Natco Pharma receives FDA inspection report on Kothur formulations facility

EIR is given when the unit meets the expectations of the US drug regulator on CGMP regulations

Natco Pharma on Thursday announced it had received the Establishment Inspection Report (EIR) from the United States (US) Food and Drug Administration (FDA) for the inspection conducted at its drug formulations facility at Kuthur Unit, Telangana.

EIR is given when the unit meets the expectations of the US drug regulator on current good manufacturing practice (CGMP) regulations and other aspects. According to the company, the inspection was conducted from January 16 to January 24. This formulations facility predominantly caters to regulated international markets, including the US.

The Hyderabad-based generics company has five formulations facilities in India — two in Dehradun, one in Kothur (Telangana), one near Nagarjuna Sagar (Telangana) and one in Guwahati (Assam). It also has two API units, one in Telangana and the other one in Chennai, Tamil Nadu.