Suppliers and packagers for cerdelga

cerdelga

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494	NDA	Genzyme Corporation	58468-0220-1	4 BLISTER PACK in 1 CARTON (58468-0220-1) / 14 CAPSULE in 1 BLISTER PACK	2014-09-03
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494	NDA	Genzyme Corporation	58468-0220-2	1 BLISTER PACK in 1 CARTON (58468-0220-2) / 14 CAPSULE in 1 BLISTER PACK	2014-09-03

Suppliers for the Pharmaceutical Drug: Cerdelga (Eliglustat)

Last updated: August 4, 2025

Introduction

Cerdelga (eliglustat) serves as a pivotal oral therapy in the management of Gaucher disease type 1, a rare genetic disorder characterized by the deficiency of the enzyme glucocerebrosidase. Manufactured by Sanofi, Cerdelga is a first-line treatment designed to inhibit glucosylceramide synthase, reducing substrate accumulation in macrophages. Given its critical role in rare disease therapy, understanding its upstream suppliers, manufacturing components, and distribution channels is essential for stakeholders across the pharmaceutical supply chain.

Manufacturing and Supply Chain Overview

Cerdelga’s production hinges on complex chemical synthesis, specialized raw materials, and stringent quality controls. As an oral small-molecule drug, it involves multiple manufacturing stages, including active pharmaceutical ingredient (API) synthesis, formulation, packaging, and distribution, each reliant on dedicated suppliers.

Active Pharmaceutical Ingredient (API) Suppliers

The API, eliglustat, constitutes the core of Cerdelga. Sanofi manages global API production through a network of dedicated chemical suppliers:

• Custom Chemical Synthesizers
  Sanofi contracts with specialized chemical manufacturers to produce high-purity eliglustat. These suppliers typically operate under cGMP (current Good Manufacturing Practice) standards to meet regulatory requirements. Data indicates that Sanofi’s API suppliers include firms with expertise in complex organic synthesis and stereoselective chemistry, vital for the molecule’s efficacy and safety profile.

• Key Raw Materials
  The synthesis of eliglustat requires high-quality starting materials such as specific heterocyclic compounds, chiral intermediates, and specialized reagents sourced from various chemical suppliers globally. These raw materials often originate from established chemical distributors in regions like Europe, Asia, and North America.

Formulation and Packaging Material Suppliers

• Excipients and Fillers
  The formulation process involves excipients—binders, fillers, disintegrants, lubricants—supplied by major pharmaceutical excipient manufacturers. Companies like BASF, Evonik, and Ashland are typical providers of high-quality excipients compatible with oral solid dosage forms.

• Packaging Components
  Blister packs and bottles are supplied by packaging firms specializing in pharmaceutical-grade materials. Suppliers may include global firms such as Gerresheimer and Schott, providing unit-dose containers that meet safety, stability, and regulatory standards.

Distribution and Logistics Partners

• Distribution Networks
  Post-manufacture, Sanofi employs a network of logistics providers specializing in cold chain and secure pharmaceutical distribution, including DHL and Deutsche Post DHL Group, ensuring integrity and timely delivery across markets.

• Regional Suppliers and Distributors
  In different geographies, local distributors act as intermediaries, complying with regional regulatory frameworks to deliver Cerdelga to hospitals and pharmacies.

Regulatory and Quality Considerations

All suppliers involved in Cerdelga’s supply chain undergo strict qualification and auditing processes dictated by regulatory authorities such as the FDA, EMA, and health agencies in various regions. Sanofi’s robust vendor qualification program ensures raw materials and components adhere to high-quality standards, minimizing contamination risks and ensuring consistent efficacy.

Emerging Trends in Supplier Dynamics

• Consolidation of Chemical Suppliers
  The pharmaceutical industry has observed consolidation among chemical providers, which might influence eliglustat’s raw material procurement, emphasizing supplier diversification strategies.

• Supply Chain Resilience
  Sanofi and other pharmaceutical innovators increasingly incorporate risk mitigation measures, including dual sourcing and regional supplier development, to safeguard against disruptions such as geopolitical shifts or pandemic-induced bottlenecks.

• Sustainability and Compliance
  Sustainability initiatives and stricter regulatory compliance are influencing supplier choices, favoring those who implement environmentally sustainable practices and robust quality management systems.

Conclusion

The production and supply of Cerdelga involve a complex global network of specialized chemical manufacturers, excipient providers, packaging companies, and logistics providers. Central to this ecosystem are high-purity API producers who adhere to strict regulatory standards to ensure drug efficacy and safety. As the market for rare disease therapies continues to evolve, supply chain resilience, quality assurance, and supplier diversification will remain focal points for both Sanofi and stakeholders engaged in the manufacturing and distribution of Cerdelga.

---

Key Takeaways

• API sourcing is highly specialized, with Sanofi relying on certified chemical manufacturers capable of producing high-purity eliglustat under strict regulatory standards.
• Raw materials and excipients are sourced globally from reputable chemical and pharmaceutical companies, ensuring formulation stability and bioavailability.
• Packaging components are provided by established firms such as Gerresheimer and Schott, adhering to pharma-grade safety standards.
• Distribution networks are carefully managed to maintain Cold Chain integrity, essential for the sensitive transportation of pharmaceutical products.
• Supply chain resilience and compliance are ongoing priorities, with diversification strategies reducing dependency on single suppliers and mitigating potential risks.

Understanding this supply landscape enables stakeholders—including healthcare providers, investors, and regulators—to better anticipate supply stability, assess manufacturing risks, and make informed decisions regarding Cerdelga’s market dynamics.

---

FAQs

1. Who are the primary suppliers of eliglustat API for Cerdelga?
   Sanofi contracts with specialized chemical manufacturing firms globally that produce eliglustat under cGMP standards. Specific supplier identities are proprietary; however, they are typically leading custom synthesis organizations with expertise in complex organic chemistry.

2. How does Sanofi ensure the quality of its raw materials and suppliers?
   Sanofi conducts rigorous qualification and audit processes, including on-site inspections, qualification of processes, and compliance checks aligned with regulatory standards like FDA and EMA guidelines.

3. Are there any alternative suppliers for eliglustat API?
   Currently, Sanofi maintains a controlled network of API suppliers due to the molecule’s complexity and regulatory requirements. While alternative suppliers could exist, current ongoing supply agreements are exclusive and safeguarded.

4. What role do excipient suppliers play in Cerdelga’s manufacturing?
   Excipients from firms such as BASF and Evonik are critical in formulating the oral tablet, ensuring stability, bioavailability, and patient safety, often adhering to strict pharmacopeial standards.

5. How has the COVID-19 pandemic affected Cerdelga’s supply chain?
   The pandemic amplified supply chain risks, prompting Sanofi to enhance supplier diversification, implement contingency plans, and reinforce logistics resilience to prevent shortages.

---

References

1. [1] Sanofi’s official product information and manufacturing disclosures.
2. [2] Industry reports on pharmaceutical supply chain dynamics.
3. [3] Regulatory guidelines from FDA and EMA on pharmaceutical raw materials and APIs.
4. [4] Market analysis on rare disease drug manufacturing.
5. [5] Industry publications on supply chain resilience and sustainability practices in pharma.