Last updated: February 19, 2026
Who are the primary suppliers of Dasiglucagon Hydrochloride?
Dasiglucagon hydrochloride is a synthetic peptide used primarily for treating severe hypoglycemia in patients with diabetes. It is marketed under the brand name Zegalogue by Zealand Pharma and has recently seen increased demand, which has led to multiple suppliers entering the market.
Which manufacturers produce Dasiglucagon Hydrochloride?
Several pharmaceutical companies and contract manufacturing organizations (CMOs) supply Dasiglucagon Hydrochloride or its bulk active pharmaceutical ingredient (API). These suppliers include:
1. Zealand Pharma
- Role: Original developer and marketer
- Status: Produces commercially available Dasiglucagon Hydrochloride under Zegalogue
- Manufacturing: Owns manufacturing facilities or contracted production for API and finished drug product
2. EpiVax and other CMOs
- Role: Contract manufacturing organizations for API production
- Supply: Offer bulk API to pharmaceutical companies
- Locations: Several based in Europe and Asia, including India and China
3. Generic API Manufacturers
- Market Entry: Emerged post-approval of Zegalogue
- Countries: India, China, South Korea
- Status: Vary from pre-approval testing batches to commercially licensed suppliers
4. Global Bulk API Suppliers
- Several large-scale suppliers with capabilities in peptide synthesis provide Dasiglucagon hydrochloride to pharmaceutical companies, though their identities often remain undisclosed due to confidentiality agreements.
Key considerations for sourcing
| Criterion |
Details |
| Regulatory Approval |
Suppliers must have validation and approval from FDA or EMA. |
| Quality Standards |
Compliance with cGMP standards mandated in the US, Europe, or other jurisdictions. |
| Capacity |
Suppliers must meet demand volume, especially amid surge in hypoglycemia treatment needs. |
| Cost |
Competitive pricing typically varies depending on batch size, purity, and origin. |
Supply chain dynamics
- Current Shortages: Reported in some regions due to manufacturing delays, particularly in non-validated Asian suppliers.
- Autonomy of Supply: Original supplier Zealand Pharma maintains control over API quality, but access to the API from third-party suppliers is critical for new market entrants or off-label uses.
- Regulatory hurdles: Suppliers need to demonstrate compliance with strict regulations, including stability data and purity specifications.
Summary table: Key suppliers and their roles
| Supplier |
Role |
Location |
Certification |
Market Share |
| Zealand Pharma |
Original marketer |
Denmark |
EMA, FDA-approved manufacturing |
High (controlled supply) |
| API CMOs |
Contract manufacturing |
India, China |
cGMP |
Variable (growing with market) |
| Generic drugmakers |
API and finished product |
India, South Korea |
cGMP |
Increasing, especially in generic markets |
Conclusion
Supply of Dasiglucagon Hydrochloride primarily depends on Zealand Pharma’s production and quality controls. Contract manufacturing organizations in Asia provide alternative sources for API, with quality and regulatory compliance varying. Global demand for hypoglycemia treatments continues to influence market access and supply chain stability.
Key Takeaways
- Zealand Pharma is the primary supplier of the marketed product.
- Asian CMOs provide bulk API, often used for generics or biosimilar development.
- Regulatory standards and manufacturing capacity are critical factors influencing supply stability.
- Market dynamics are increasingly driven by approvals in emerging markets and the growth of peptide manufacturing capabilities.
FAQs
1. Who manufactures the active pharmaceutical ingredient (API) for Dasiglucagon Hydrochloride?
Primarily contract manufacturers in India and China supply the API, alongside Zealand Pharma’s controlled supply.
2. Are there generic alternatives to Zegalogue?
Generic versions are emerging as API manufacturing expands, but regulatory approval varies across regions.
3. What are the main regulators for suppliers of Dasiglucagon?
The FDA in the US and EMA in Europe oversee quality and approval standards for API and finished drugs.
4. Is supply chain disruption common for Dasiglucagon Hydrochloride?
Yes, supply disruptions have occurred due to manufacturing delays, especially outside of the original manufacturer's control.
5. How does demand influence supplier capacity?
Rising demand for hypoglycemia treatments has led to increased production and new supplier participation, but capacity remains a concern.
Citations
[1] European Medicines Agency. (2022). Zegalogue API approval documentation. EMA.
[2] U.S. Food and Drug Administration. (2022). Drug Approval Files for Zegalogue. FDA.
[3] Zealand Pharma. (2023). Annual Report. Zealand Pharma.
[4] IMARC Group. (2022). Peptide Market Report.
[5] Contract Pharma. (2023). Peptide API manufacturing trends.
