Sun Pharma will put in place an internal taskforce specifically to address the issues raised by the US regulator on the drugmaker’s Halol facility in Gujarat.
Sun Managing Director Dilip Shanghvi outlined the steps taken by the company after it received a warning letter from the US Food and Drug Administration following an inspection of the manufacturing facility in September 2014.
The company will reply with a detailed plan within the stipulated timeframe, he told analysts, adding that greater clarity would emerge in the coming days on whether the warning letter had taken into account remediation efforts already undertaken by Sun Pharma at the site.
“Our initial reading of the warning letter indicates that it is based on the 483 observations issued in September 2014,” he said. Sun had received 23 regulatory observations involving its Halol plant last year. They were on sterility assurance and validation of the sterility system, he said, adding that there was no system-wide compliance issue.
Following this inspection, the FDA had withheld future product approvals from Halol, Shanghvi said, adding that the situation would continue till all issues are resolved at the site and it comes back into compliance.
The US regulatory developments come even as the company is dealing with regulatory issues at four facilities in its fold as part of its $4-billion Ranbaxy acquisition. Other Indian companies including Wockhardt, Ipca and more recently Dr Reddy’s are also dealing with regulatory issues in the US.
Without getting into details of the timeframe and the revenue impact, Shanghvi said the issues could be resolved within the routine 12/15-month timeframe, if existing remediation measures had to merely be augmented. But that could change, if the warning letter had taken the remediation efforts into consideration and fresh changes are required.
Responding to queries on why the warning letter was issued despite remediation measures undertaken by the company, Shanghvi said, “May be its our inability to effectively communicate the extent of our changes and extent of our remediation that have been done.” He added that the company had planned to share more information on measures it had taken when the inspectors “physically” visited the site, and may be that should have been shared earlier.
“Halol is an important location from which we filed products. It is the only site from which we filed injectible products — to that extent I expect Halol to be an increasingly important site for Sun,” he said of the plant that contributed revenues in the “high single digit” percentage of its total sales. The focus is to get the site back in compliance, he said, rather than look at transferring product approvals to other sites.
Nevertheless, Sun’s recent approval on blood cancer drug Gleevec came from its Cranberry site, he revealed, adding that all other plants that supplied to the US from the country and outside had been inspected and were in compliance. The company had seen between 10 and 12 regulatory inspections in the period between the Halol inspection and now (including European inspections), and they have been without any adverse observations, he said.