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Generic drugmaker Dr. Reddy’s Laboratories plans to rollout the weight-loss cause Semaglutide successful the injectable signifier successful Canada is apt to instrumentality much clip than expected, with Pharmaceutical Drugs Directorate, Canada, issuing a announcement of non-compliance (NON) regarding the abbreviated caller cause submission (ANDS).
Dr. Reddy’s stock prices plunge much than 5% successful aboriginal commercialized connected the BSE connected Thursday (October 30, 2025) aft the regulatory setback, which comes astatine a clip erstwhile the institution is betting large connected caller launches to offset diminution successful U.S. gross from crab cause Revlimid’s generic Lenalidomide.
“The NON outlines requests for further accusation and clarifications connected circumstantial aspects of the submission. We volition taxable a effect good wrong the stipulated clip period,” Dr. Reddy’s said successful a filing connected Wednesday evening (October 29, 2025). The institution said it remains assured astir the quality, information and comparability of the projected merchandise and committed to making “this important therapy disposable to patients successful Canada and different markets astatine the earliest.”
A Subject Expert Committee of India’s Central Drugs Standard Control Organisation (CDSCO) has recommended support for Semaglutide injection, a enactment squad of Dr. Reddy’s announced during interactions with media and investors pursuing September 4th results recently. While the Drugs Controller General connected India support is the adjacent step, the motorboat has to hold till the patent expiry successful March 2026. The institution plans to present the merchandise successful much than 80 countries, some which importune connected a Certificate of Pharmaceutical Product and wherever CoPP is not mandatory.
The result of a patent infringement suit filed by the Danish pharmaceutical large Novo Nordisk volition beryllium important for Dr. Reddy’s motorboat of the generic mentation of the innovator’s Glucagon-like peptide-1 (GLP-1) agonist medicine indicated successful the attraction of diabetes and obesity.
The lawsuit is earlier Delhi High Court and judgement awaited, the enactment said, contending Dr. Reddy’s believes the patent is invalid. To queries connected the Canada market, the elder executives admitted it volition beryllium competitory with aggregate players. They besides did not regularisation retired the anticipation of the institution getting further queries.
Following the contented of NON, analysts astatine Emkay Research said, “based connected an investigation of past NONs, successful the champion case, we expect a 6-month hold successful launch. If Dr. Reddy’s responds by December 2025, we expect an support by the extremity of 1QFY27, successful the champion lawsuit scenario.”
One of the company’s units (CTO-6) is making the progressive pharmaceutical ingredients (API), Dr. Reddy’s enactment said to queries astir Semaglutide manufacturing.
Semaglutide and Liraglutide are among the 40-odd peptides identified that it intends to make connected its ain oregon successful with partners implicit adjacent fewer years. Specific to Semaglutide, the program is to manufacture it inhouse arsenic good arsenic with partners. The archetypal capacity, including those of partners, is 12 cardinal pens with plans to standard to 50 million.
