Sun Pharma resolves FDA issue at US plant
19 Sep 2011
Sun Pharmaceutical Industries Ltd told the Bombay Stock Exchange today that one of its US units has successfully resolved an issue raised by the Food and Drug Administration arising.
A brief press release said the FDA has informed Sun Pharmaceutical Industries Inc, its wholly owned subsidiary, that after a June 2011 re-inspection of its Cranbury, New Jersey manufacturing facility, the company was found to have an acceptable regulatory status.
"Therefore, the issues noted in the 25 August 2010 warning letter are considered to be resolved,"Sun Pharma said in a statement.
It added, "Caraco, now wholly owned by Sun Pharma, continues to work with consultants to resolve the issues raised by the USFDA at its Detroit plant."
In June this year, US FDA raided Caraco Pharmaceutical Laboratories and seized drugs manufactured by Caraco at its Detroit, Farmington Hills, and Wixom, Michigan facilities and temporarily halted all manufacturing at the plants for repeat violations of FDA's good manufacturing practice (cGMP) requirements (See: US FDA seizes drugs from Sun Pharma subsidiary Caraco).
Since January 2009, Caraco has been forced to recall a number of products due to manufacturing defects, including Digoxin tablets, a drug used to treat heart failure and abnormal heart rhythms, since the tablets were oversized.