Sun Pharma Halol site being inspected by US FDA: Sources

MUMBAI : The US FDA has begun its inspection at Sun Pharma's Halol manufacturing facility, considered to be the most crucial for the company, according to three industry sources. Last December, the US drug regulatory agency had issued a warning letter to the same site. The action followed over 20 observations that were detected in 2014 as part of US FDA's routine inspections.

Sun Pharma did not comment on the news.

Over its recent call with investors, Sun Pharma management had maintained that the remediation exercise at the site have been completed and the US FDA have been requested for a re-inspection.

The clearance of the Halol site by the US FDA holds key for the company to accelerate its growth in the US. It is estimated that the Halol site, that produces a range of products from tablets to nasal sprays to injectables, contributes over 15% of Sun Pharma's revenues in the US. For FY2016, Sun had combined sales of $4.3 billion of which the US alone contributed $2.1 billion.

"The same team of US FDA officials that visited Mohali are visiting Halol," said a source, requesting not to be identified.