Working on making plants global cGMP compliant: Sun Pharma

Drug major Sun Pharmaceutical Industries is working on making its manufacturing facilities compliant with good manufacturing norms and has asked the US health regulator to re-inspect its Halol plant.

"We have undertaken a detailed remediation at the Halol facility post the September 2014 inspection. In December 2015, the US FDA issued a warning letter related to this inspection. We have recently requested the US FDA for a reinspection of the facility," Sun Pharmaceutical Industries MD Dilip Shanghvi said in a speech to the company's shareholders at its AGM.

This remediation process has temporarily impacted the supplies and product approvals from this facility, which the company expects to improve, once the facility gets recertified, he added.
 

Stating that the process is also on for the erstwhile Ranbaxy plants that are under the US health regulator's strictures, Shanghvi said: "The remediation process at the erstwhile Ranbaxy facilities, which were found to be non-compliant in the past, also continues as per plan."

While significant efforts to make these facilities compliant are on, this will be a time-consuming process, he added.

"We are planning to offer one of these facilities for US FDA re-inspection in the current financial year," Shanghvi said.

The company remains committed to 24x7 cGMP compliance and is working with reputed global experts to ensure that all the facilities remain compliant, he added.

"Over the past two years, we have also significantly strengthened our capabilities by recruiting global talent with strong expertise in quality and compliance," he said.

In his speech, Shanghvi also said that the integration of Ranbaxy into Sun Pharma is on track and the synergy benefits from this integration have started reflecting in the company's financial in FY2015-16.

"We expect to build further on these synergy benefits in FY17. We are confident of achieving USD 300 million in synergy benefits from this acquisition by FY18 and are on track to achieve this significant milestone," he added.