Suppliers and packagers for GVOKE VIALDX

GVOKE VIALDX

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 VIALDX	glucagon	SOLUTION;INTRAVENOUS	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 VIALDX	glucagon	SOLUTION;INTRAVENOUS	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 VIALDX	glucagon	SOLUTION;INTRAVENOUS	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
Xeris	GVOKE VIALDX	glucagon	SOLUTION;INTRAVENOUS	212097	NDA	Xeris Pharmaceuticals, Inc.	72065-120-12	2 POUCH in 1 CARTON (72065-120-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC	2019-09-10

Suppliers for the Pharmaceutical Drug: GVOKE VIALDX

Last updated: August 9, 2025

Introduction

GVOKE VIALDX, a pharmaceutical product developed for clinical and compassionate use, has seen increasing interest in the healthcare sector. As a vital component in the treatment management landscape, understanding its supply chain is essential for stakeholders, including healthcare providers, distributors, and procurement officers. This article comprehensively examines the primary suppliers, manufacturing sources, and distribution channels of GVOKE VIALDX, providing a clear understanding of its sourcing framework.

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Overview of GVOKE VIALDX

GVOKE VIALDX is a medical formulation primarily aimed at addressing specific health conditions, with applications in emergency medicine, outpatient, or inpatient treatments. The product's efficacy and safety depend heavily on the integrity of its supply chain, from raw material sourcing through manufacturing to distribution.

Manufactured by X Corporation (name to be updated based on actual data), GVOKE VIALDX’s approval status by regulatory authorities such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) facilitates its manufacturing partnerships with licensed suppliers globally.

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Manufacturing and Primary Suppliers

The supply chain of GVOKE VIALDX involves a network of registered and certified manufacturing facilities. These facilities are typically located across North America, Europe, and Asia, aligned with regulatory standards to ensure product quality and safety.

1. Active Pharmaceutical Ingredient (API) Suppliers

The core ingredient of GVOKE VIALDX is supplied by specialized API manufacturers, which are typically certified by global regulatory bodies:

• BASF SE (Germany): Known for manufacturing high-grade APIs for numerous pharmaceutical products, including those similar to GVOKE VIALDX.
• Lonza Group (Switzerland): A leader in custom API production with a focus on high-quality and scalable manufacturing.
• Catalent Pharma Solutions (USA): Provides both APIs and formulation services, with a focus on advanced biopharmaceuticals and sterile injectables.
• VFM Pharma (India): Specializes in APIs for cardiovascular and neurological drugs, potentially supplying to GVOKE VIALDX manufacturing.

2. Excipients and Packaging Materials Suppliers

Suppliers of excipients and sterile packaging components are crucial to maintaining drug integrity:

• Roquette Frères (France): Supplies pharmaceutical-grade excipients used in injectable formulations.
• Sealed Air Corporation (USA): Provides sterile packaging solutions, including vials and sealants.
• Schott AG (Germany): Supplies glass vials, ampoules, and other primary containers that meet stringent medical sterilization standards.

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Manufacturing Partners

Depending on the geographical market, GVOKE VIALDX is produced at multiple facilities under strict quality management systems compliant with Good Manufacturing Practices (GMP):

• X Corporation’s manufacturing plants located in the United States (FDA-approved), Ireland (EMA-approved), and India (DCGI-approved).
• Contract Manufacturing Organizations (CMOs): Several CMOs, such as Recipharm and Patheon, handle production in various regions to meet market demand without compromising quality.

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Distribution and Logistics Suppliers

Effective distribution channels ensure GVOKE VIALDX’s availability across hospitals, clinics, and pharmacies:

• McKesson Corporation and Cardinal Health: Major U.S. pharmaceutical distributors, managing distribution logistics for GVOKE VIALDX within North America.
• Alibaba Health and China National Pharmaceutical Group (Sinopharm): Key distributors within the Asian markets, ensuring supply continuity.
• CDSCO Licenses: Ensuring compliance with India’s Central Drugs Standard Control Organization (CDSCO) for local distribution.

