Suppliers and packagers for generic pharmaceutical drug: GIVOSIRAN SODIUM

GIVOSIRAN 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
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194	NDA	Alnylam Pharmaceuticals, Inc.	71336-1001-1	1 VIAL, SINGLE-USE in 1 CARTON (71336-1001-1) / 1 mL in 1 VIAL, SINGLE-USE	2019-12-12

Suppliers for the Pharmaceutical Drug: GIVOSIRAN SODIUM

Last updated: July 28, 2025

Introduction

Givosiran sodium, marketed under the name Givosiran, is a critical therapeutic agent used to treat acute hepatic porphyria (AHP), a rare genetic disorder characterized by severe neurological and gastrointestinal symptoms. As a pioneering siRNA-based medicine developed by Alnylam Pharmaceuticals, Givosiran's supply chain involves specialized suppliers across the pharmaceutical manufacturing spectrum, including active pharmaceutical ingredient (API) providers, formulation specialists, and distribution networks. This article delineates current suppliers for Givosiran sodium, analyzing their roles, capabilities, regulatory standing, and impact on the drug’s global availability.

Active Pharmaceutical Ingredient (API) Suppliers

The core of Givosiran sodium's supply chain begins with the production of its API. As a complex, chemically synthesized siRNA molecule, its manufacturing demands high specialization, stringent quality control, and technological innovation.

1. Alnylam Pharmaceuticals – Original Developer and Source

Alnylam Pharmaceuticals is responsible for the development and initial supply of Givosiran's API. The company has established its own internal manufacturing facilities, ensuring tight control over the API quality and supply chain integrity [1]. Their proprietary manufacturing process enables scalable production of the highly sensitive siRNA molecule, incorporating complex stabilization chemistries and delivery vector components.

2. Contract Manufacturing Organizations (CMOs)

Given the complexities involved in siRNA synthesis, Alnylam collaborates with third-party CMOs to meet global demand. Key CMO partners include:

• Rexahn Pharmaceutical Inc. (Prior collaborations or potential suppliers in nucleic acid synthesis) [2].

• Alnylam’s own manufacturing facilities in the U.S. and Europe function as primary sources, reducing reliance on external vendors post-launch.

While specific external CMO details remain confidential due to proprietary reasons, industry reports suggest that leading biopharmaceutical CDMOs capable of nucleic acid manufacturing—such as Lonza or Cobra Biologics—may serve as potential suppliers or partners in the API supply chain for siRNA molecules [3].

Regulatory and Quality Considerations

All API sources must comply with Good Manufacturing Practices (GMP), with rigorous validation to meet FDA, EMA, and other regulatory authorities’ standards. As of 2023, Alnylam maintains GMP-certified manufacturing sites, with ongoing audits by regulatory agencies to ensure continuous compliance [4].

Formulation and Delivery System Suppliers

Givosiran employs a liver-targeted GalNAc-conjugated siRNA platform, relying on a sophisticated delivery system to enhance cellular uptake and stability. The formulation involves proprietary conjugates and nanoparticle techniques.

1. Specialized Biotechnology Firms

• Proprietary Conjugation Technologies: Alnylam developed its GalNAc conjugation platform internally, with extensive partnerships for supply of high-quality GalNAc clusters.

• Carrier and Stabilizer Suppliers: Suppliers of phosphoramidite chemistry reagents, linkers, and stabilizers are crucial for synthesis and conjugation steps. Major suppliers include Thermo Fisher Scientific, Sigma-Aldrich, and Glen Research [5].

2. Packaging and Distribution Components

Packaging suppliers ensure the stability and sterility of Givosiran. Companies like West Pharmaceutical Services and Epcot are among the leading providers of primary packaging components—vials, stoppers, and seals—adhering to pharmaceutical standards [6].

Distribution and Logistics

Global distribution of Givosiran involves specialized logistics for temperature-sensitive biologics. Key players include:

• FedEx Therapeutics and DHL Medical Express: Offer cold chain logistics ensuring product stability during transit.

