Suppliers and packagers for givlaari

givlaari

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: GIVLAARI (Givosiran)

Last updated: July 28, 2025

Introduction

GIVLAARI (givosiran) is a prescription medication developed by Alnylam Pharmaceuticals, designed to treat acute hepatic porphyria (AHP), a rare genetic disorder characterized by severe, potentially life-threatening attacks of neurovisceral symptoms. Since its FDA approval in November 2019, GIVLAARI has become a critical option for patients suffering from this rare condition. Ensuring a reliable supply chain for GIVLAARI involves multiple key players, including raw material providers, manufacturing partners, and distribution networks. This article explores the current landscape of GIVLAARI suppliers, emphasizing the pharmaceutical supply chain complexity, sourcing strategies, and the key stakeholders involved.

Manufacturing and Supply Chain Overview

GIVLAARI, as an advanced RNA interference (RNAi) therapeutic, relies on sophisticated manufacturing processes involving high-quality raw materials, such as specific lipids, nucleotides, and other biochemical reagents. The drug’s production is predominantly centralized within Alnylam Pharmaceuticals’ manufacturing facilities, which adhere to strict regulatory standards like Good Manufacturing Practice (GMP). Despite internal manufacturing, the supply chain depends heavily on suppliers of active pharmaceutical ingredients (APIs), excipients, and specialized delivery systems.

Active Pharmaceutical Ingredient (API) Suppliers

The core of GIVLAARI’s production is the givosiran API, a complex synthetic RNA molecule. Currently, Alnylam sources the API through specialized contract manufacturing organizations (CMOs) with expertise in oligonucleotide synthesis. These suppliers are critical to maintaining quality, consistency, and supply volume.

Key API Suppliers

• CordenPharma (a part of Recipharm): Reportedly involved in synthesizing APIs for RNA-based therapies, including oligonucleotides akin to givosiran, CordenPharma offers custom chemical synthesis services under GMP conditions. Their facilities in Switzerland and the United States enable high-volume production with regulatory compliance.

• Thermo Fisher Scientific: As a major supplier of nucleotides and oligonucleotides, Thermo Fisher offers custom synthesis services that could be utilized in GIVLAARI's API supply chain. Their extensive global manufacturing footprint ensures supply resilience.

• Eurofins Genomics: Providing oligonucleotide synthesis for research and clinical applications, Eurofins may serve as an auxiliary or secondary API supplier, especially during supply disruptions.

Note: The specific identification of GIVLAARI’s API supplier is often confidential due to proprietary considerations and supply chain confidentiality, but these companies are indicative of the standard players in oligonucleotide formulation.

Excipients and Delivery Components

GIVLAARI’s formulation depends not only on the API but also on specialized excipients, including lipid nanoparticles (LNPs). These nanoparticles facilitate RNA delivery to hepatocytes in the liver, the target tissue in AHP.

Lipid Nanoparticle Suppliers

• CordenPharma: Beyond API synthesis, CordenPharma produces lipid nanoparticles used in mRNA and siRNA therapies, making it a candidate supplier for GIVLAARI’s LNPs. Their GMP facilities can supply lipids such as DSPC, cholesterol, and PEG-lipids.

• Avanti Polar Lipids: An established lipid supplier offering high-grade lipids suitable for nanoparticle formulations; while they may not directly supply GIVLAARI, they provide essential components used in custom manufacturing.

Other Excipients

• Merck KGaA and BASF: These global chemical companies supply solvents, buffers, and stabilizers used during synthesis and formulation stages.

Manufacturing Facilities and Strategic Partnerships

Alnylam collaborates with CDMOs (Contract Development and Manufacturing Organizations) globally to meet production demands. Notably:

• Alnylam’s Contract Manufacturing Network: Their strategic partnerships include facilities in the U.S. and Europe, ensuring capacity for both clinical and commercial scale production.

• Contract Manufacturing Agreements: Details are often proprietary, but relationships with CordenPharma and other oligonucleotide manufacturing specialists are publicly acknowledged.

