- Generic Semaglutide Injection developed by Orbicular receives Notice of Compliance from Health Canada — our second G-7 Approval by stringent regulatory authority (SRA) to greenlight the program after the U.S. FDA’s Tentative Approval
- A fully indigenous Indian innovation: API, pen device, formulation, manufacturing and analytical technology developed end-to-end within India
Orbicular Pharmaceutical Technologies Pvt. Ltd., a specialty pharmaceutical company focused on complex generics and peptide-based therapeutics, today announced that a generic version of Ozempic (semaglutide injection), developed in partnership with Apotex, has received a Notice of Compliance (NOC) from Health Canada. The product will be marketed and commercialized in Canada by Apotex Inc., the applicant of record and Canada’s largest pharmaceutical company.
The market authorization covers two presentations — 2 mg / 3 mL (0.68 mg/mL) and 4 mg / 3 mL (1.34 mg/mL) — matching the concentration and fill-volume profile of the reference product, which patients and prescribers in Canada are already familiar with. This approval marks the Health Canada Notice of Compliance issued for a generic semaglutide injection. With diagnosed diabetes affecting an estimated 3.9 million Canadians and Canada recognised as the world’s second-largest market for semaglutide, immediate availability is expected to be a meaningful differentiator for patients, payers and the healthcare system.
Back-to-back G7 approvals — scientific rigor translated into delivery
The Health Canada NOC follows the U.S. FDA’s Tentative Approval of the same program earlier this year. Securing back-to-back authorizations from two of the world’s most demanding regulators — for a product class where peptide stability, device compatibility and analytical comparability have historically delayed generic entry — underscores the scientific and quality robustness of Orbicular’s program. Health Canada itself has noted that semaglutide is a complex synthetic peptide whose generic versions must demonstrate equivalence in safety, efficacy and quality without any differences that could affect those parameters — a bar that has slowed the broader competitive field. The program reflects Orbicular’s integrated development model, which combines advanced analytical capabilities, deep peptide and process understanding, and disciplined regulatory execution to bring technically complex products to global regulated markets.
Dr. M. S. Mohan, Managing Director, Orbicular Pharmaceutical Technologies, said: “Receiving Notice of Compliance from Health Canada, following the U.S. FDA’s Tentative Approval, is a significant milestone for Orbicular and reflects the depth of capability we have built in complex peptide development. This outcome is driven by the strength, rigor, and resilience of our teams, whose integrated approach across formulation, analytics, and regulatory strategy enables us to convert complexity into speed and certainty. It further validates our model of delivering high-value, IP-led assets in challenging therapeutic segments. Peptides remain a strategic growth area for Orbicular, with Semaglutide the first of several programs in our pipeline targeted at global regulated markets. With commercial inventory in place and Apotex as our market partner, we are well positioned to support timely access for Canadian patients.”
Martin Arès, President, Apotex Canada and Rest of World (ROW), said: “This approval reflects our Canadian roots and our commitment to improving access to medicines. As a Canadian-based global health company, we are proud to bring forward a high-quality, affordable alternative that supports patients, prescribers, and the long-term sustainability of our healthcare system. We look forward to bringing this product to market in the very near future.”
About Orbicular
Orbicular is an R&D focussed, partnership driven B2B specialty pharmaceutical platform, developing and licensing IP-owned assets in complex generics and advanced drug delivery systems across global markets. With integrated capabilities spanning development, advanced analytical characterization, regulatory strategy, and technology transfer, Orbicular enables partners to bring high-value, technically complex products to global markets.
