Dr. Reddy’s Laboratories, a leading generic drug manufacturer, is facing an unexpected delay in its plans to launch the injectable weight-loss drug Semaglutide in Canada. The Pharmaceutical Drugs Directorate of Canada has issued a notice of non-compliance (NON) concerning the company’s abbreviated new drug submission (ANDS), indicating that the rollout will likely take longer than anticipated.
This regulatory setback immediately impacted Dr. Reddy’s, with its share prices plummeting over 5% in early trading on the BSE on Thursday, October 30, 2025. This news is particularly significant for the company, as it has been heavily relying on new product launches to mitigate a decrease in U.S. revenue following the introduction of generic Lenalidomide, a cancer drug originally known as Revlimid.
In response to the NON, Dr. Reddy’s issued a statement on Wednesday evening, October 29, 2025, confirming that the notice “outlines requests for additional information and clarifications on specific aspects of the submission.” The company affirmed its intention to submit a comprehensive response within the given timeframe, expressing confidence in the “quality, safety and comparability of the proposed product.” They reiterated their commitment to making “this important therapy available to patients in Canada and other markets at the earliest opportunity.”
Meanwhile, the Semaglutide injection has received a recommendation for approval from a Subject Expert Committee of India’s Central Drugs Standard Control Organisation (CDSCO). Dr. Reddy’s leadership team shared this update with media and investors after the recent September quarter results. Although approval from the Drugs Controller General of India is the next step, the product’s launch in India is contingent upon the patent expiry in March 2026. Globally, the company aims to introduce Semaglutide in over 80 countries, targeting both markets that require a Certificate of Pharmaceutical Product and those where it is not mandatory.
Adding another layer of complexity, the fate of Dr. Reddy’s generic Semaglutide is also tied to the outcome of a patent infringement lawsuit. This legal challenge was brought by Danish pharmaceutical giant Novo Nordisk, the innovator of the Glucagon-like peptide-1 (GLP-1) agonist medication, which is prescribed for both diabetes and obesity management.
The patent case is currently awaiting judgment from the Delhi High Court, with Dr. Reddy’s maintaining its belief that the patent in question is invalid. Addressing concerns about the Canadian market, senior executives acknowledged that it would be highly competitive, with numerous players already present. They also conceded that the company might face further inquiries from Canadian regulators beyond the current NON.
Analysts at Emkay Research have weighed in on the Canadian delay, predicting a minimum six-month postponement in the launch based on their analysis of similar past non-compliance notices. They project that if Dr. Reddy’s submits its response by December 2025, the earliest possible approval could be expected by the end of the first quarter of fiscal year 2027.
Regarding the manufacturing of Semaglutide, Dr. Reddy’s leadership confirmed that one of its own units, CTO-6, is responsible for producing the active pharmaceutical ingredients (API).
Semaglutide and Liraglutide are just two of approximately 40 peptides Dr. Reddy’s plans to develop, either independently or through partnerships, in the coming years. For Semaglutide specifically, the strategy involves both in-house manufacturing and collaboration with partners. The current initial production capacity, including contributions from partners, stands at 12 million pens, with ambitious plans to expand this to 50 million pens in the future.