News

Dr Reddy's Has Just Become the First Company in the World to Get a Generic Ozempic Approval in Canada — Manufactured at a Bengaluru Facility

By Mustafa Shariff, Editor in chief · May 03, 2026 · 5 min read

Summary

• Dr Reddy's Becomes First in World to Get Generic Ozempic Approval in Canada — With Bengaluru Manufacturing
• Dr Reddy's Laboratories has received the first-ever Health Canada approval for generic semaglutide, manufactured by OneSource Specialty Pharma in Bengaluru. Here is the full story.

"The approval of our generic Semaglutide Injection by Health Canada represents a significant milestone in our GLP-1 journey and underscores our expertise in complex product development, peptide science, and our ability to build strong partnerships across the supply chain."

On April 29, 2026, Dr Reddy's Laboratories announced that it had received a Notice of Compliance from Health Canada — the Canadian drug regulatory authority — for its generic Semaglutide Injection, the generic equivalent of Novo Nordisk's Ozempic. Dr Reddy's states it is the first company globally to obtain market authorisation for generic semaglutide in Canada. The manufacturing partner for this programme is OneSource Specialty Pharma Limited, whose US FDA-approved flagship manufacturing facility is located in Bengaluru, Karnataka.

The approval covers 2 mg/pen and 4 mg/pen strengths at 1.34 mg/mL — matching the commercially available Ozempic presentations — and has no fixed expiry date, meaning it is a durable commercial authorisation rather than a temporary or provisional approval.

Why This Approval Is Globally Significant

Canada is recognised as the world's second-largest market for semaglutide by sales volume. Unlike the United States — where Novo Nordisk's patents and exclusivities remain in force for several years, meaning the FDA Tentative Approval received by Orbicular and Apotex cannot yet translate into market launch — Canada has a different patent landscape that has allowed Dr Reddy's to move from regulatory submission to approved commercialisation. This makes Canada the first major regulated market where a generic semaglutide product has received full approval and can be actively launched.

The commercial implications are direct. Novo Nordisk's Ozempic franchise generates billions of dollars annually globally, with Canadian revenues representing a significant portion of that figure. A generic entrant at substantially lower price points — which is what Health Canada-approved generic products typically achieve in Canada's pricing environment — creates meaningful patient access improvement for diabetic and metabolic disease patients in Canada while establishing Dr Reddy's as a commercially operational generic semaglutide provider ahead of markets where the generic opportunity will arrive later.

The Bengaluru Connection — OneSource as CDMO

The manufacturing partnership with OneSource Specialty Pharma is the story within the story for BHC Media's audience. OneSource — listed on both BSE and NSE — operates a US FDA-approved peptide manufacturing facility in Bengaluru that provided the scale-up and commercial manufacturing capability for Dr Reddy's Canadian semaglutide programme. Neeraj Sharma, CEO and MD of OneSource, has framed the partnership as a combination of Dr Reddy's expertise in peptide development with OneSource's CDMO capabilities — a clean articulation of the API-to-finished product collaboration model.

Bengaluru has been quietly building a peptide manufacturing capability that is now delivering globally significant regulatory approvals. OneSource is simultaneously investing nearly $100 million to ramp up production capacity by five times over the next 18-24 months — anticipating the wave of semaglutide and other GLP-1 generic demand that will roll in as more market approvals are secured globally.

India's GLP-1 Generic Ecosystem

The Dr Reddy's-OneSource Health Canada approval completes a pair of regulatory landmarks for Indian semaglutide manufacturing. Earlier in April 2026, BHC Media reported that Orbicular Pharmaceutical Technologies and Apotex had received the world's first US FDA Tentative Approval for generic semaglutide — positioning them at the front of the queue for US market launch when Novo Nordisk's US exclusivities expire. Together, these two approvals in two different markets demonstrate that India has the peptide API development, formulation, and manufacturing capability to deliver generic semaglutide at the quality standard required by the world's most stringent drug regulatory authorities.

At least 10 Indian companies are pursuing semaglutide generic programmes — including Cipla, Biocon, Sun Pharma, and Zydus alongside Dr Reddy's and Orbicular. India's domestic semaglutide market alone is projected to grow to $1 billion, and analysts at Jefferies describe the generic GLP-1 opportunity as a 'magic pill moment' for Indian pharma — analogous in commercial significance to India's role in making HIV antiretrovirals affordable globally in the early 2000s.

BHC Perspective

At Bengaluru Health Community, the Dr Reddy's-OneSource semaglutide approval is a landmark story for our city's pharmaceutical manufacturing capability. A Bengaluru facility just manufactured the world's first approved generic Ozempic for the Canadian market. That is a statement about what Bengaluru's pharma ecosystem has built. For BHC founders in peptide manufacturing, drug delivery technology, or pharmaceutical CDMO services — this approval is the market validation that demonstrates the commercial value of Bengaluru's emerging peptide manufacturing cluster.

Frequently Asked Questions

Q: What did Dr Reddy's achieve with Health Canada?
A: Dr Reddy's Laboratories received a Notice of Compliance from Health Canada on April 29, 2026, for generic Semaglutide Injection — making it the first company globally to receive market authorisation for generic Ozempic in Canada. Manufacturing was done by OneSource Specialty Pharma's Bengaluru facility.

Q: Why is Canada significant for generic semaglutide?
A: Canada is the world's second-largest semaglutide market, and unlike the US (where Novo Nordisk's patents prevent generic launch), Canada's patent landscape enabled Dr Reddy's to achieve a full market authorisation and proceed with commercial launch — the first generic semaglutide to market in any major regulated country.

Q: Who is OneSource Specialty Pharma?
A: OneSource Specialty Pharma is a BSE/NSE-listed Indian CDMO with a US FDA-approved peptide manufacturing facility in Bengaluru, Karnataka. The company is investing ~$100 million to expand capacity five-fold over 18-24 months to meet GLP-1 generic manufacturing demand.