Sun Pharma hit by FDA inspection warning
pharmafile | December 22, 2015 | News story | Manufacturing and Production | FDA, Sun Pharma, manufacturing, production
Sun Pharma shares fell some 7% early this week after it emerged the Indian company received a warning letter from the US FDA over standards at its formulation factory at Halol.
The FDA issued the warning on Saturday over the site at Gurjarat, which was found during an inspection in September 2014 to be deficient in several parts of the manufacturing process, and to have incomplete records.
Sun Pharma says it has responded to the inspectors’ observations “with a robust remediation process that is still on-going, with significant investments in automation and training to enhance its Quality Systems,” and to have been “working with external consultants to ensure its remediation activities have been completed in an appropriate manner.”
Since last year’s inspection, Sun has been in regular contact with the FDA on the progress of the remediation efforts and regarding issues of product supply. The FDA has withheld further product approvals from Halol since the inspection, and Sun will be concerned that the new warning could lead to the US regulator placing a complete ban on imports from the site – if the issues are not completely addressed in the near future. The Halol factory accounts for around 15% of Sun’s US sales.
Commenting on the development, Dilip Shanghvi, managing director of Sun Pharma, says: “While our team is working hard to ensure that the commitments made to the US FDA in September 2014 are fully completed, we will continue to co-operate 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 cGMP compliant and are committed to continuing to supply our customers and patients across the world with quality products that meet all specifications.”
Sun Pharma expects to request a re-inspection by US FDA upon completion of its remediation commitments. The company says in a statement that it and the Halol facility “will continue to supply important drug products to meet its obligations to its customers and the patients who use its drugs in the United States and around the world,” and that it “will respond to this warning letter with a detailed plan within the stipulated time frame.”
The warning follows that received by Sun’s rival Dr. Reddy’s Laboratories last month, pertaining to three of its API manufacturing plants. It increases scrutiny on Indian pharma manufacturing, and further places the spotlight on standards at facilities in India, where several companies have had products banned from exporting to the US.
Joel Levy
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