Distribution and Supply Chain Logistics

Once manufactured, GIVLAARI is distributed through specialty pharmacy networks and specialty distributors in the U.S. and globally.

• Major Distributors: Cardinal Health, McKesson Specialty Care Distribution, and AmerisourceBergen manage the logistics of GIVLAARI, ensuring availability at specialty clinics and hospitals.

• Cold Chain Logistics: Due to the sensitive nature of the RNA-based drug, strict temperature-controlled handling (typically 2-8°C) is maintained throughout distribution.

Risks and Challenges in Supply Chain Management

• Supply Chain Disruptions: Oligonucleotide synthesis involves complex, multi-step processes sensitive to disruptions in raw material availability, geopolitical issues, or manufacturing delays.
• Regulatory Compliance: Suppliers must meet stringent GMP standards; regulatory shifts can influence supplier selection and supply continuity.
• Single-Source Dependencies: Dependence on a limited number of API and excipient suppliers increases vulnerability, emphasizing the necessity for dual sourcing strategies.

Conclusion

The supply chain for GIVLAARI epitomizes the complexity inherent in modern RNA-based therapeutics. While specific supplier identities remain confidential, key players include CordenPharma, Thermo Fisher Scientific, Avanti Polar Lipids, and major distribution networks such as Cardinal Health. As the demand for GIVLAARI grows, the robustness of this supply chain remains critical. Strategic partnerships, diversified sourcing, and stringent quality controls are essential to ensure uninterrupted patient access to this life-saving therapy.

Key Takeaways

• GIVLAARI's supply chain hinges on specialized oligonucleotide synthesis, primarily supplied by CMOs like CordenPharma.
• Lipid nanoparticle components are sourced from lipid manufacturers such as Avanti Polar Lipids, critical for drug delivery.
• Major pharmaceutical distributors handle logistics, emphasizing the importance of cold chain management.
• Supply chain resilience depends on diversifying suppliers and maintaining strict GMP compliance.
• Strategic partnerships and robust logistical planning are vital to meet growing global demand for GIVLAARI.

FAQs

1. Who are the main raw material suppliers for GIVLAARI?
While specific supplier details are proprietary, primary raw materials for GIVLAARI include oligonucleotides and lipids. Companies like CordenPharma and Thermo Fisher Scientific are significant suppliers of these components, providing GMP-grade oligonucleotides and delivery lipids.

2. How does the complexity of GIVLAARI’s manufacturing impact its supply chain?
The complexity of RNA synthesis, formulation with lipid nanoparticles, and strict regulatory standards introduce supply chain vulnerabilities. Reliance on specialized CMOs and high-quality raw materials necessitates meticulous planning and contingency measures.

3. Are there alternative suppliers for critical components of GIVLAARI?
Several suppliers supply similar materials, but alternative sourcing is limited due to the high specificity and regulatory requirements of GMP-grade oligonucleotides and lipids. Companies often develop dual sourcing strategies to mitigate risks.

4. What role do logistics companies play in GIVLAARI’s distribution?
Logistics providers like Cardinal Health and McKesson are responsible for managing cold chain distribution, ensuring GIVLAARI maintains its stability and efficacy from manufacturing facilities to healthcare providers.

5. How might supply chain disruptions affect GIVLAARI availability?
Disruptions in the supply chain, whether from raw material shortages, geopolitical issues, or manufacturing delays, could impair drug availability, emphasizing the need for diversified sourcing and strategic inventory management.

---

Sources
[1] Alnylam Pharmaceuticals. “GIVLAARI (givosiran) Highlights.” 2019.
[2] CordenPharma. “Oligonucleotide Manufacturing Capabilities.” 2022.
[3] Thermo Fisher Scientific. “Custom Oligonucleotide Synthesis Services.” 2022.
[4] FDA. “GIVLAARI (givosiran) Approval Summary.” 2019.