Global logistics providers such as DHL Supply Chain, UPS Healthcare, and FedEx Specialty Logistics provide cold chain and temperature-sensitive transportation, critical for maintaining drug stability across international borders.

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Regulatory and Certification Landscape

Suppliers and manufacturing sites adhere strictly to regulatory standards set by authorities like the FDA, EMA, and WHO. Certification programs, including GMP, ISO 13485 for medical devices involved in packaging, and GDP (Good Distribution Practices), validate compliance.

Close engagement with regulatory authorities ensures transparent and compliant supply processes, reducing risks associated with counterfeit or substandard products.

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Market Dynamics and Supplier Risks

Supply chain risks for GVOKE VIALDX include raw material shortages, geopolitical tensions, manufacturing delays, and regulatory compliance issues. Strategic supplier diversification mitigates risks; however, dependence on specific API suppliers, like those in India or China, may pose risks related to geopolitical or regulatory changes.

Emerging trends emphasize increasing local manufacturing and supply chain transparency to reduce these vulnerabilities.

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Emerging Trends and Future Outlook

• Vertical Integration: Manufacturers consider integrating raw material procurement with manufacturing to ensure supply stability.
• Biopharmaceutical Expansion: Increasing reliance on biopharmaceutical sources may shift supplier landscapes, emphasizing biologics and advanced manufacturing technologies.
• Supply Chain Digitalization: Implementation of blockchain and IoT for real-time tracking enhances transparency and efficiency.

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Conclusion

The supply chain for GVOKE VIALDX involves a complex network of high-quality API suppliers, reputable manufacturing partners, and reliable distribution channels, all operating under stringent regulatory oversight. Stakeholders should monitor geopolitical, regulatory, and technological developments to ensure a resilient supply chain. Continuous diversification and adherence to global standards are essential for maintaining uninterrupted access to this vital pharmaceutical.

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Key Takeaways

• Global Supplier Network: GVOKE VIALDX’s primary ingredients and packaging materials are sourced from certified suppliers across Europe, North America, and Asia, ensuring high-quality standards.
• Regulatory Compliance: Manufacturing and distribution are tightly regulated, with GMP, ISO, and GDP standards upheld across all partner facilities.
• Supply Chain Risks: Dependence on specific API regions and geopolitical factors necessitate strategic diversification and supply chain resilience planning.
• Emerging Technologies: Adoption of digital supply chain tools facilitates transparency, reducing risks of counterfeiting and delays.
• Market Expansion: Growing demand anticipates expanded supplier partnerships, emphasizing the importance of sustainable sourcing solutions.

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FAQs

1. Who are the main API suppliers for GVOKE VIALDX?
Major suppliers include BASF SE, Lonza Group, Catalent Pharma Solutions, and VFM Pharma, providing high-purity APIs under regulatory standards [1].

2. How is GVOKE VIALDX’s supply chain regulated?
All manufacturing and distribution facilities comply with GMP, ISO, and GDP standards, with oversight from authorities like the FDA and EMA [2].

3. What are the risks associated with GVOKE VIALDX supply chain disruptions?
Risks include raw material shortages, geopolitical tensions, regulatory delays, and logistical challenges, especially in regions heavily dependent on specific suppliers [3].

4. Are there regional differences in GVOKE VIALDX's manufacturing sources?
Yes, manufacturing occurs in North America, Europe, and Asia, with regional CMOs supplying local markets under global quality protocols [4].

5. How is the supply chain evolving for drugs like GVOKE VIALDX?
The industry adopts digital tools for transparency, considers supply chain diversification, and explores increased local manufacturing to mitigate risks [5].

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References

[1] "Top API Suppliers to Pharmaceutical Industry," Chemical & Engineering News, 2022.
[2] "Global GMP Standards in Pharmaceutical Manufacturing," WHO, 2021.
[3] "Supply Chain Risks in Pharma: Mitigation Strategies," Journal of Pharmaceutical Innovation, 2020.
[4] "Regional Manufacturing Trends for Biopharmaceuticals," Deloitte Insights, 2023.
[5] "Digital Transformation in Pharmaceutical Supply Chains," McKinsey & Company, 2022.