Hyderabad, October 29, 2025:
In a regulatory filing, Dr. Reddy’s Laboratories Limited (DRL) announced that it has received a Notice of Non-Compliance (NON) from the Pharmaceutical Drugs Directorate of Canada in connection with its Abbreviated New Drug Submission (ANDS) for the Semaglutide Injection. The NON highlights areas where the regulatory body has requested further clarification and additional data before the application can proceed toward approval.
The company stated that the queries are largely procedural and that it intends to respond promptly and comprehensively within the stipulated time period. “We remain confident in the quality, safety, and comparability of our proposed product,” said K. Randhir Singh, Company Secretary and Head of CSR at Dr. Reddy’s. “We are committed to addressing all regulatory requirements and making this important therapy available to patients in Canada and other markets at the earliest.”
Semaglutide Injection is widely known for its use in the management of Type 2 Diabetes and has also shown potential for weight management in recent years. It belongs to the class of GLP-1 receptor agonists, a rapidly growing market segment globally. The drug has been a commercial blockbuster for its original innovator brand, and approval of the generic version could open a lucrative opportunity for Dr. Reddy’s in the North American market.
The company emphasized that receiving a Notice of Non-Compliance is a standard step in the regulatory review process and does not imply rejection of the application. Such notices often arise from data clarification requests or additional testing requirements to ensure full adherence to quality and efficacy benchmarks set by Health Canada.
Dr. Reddy’s has a long-standing presence in the Canadian market and maintains an extensive portfolio of generic pharmaceuticals approved by both Health Canada and the U.S. Food and Drug Administration (USFDA). Over the years, the company has earned a reputation for its scientific rigor and adherence to global quality standards.
Industry analysts view this notice as part of routine regulatory scrutiny rather than an indication of serious deficiencies. “These correspondences are a part of the due diligence regulators follow to ensure patient safety and therapeutic consistency. Large generic manufacturers like Dr. Reddy’s are well-equipped to handle such technical queries,” said a pharma sector analyst.
The company’s filing also reaffirmed its commitment to ongoing innovation and global healthcare access. “Dr. Reddy’s continues to pursue affordable and high-quality solutions for patients worldwide,” the statement added. “Our goal remains to expand the availability of critical therapies, including biosimilars and injectables, across developed and emerging markets.”
Semaglutide, known commercially under brands like Ozempic and Wegovy, has witnessed surging global demand, making it one of the most competitive generic targets in the pharmaceutical sector. Dr. Reddy’s entry into this market segment could strengthen its footprint in North America’s high-value injectables domain once approval is secured.
The company’s shares are listed on multiple exchanges, including the National Stock Exchange of India (NSE: DRREDDY), BSE Limited (BSE: 500124), and the New York Stock Exchange (NYSE: RDY). It operates across more than 60 countries and employs a research-driven approach to drug development.
Dr. Reddy’s also reiterated its ongoing dialogue with global regulators and stakeholders, ensuring transparency in every stage of product development and approval. “We are committed to maintaining the highest ethical and quality standards as part of our global operations,” the company concluded.
While the receipt of a NON temporarily pauses the progress of approval, it is viewed as a corrective procedural step rather than a setback. Market experts expect the company to submit a revised dossier soon, paving the way for future approval in Canada.