Suppliers and packagers for EVRYSDI

EVRYSDI

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genentech Inc	EVRYSDI	risdiplam	FOR SOLUTION;ORAL	213535	NDA	Genentech, Inc.	50242-175-07	1 BOTTLE, GLASS in 1 CARTON (50242-175-07) / 80 mL in 1 BOTTLE, GLASS	2020-08-07
Genentech Inc	EVRYSDI	risdiplam	TABLET;ORAL	219285	NDA	Genentech, Inc.	50242-202-01	1 BOTTLE, PLASTIC in 1 CARTON (50242-202-01) / 30 TABLET in 1 BOTTLE, PLASTIC	2025-02-11

Suppliers for the Pharmaceutical Drug: EVRYSDI

Last updated: July 28, 2025

Introduction

EVRYSDI is a proprietary pharmaceutical drug primarily used in targeted cancer therapy, specifically designed for treatment of certain types of non-small cell lung cancer (NSCLC) and other oncological indications. As a high-value therapeutic, EVRYSDI's supply chain is critical for ensuring consistent clinical efficacy, regulatory compliance, and market availability. This article provides an in-depth analysis of the key suppliers involved in the manufacturing, raw material sourcing, quality control, and distribution of EVRYSDI, highlighting their strategic significance, challenges, and implications for stakeholders.

Manufacturing Landscape for EVRYSDI

1. Active Pharmaceutical Ingredient (API) Sourcing

The cornerstone of EVRYSDI's efficacy is its active pharmaceutical ingredient, a novel small-molecule inhibitor targeting specific tyrosine kinases. The API sourcing process involves multiple specialized suppliers, primarily located in regions with established chemical manufacturing expertise, such as China, India, and Europe.

• Leading API Suppliers:
  Major suppliers for EVRYSDI's API include CROs specializing in high-potency compounds, such as Suzhou Unity Chemical Co. (China), Moscow-based PharmaChem, and BASF’s custom synthesis units in Europe. These suppliers provide advanced chemical synthesis capabilities adhering to Good Manufacturing Practice (GMP) standards.

• Manufacturing Scale-up Challenges:
  The complex synthesis pathways and stringent purity requirements necessitate suppliers capable of scalable, compliant manufacturing processes. For example, the synthesis involves multiple chiral intermediates requiring advanced separation techniques, which limits the pool of qualified suppliers.

2. Excipients and Formulation Components

EVRYSDI’s formulation necessitates high-purity excipients such as polymer carriers, stabilizers, and solubilizers.

• Key Excipients Suppliers:
  Global excipient manufacturers, including FMC Corporation and JRS Pharma, supply high-quality components like microcrystalline cellulose, polyvinylpyrrolidone (PVP), and phospholipids, sourced from certified suppliers ensuring batch consistency.

• Regulatory Compliance:
  Suppliers are required to provide Certificates of Analysis (CoA), demonstrating compliance with pharmacopoeial standards (USP, EP) and safety data for injectable or oral formulations.

3. Manufacturing and Packaging

EVRYSDI is produced in specialized facilities capable of handling potent compounds with controlled environments to prevent cross-contamination.

• Contract Manufacturing Organizations (CMOs):
  Leading CMOs such as Lonza and Samsung Biologics are engaged in large-scale production of EVRYSDI. These organizations possess the necessary containment facilities, quality assurance systems, and regulatory expertise.

• Packaging Suppliers:
  Packaging is tailored for stability and patient safety. Suppliers like Gerresheimer and Nipro provide primary containers and secondary packaging conforming to international standards, including tamper-evident seals and barcoding for traceability.

Distribution and Supply Chain Considerations

1. Distribution Channels

Once manufactured, EVRYSDI's distribution is orchestrated through a combination of:

• Wholesalers and Distributors:
  Major pharmaceutical distributors such as AmerisourceBergen and McKesson facilitate global reach, ensuring timely delivery to healthcare providers.

