The stock of drug major Lupin dropped over 15 per cent last week. This was a fall-out of the adverse remarks by the US FDA after its inspection of the company’s Goa facility. The US drug regulator had cited nine adverse observations relating to inadequacy and adherence to standard operating procedures at the facility. While these unfavourable observations may not result in an immediate issue of warning letter or import ban on the facility, delays in addressing the concerns may remain an overhang on the stock. The company is expected to take steps soon to address the concerns raised. In its filing to the stock exchange, it said that it is putting together a response for the US regulator.
In February 2015, Lupin’s Pithampur facility in Madhya Pradesh had received six regulatory observations from the US FDA. An earlier warning from the US FDA in May 2009 for its Mandideep site was sorted out by the company in seven months.
For the nine months ending December 2015, 42 per cent of the company’s revenue came from exports to the US.