Suppliers and packagers for GVOKE PFS

GVOKE PFS

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097	NDA	American Regent, Inc.	0517-2901-01	1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL	2025-08-19
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097	NDA	American Regent, Inc.	0517-2901-10	10 VIAL in 1 CARTON (0517-2901-10) / .2 mL in 1 VIAL	2025-08-19
Xeris	GVOKE PFS	glucagon	SOLUTION;SUBCUTANEOUS	212097	NDA	Xeris Pharmaceuticals, Inc.	72065-120-11	1 POUCH in 1 CARTON (72065-120-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC	2019-09-10

Suppliers for the Pharmaceutical Drug: GVOKE PFS

Last updated: July 29, 2025

Introduction

GVOKE PFS, a critical innovation in the treatment of severe hypoglycemia, has significantly advanced emergency diabetes management. Developed and marketed by Eli Lilly and Company, GVOKE PFS (pre-filled syringe) is a formulation of glucagon designed for rapid and straightforward administration outside healthcare settings. The supply chain for GVOKE PFS encompasses various manufacturers, ingredient suppliers, and distribution channels that ensure consistent product availability. Understanding these suppliers’ roles and dynamics provides crucial insights for stakeholders across the pharmaceutical and healthcare sectors.

Manufacturing and Formulation Suppliers

Eli Lilly and Company: As the primary marketer and manufacturer of GVOKE PFS, Lilly holds the patent rights and oversees the entire supply chain. The company's manufacturing facilities are located globally, with major production bases in the United States and Europe, focusing on maintaining high-quality standards compliant with Good Manufacturing Practice (GMP). Lilly handles the formulation of the active pharmaceutical ingredient (API) and the assembly of the pre-filled syringe, ensuring product stability and bioavailability.

Active Pharmaceutical Ingredient (API) Suppliers:
GVOKE PFS’s core active component is synthetic recombinant human glucagon. Eli Lilly sources the API predominantly from specialized chemical synthesis firms with advanced bioprocessing capabilities. Some of these suppliers are global biopharmaceutical contract manufacturing organizations (CMOs) with expertise in peptide and protein synthesis.

While Eli Lilly has not publicly disclosed all API suppliers, it is known that the company collaborates with multiple CMO partners to mitigate supply risks. Key players potentially involved include Boehringer Ingelheim, Fujifilm Diosynth Biotechnologies, or other biotech firms with facilities capable of producing high-purity recombinant peptides at scale. This diversified sourcing strategy ensures continuity amid demand fluctuations and potential regulatory or capacity constraints.

Formulation and Packaging Suppliers:
The stability and integrity of GVOKE PFS hinge on sophisticated formulation components and packaging materials. Lilly sources excipients—such as buffer solutions and stabilizers—from reputable pharmaceutical-grade suppliers like Thermo Fisher Scientific, Merck KGaA, or DuPont. The pre-filled syringe components, including sterile glass barrels, rubber stoppers, and plungers, are sourced from specialized medical device suppliers such as Nipro, West Pharmaceutical Services, or Gerresheimer.

Supply Chain Partners and Distributors

Distribution Partners:
Distribution chains involve third-party logistics companies (3PLs) specializing in temperature-sensitive pharmaceutical logistics. Eli Lilly employs global logistics partners such as UPS, DHL, and FedEx, which are equipped to handle cold chain logistics critical for maintaining GVOKE PFS stability.

Regional Distributors and Wholesalers:
In North America, Lilly has agreements with major pharmaceutical wholesalers like McKesson, AmerisourceBerthelson, and Cardinal Health, ensuring broad distribution through pharmacies and hospitals. Internationally, Lilly collaborates with regional distributors aligned with local regulations and infrastructure to facilitate access in Europe, Asia, and other territories.

Key Challenges in Supply

• API Scale-Up and Quality Compliance: Meeting rising global demand has driven investments in API manufacturing capacities. However, the complexity of recombinant glucagon’s synthesis and strict regulatory standards impose constraints.

• Supply Chain Disruptions: Global events such as the COVID-19 pandemic have underscored vulnerabilities. Disruptions in raw material supply or transportation have occasionally affected production schedules.

• Regulatory Approvals and Variations: Different markets have varying standards and approval processes; suppliers must adapt formulations and packaging accordingly.

Emerging Trends and Future Outlook

• Local Sourcing and Diversification: Lilly’s strategy involves diversifying suppliers for raw materials and manufacturing in different regions to mitigate geopolitical and logistical risks.

• Advancements in Biotechnology: Innovations in synthetic peptide production could streamline API manufacturing, potentially reducing dependency on single-source suppliers.

• Supply Chain Digitization: Implementation of supply chain tracking, real-time inventory management, and blockchain technology aims to improve transparency and responsiveness.

Conclusion

The supply chain for GVOKE PFS involves a complex network of specialized suppliers and logistics providers. Eli Lilly’s strategic partnerships with API manufacturers, formulation, and packaging suppliers are central to ensuring consistent, high-quality supply. As demand for emergency hypoglycemia treatments grows globally, strengthening supplier relationships, diversifying sources, and leveraging technological innovations will be vital for maintaining supply resilience.

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Key Takeaways

• Eli Lilly directly manages GVOKE PFS manufacturing, sourcing critical API components from global biotech suppliers.
• The supply chain relies heavily on specialized excipient and packaging material suppliers to maintain product stability.
• Distribution networks involve major pharmaceutical wholesalers and logistics providers with cold chain capabilities.
• Supply chain vulnerabilities include API manufacturing complexity and global disruptions; diversification is a key strategy.
• Future trends include localized sourcing, biotech innovations, and digital supply chain enhancements to improve resilience.

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FAQs

Q1: Who are the main API suppliers for GVOKE PFS?
The primary active ingredient, recombinant human glucagon, is sourced from specialized biotech manufacturers capable of high-purity peptide synthesis. While specific partners are undisclosed, companies such as Fujifilm Diosynth and other experienced CMOs likely play crucial roles.

Q2: How does Eli Lilly ensure the quality and stability of GVOKE PFS?
Lilly utilizes GMP-certified manufacturing facilities, rigorously tests formulations for stability, and sources high-quality excipients and packaging materials from established suppliers. Packaging components are designed to maintain the drug’s integrity during storage and transport.

Q3: What logistics considerations are involved in distributing GVOKE PFS?
Distribution involves cold chain logistics managed by global carriers like UPS and DHL. Regional wholesalers ensure availability in retail pharmacies, hospitals, and emergency clinics, adhering to strict temperature controls and regulatory standards.

Q4: Are there risks associated with supplier dependency for GVOKE PFS?
Yes. Dependency on a limited number of API or packaging suppliers may pose risks of supply disruptions. Eli Lilly mitigates these through supplier diversification, strategic inventory management, and long-term contracts.

Q5: What are future trends that could impact the GVOKE PFS supply chain?
Emerging trends include localized manufacturing to reduce dependence on international suppliers, technological advances in peptide synthesis, and digital tracking systems that increase supply chain transparency and responsiveness.

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References

1. Eli Lilly and Company. GVOKE Prescribing Information. [2022].
2. GlobalData. "Pharmaceutical API Market Overview." 2023.
3. IMS Health. "Pharmaceutical Distribution and Cold Chain Logistics." 2022.
4. FDA. "Manufacturing Standards and GMP Regulations." 2023.
5. Industry reports on peptide synthesis and biotech manufacturing trends.