No Observations, No Delays—Natco Pharma’s FDA Inspection Ends on a Strong Note

Natco Pharma Ltd has successfully completed a US FDA inspection at its Hyderabad facility, a key regulatory milestone for the company. The October 30November 1, 2023, inspection for compliance of pharmacovigilance resulted in zero observations, affirming Natco's adherence to international quality standards.

 

Key Highlights:

The audit assessed the pharmacovigilance processes of Natco to assure that its drugs meet high safety and monitoring standards, particularly for the US market. The company's compliance with the regulations of FDA strengthens its global pharmaceutical player status, which boosts investor confidence and reinforces its regulatory excellence image.

 

Natco Pharma has been expanding its presence in the US generic market, and recent approvals for its key formulations. Clearance of the inspection would facilitate followup product registrations and establish its pipeline for overseas markets.

 

Source: Indian Pharma Post, Official Announcement by Natco Pharma