Sun Pharma comes under FDA import alert
pharmafile | March 17, 2014 | News story | Manufacturing and Production | Sun Pharma, diabetes, gabapentin, manufacturing, metformin, recall
The reputation of India’s pharma sector has been dealt a further blow after yet another drugmaker was placed under an import alert by the US Food and Drug Administration.
The latest company to come under the scrutiny of the regulator is Sun Pharmaceutical, whose antibiotic facility in Karkhadi, Gujarat, was found to be operating in violation of Good Manufacturing Practices (GMP) during the FDA’s latest inspection.
News of the import alert emerged shortly after Sun Pharma ordered a recall of around 2,500 bottles of diabetes drug metformin made at subsidiary Caraco Pharmaceutical Labs, after some were found to contain gabapentin – an anti-epilepsy medicine.
“The company remains fully committed to compliance and has already initiated several corrective steps to address the observations made by the FDA,” said Sun Pharma in a statement. Karkhadi is one of more 26 manufacturing facilities operated by the company worldwide.
It also said the contribution of products made at Karkhadi is ‘negligible’ at less than 1% of group turnover, so it does not anticipate any impact on its sales guidance for the current financial year. The facility makes both active pharmaceutical ingredients (APIs) and finished dosage form products.
Sun Pharma is the third major Indian generic drug manufacturer to have a manufacturing plant placed under an import alert by the FDA in recent years, joining Ranbaxy and Wockhardt.
The FDA recently signed a memorandum of understanding with its Indian counterpart – the Ministry of Health and Family Welfare – to improve ‘bilateral cooperation and information sharing’.
India’s pharma industry supplies 40% of over-the-counter (OTC) and generic prescription drugs consumed in the US, and around 80% of its APIs, according to the FDA.
The manufacturing issues come after a buoyant spell at Sun Pharma in recent quarters, helped by the fact that it is currently the only supplier of generic Doxil (doxorubicin) in the US as a result of the manufacturing issues facing brand owner Johnson & Johnson.
It also recently launched a generic of Eli Lilly’s antidepressant blockbuster Cymbalta (duloxetine), which along with the Doxil windfall helped its turnover rise nearly 46% in the first nine months of fiscal 2013-2014.
The US formulations business accounts for more than half (54%) of Sun Pharma’s total turnover following the acquisition of URL Pharma last year and DUSA in 2012.
Shares in the company fell sharply on the news, but recovered just as quickly after the company downplayed the impact of the import alert.
Phil Taylor
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