Trust signals
> Reviewed by FormBlends Medical Team · Last updated May 2026 · 11 sources cited
Key Takeaways
- Ozempic's semaglutide active pharmaceutical ingredient is produced primarily at Novo Nordisk's Kalundborg complex in Denmark, the largest pharmaceutical site in Northern Europe.
- Fill-finish operations are distributed across Denmark, Chartres in France, Montes Claros in Brazil, and Clayton, North Carolina in the United States.
- Clayton, North Carolina is the principal fill-finish site for Ozempic and Wegovy serving the North American market.
- Fill-finish capacity, not active ingredient supply, was the principal bottleneck during the 2022 through early 2025 semaglutide shortage.
- Novo Nordisk announced multibillion-dollar manufacturing expansions through 2023, 2024, and 2025 to meet demand and reduce shortage risk.
Direct answer
Ozempic is manufactured by Novo Nordisk. The semaglutide active ingredient is produced primarily in Denmark, especially at the Kalundborg site. Fill-finish operations, where the active ingredient is filled into prefilled pens, take place in Denmark, France, Brazil, and the United States. The Clayton, North Carolina facility is the principal US fill-finish site for the North American market. The company expanded capacity at all major sites during 2023 through 2025 in response to GLP-1 demand.
Get medications from a trusted source
FormBlends sources through 503A compounding pharmacies with third-party purity testing on every batch.
Start Free Assessment →Table of contents
- The two stages of pharmaceutical manufacturing
- The Kalundborg complex in Denmark
- The Clayton, North Carolina facility
- Other Novo Nordisk production sites
- Why fill-finish was the shortage bottleneck
- The capacity expansions announced through 2025
- How a pen of Ozempic actually moves through the supply chain
- Counterfeits and the FDA's parallel concerns
- What this means for patients and pharmacies
- FAQ
- Sources
The two stages of pharmaceutical manufacturing
Injectable biologics like semaglutide move through two principal production stages.
Stage 1: Active pharmaceutical ingredient (API) production. The molecule itself is manufactured. Semaglutide is produced through a combination of recombinant expression in yeast (using genetically modified Saccharomyces cerevisiae) followed by chemical modification to add the fatty-acid linker and protein-engineering substitutions that give semaglutide its long half-life. The result is a complex peptide drug substance.
Stage 2: Fill-finish. The drug substance is formulated into the final liquid product, filled into sterile cartridges, assembled into prefilled pens, packaged, and labeled. Fill-finish is highly automated, requires aseptic processing, and is often the rate-limiting step for injectable drugs at scale.
Both stages are highly regulated. The FDA inspects manufacturing sites for compliance with Current Good Manufacturing Practice (cGMP). Sites in foreign countries that supply the US market are subject to FDA inspections as well.
The Kalundborg complex in Denmark
Novo Nordisk's largest production site is in Kalundborg, on the western coast of Zealand in Denmark. The complex covers a large industrial area and produces:
- Active pharmaceutical ingredients for insulins, GLP-1s, and other products.
- Bulk drug substance for fill-finish sites worldwide.
- Some finished-product manufacturing.
Kalundborg is part of a broader industrial symbiosis ecosystem with neighboring plants in heat, water, and byproduct exchange. The site has expanded repeatedly to support Novo Nordisk's growth, and several of the company's largest recent capital investments have been directed there.
The Clayton, North Carolina facility
The Clayton site, located approximately 20 miles southeast of Raleigh, North Carolina, is Novo Nordisk's principal US production facility. Established for insulin manufacturing in 1993, the site has grown over three decades into a multibillion-dollar campus.
Clayton currently performs:
- Fill-finish for Ozempic, Wegovy, and other Novo Nordisk products for the North American market.
- Some active ingredient production, including capacity additions announced through 2023 to 2024.
- Quality control, device assembly, and packaging.
Novo Nordisk announced an additional fill-finish facility in Clayton in 2023 and broke ground on additional capacity in 2024, with phased commissioning expected through the late 2020s.
Other Novo Nordisk production sites
Beyond Denmark and the United States, the company operates additional manufacturing sites globally.
| Site | Country | Primary role |
|---|---|---|
| Bagsvaerd | Denmark | R&D, some pilot production |
| Kalundborg | Denmark | API and bulk production |
| Hillerod | Denmark | Fill-finish for European market |
| Chartres | France | Fill-finish, devices |
| Clayton | United States | Fill-finish, expanding API capacity |
| Montes Claros | Brazil | Fill-finish for Latin America |
| Tianjin | China | Fill-finish for China |
| Koriyama | Japan | Fill-finish for Japan |
This distributed footprint reduces single-site risk but multiplies regulatory inspection burden. Each site is qualified separately by the FDA, the European Medicines Agency, and other regulators.
