Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

Even as India-based drug majors Ranbaxy and Wockhardt reel under the impact of US Food and Drug Administration import bans on certain products, the drug regulator has issued another import alert, this time on Sun Pharmaceuticals' (BSE: 524715) Karkhadi plant, in Gujarat, which saw its shares decline 6.5% on the news, reports The Pharma Letter’s India correspondent.

The Mumbai based company manufactures active pharmaceutical ingredients (APIs) and formulations at its Karkhadi unit. The alert was issued by the US FDA as a follow up to the last inspection, wherein it was found that certain Good Manufacturing Practice (GMP) regulations were not being complied with.

Sun Pharma said it has initiated several corrective steps to address the observations made by US regulator, and that it is fully committed to compliance. The facility in question is a dedicated cephalosporin plant (API and formulations), and is the first of Sun's 14 global FDA approved facilities (excluding Caraco) to receive an import alert. According to IMS, the product at the facility contributed $6 million to sales in calendar year 2013 and accounted for less than 1% of Sun's revenue.