Shares of Dr. Reddy’s Laboratories Limited fell by about 3% on Wednesday, 15 April, after Brazil’s drug regulator denied the company’s registration application for semaglutide, citing unmet technical requirements in the filing.

Brazil’s regulatory authority rejected the submission on technical grounds. The Brazilian semaglutide market is fiercely contested, with around 16 applications currently pending with the regulator, making the early-mover window critical for generics players looking to establish a foothold.

The setback compounds pressure on the company’s semaglutide pipeline on a second front. Canada’s approval for Dr. Reddy’s remains pending, while rival Apotex has received a tentative nod from the US Food and Drug Administration for the same molecule, a development that could tilt competitive dynamics in the Canadian market as well.

The stakes are considerable. CEO Erez Israeli had previously stated that generic semaglutide could generate “hundreds of millions of dollars” in sales, with the firm targeting launches across 87 countries in 2026, starting with Canada, Brazil, and India. India’s injectable GLP-1 segment, which includes semaglutide and tirzepatide, has already seen a 177% rise in sales on a moving annual turnover basis, climbing from Rs 571 crore in February 2025 to Rs 1,446 crore in February 2026. Brazil was meant to be part of that first wave. The setback in the country now leaves that ambition short.

At 11:35 am, shares were down by 1.50% at Rs 1,217.30 on NSE, recovering from the session low of Rs 1,195.40. The stock has shed roughly 5% over the past month and has turned negative for the calendar year.

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