U.S. FDA issues 7 observations to Natco Pharma’s formulations unit in Hyderabad 

Natco Pharma's Kothur facility receives seven observations from U.S. FDA, committed to addressing and maintaining high-quality standards.

The U.S. Food and Drug Administration (U.S. FDA) has issued seven observations to Natco Pharma’s formulations facility in Kothur, Hyderabad.

The facility was inspected by the U.S. FDA from June 9-19. On conclusion, the company received seven observations in Form-483, Natco Pharma said on Thursday. The company said it is confident of addressing the observations within the stipulated timeline.

“The company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally,” Natco Pharma said.

The U.S. FDA had in April 2024 issued a warning letter to the facility while raising quality concerns. The action followed an inspection and issue of eight observations in October 2023 by the regulator. The company then said the move may result in delay or withholding of pending product approvals from the site.

The facility is for oral solid dosages, including cytotoxic orals; cytotoxic injectables; and pre filled syringes. The focus product categories are oncology, gastroenterology, central nervous system and cardiology.

EOM