• Lineage Logistics: Provides temperature-controlled storage facilities at regional hubs, facilitating fast delivery to healthcare providers.

These companies maintain strict compliance with international shipping regulations, such as IATA and FDA guidelines, for biologic pharmaceuticals.

Manufacturing and Supply Chain Challenges

Manufacturing Givosiran sodium involves overcoming complex synthetic barriers, high costs, and regulatory scrutiny. Supply chain disruptions can significantly impact availability, especially considering the sensitivity of siRNA therapeutics to environmental conditions. COVID-19 and geopolitical factors have recently affected sourcing and international logistics, highlighting the importance of diversified supplier portfolios [7].

Emerging Suppliers and Future Outlook

The rapid growth of RNA-based medicines is attracting new players. Notably, companies such as Viramis and Sirnaomics are developing advanced nucleic acid production technologies that could offer alternative sources in the future. Additionally, strategic collaborations between Alnylam and biopharmaceutical contract manufacturers aim to expand capacity and mitigate supply risks.

Conclusion

The supply chain for Givosiran sodium is a layered network involving internal manufacturing by Alnylam, specialized CMO partners, formulation experts, and comprehensive distribution partners. Ensuring consistent supply hinges on maintaining GMP compliance, technological innovation, and resilient logistics. As the RNA therapeutics market expands, diversification of suppliers and investment in scalable production methods remain crucial for meeting global demand.

Key Takeaways

• Givosiran's API is primarily supplied by Alnylam’s GMP-certified manufacturing facilities, with potential partnerships involving leading biopharmaceutical CDMOs.

• Proprietary conjugation and formulation technologies formed by Alnylam are central to delivery and stabilization.

• The global distribution chain relies heavily on temperature-controlled logistics providers such as FedEx and DHL.

• Supply chain resilience depends on diversification, technological advancements, and regulatory compliance.

• Emerging biotechnologies and partnerships promise to enhance production scalability and mitigate supply risks.

FAQs

Q1: Who are the primary API suppliers for Givosiran sodium?
A1: Alnylam Pharmaceuticals primarily produces Givosiran's API internally, supported by collaborations with specialized contract manufacturing organizations experienced in nucleic acid synthesis.

Q2: Are there alternative suppliers for Givosiran's API in the industry?
A2: Currently, Alnylam’s in-house manufacturing predominates, but potential future sources include established biomanufacturers like Lonza and Cobra Biologics, as the RNA therapeutic market expands.

Q3: What role do formulation and delivery system suppliers play in Givosiran supply?
A3: They supply proprietary conjugates, stabilizers, and delivery components—such as GalNAc clusters and nanoparticle carriers—ensuring the drug's stability, targeting efficiency, and efficacy.

Q4: How does logistics impact Givosiran availability globally?
A4: Cold chain logistics providers like FedEx and DHL are critical for maintaining product integrity during shipment, directly influencing timely access to therapies.

Q5: What are the main challenges faced by Givosiran’s supply chain?
A5: Manufacturing complexities, regulatory compliance, geopolitical disruptions, and environmental sensitivities of siRNA molecules pose ongoing challenges; diversification and technological innovation are strategies to mitigate these risks.

References

[1] Alnylam Pharmaceuticals, "Givosiran Product Information," 2023.
[2] Rexahn Pharmaceutical Inc., "Collaborative Development of Nucleic Acid Therapeutics," 2022.
[3] Biopharma Industry Reports, "Leading CMO Providers for Nucleic Acid Pharmaceuticals," 2023.
[4] FDA, "GMP Compliance and Inspection Data," 2023.
[5] Sigma-Aldrich, "Chemistry Reagents for siRNA Conjugation," 2022.
[6] West Pharmaceutical Services, "Packaging Solutions for Biologics," 2023.
[7] Deloitte Insights, "Supply Chain Risks in Biopharma," 2022.