More Stories

Informist, Wednesday, Oct. 29, 2025

 

--Canada regulator sends non-compliance notice to Dr Reddy's for semaglutide

 

HYDERABAD - Dr. Reddy's Laboratories Ltd. on Wednesday said the company has received a Notice of Non-Compliance from the Pharmaceutical Drugs Directorate, Canada, for its Abbreviated New Drug Submission for semaglutide injection, used to treat diabetes and obesity.

 

The notice comes at a time when Dr. Reddy's is preparing to launch the drug in Canada to capture the first wave of sales. The drug has estimated annual sales of $1.6 billion in Canada, and the company was confident of achieving at least $300 mln in revenue from semaglutide in the initial phase. Besides Dr. Reddy's, at least three other generic companies are in the fray to secure the approval for the semaglutide generic.

 

Earlier in July, Dr. Reddy's Chief Financial Officer M.V. Narasimham said the company was confident of securing regulatory approval for semaglutide. The drug is set to go off-patent on Jan. 4 in Canada, and Dr. Reddy's was preparing to launch it immediately after that. The company is the first generic manufacturer to file for approval for semaglutide in Canada. In its September-quarter earnings call, Dr. Reddy's said semaglutide would be a key revenue driver going forward, as sales of its generic cancer drug Revlimid have declined significantly due to increased competition.

 

A Notice of Non-Compliance is a formal communication issued by Health Canada, the national drug regulatory authority, when a company's drug submission — such as a New Drug Submission or Abbreviated New Drug Submission — fails to meet the required standards for approval. The Pharmaceutical Drugs Directorate operates under Health Canada.

 

"The NoN (Notice of Non-Compliance) outlines requests for additional information and clarifications on specific aspects of the semaglutide submission. We will submit a response at the earliest and well within the stipulated time period," Dr. Reddy's said in an exchange filing.

 

"We remain confident in the quality, safety, and comparability of our proposed product and are committed to making this important therapy available to patients in Canada and other markets at the earliest," the company said.

 

Besides Canada, Dr. Reddy's is also preparing to launch semaglutide in Brazil and India by March, and in about 87 other international markets in a phased manner.

 

On Wednesday, Dr. Reddy's shares ended at INR 1,250.90 on the National Stock Exchange, down 3% from its previous close.  End

 

US$1 = INR 88.20

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Reported by Narayana Krishna

Edited by Saji George Titus

 

For users of real-time market data terminals, Informist news is available exclusively on the NSE Cogencis WorkStation.

 

Cogencis news is now Informist news. This follows the acquisition of Cogencis Information Services Ltd. by NSE Data & Analytics Ltd., a 100% subsidiary of the National Stock Exchange of India Ltd. As a part of the transaction, the news department of Cogencis has been sold to Informist Media Pvt. Ltd.

 

Informist Media Tel +91 (22) 6985-4000

Send comments to feedback@informistmedia.com

 

© Informist Media Pvt. Ltd. 2025. All rights reserved.