US FDA issues establishment inspection report for Natco's Kothur facility

The US Food and Drug Administration (FDA) has issued an establishment inspection report (EIR) to the Hyderabad-based Natco Pharma Ltd for its Kothur facility in Mahaboob Nagar (Telangana). “The company is pleased to announce successful establishment inspection report (EIR) from the US Food and Drug Administration (FDA) for the inspection conducted at its drug manufacturing facility in Kothur Village, Mahaboob Nagar District, Telangana, during the period February 29-March 7, 2016,” said Natco in a BSE filing today.

The Kothur facility predominantly caters to regulated international markets, including USA.

The US drug regulator issues a copy of EIR to the inspected establishment once the agency concludes that the inspection is closed.