By Rishika Sadam and Kashish Tandon
July 9 (Reuters) – India’s Dr Reddy’s Laboratories said on Thursday that supplies of its generic semaglutide would remain unavailable in India and face disruptions in Canada until at least late October after an issue with the active pharmaceutical ingredient (API) halted new production.
On a call with analysts, CEO Erez Israeli said shipments already made to Canada, where Dr Reddy’s launched its generic semaglutide earlier this year, were unaffected. However, the production halt will disrupt future supplies until manufacturing resumes.
Israeli said the issue was identified during validation of a production scale-up.
The setback is a blow to Dr Reddy’s ambitions in India’s fast-growing semaglutide market, which opened up after the drug’s patent expired in March. It also threatens the company’s goal of selling 12 million injectable pens in its first year.
Semaglutide is the active ingredient in Danish drugmaker Novo Nordisk’s blockbuster diabetes drug Ozempic and weight-loss drug Wegovy.
The disruption has rippled across the industry, prompting Torrent Pharmaceuticals to recall selected batches of its Semalix injection pens for technical evaluation after a notification from Dr Reddy’s.
Earlier on Thursday, Dr Reddy’s lost about $678 million in market value after saying it would delay commercial supplies of the generic diabetes drug because certain batches of semaglutide API were found to be “out of specification”.
Israeli said the company was on track to supply 6 million to 7 million semaglutide injection pens in the second half of the year, but acknowledged this would fall short of its earlier target.
“When we gave the earlier target we assumed we would sell between July to September. Now unlikely we will do that,” he said.
“There is no impact on patient safety or on the product’s existing global regulatory filings,” the company said.
Shares in Dr Reddy’s closed down 5.9% at 1,269.50 rupees, their steepest one-day decline in more than three years.
Dr Reddy’s sells semaglutide under the brand name Obeda.
($1 = 95.3775 Indian rupees)
(Reporting by Rishika Sadam and Kashish Tandon. Writing by Chandini Monnappa. Editing by Sherry Jacob-Phillips, Mrigank Dhaniwala and Mark Potter)
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