Sun Pharma Gets FDA Warning After Inspection of Facility

  • FDA withholds future approvals from company's Halol Facility
  • Company working on completing its remediation process

Sun Pharmaceutical Industries Ltd., India’s largest drugmaker, has received a warning letter from the U.S. Food and Drug Administration following an inspection at one of its facilities.

Sun got the FDA warning as a result of the inspection in September 2014 at its Halol facility in India’s Gujarat state, the company said in a statement Saturday. The FDA has withheld future product approvals from this facility. Sun said it expects to seek a re-inspection by the FDA on completing its “remediation commitments.”

“This situation may continue until all issues are resolved,” the company said. Sun will respond to the warning letter with a “detailed plan” within the stipulated time, it said.

“We will continue to cooperate with the US FDA and undertake any additional steps necessary to ensure that the U.S. Agency is completely satisfied with our remediation of the Halol facility,” Managing Director Dilip Shanghvi said in the statement.

The company said it responded to the FDA inspection with “a robust remediation process that is still on-going.” The company is investing in automation and training to enhance its quality systems and has been working with external consultants to ensure the “remediation activities” are completed appropriately, Sun Pharma said.

Sun, which became the world’s fifth biggest generic drugmaker with its purchase of Ranbaxy Laboratories Ltd., faces the challenge of resolving U.S. import bans on four of Ranbaxy’s Indian facilities while maintaining its profitability. Daiichi Sankyo Co. last year agreed to sell its controlling stake in Ranbaxy to Sun.

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