Synopsis:
Dr Reddy’s Laboratories shares fell 6% after receiving a non-compliance notice from Canada’s drug regulator for its Semaglutide injection, raising concerns of delayed approval, loss of first-mover advantage, and potential revenue impact in FY26–FY27.
This company is a leading India-based pharmaceutical company which offers a portfolio of products and services is now in the spotlight after it received a non compliance notice from Canada’s drug regulator for its injection.
With market capitalization of Rs. 1,00,529 cr, the shares of Dr Reddy’s Laboratories Ltd are currently trading at Rs. 1,207 per share, down by 6% in today’s market session making a low of Rs. 1,180.90, from its previous close of Rs. 1,250.90 per share.
News
Shares of Dr Reddy’s Laboratories fell nearly 6% on October 30, 2025, after the company announced that it received a Notice of Non-Compliance from Canada’s Pharmaceutical Drugs Directorate regarding its Abbreviated New Drug Submission (ANDS) for Semaglutide Injection.
The notice requested additional information and clarifications on specific aspects of the submission, prompting concerns of a regulatory delay in the drug’s approval process in Canada. The semaglutide injection is a generic version of Novo Nordisk’s Ozempic and Wegovy, which is a high-revenue product used for diabetes and weight management.
Analysts from JP Morgan and Emkay Global believe this regulatory setback will delay the launch of Dr Reddy’s semaglutide injection in Canada, likely pushing it beyond the original planned launch date in January 2026. This delay is expected to crumble Dr Reddy’s anticipated first-mover advantage in the Canadian market. The analysts estimate the delay may impact projected revenues of approximately $30 million for the fiscal year 2026 and $100 million for fiscal year 2027.
Dr Reddy’s has expressed confidence in the quality, safety, and comparability of its semaglutide product and is committed to responding promptly within the stipulated timeframe.
The company’s delay in approval also affected related suppliers like Shaily Engineering Plastics, whose shares dropped due to the setback, given Dr Reddy’s is a major client for drug delivery devices used in semaglutide pens.
About the company
Dr Reddy’s Laboratories Ltd is one of India’s leading multinational pharmaceutical companies, engaged in the development, manufacture, and marketing of a wide range of generic medicines, active pharmaceutical ingredients (APIs), and biosimilars. Headquartered in Hyderabad, the company serves global markets, including the U.S., Europe, and emerging economies.
The company reported steady performance for the Q2FY26 quarter with sales rising 10% year-on-year to Rs. 8,828 crore, compared to Rs. 8,038 crore in the same period last year. EBITDA declined 3% YoY to Rs. 2,010 crore, while net profit is down by 0.4% year-on-year to Rs. 1,337 crore. Earnings per share (EPS) stood at Rs. 16.14, up from Rs. 15.05 in the previous year.
Written by Manideep Appana
Disclaimer
The views and investment tips expressed by investment experts/broking houses/rating agencies on tradebrains.in are their own, and not that of the website or its management. Investing in equities poses a risk of financial losses. Investors must therefore exercise due caution while investing or trading in stocks. Trade Brains Technologies Private Limited or the author are not liable for any losses caused as a result of the decision based on this article. Please consult your investment advisor before investing.
