Sun Pharma receives import alert for Karkhadi unit from US FDA

Sun Pharmaceutical Industries Ltd has received an import alert from the US FDA for its cephalosporin facility located at Karkhadi, Gujarat in India. This import alert was issued by the US FDA as a follow up to the last inspection of the facility, during which some non-compliance of current Good Manufacturing Practice (cGMP) regulations were identified.
 
“The company remains fully committed to compliance and has already initiated several corrective steps to address the observations made by the US FDA. The contribution of this facility to Sun Pharma’s consolidated revenues is negligible. Sun Pharma maintains its FY2013-14 consolidated sales growth guidance,” said a company press release.
 
Sun Pharma manufactures active pharma ingredients and formulations at its Karkhadi unit, which is one of the company’s 11 manufacturing units in India. The company has about 12 US-approved facilities.