Sun Pharma gets US FDA clearance for its Halol plant
13 June 2018
India’s largest drug maker Sun Pharmaceutical Industries Ltd said it has received US drug regulator’s report clearing its Halol, Gujarat plant of lapses, paving way for fresh approvals for its products in its largest market.
In a stock exchange filing Sun Pharma said it has received the establishment inspection report from the US Food and Drug Administration for the unit. The inspection is now closed and issues raised in the December 2015 warning letter have been addressed, it said.
“This is an important development for Sun Pharma,” Dilip Shanghvi, managing director of Sun Pharma, said in the statement. “We remain committed to following the highest levels of quality and 24x7 cGMP compliance at all our manufacturing facilities globally.”
Shares of Sun Pharmaceuticals ended about 1 per cent higher. The stock had spiked over 8 per cent on 8 June after the US FDA changed the status of Halol plant to VAI (voluntary action indicated) — suggesting that it was on the verge of getting cleared.
A major part of Sun Pharma’s drug portfolio and niche future filings, including injectables, come from this plant. The clearance paves the way for new approvals after four years.
The Halol facility accounts for 11 per cent of Sun Pharma’s US sales and about 4 per cent of total sales — down from 22 per cent and 12 per cent, respectively, before it ran into regulatory trouble.
The company attributes the drop in sales to an increased base after the acquisition of Ranbaxy Laboratories and price erosion due to competition in the US.