Lupin Ltd, India’s third-largest drugmaker, reported a higher than expected fourth-quarter profit helped mainly by sales of a new diabetes medicine it launched in its largest market, the United States.
Net profit for the January-March quarter rose to 8.07 billion rupees ($119.91 million) from 5.47 billion rupees a year earlier. Analysts polled by Thomson Reuters expected an average profit of 6.78 billion rupees.
Lupin has benefited in recent months from a steady pace of new drug approvals in the United States at a time when most of its peers faced delays in getting approvals due to regulatory troubles.
But the US Food and Drug Administration raised concerns over inadequate manufacturing standards at Lupin’s Goa factory in western India in March, worrying investors. Lupin depends on that plant for about 40 percent of its U.S. sales.
It has been updating the FDA on remediation work it has been undertaking at Goa, and plans to give a final update “in the next few months,” Chief Executive Vinita Gupta told Reuters.
Net sales in the United States jumped 59% in the fourth quarter, boosted by the launch of Lupin’s generic version of the diabetes drug Glumetza.
India sales were up 15%, while in Japan, Lupin’s third-biggest market, sales rose 17%. Gupta said the company faced pressure on margins in Japan, where the government has imposed price cuts more frequently.
India’s generic drugmakers such as Lupin have increasingly focused in recent years on complex therapy areas such as injectables, dermatology and opthalmology, where products are harder to make than plain generics, and competition is limited.
Lupin, which started making inhalation products about three years ago, plans to launch its first metered-dose inhaler this year, and first dry powder inhaler next year, Gupta said. The company expects its inhalation products portfolio to start contributing to revenue by 2018 or 2019.
The company plans to launch more dermatology products in the United States in the next few years.
“The products that we’ll file (for approval) in the next 12 to 18 months will complete our whole dermatology pipeline wish list,” Gupta said.