Dr Reddy's Laboratories has received a Notice of Compliance (NOC) from Health Canada for its generic Semaglutide injection on April 29, 2026. The pharmaceutical company has become the first to obtain marketing authorization for this diabetes medication in Canada, receiving approval ahead of Health Canada's review target date.

Official Regulatory Disclosure

Dr Reddy's Laboratories disclosed the regulatory milestone under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015. The Notice of Compliance was granted by the Pharmaceutical Drugs Directorate, Canada (Health Canada) for the company's Abbreviated New Drug Submission (ANDS) of Semaglutide Injection.

Market Leadership and Product Details

The market authorization covers Semaglutide injection in 2 mg/pen (1.34 mg/mL) and 4 mg/pen (1.34 mg/mL) formulations. Dr Reddy's has positioned itself as the first company to receive market authorization for generic Semaglutide injection in Canada, establishing a competitive advantage in this therapeutic segment. Canada is recognized as the world's second-largest market for Semaglutide according to IQVIA MAT Q3 2025 data.

Manufacturing and Development Capabilities

Health Canada's approval demonstrates Dr Reddy's expertise in complex generics and peptide-based therapeutics, supported by in-house API and formulation development capabilities. The API is entirely produced in-house, with finished product manufacturing currently carried out by the company's manufacturing partner, OneSource Specialty Pharma Limited.

Market Impact and Commercial Readiness

With launch preparations underway, Dr Reddy's is positioned to bring this treatment option to Canadian patients. The approval addresses a significant market need, as approximately 3.9 million people (9.7% of the population) in Canada over one year old live with diagnosed diabetes, according to the Public Health Agency of Canada. The NOC authorizes immediate commercialization, sale, and distribution of Semaglutide injection across Canada.

Leadership Commentary

Erez Israeli, Chief Executive Officer of Dr Reddy's, emphasized that the approval represents a significant milestone in the company's GLP-1 journey and underscores expertise in complex product development and peptide science. The achievement fortifies the company's long-standing presence in Canada and enhances its diabetes management portfolio for regulated markets.

Dr. Reddy's Laboratories is facing judicial scrutiny as the Delhi High Court has issued a warning regarding the company's compliance with trademark directives. The court's latest intervention concerns the pharmaceutical giant's weight-loss drug naming controversy that has been under legal review.

Court's Compliance Directive

The Delhi High Court has specifically asked Dr. Reddy's Laboratories to file a fresh undertaking that details the current status of compliance with the court's previous directive. This requirement stems from the court's need to assess whether the company has adequately addressed the trademark concerns raised in the proceedings.

Trademark Transition Requirements

The court's 30 March order had specifically directed the Hyderabad-based pharmaceutical company to discontinue the use of the 'Olymviq' name for its weight-loss drug. As part of the compliance requirements, Dr. Reddy's was instructed to transition to using the alternative name 'Olymra' for the same product.

Current Legal Status

The warning from the Delhi High Court indicates that the judicial body requires updated information regarding the company's progress in implementing the trademark changes. The fresh undertaking that Dr. Reddy's must file will need to comprehensively detail how the company has addressed the court's directives since the March order was issued.

This legal development represents an ongoing trademark dispute that requires the pharmaceutical company to demonstrate full compliance with the court's naming directives for its weight-loss medication product.