MUMBAI: India’s largest drug maker Sun Pharma has received a warning letter from the US FDA for manufacturing lapses at its facility in Halol. The site is among the largest for Sun Pharma , and important for the company as it is used for producing multiple formulations, including injectables, which are mainly exported to the US, its largest market.

The Halol facility was inspected by the US FDA in September 2014, following which the regulatory agency had notified around 23 issues that were seen to be in violation of standard manufacturing norms.

Regulatory trouble at Halol has already had an adverse impact on the company, given its importance to the company’s US revenues as well as for its overall performance going forward. The Halol site has been a primary contributor to Sun’s revenues from the US. Prior to the US FDA’s objections raised last year, analysts estimate the Halol facility had accounted for about 10% or $440 million of Sun Pharma’s global revenues of $4.3 billion. It has declined to around $240 million post the FDA audits.

“Sun Pharma responded to the USFDA inspection observations with a robust remediation process that is still ongoing, with significant investments in automation and training to enhance its quality systems. Sun Pharma has been working with external consultants to ensure its remediation activities have been completed in an appropriate manner,” the company said in its statement.

Responding to a query during a conference call by analysts on whether the Halol site can be expected to be cleared by the US FDA in the next 12 to 15 months (as seen in most cases), Sun Pharma Managing Director Dilip Shanghvi said the remediation process for compliance at Halol site is underway, and therefore it may not take that long. He, however, clarified that the company will engage with subject matter experts and assess the likely possibilities.

He said that Sun’s other manufacturing facilities had been inspected successfully post the Halol inspection and those were found to be compliant with regulatory requirements.

During FY2014, the US business accounted for 60% of the overall sales of the company (Rs 16,000 crore). Going forward, after the merger with Ranbaxy, its dependence on the region would reduce to around 45% of the expected sales in FY2016, analysts say.

