The clearance of Cipla's Goa facility opens the doors for the launch of Abraxane, which could be a around $120 million opportunity at peak.
"The United States Food and Drug Administration (USFDA) has classified the inspection conducted at its Goa manufacturing facility from 16-27 September 2019 as Official Action Indicated (OAI).
The company, in an exchange to BSE said the plant-1 was inspected by MHRA in December last year.
The company in conference call with analysts said the impact of the warning letter on the revenues is minimal, as the US FDA warning letter doesn't restrict the company from shipping product to the US, though new approvals may get impacted.
The US FDA had inspected Indoco's manufacturing facilities Plant II and Plant III located in Verna Industrial Estate Area, Goa), from August 31 to September 4, 2016 and issued six observations in Form 483.
Credit Suisse feels Lupin is trading at high end of historical valuations (23x FY18 EPS) and has low margin of safety with high concentration risk.
Nipun Mehta, Founder & CEO, Blue Ocean Capital Advisors is of the view that market is currently consolidatng and it is possible for the Indian benchmark indices to see a 3-5 percent upmove or down move.
"Indoco has received the establishment inspection report (approval) from US Food and Drug Administration (USFDA) for its solid dosages manufacturing facility at Goa (plant I)," says the Mumbai-based pharma company in its filing.
Lupin‘s Goa facility had faced a similar inspection in July last year, when nine observations had been raised by the USFDA. As this facility contributes around 50 percent of its US market sales, which in turn contributes nearly 45 percent to total sales, analysts have been worried on loss of future product approvals.