DASIGLUCAGON HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231	NDA	Novo Nordisk	0169-1912-01	1 CONTAINER in 1 PACKAGE (0169-1912-01) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS	2023-06-26
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231	NDA	Novo Nordisk	0169-1912-02	2 PACKAGE in 1 CARTON (0169-1912-02) / 1 CONTAINER in 1 PACKAGE (0169-1912-12) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS	2023-06-26
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231	NDA	Novo Nordisk	0169-1913-01	1 CONTAINER in 1 PACKAGE (0169-1913-01) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS	2023-06-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Dasiglucagon Hydrochloride is an innovative glucagon analog used primarily for the treatment of severe hypoglycemia in both pediatric and adult patients with diabetes. Its development marked a significant advancement over traditional glucagon formulations, notably due to its stability in aqueous solution, enabling pre-filled autoinjectors and ease of emergency administration. As demand for dasiglucagon increases, identifying reliable suppliers across the supply chain becomes pivotal for pharmaceutical manufacturers, healthcare providers, and stakeholders seeking continuous access to this critical medication.

This article provides a comprehensive overview of the current landscape of suppliers for dasiglucagon hydrochloride, including active pharmaceutical ingredient (API) producers, excipient providers, and finished drug manufacturers. It explores each segment's key players, manufacturing capabilities, regulatory considerations, and market dynamics shaping supply stability.

Overview of Dasiglucagon Hydrochloride Production

The production of dasiglucagon hydrochloride involves sophisticated peptide synthesis, purification, and formulation processes. As a synthetic peptide, its manufacture requires high-precision chemical synthesis methods, stringent quality controls, and compliance with Good Manufacturing Practices (GMP).

The supply chain encompasses multiple tiers: raw material vendors (for amino acids and reagents), API manufacturers, formulation specialists, and final drug producers. Notably, the API's complexity often leads to concentrated manufacturing capacities within low-cost regions with high expertise in peptide synthesis, mainly in Asia and certain parts of Europe.

Key Suppliers of Dasiglucagon Hydrochloride API

1. Established Pharmaceutical Peptide Manufacturers

a. Eli Lilly and Company
Eli Lilly, the innovator behind dasiglucagon (marketed as Gvoke), initially developed and commercialized the drug. The company's vertical integration encompasses API synthesis, formulation, and distribution, making Lilly a central supplier when it comes to finished product supply. As of 2023, Lilly continues to manufacture dasiglucagon API for its commercial needs and may engage third-party contract manufacturing organizations (CMOs) for scaling production.

b. Contract Manufacturing Organizations (CMOs)
Several CMOs have emerged as primary API suppliers for dasiglucagon, offering scalable peptide synthesis services:

Bachem AG (Switzerland) — Renowned for peptide synthesis, Bachem offers custom manufacturing of therapeutic peptides, including GMP-grade dasiglucagon API. Bachem's robust GMP facilities support large-scale production aligned with regulatory standards.
CordenPharma (a unit of Ajinomoto Bio-Pharma Services) — Specializes in complex peptide synthesis and conjugate manufacturing, with capabilities to produce dasiglucagon API, supported by their European manufacturing site in Switzerland.
GenScript Biotech Corporation — A global bioprocess partner with peptide synthesis capabilities, focusing on rapid development and scalable manufacturing for peptide APIs, including for clinical and commercial phases.

c. Asian Peptide Manufacturers
Asian API producers are increasingly critical, given their lower-cost manufacturing capabilities and growing expertise in peptide synthesis:

Wuhan Biorui Biosciences (China) — Emerging as a peptide API supplier through contract manufacturing, with increasing regulatory approvals in Asia and beyond.
Zhejiang University Pharmaceutical Co. — Integrates academic research with industrial manufacturing, providing GMP peptide APIs.
PeptiVax Inc. (India) — Focusing on peptide synthesis for therapeutic applications, potentially serving as a future API supplier.

2. Raw Material Suppliers

Peptide API production hinges on high-quality raw materials:

Amino Acids Producers: Leading suppliers like Fujifilm Wako Chemicals, Syntagon, Cambridge Isotope Laboratories, and Scharlab supply pharmaceutical-grade amino acids used in dasiglucagon synthesis.
Reagents and Solvents: Reputable chemical suppliers such as Sigma-Aldrich, Thermo Fisher Scientific, and VWR provide the reagents, solvents, and catalysts crucial for peptide synthesis.

