The Company informed in its’s update that the US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Ltd.’s Halol facility (Gujarat, India) from February 12 to 23, 2018.
At the conclusion of the inspection, the agency issued a Form 483, with three observations.
The Company informed to Regulators that the company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days.
Halol plant is one of the biggest unit and an important plant for Sun Pharma which holds a key stack for Sun Pharma’s US formulation business. Company gets about half of its revenue from the U.S. market. The Halol unit contributes a majority of its drug filings but
Sun Pharma’s US business has been impacted in the last couple of years as ANDA approvals have been delayed because of the 9 observations the Halol facility received in the re-inspection by USFDA in year 2017. Currently Halol facility is barred from selling new products in the U.S. following a 2015 warning letter.
In January 2018, this facility, received a clearance from a Dutch drug regulator