Dr. Reddy’s weight-loss drug Semaglutide rollout in Canada delayed over compliance notice

Generic drugmaker Dr. Reddy’s Laboratories plans to rollout the weight-loss drug Semaglutide in the injectable form in Canada is likely to take more time than expected, with Pharmaceutical Drugs Directorate, Canada, issuing a notice of non-compliance (NON) regarding the abbreviated new drug submission (ANDS).

Dr. Reddy’s share prices plunge more than 5% in early trade on the BSE on Thursday (October 30, 2025) after the regulatory setback, which comes at a time when the company is betting big on new launches to offset decline in U.S. revenue from cancer drug Revlimid’s generic Lenalidomide.

“The NON outlines requests for additional information and clarifications on specific aspects of the submission. We will submit a response well within the stipulated time period,” Dr. Reddy’s said in a filing on Wednesday evening (October 29, 2025). The company said it remains confident about the quality, safety and comparability of the proposed product and committed to making “this important therapy available to patients in Canada and other markets at the earliest.”

A Subject Expert Committee of India’s Central Drugs Standard Control Organisation (CDSCO) has recommended approval for Semaglutide injection, a leadership team of Dr. Reddy’s announced during interactions with media and investors following September quarter results recently. While the Drugs Controller General on India approval is the next step, the launch has to wait till the patent expiry in March 2026. The company plans to introduce the product in more than 80 countries, both which insist on a Certificate of Pharmaceutical Product and where CoPP is not mandatory.

The outcome of a patent infringement lawsuit filed by the Danish pharmaceutical major Novo Nordisk will be crucial for Dr. Reddy’s launch of the generic version of the innovator’s Glucagon-like peptide-1 (GLP-1) agonist medication indicated in the treatment of diabetes and obesity.

The case is before Delhi High Court and judgment awaited, the leadership said, contending Dr. Reddy’s believes the patent is invalid. To queries on the Canada market, the senior executives admitted it will be competitive with multiple players. They also did not rule out the possibility of the company getting additional queries.

Following the issue of NON, analysts at Emkay Research said, “based on an analysis of past NONs, in the best case, we expect a 6-month delay in launch. If Dr. Reddy’s responds by December 2025, we anticipate an approval by the end of 1QFY27, in the best case scenario.”

One of the company’s units (CTO-6) is making the active pharmaceutical ingredients (API), Dr. Reddy’s leadership said to queries around Semaglutide manufacturing.

Semaglutide and Liraglutide are among the 40-odd peptides identified that it intends to develop on its own or in with partners over next few years. Specific to Semaglutide, the plan is to manufacture it inhouse as well as with partners. The initial capacity, including those of partners, is 12 million pens with plans to scale to 50 million.