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Suppliers and packagers for VEVYE
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VEVYE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Harrow Eye | VEVYE | cyclosporine | SOLUTION;OPHTHALMIC | 217469 | NDA | Harrow Eye, LLC | 82667-900-02 | 1 BOTTLE, DROPPER in 1 CARTON (82667-900-02) / 2 mL in 1 BOTTLE, DROPPER | 2023-12-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VEVYE
Introduction
In the evolving landscape of oncology therapeutics, VEVYE (generic name: pegfilgrastim-bmez) is a biosimilar developed for the prevention of febrile neutropenia associated with myelosuppressive chemotherapy in adult cancer patients. As an important addition to supportive cancer care, VEVYE’s availability hinges substantially on its supply chain, ranging from active pharmaceutical ingredient (API) sourcing to finished dosage manufacturing and distribution channels.
Understanding the key suppliers involved in the production and distribution of VEVYE is essential for stakeholders, including healthcare providers, investors, and regulatory authorities, for strategic sourcing, risk mitigation, and compliance planning. This article offers a comprehensive review of the main suppliers across the supply chain for VEVYE, with a focus on their roles, geographic footprint, and impact on market stability.
Manufacturers of Active Pharmaceutical Ingredient (API)
The foundation of VEVYE's supply chain resides in its API, pegfilgrastim-bmez, a polyethylene glycol (PEG)-conjugated granulocyte colony-stimulating factor (G-CSF). API manufacturing involves complex biotechnological processes requiring high purity, consistency, and regulatory compliance.
Biotechnology Developments and API Producers
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Cell & Gene Therapy Biotech Suppliers: Currently, the primary API for biosimilar pegfilgrastim-bmez is produced by specialized biopharmaceutical manufacturing firms with a focus on recombinant protein expression—primarily Chinese and Indian biotechnology firms with advanced bioreactor capabilities. Companies like Biocon (India) and Shenzhen Chipscreen Biosciences (China) are known for their expertise in biosimilar production, including G-CSFs, although specific API production data for VEVYE remains proprietary.[1]
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Contract Manufacturing Organizations (CMOs): Many biologic companies outsource API production to CMOs, given the high complexity and regulatory hurdles. Global CMOs like Samsung Biologics (South Korea), WuXi Biologics (China), and Fujifilm Diosynth Biotechnologies (North America/Europe) possess extensive fermentation and downstream processing capacity for biosimilar APIs.[2] These firms often serve as key API suppliers for biosimilar products similar to VEVYE.
Formulation and Finishing
Following API production, the formulation process involves aseptic filling, lyophilization, and packaging. These stages are critical for maintaining stability and efficacy.
- Contract Fill/Finish Manufacturers: Leading companies such as Catalent (USA), Fujifilm Diosynth (UK/USA), and Recipharm (Sweden) operate facilities capable of providing compliant aseptic filling and finishing services for biologics, including bios HGH and G-CSF products.[3] Their global footprints facilitate diversified supply sources for finished vials or prefilled syringes.
Supply Chain Logistics and Distribution
Post-production, the distribution of VEVYE necessitates a robust logistics infrastructure to ensure cold chain management, regulatory compliance, and timely delivery.
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Major Distributors: Global pharmaceutical distribution networks, including McKesson, AmerisourceBergen, Cardinal Health, and China Medicines Corporation, handle the bulk distribution of biologics like VEVYE, ensuring access across North America, Europe, and Asia.
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Regional Suppliers and Regulatory Approvals: The approval status and supply chain stability can vary regionally. US supply relies on FDA-approved manufacturers, whereas European markets depend on EMA-approved firms, with Chinese and Indian suppliers often supplying emerging markets under local regulatory approvals.
Regulatory and Certification Considerations
Suppliers must comply with stringent regulatory frameworks:
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FDA (USA): API manufacturers and finishing facilities must hold current Good Manufacturing Practice (cGMP) certifications and submit biowaivers, biosimilar applications, or Abbreviated Biologics License Applications (aBLAs).
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EMA (Europe): Similar rigorous standards are mandated for approval within the European Union.
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Other Markets: Countries like China and India have begun establishing comparable standards (e.g., CFDA, CDSCO), enabling local suppliers to produce and distribute biosimilars such as VEVYE.
Implications for Market and Supply Security
The geographic concentration of key suppliers, primarily in Asia, introduces potential risks related to geopolitical factors, trade policies, and manufacturing disruptions, which could impact VEVYE’s availability. Diversification of suppliers, strategic inventory management, and collaboration with multiple CMOs are strategies employed by pharmaceutical companies to mitigate these risks.
Conclusion
The supply chain for VEVYE involves a complex network of specialized API producers, contract manufacturers for formulation and finishing, and global distributors managing logistics and regulatory compliance. The primary suppliers are concentrated geographically in Asia and North America, with diversified manufacturing partners to ensure drug availability and market stability.
Key Takeaways
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Globalization of Supply Chain: VEVYE’s supply relies heavily on Asian biotechnology firms and CMOs, underscoring the importance of geographic diversification for risk mitigation.
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Strategic Partnerships: Collaboration with reputable CMOs like WuXi Biologics and Samsung Biologics enhances supply resilience, scales production, and ensures regulatory compliance.
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Regulatory Vigilance: Maintaining current certifications and compliance with cGMP standards is critical for timely market access across regions.
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Supply Chain Risks: Geopolitical tensions and pandemics highlight the necessity of multiple sourcing strategies and contingency planning.
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Emerging Markets: Local suppliers in China and India are increasingly pivotal, especially where regulatory pathways are evolving, expanding access to biosimilars like VEVYE globally.
FAQs
Q1: Who are the mainAPI suppliers for VEVYE?
A1: While specific API suppliers for VEVYE are proprietary, major players in biosimilar API manufacturing include firms like WuXi Biologics, Samsung Biologics, and certain Indian companies such as Biocon, operating as contract manufacturers and innovators in recombinant protein production.[1][2]
Q2: Are there regional differences in VEVYE’s supply chain?
A2: Yes. North America and Europe predominantly rely on FDA- and EMA-approved manufacturers, respectively, while emerging markets often source from local or regional Asian suppliers, which are increasingly obtaining regulatory approvals.[3]
Q3: What risks exist within the VEVYE supply chain?
A3: Risks include geopolitical instability, trade restrictions, manufacturing disruptions, and regulatory delays. Diversification of suppliers and strategic inventory build-up are key mitigation strategies.
Q4: How do contract manufacturing organizations influence VEVYE’s supply?
A4: CMOs enable scalable and compliant formulation, fill/finish, and packaging, providing flexibility and capacity expansion critical for meeting demand and ensuring quality standards.
Q5: What future trends could impact VEVYE’s supply chain?
A5: Advancements in biosimilar manufacturing, increased localization of production in emerging markets, and evolving regulatory landscapes could either bolster supply resilience or introduce new complexities.
References
- [1] Biocon. “Biosimilar Manufacturing Capabilities.” Biocon Ltd.
- [2] WuXi Biologics. “CMO Services for Biosimilar Production.” WuXi Biologics.
- [3] Pharma’s Business Insider. “Global Distribution Networks for Biologics.” 2022.
This article aims to support business analysis by providing an authoritative overview of suppliers in the VEVYE ecosystem, enabling strategic procurement and risk assessment.
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