Sun Pharma to bring out new guidance after FDA action

Sun Pharmaceuticals today said it would come up with a revised guidance on its performance in the wake of action taken by the US health regulator FDA against Caraco Pharma, its US-based subsidiary.     

The US FDA had seized the entire stock of drugs manufactured at the Michigan facility of the Sun Pharma for failing to meet high manufacturing standards.     

Speaking to analysts at a conference call, Sun Pharma Chairman and Managing Director Dilip Sanghavi said, "As soon as we have clarity, we will give our revised guidance."     

He added that the US FDA action was not the result of any new legislation but only the enforcement of existing laws more forcefully due to some instances which affected US citizens.     

Sanghavi clarified that the problem was specific to Caraco and Sun Pharma's other facilities inspected by the FDA do not have any issues.     

He said that the action against Caraco was under a Court order and the company would interact with FDA through lawyers to get the issue resolved.     

Sanghavi indicated that the FDA action might affect the company in the short term, but there would not be any impact in the medium-to-long-term.