The shareholders of Biocon must be breathing easy today.

The company’s Bengaluru unit had received an Establishment inspection report (ER) from the US FDA has now been cleared by the regulatory authority after an inspection.

The FDA had audited the pharmaceutical company’s aseptic drug facility between May 25 and June 3.  

The FDA had classified the outcome as ‘voluntary action indicated’, and the letter from the regulator states that the inspection is closed.

The company has also clarified that post this, there is currently no pending inspections related to current Goods Manufacturing Practice with U.S. FDA at the moment.

The stock is today amongst the top five gainers on the BSE; the price rose 6.5% to Rs.419.75, very close to its 52-week high of Rs.424.15.