Sun Pharma: Unit Has Resolved Issue Arising From US FDA Warning

Sun Pharma: Unit Has Resolved Issue Arising From US FDA Warning

September 19th, 2011 // 12:31 pm @

Sun Pharmaceutical Industries Ltd. (524715.BY) said Monday one of its U.S. units has successfully resolved an issue arising from a U.S. Food and Drug Administration warning to its manufacturing facility in Cranbury, New Jersey, over regulatory violations.

Sun Pharmaceutical Industries Inc.’s facility has been found to have an “acceptable” regulatory status after the FDA re-inspected it in June, the Indian generic drug maker said in a statement.

NEW WEBINAR – What You’ve Got to Know About the Incoming Bombshell – FDA’s 2011 Process Validation Guidance

The FDA issued a warning letter to the facility on Aug. 25, 2010, after identifying violations of good manufacturing practice regulations during an inspection.


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