Sun Pharma gets FDA warning over Halol plant

Sun Pharmaceutical's hopes of an early resolution of regulatory concerns on Friday suffered a setback with US Food and Drugs Administration issuing a warning letter to its Halol plant.

India's largest generic drugs maker said it had received the warning letter, following the USFDA's inspection of the plant last September.

Warning letters are issued for violations of regulatory significance and could potentially lead to enforcement action such as import alerts, if not promptly and adequately corrected in compliance with US regulations.

"Sun Pharma responded to the US FDA inspection observations with a robust remediation process that is still on-going, 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 drug maker said in a statement.

US accounts for half of consolidated revenue for Sun Pharma; the warning letter, therefore, is likely to have an adverse impact on the company, given that the US drug regulator has banned new product approvals from the Halol plant since last September. The company's US market sales have declined in first two quarters because of pricing pressure and supply constraints from the plant.

Commenting on the development, Dilip Shanghvi, Managing Director, Sun Pharma said in the statement that "(we) will continue to cooperate with the US FDA and undertake any additional steps necessary to ensure that the US Agency is completely satisfied with our remediation of the Halol facility. Sun Pharma has always ensured that its products are safe and effective and there is no doubt on the safety of our products in the market. We are pledged to being current good manufacturing practices compliant and are committed to continuing to supply our customers and patients across the world with quality products that meet all specifications."

The company had earlier indicated that securing clearance from FDA would be a time consuming affair.

Last month Dr Reddy's Laboratories has received a warning letter from the US Food and Drug Administration (FDA) over quality control issues at three of its manufacturing facilities. Dr Reddy's Laboratories has responded to the warning letter, the company later said.