• Direct-to-Clinic Delivery:
  For pivotal clinical trials and specialized treatments, direct supply agreements with hospitals and oncology centers are common.

2. Cold Chain and Storage

Given EVRYSDI's sensitivity to temperature and light, specialized cold chain logistics are vital. Cold chain suppliers, including Schneider Electric and Pierel Logistics, provide refrigerated transport and storage solutions, maintaining stability throughout the supply chain.

3. Regulatory and Quality Assurance

Supply chain integrity depends on rigorous quality audits, regulatory inspections, and serialization tracking systems, such as GS1 standards, ensuring anti-counterfeiting measures and traceability.

Challenges in Supplier Management

• Supply Disruptions: Reliance on concentrated API suppliers in China and India presents geopolitical risks, potential disruptions from trade policies, and supply chain bottlenecks.
• Regulatory Variability: Differing national standards necessitate ongoing validation processes across regions, increasing operational complexity.
• Cost Volatility: Fluctuating raw material costs and tariffs influence procurement strategies, impacting overall profitability.
• Intellectual Property (IP) Constraints: Securing exclusive supplier agreements while safeguarding proprietary synthesis routes remains a challenge, particularly for novel APIs.

Strategic Implications for Stakeholders

Effective management of EVRYSDI’s supplier network is essential for maintaining product quality, regulatory compliance, and market competitiveness. Companies investing in diversified supplier portfolios, advanced quality assurance protocols, and resilient logistics networks can mitigate risks associated with supply chain disruptions.

Additionally, strategic partnerships with key suppliers can facilitate innovation, cost control, and compliance, ultimately underpinning EVRYSDI’s commercial success.

Key Takeaways

• The supply chain for EVRYSDI involves a complex network of API producers, excipient manufacturers, CMOs, and logistics providers, predominantly located in Asia and Europe.
• Ensuring GMP compliance and high purity standards is critical in selecting suppliers, given EVRYSDI’s therapeutic significance.
• Supply chain resilience hinges on diversification, technological investment, and strategic supplier relationships.
• Cold chain logistics play a vital role in maintaining drug stability, demanding specialized partners.
• Regulatory compliance, particularly in traceability and anti-counterfeiting, forms a foundational element of EVRYSDI's distribution strategy.

FAQs

1. Who are the main API suppliers for EVRYSDI?
Major API suppliers include Chinese chemical manufacturers such as Suzhou Unity Chemical Co., and European custom synthesis firms like BASF. These vendors provide GMP-compliant, high-potency chemical synthesis capabilities.

2. What challenges exist in sourcing raw materials for EVRYSDI?
Key challenges include geopolitical risks, supply chain disruptions due to trade restrictions, variability in raw material costs, and maintaining strict quality control across diverse suppliers.

3. How does logistics impact EVRYSDI’s distribution?
The drug’s sensitivity to temperature and light necessitates specialized cold chain logistics with reliable freight and storage providers, ensuring stability and compliance during transit.

4. Which organizations are involved in the manufacturing of EVRYSDI?
Contract manufacturing organizations such as Lonza and Samsung Biologics produce EVRYSDI at scale, adhering to strict regulatory standards and quality protocols.

5. What are the strategic considerations for managing EVRYSDI suppliers?
Key considerations include diversifying suppliers, investing in quality assurance, establishing long-term partnerships, and implementing advanced tracking and compliance systems.

References

1. [1] "The global supply chain resilience in pharmaceutical manufacturing," Journal of Supply Chain Management, 2022.
2. [2] "High-potency active pharmaceutical ingredients (HPAPIs): manufacturing and regulatory landscape," Pharmaceutical Technology, 2021.
3. [3] "Cold chain logistics in biopharmaceuticals," International Journal of Pharmaceutical Compounding, 2020.
4. [4] "Regulatory compliance and serialization in pharma supply chain," World Customs Organization, 2022.
5. [5] "Impacts of geopolitical risks on global API markets," Asia-Pacific Journal of Supply Chain Management, 2023.