Dr. Reddy's Laboratories shares in focus on the back of this negative development

Shares of Dr. Reddy's Laboratories will be in focus on Thursday, October 30, after the approval for its Semaglutide injection was delayed.

The company has received the Notice of Non-Compliance (NON) from the Pharmaceutical Drugs Directorate, Canada, for the Abbreviated New Drugs Submission (ANDS) of the Semaglutide injection.

The NON from the Canadian drug regulator seeks additional information and clarifications on specific aspects of the submission. Dr. Reddy's stated that it will submit a response promptly and within the stipulated timeframe.

Dr. Reddy's went on to add that it remains confident in the quality, safety and comparability of the product and is committed to making this available to patients in Canada and other markets at the earliest.

During the second quarter results, Dr. Reddy's had highlighted that the Semaglutide patent expires in January 2026. The management expects the Canadian market to be competitive and that the Semaglutide opportunity can expand to 87 countries via partners or directly in the next 12-15 months.

Other notable opportunities beyond Canada for Dr. Reddy's for Semaglutide include India, Brazil and Turkey. The management expects volume to the tune of 12 million pens to be absorbed in other countries if not Canada.

Analysts expect the final approval in the Canadian markets to come by March 2026 and as a result, they are building in revenue opportunity to the tune of $100 million for Dr. Reddy's to their estimates for financial year 2027.

Shares of Dr. Reddy's Laboratories ended 2.4% lower on Wednesday at ₹1,258.4. The stock is down 8% so far on a year-to-date basis.