Expect Canada authority approval to Semaglutide in 2 days, Dr. Reddy's says
This story was originally published at 20:19 IST on 24 October 2025
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--Dr Reddy's: Ready to launch Semaglutide in Canada, regulatory OK awaited
--Dr Reddy's: Working on cost optimisation to improve performance
--Dr Reddy's: Filed application for Semaglutide in some non-regulated mkts
--Dr Reddy's: To launch anti-diabetic drug after Semaglutide patent expires
--Dr Reddy's: Nicotine replacement therapy ops integration completed by Mar
--Dr Reddy's: Launched 7 new products in US Jul-Sept
--CONTEXT: Dr Reddy's mgmt comments in post-earnings press conference
--Dr Reddy's: Price erosion in US product specific for Jul-Sept
--Dr Reddy's: Faced moderate price erosion in US for Jul-Sept
MUMBAI/HYDERABAD – Dr. Reddy's Laboratories Ltd. is expecting to get approval from the Canadian authorities for its anti-diabetic and weight loss drug Semaglutide in the next two days, ahead of the drug's patent expiry in January. The company plans to launch the drug across markets including Canada, India, Turkey, and others.
The patent for Semaglutide, a medication that mimics a naturally occurring hormone called glucagon-like peptide-1, also known as GLP-1, will expire on Jan. 4. "There are three milestones that we have to cross in order to successfully launch in Canada," an executive of the company said. "We need to seek approval and yes, we may get traditional queries, and then it may get delayed," the executive said.
Dr. Reddy's is awaiting approval from the Drugs Controller General of India to launch the product here. "We need to get the approval from the DCGI where they look into the integrity of the dose here. And in the normal course of action, we should get an approval," a top executive of the company said. It plans to launch the product in India as soon as the patent expires.
Dr. Reddy's reported a consolidated net profit of INR 13.47 billion for the September quarter on revenue of INR 88.28 billion.
The semaglutide opportunity refers to the rapidly expanding market for GLP-1 drugs used in diabetes and obesity management, led by Novo Nordisk's Ozempic and Wegovy. With key patents starting to expire from 2026, several pharma companies are positioning to enter the space through active pharmaceutical ingredients, generics, and biosimilars. Indian firms such as Dr. Reddy's, Sun Pharma, and Biocon are building peptide capabilities to capture a share of this multi-billion-dollar market.
The company has been filing applications to get approval for the drug in multiple markets. These include countries that require a Certificate of Pharmaceutical Product and countries that don't. A Certificate of Pharmaceutical Product is used to certify that a medicine is legally approved for sale in its country of origin and meets global standards.
"In countries that don't require a COPP (certificate of pharmaceutical product), we have already done the filings and the dossiers are under registration and we are in constant touch with the regulatory authorities," an executive said. "The regulatory process across the developed and the developing markets is consistently on track," he added.
Dr. Reddy's said the integration of its nicotine replacement therapy portfolio is on track, with two-thirds of the business already integrated into its operations. Integration of the remaining portfolio is expected to be completed by March.
The Hyderabad-based pharmaceutical major launched seven new products in the US during the reporting quarter. Revenue from this market fell 13% on year to INR 32.41 billion in Jul-Sept. The company reported a contraction of 2.1% in the US market, compared with a 0.1% contraction registered by the generic market there. The fall in revenue was due to product-specific price erosion and lower sales of blood cancer drug Lenalidomide.
Dr. Reddy's is focusing on a few metrics to boost its growth, one of it being cost control. "We are managing the costs and containing the cost in a way that the cost is increasing less than the growth of the sales to increase profitability," the executive said.
The company reported its September quarter earnings after the market closed. Friday, its shares ended 0.3% higher at INR 1,283.60. End
Reported by Anand JC and Narayana Krishna
Edited by Akul Nishant Akhoury
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