Why fill-finish was the shortage bottleneck
During the 2022 through early 2025 semaglutide shortage, the primary constraint was not the supply of active ingredient. It was the supply of finished pens.
Fill-finish for an injectable peptide pen requires:
- Aseptic filling lines capable of handling viscous biologic formulations.
- Cartridge assembly into prefilled pen devices.
- Functional testing of the assembled pen.
- Labeling and packaging compliant with each market's regulatory requirements.
- Quality release testing for each lot.
Adding a new fill-finish line takes years from site selection through facility build-out, equipment qualification, process validation, regulatory inspection, and product release. New API capacity can come online somewhat faster but cannot substitute for fill-finish capacity. The result was a multi-year gap between announced demand growth and added pen output.
The capacity expansions announced through 2025
Novo Nordisk's response to GLP-1 demand has been a sequence of capital announcements:
- Kalundborg. Multibillion-dollar expansion of API and bulk drug substance capacity, with phased commissioning through the 2020s.
- Chartres. Expansion of fill-finish capacity for European supply.
- Clayton. Multiple announced phases of fill-finish and API expansion, including the high-profile Bagsvaerd-to-Clayton capacity shift announced in 2024.
- Catalent acquisition. Novo Holdings, the investment vehicle of the Novo Nordisk Foundation, completed the acquisition of Catalent in late 2024, with Catalent's fill-finish facilities then made available to Novo Nordisk under a manufacturing arrangement.
By the time the FDA removed semaglutide from the shortage list on February 21, 2025, capacity had grown sufficiently to support sustained supply of Ozempic and Wegovy at higher than prior production levels.
How a pen of Ozempic actually moves through the supply chain
From molecule to medicine cabinet, a single pen of Ozempic typically passes through:
- Yeast fermentation of the semaglutide precursor at an API site, principally in Denmark.
- Chemical modification, purification, and lyophilization to produce drug substance.
- Shipment of drug substance to a fill-finish facility (Denmark, France, the United States, or another country, depending on destination market).
- Formulation into the final injectable liquid.
- Aseptic filling into glass cartridges.
- Assembly of cartridges into prefilled pens with attached dosing mechanism.
- Functional testing, labeling, packaging, and lot release.
- Distribution to authorized wholesalers, which then distribute to pharmacies.
- Pharmacy dispensing on a prescription basis.
Each step is documented and traceable under cGMP requirements. The supply chain is more complex than the simple geographic answer "made in Denmark" suggests.
Counterfeits and the FDA's parallel concerns
Manufacturing-related issues distinct from Novo Nordisk's own production have included counterfeit and unauthorized products.
- The FDA has issued warnings about counterfeit Ozempic pens entering the US supply chain through unauthorized distributors.
- Some products labeled as "semaglutide" have been found to contain different ingredients, including unrelated peptides or no active ingredient.
- Patients purchasing GLP-1 medications outside the licensed US distribution chain face a higher risk of receiving counterfeit or substandard products.
Patients should fill prescriptions only at state-licensed pharmacies and should be cautious of online sources offering substantially below-market prices for what is presented as authentic Ozempic or Wegovy.
What this means for patients and pharmacies
The practical implications of the manufacturing footprint:
- Supply availability depends on global fill-finish capacity, not just US production. Disruptions at any site can affect downstream availability.
- The shortage resolution announced in February 2025 reflected expanded capacity, not changes in demand.
- Authentic Ozempic distributed in the United States passes through Novo Nordisk's authorized US distribution chain, which provides traceability and counterfeit protection.
- Compounded semaglutide is a separate product category prepared by state-licensed compounding pharmacies. It is not manufactured by Novo Nordisk and is not FDA-approved.
The contrary view: why distributed manufacturing has trade-offs
A multi-site network reduces single-point-of-failure risk but creates other challenges.
Trade-offs to consider:
- Regulatory complexity. More sites mean more inspections, more validations, and more opportunities for any single site's findings to trigger constraints.
- Quality consistency. Multi-site production requires rigorous standardization. Differences in raw material sourcing, equipment, or training can produce subtle quality variability.
- Geopolitical exposure. Production in multiple countries introduces exposure to local regulation, trade policy, and political risk in each jurisdiction.
- Capital intensity. Maintaining several large facilities is more capital-intensive than consolidating production at fewer sites with greater throughput.
Novo Nordisk's choice to operate a distributed footprint reflects the scale of demand, regulatory considerations, and the geographic distribution of markets. It is not the only viable model; some pharmaceutical companies concentrate production at fewer sites.
Compounded medication note for this topic
For Where Is Ozempic Manufactured? Mapping Novo Nordisk's Global Supply Chain, keep the pharmacy distinction clear: when compounded semaglutide or tirzepatide is prescribed, it is prepared for an individual patient by a licensed 503A compounding pharmacy. Compounded preparations are not FDA-approved drug products and are not interchangeable with Ozempic, Wegovy, Mounjaro, or Zepbound.
