Sun Pharmaceuticals today said that 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 Pharmaceutical laboratories, its US-based subsidiary.
In a jolt to the company, the US Food and Drugs Administraton had on Friday seized the entire stock of drugs manufactured at the Michigan facility of the Sun Pharma subsidiary for "repeated manufacturing standards violations'' (See: US FDA seizes drugs from Sun Pharma subsidiary Caraco)
Speaking to analysts in 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 stronger enforcement of existing laws due to some instances which affected US citizens. Sanghavi said the problem was specific to Caraco and Sun Pharma's other facilities inspected by the FDA do not have any issues.
Sanghvi 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. He claimed that the FDA action might affect the company in the short term, but there would not be any impact in the medium or long term.
According to reports, US officials had on Thursday seized all medicines made at Caraco Pharmaceutical's manufacturing plant in Michigan, which makes 35 drugs, including generic versions of anti-diabetes, analgesics, anti-hypertensives, cardiovascular and psychiatric drugs. Caraco also has two packaging plants in Michigan.