Why a Credit Suisse note has made Sun Pharma shoot up 6% in trade today

Sun Pharmaceutical Industries gained more than 6 percent today, heading towards its biggest single-day gain since April 9 after brokerage Credit Suisse said the pharma major has received a Form 483 from the US FDA on a Gujarat facility.

Submission of Form 483 means the FDA team found certain procedural issues with respect to the plant’s running and seeks corrective action but may not imply an immediate import ban, CNBC-TV18 reported today.

Traders said there are low chances of an import alert.

Credit Suisse notes letter given to Sun contained “no data integrity issues” and said chances of an import alert are “low.”

According to the note, the FDA team has made 23 observations (four for injectable units, four for oral solid unit and rest for the quality-control lab) at the Halol unit in Gujarat, which accounts for about 25 percent of Sun’s US sales. The US market accounts for 60 percent of the company’s total sales.

“Based on past inspections, the FDA typically takes two-three months to resolve 483s. The current inspection concluded on September 19 and the next step is for Sun is to reply to the FDA on its proposed corrective action plan within 15 days,” Credit Suisse said, adding that there is a possibility of fresh approvals being blocked in the US, if the procedural issues take time to get resolved.

The brokerage added that the overhang from the Form 483 observation could weigh on the stock for the next three months, even though Sun shares rose over 3 percent following the news amid earlier concerns that the market was fearing the worst.

“It’s a great relief for Sun,” Prabhudas Lilladher Pharma Analyst Surajit Pal told CNBC-TV18, referring to the lack of observations related to data integrity issues. “Rest [of the observations> would be procedural, which would be addressable, and may not be of a very serious nature.”

Ranbaxy Laboratories, a unit of Sun Pharma, was also up 5.5 percent.

Sun said on September 12 the FDA inspected its plant, but expected “no material impact.”

Sun spokesman did not immediately respond to request for comment.

With inputs from Reuters