Dr. Reddy’s Laboratories shares fall over 4% after delay in Semaglutide approval in Canada

Dr. Reddy’s Laboratories’ shares fell more than 4% in early trade on Thursday, October 30, after the company announced a delay in approval for its Semaglutide injection in Canada. The stock declined to ₹1,192.90, down ₹58.00 from the previous close of ₹1,250.90. Market participants reacted to regulatory developments affecting one of Dr. Reddy’s key future product opportunities.

Regulatory Update

Dr. Reddy’s received a Notice of Non-Compliance (NON) from Canada’s Pharmaceutical Drugs Directorate for the Abbreviated New Drugs Submission (ANDS) of its Semaglutide injection. The NON requests additional information and clarifications on certain aspects of the submission.

The company stated it will respond promptly within the stipulated timelines and reiterated confidence in the product’s quality, safety, and comparability, emphasizing its commitment to making Semaglutide available in Canada and other global markets at the earliest.

Semaglutide Market Outlook

In its Q2 commentary, Dr. Reddy’s highlighted that the Semaglutide patent expires in January 2026. The company expects the opportunity to expand across 87 countries through direct or partner-led entry within 12–15 months.

Meanwhile, markets such as India, Brazil, and Turkey are expected to absorb up to 12 million pens if Canadian volumes are delayed.

Analysts estimate that five more filers are pursuing Semaglutide approval. The Street anticipates a 5–12 month delay for Dr. Reddy’s timeline and forecasts a revenue opportunity of $100 million in FY27, post-approval.

Brokerage View

Nomura maintained a Buy rating on the stock but revised its price target to ₹1,580, cutting FY earnings estimates by 3–6% to reflect potential lower Canada revenue.

Stock Snapshot (October 30)