Lupin Receives the US FDA Somerset Plant Warning Notice

Lupin Ltd, one of the world’s leading generic drug manufacturers, gets the US Food and Drug Administration (FDA) a notice today about its US factory situated in Somerset, New Jersey.”We would like to tell you that the Company has received a letter of warning to the Somerset plant, New Jersey, from the US FDA,” Lupin stated in an investor update today.From 10 September to 5 November last year, the facility was examined by FDA authorities.

The factory was subject to ‘official action’ or OAI status before the inspection last year. Lupin had asked for a re-inspection to address the issues.But, after the observation late last year, the US FDA inspectors issued 13 observations, now issuing an alert letter.As part of its 2015 acquisition of Gavis Pharmaceuticals, the Somerset plant generates less than 5% of Lupin total sales.

Lupin purchased Gavis Pharma from the US for $880 million in 2016, which is the first firm in an Indian country to contribute more than a third of its income.At the time the transaction was made, Gavis had 62 novel medicinal items abbreviated, and over 65 pipelines in development were waiting for clearance with the US FDA.

In general, the rate of new medicine approvals to be made at a specific facility might be affected by unfavorable regulatory events.At the same time, Lupin said today that it is unlikely the warning letter will interfere with existing supply and plant income.”The business doesn’t expect the warning letter will affect the supply interruption or existing revenues generated by this facility’s operations,” the Indian pharmaceutical maker stated.