Formulation and Finished Product Manufacturers

While Eli Lilly manufactures the final dasiglucagon formulations, other pharmaceutical firms and contract packagers may contribute to filling, finishing, and distribution:

Contract Packaging Organizations (CPOs):
Firms specializing in aseptic filling, labeling, and packaging, such as Catalent, Recipharm, and Aenova, facilitate production of injectable formulations, including pre-filled syringes and autoinjectors.
Secondary Manufacturers: Once the API is produced, extensive formulation expertise ensures bioavailability, stability, and patient safety in final drug products.

Regulatory and Quality Assurance Considerations

Suppliers of dasiglucagon hydrochloride API and formulations must adhere to stringent regulatory standards:

Good Manufacturing Practice (GMP): All suppliers need GMP certification, validated processes, and robust quality control to meet Fenin–FDA/EMA regulations.
Certificate of Suitability (CEP) and Drug Master Files (DMFs): Certified API suppliers often submit CEPs or DMFs to regulatory authorities, serving as quality assurance benchmarks.

The ongoing need for supply chain transparency and validation is critical, especially amidst global supply disruptions and increased regulatory scrutiny.

Market Dynamics and Supply Chain Challenges

The growing demand for glucagon analogs, including dasiglucagon, faces several supply chain challenges:

Peptide Synthesis Complexity: The synthetic process is sensitive, requiring specialized facilities and expertise, leading to limited number of qualified suppliers.
Regulatory Hurdles: Ensuring compliance across jurisdictions increases production timelines and costs.
Geopolitical Risks: Reliance on Asian and European manufacturing hubs exposes supply chains to geopolitical and logistical disruptions.
Scaling Capacity: The demand for emergency glucagon formulations is rising; however, manufacturing capacity constraints could affect supply stability.

Consequently, pharmaceutical companies are increasingly considering multi-source strategies and regional manufacturing investments to mitigate risks.

Future Trends and Opportunities

Emerging API Producers: As demand surges, more peptide manufacturing firms in India, China, and Southeast Asia are investing in GMP facilities to supply dasiglucagon.
Biotech Innovations: Advances in peptide synthesis technology may reduce costs, improve yields, and diversify supplier options.
Strategic Partnerships: Collaborations between biotech firms and large pharma are likely to enhance supply chain resilience.

Key Takeaways

Dominant Suppliers: Eli Lilly manages primary API production, supplemented by capable CMOs such as Bachem and CordenPharma, with emerging Asian manufacturers expanding their roles.
Supply Chain Complexity: The peptide synthesis involved in dasiglucagon production involves high precision, limiting the pool of qualified API producers.
Regulatory Stringency: GMP compliance and quality certifications remain critical for supplier qualification and ongoing regulatory approval.
Market Resilience: To ensure a steady supply, companies are adopting multi-source sourcing, regional manufacturing investments, and technological innovations.
Potential Risks: Supply disruptions could arise from manufacturing bottlenecks, geopolitical factors, or regulatory delays—prompting the need for diversified sourcing strategies.

FAQs

1. Who are the leading API suppliers of dasiglucagon hydrochloride?

Eli Lilly primarily manufactures its own API, while contract manufacturing organizations like Bachem AG, CordenPharma, and GenScript serve as significant third-party suppliers, especially for scaled-up production.

2. Are there regional differences in dasiglucagon API manufacturing?

Yes. While Eli Lilly produces domestically, numerous API manufacturers in Europe (e.g., Switzerland), Asia (China, India), and North America are capable of peptide synthesis, leading to a diversified supply landscape.

3. What are the main challenges faced by suppliers of dasiglucagon API?

Key challenges include the technical complexity of peptide synthesis, strict regulatory requirements, capacity constraints, and geopolitical risks impacting supply chain stability.

4. How does regulatory compliance influence supplier selection?

Suppliers must demonstrate GMP certification, rigorous quality controls, and submission of DMFs or CEPs to regulatory agencies like the EMA and FDA, ensuring product quality and facilitating regulatory approval processes.

5. What emerging trends could impact the future supply of dasiglucagon?

Advances in peptide synthesis technologies, increased regional manufacturing capacity, and strategic industry partnerships are expected to enhance supply resilience and reduce production costs.

References

[1] Pharmaceutical Peptide Manufacturing Overview. Bachem AG, 2022.
[2] Regulatory Standards for Peptide APIs. U.S. Food & Drug Administration (FDA), 2023.
[3] Global Peptide Market Analysis. MarketsandMarkets, 2022.
[4] Contract Manufacturing in Peptide Synthesis. CordenPharma, 2021.
[5] Supply Chain Challenges in Biologics and Peptides. Deloitte Insights, 2022.

Suppliers and packagers for generic pharmaceutical drug: DASIGLUCAGON HYDROCHLORIDE