabad: NATCO Pharma Limited has announced that the company has received one observation from the United States Food and Drugs Administration (USFDA) after the inspection at its Mekaguda, Hyderabad Active Pharmaceutical Ingredients (API) Unit.

The inspection was conducted from June 9th – June 13th, 2025.
"On conclusion of the inspection, the Company received 1 (One) observation in the Form-483," the company stated. 
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. 
FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. 
"The Company believes that the observation is procedural in nature. The Company is confident to address this observation comprehensively. Company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally," Natco stated in a BSE filing.

NATCO Pharma Limited, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven, leading Oncology player in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. 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.

Read also: Natco Pharma Executive VP - Technology Transfer, Intellectual Property Rights & Regulatory Affairs (API), Dr Ramesh Dandala, superannuates

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