Orbicular’s generic semaglutide injection received a Notice of Compliance from Health Canada, its second G‑7 regulator approval after U.S. FDA tentative approval.
The product, co‑developed with Apotex, will be marketed in Canada in two strengths (2 mg/3 mL and 4 mg/3 mL) matching the reference Ozempic formulation.
Diabetes affects about 3.9 million Canadians, making Canada the world’s second‑largest semaglutide market; the generic aims to improve access and cut costs.
The generic is an entirely Indian‑developed product, with API, pen device, formulation, manufacturing and analytical technology created end‑to‑end in India.