in 2008 which was lifted in August 2012. Its New Jersey unit was also the recipient of a warning letter in 2010 which was later resolved in October 2011.
Mumbai’s Glenmark Pharmaceuticals’ subsidiary Glenmark Generics received two Form 483s in 2013 and two in 2011. The company’s Colvale Bardez facility in Goa received negative observations in 2011 and again when it was inspected in July 2013. The other two units to receive the Form were its Ankleshwar and Indore units.
“We have been inspected several times over the last few years and we believe that we are compliant on all our manufacturing facilities. We believe that we have no outstanding issues with the FDA at this point in time,” Glenmark said.
Mumbai-based Lupin received three Form 483s, of which one was issued against Lupin Bioresearch Center in Pune. The other two facilities were its Madideep unit located in Madhya Pradesh and its unit in Indore. The company has not responded to queries regarding whether the facilities are now cleared by the FDA. Three of Dr Reddy’s Laboratories’ manufacturing facilities were inspected in 2012 – while one was checked in 2011. The Hyderabad-based company said that all 483s were resolved to the satisfaction of the regulator. The company’s Mexico facility received a warning letter in June 2011 which was cleared in July 2012.
“Regulatory headwinds remain one of the key risks to the Indian pharmaceutical sector especially in light of the increasing scrutiny by the USFDA to ensure quality and compliance. While the volume of warning letters issued by USFDA has increased over the last four years, there has been a higher impact on Indian companies recently from the increasing activities of the US regulator (import alerts, warning letters, Form 483s),” a JPMorgan report dated Sept 2013 said.
Eight Indian companies received US-FDA warning letters in FY2013, all of which are still being resolved.
Wockhardt Ltd and Aurobindo are some of the Indian companies that have faced the short end of the regulatory straw in the last two years. While Aurobindo has resolved the import