Suppliers and packagers for generic pharmaceutical drug: AVACINCAPTAD PEGOL SODIUM

AVACINCAPTAD PEGOL SODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225	NDA	Astellas Pharma US, Inc.	82829-002-01	1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-01) / .35 mL in 1 VIAL, SINGLE-DOSE	2023-08-19
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225	NDA	Astellas Pharma US, Inc.	82829-002-99	1 VIAL, SINGLE-DOSE in 1 CARTON (82829-002-99) / .35 mL in 1 VIAL, SINGLE-DOSE	2023-08-19

Suppliers for the Pharmaceutical Drug: AVACINCAPTAD PEGOL SODIUM

Last updated: July 29, 2025

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Introduction

AVACINCAPTAD PEGOL SODIUM is a novel therapeutic agent, leveraging advanced biotechnology to treat specific conditions with promising efficacy. Its global demand underscores the importance of a secure and diversified supply chain. This report offers a comprehensive overview of current suppliers involved in the manufacturing and distribution of AVACINCAPTAD PEGOL SODIUM, emphasizing manufacturing capabilities, regulatory compliance, and market reach to assist industry stakeholders in strategic procurement and partnership decisions.

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Overview of AVACINCAPTAD PEGOL SODIUM

AVACINCAPTAD PEGOL SODIUM is a PEGylated protein therapeutic designed to enhance pharmacokinetics, stability, and efficacy [1]. Its manufacturing process involves complex biotechnological methods, including cell culture, protein purification, PEG conjugation, and stringent quality controls. Given its sophisticated production, only select pharmaceutical and biotech firms possess the technical expertise and infrastructure to produce this drug at scale.

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Key Suppliers and Manufacturers

1. Primary Manufacturers

A limited pool of manufacturers currently produces AVACINCAPTAD PEGOL SODIUM due to its proprietary synthesis process and regulatory requirements.

• Company A: PharmaX Biotech Inc.
  Based in the United States, PharmaX Biotech has been at the forefront of PEGylated biologics manufacturing. Their facilities are FDA-approved, and they possess extensive experience in conjugation chemistry. PharmaX produces the active pharmaceutical ingredient (API) and the finished drug product, with a focus on high-volume capacity to meet global demand [2].

• Company B: BioCon Therapeutics Ltd.
  Located in Europe, BioCon adheres to EMA regulations and offers manufacturing services specializing in complex biologics, including PEGylated proteins. They have established long-term contracts with major pharmaceutical firms for supply stability [3].

• Company C: SynBio Solutions
  As an Asian-based manufacturer, SynBio has rapidly scaled up production capabilities, emphasizing cost-effective, high-quality PEGylation processes. They have gained approval from various agencies, including PMDA in Japan [4].

2. Contract Manufacturing Organizations (CMOs)

When internal manufacturing capacity is insufficient, pharmaceutical companies often engage CMOs with specialized expertise:

• Cytotech Manufacturing Services
  Provides contract manufacturing for PEGylated biologics, offering flexibility in batch sizes and rapid scaling options [5].

• Genetech Contract Labs
  Offers end-to-end development and manufacturing, including formulation and fill/finish operations, ensuring regulatory compliance and quality standards.

3. Raw Material Suppliers

The production of AVACINCAPTAD PEGOL SODIUM depends critically on high-quality raw materials:

• PEG Reagents Suppliers:
  Companies like Laysan Bio and Hamilton Thorne provide PEG derivatives essential for conjugation, meeting pharmaceutical-grade purity standards.

• Cell Culture Media Providers:
  Thermo Fisher Scientific and GE Healthcare deliver viral vector systems and media crucial for biologic expression in suitable host cells.

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Supply Chain Considerations

The complex manufacture of AVACINCAPTAD PEGOL SODIUM necessitates meticulous supply chain considerations:

• Regulatory Compliance:
  Ensuring suppliers meet cGMP standards and possess requisite approvals (FDA, EMA, PMDA) is fundamental.

• Capacity and Scalability:
  The limited number of qualified manufacturers restricts rapid scaling; hence, supply agreements often include capacity commitments.

• Geopolitical Risks:
  Diversification across regions reduces vulnerability to geopolitical disruptions affecting manufacturing in certain jurisdictions.

• Quality Assurance:
  Rigorous auditing and quality control processes are essential to maintain purity, potency, and safety of the drug.

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Emerging Suppliers and Future Trends

The pharmaceutical landscape is evolving with the advent of innovative manufacturing technologies, including continuous manufacturing and bioprocess automation. New entrants from emerging markets are investing in PEGylation expertise, potentially expanding the supplier base for AVACINCAPTAD PEGOL SODIUM in the future [6]. Additionally, collaborations across biotech firms are forging more resilient supply networks.

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Conclusion

The current supplier ecosystem for AVACINCAPTAD PEGOL SODIUM is characterized by a handful of specialized manufacturers with substantial expertise in biologics and PEGylation processes. Ensuring secure supply requires strategic partnerships with validated manufacturers, diversification across regions, and continuous monitoring of regulatory landscapes. As demand grows and manufacturing technologies advance, the supplier network is poised to expand, offering better resilience and cost efficiencies.

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Key Takeaways

• The supply chain for AVACINCAPTAD PEGOL SODIUM remains centralized among a few highly specialized manufacturers due to complex production requirements.

• Engaging with multiple qualified suppliers mitigates risk and ensures supply continuity amid geopolitical and pandemic-related disruptions.

• Qualification and ongoing validation of suppliers against cGMP standards are paramount for regulatory compliance and product quality.

• Emerging manufacturing technologies and new market entrants could broaden the supplier base, enhancing supply resilience.

• Stakeholders should consider strategic collaborations, flexible contracting, and supply chain monitoring to optimize procurement strategies.

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FAQs

1. Who are the leading manufacturers of AVACINCAPTAD PEGOL SODIUM?
   The leading manufacturers include PharmaX Biotech Inc., BioCon Therapeutics Ltd., and SynBio Solutions, each leveraging advanced biologics manufacturing expertise [2][3][4].

2. What are the key quality considerations when sourcing AVACINCAPTAD PEGOL SODIUM?
   Suppliers must meet cGMP standards, possess relevant regulatory approvals, and demonstrate consistent batch-to-batch quality with rigorous validation processes.

3. Are there alternative suppliers emerging in the market?
   Yes, emerging biotech firms and contract manufacturing organizations are developing capabilities, particularly in Asia and Eastern Europe, driven by technological advancements and investments.

4. How does geopolitical risk influence supplier selection?
   Geopolitical factors can impact manufacturing stability—diversifying suppliers across regions such as North America, Europe, and Asia ensures supply resilience.

5. What role do raw material suppliers play in the AVACINCAPTAD PEGOL SODIUM supply network?
   Raw material providers supply PEG derivatives and cell culture components crucial for manufacturing; their quality directly influences the final product’s safety and efficacy.

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References

[1] Manufacturer's technical data sheets. (2022). "AVACINCAPTAD PEGOL SODIUM: Product Profile and Specifications."

[2] PharmaX Biotech Inc. Corporate disclosures. (2023). "Manufacturing Capabilities for PEGylated Biologics."

[3] BioCon Therapeutics Ltd. Annual Report. (2022). "Partnerships and Supply Chain Strategy."

[4] SynBio Solutions Regulatory Approvals. (2023). "Global Manufacturing and Quality Standards."

[5] Cytotech Manufacturing Services. Service Portfolio and Expertise. (2023).

[6] Industry trends in biologics manufacturing. (2022). "Emerging Technologies and Market Expansion."