The practical question is not whether a compounded medication is a brand substitute. It is whether the prescription, pharmacy label, concentration, follow-up plan, and adverse-event support are clear enough for your specific medical history.
FAQ
Where is Ozempic manufactured?
Active ingredient production is primarily in Denmark (Kalundborg). Fill-finish takes place in Denmark, France, Brazil, the United States, and a handful of other locations. The Clayton, North Carolina site is the principal US fill-finish facility.
Is Ozempic made in China?
Novo Nordisk operates a fill-finish facility in Tianjin, China, primarily serving the Chinese domestic market. Ozempic distributed in the United States is not generally sourced from China.
Is Ozempic made in the United States?
Fill-finish operations for the US market are performed at Clayton, North Carolina. The active ingredient itself is principally produced in Denmark and shipped to fill-finish sites.
Who actually owns the Clayton site?
Novo Nordisk Inc., the US subsidiary of Novo Nordisk A/S, owns and operates the Clayton facility.
What is Catalent's role?
Catalent, a contract manufacturer acquired by Novo Holdings in late 2024, operates fill-finish facilities that have been made available to Novo Nordisk through manufacturing arrangements. The acquisition was a significant lever to expand fill-finish capacity quickly.
Why was there an Ozempic shortage if Novo Nordisk has so many sites?
Demand growth outpaced fill-finish capacity. Adding pen-assembly capacity takes years even with major investment. The shortage reflected capacity timing, not a manufacturing failure.
Does manufacturing location affect Ozempic quality?
All Novo Nordisk sites supplying the US market operate under FDA-inspected cGMP conditions. Manufacturing location does not produce a clinically relevant difference in the medication.
Could a future shortage happen?
Capacity additions through 2024 and 2025 reduced shortage risk substantially. Future shortages are still possible if demand grows faster than capacity or if a major site experiences disruption.
What about compounded semaglutide manufacturing?
Compounded semaglutide is prepared by state-licensed compounding pharmacies under individual prescriptions. It is not manufactured by Novo Nordisk and follows compounding rules, not the FDA approval pathway.
Related guides
- Who Makes Ozempic? Inside Novo Nordisk, the Danish Company Behind the GLP-1 Era
- Who Makes Wegovy? Novo Nordisk's Obesity-Indication Brand of Semaglutide
- Is There a Zepbound Shortage in 2026? Where Tirzepatide Supply Stands
- The GLP-1 Supply Chain Explained: How the Shortage Happened, What Fixed It, What Compounding Did
- How Long Can Ozempic Be Unrefrigerated? Cold-Chain Failures and Real Limits
- Where to Inject Ozempic: A Site-by-Site Guide
Sources
- Novo Nordisk A/S. Annual Report 2024. Manufacturing footprint disclosures.
- Novo Nordisk. Kalundborg site profile.
- Novo Nordisk Inc. Clayton, North Carolina site profile.
- Novo Holdings. Catalent acquisition completion announcement, December 2024.
- US Food and Drug Administration. Drug Shortages Database. Semaglutide resolution, February 21, 2025.
- US Food and Drug Administration. Counterfeit Ozempic warnings, 2023 and 2024.
- US Food and Drug Administration. Current Good Manufacturing Practice (cGMP) regulations.
- European Medicines Agency. GMP inspection database.
- Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine. 2021.
- Novo Nordisk. Press releases on Kalundborg and Clayton capacity expansions, 2023-2025.
- US Food and Drug Administration. Ozempic Prescribing Information.
Footer disclaimers
Platform Disclaimer. FormBlends is an independent digital health platform. We are not affiliated with Novo Nordisk. Information about manufacturing locations is summarized from public company disclosures and may not reflect the most current operational status.
Compounded Medication Notice. Compounded semaglutide is not FDA-approved and is not manufactured by Novo Nordisk. It is prepared by state-licensed compounding pharmacies under individual prescriptions and follows distinct regulatory rules from FDA-approved Ozempic and Wegovy.
Results Disclaimer. Manufacturing location does not predict individual treatment outcomes. Clinical results vary by patient and depend on many factors beyond product origin.
Trademark Notice. Ozempic, Wegovy, Rybelsus, Saxenda, and Victoza are registered trademarks of Novo Nordisk A/S. Mounjaro and Zepbound are registered trademarks of Eli Lilly and Company. Catalent is a registered trademark of Catalent Pharma Solutions. FormBlends is not affiliated with any of these companies.
See your options in about 2 minutes
Take the free quiz and see what fits you. Quick, private, and no commitment to continue.
See my options →