●
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.
