Sun Pharma's Mohali manufacturing site being inspected by US FDA: Sources

MUMBAI: After a long wait, the US FDA has commenced its scheduled inspection of the Mohali manufacturing site of Ranbaxy, a company that was acquired two years ago by Sun Pharmaceutical as part of a $4 billion deal with Japanese drug maker Daiichi Sankyo. Sources said the Mohali site inspection started on Monday and may continue for a week.

Sun Pharma declined to comment on the issue.

The US drug regulator had imposed an import alert on the facility following issues related to manufacturing violations. Mohali is one of the four sites of Ranbaxy that faced punitive action from the US FDA.

Ranbaxy pleaded guilty and was fined $500 million for a settlement in 2013. Across the sites, the US regulator had detected breaches in product filings from the such as data manipulation and a number of violation of standard manufacturing practices.

In a series of investigations that started in 2008, Ranbaxy's four sites at Paonta Sahib, Dewas, Toansa and Mohali were banned from the US market. However a few countries had cleared the manufacturing units.

Mohali was the most modern facility of Ranbaxy and had shipped heart drug atorvastatin, the company's most prized opportunity in the US generics market. In 2013 the site was banned by the US FDA. The Mohali site is seen to be best placed to clear the FDA inspections as the lapses were relatively minor, said an industry source. "However, it may be too early to reach a conclusion as the inspection is likely to be very granular and may comb through every record minutely," the source added. A few months ago, external quality control consultants had certified the Mohali site to be fit to undergo the US FDA inspections, according to sources. Industry sources also said that Sun Pharma's Halol site may also be inspected in a short time but this could not be confirmed.