Lupin sees more US drug approvals after disappointing Q2

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26 Aug, 2025 12:21

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Lupin Ltd, India's third-largest drugmaker by sales, hopes to win approvals for some key products in its largest market, the United States, by the end of this year, after fewer product launches pushed second-quarter profit below estimates.

Earnings of most Indian generic drugmakers, including Lupin, were hurt in recent quarters by a slowdown in the pace of approvals to launch new drugs, afLer the US Food and Drug Administration overhauled the review process.

Lupin shares tumbled nearly 6 percent to 1,932 rupees, their lowest in more than a month.

"We ... remain upbeat on the pace of approvals and launches to pick up by the fourth quarter," Lupin's Managing Director Nilesh Gupta said in a statement on Tuesday.

Among the drugs it expects approval for this year is its copy of the big-selling heartburn pill Nexium, for which it expects an FDA nod "anytime now," Gupta said.

To offset the lag in US approvals, Indian generic drugmakers have been trying to expand in the region by buying niche products, or companies with the capability to develop such products.

Lupin bought US firm GAVIS Pharmaceuticals LLC for USD 880 million in its largest-ever acquisition in July, gaining access to portfolio of speciality generic drugs that are harder to develop and where competition is usually limited.

The company's net profit for the July-September quarter slumped 35 percent to 4.09 billion rupees (USD 62.97 million). That was much below the 5.68 billion rupees analysts on average estimated, according to Thomson Reuters data. US sales fell about 9 percent to 11.55 billion rupees.