Sun Pharma Halol facility gets three observations by US FDA

Down from 9 it received in December 2016

Sun Pharmaceutical Industries’ on Friday said that the US Food and Drug Administration (US FDA) issued three observations to its Halol plant for inspections done during February 12-23.

The Gujarat plant has been under the scanner for good manufacturing practices (GMP) since 2014. Resolution of the regulatory issues at the plant is crucial for the revival of the company’s US business.

In a notification to the stock exchange, the drug maker said: “The company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days. The company remains committed to working closely with the