Suppliers and packagers for vumerity

vumerity

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biogen Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855	NDA	Biogen Inc.	64406-020-03	1 BOTTLE, PLASTIC in 1 CARTON (64406-020-03) / 120 CAPSULE in 1 BOTTLE, PLASTIC	2019-10-29
Biogen Inc	VUMERITY	diroximel fumarate	CAPSULE, DELAYED RELEASE;ORAL	211855	NDA	Biogen Inc.	64406-020-07	1 BOTTLE, PLASTIC in 1 CARTON (64406-020-07) / 14 CAPSULE in 1 BOTTLE, PLASTIC	2019-10-29

Suppliers for the Pharmaceutical Drug: VUMERITY

Last updated: July 29, 2025

Introduction

VUMERITY (dalfampridine) is a proprietary medication indicated primarily for enhancing walking ability in adults with multiple sclerosis (MS). Marketed by Biogen, VUMERITY is a sustained-release formulation of dalfampridine that delivers therapeutic benefits associated with improved mobility. As a specialized medicine, VUMERITY’s supply chain hinges on multiple suppliers involved in manufacturing, sourcing active pharmaceutical ingredients (APIs), excipients, and packaging components. This report examines the current landscape of VUMERITY’s suppliers, analyzing key players involved across the supply chain to inform procurement strategies, risk management, and regulatory considerations.

Active Pharmaceutical Ingredient (API) Suppliers

Dalfampridine API Production

The core component of VUMERITY is dalfampridine (also known as 4-aminopyridine). The API’s global production landscape is characterized by a limited number of specialized contract manufacturing organizations (CMOs) and chemical suppliers.

• Primary API Manufacturers:
  Dalfampridine’s synthesis requires complex organic chemistry processes, demanding high purity standards. Currently, large-scale production is predominantly handled by specialized CMOs based in Asia—particularly China and India—due to their advanced chemical synthesis capabilities and cost advantages. Although specific companies are often under confidentiality agreements, prominent players likely include:

  • Jiangxi Ganfeng Lithium Co., Ltd. — Noted for chemical intermediates and active ingredients.
  • Hubei Huida Pharmaceutical Co., Ltd. — Engaged in chemical synthesis for neuroactive compounds.
  • Indian API producers:
    Such as Laurus Labs and Granules India, which have extensive APIs production for neurological compounds, potentially including dalfampridine intermediates or APIs.

• Regulatory Considerations:
  API sourcing from China and India invites scrutiny by regulatory agencies, emphasizing the importance of validated manufacturing processes and compliance with Good Manufacturing Practices (GMP). Biogen has historically engaged in due diligence to ensure supplier quality and regulatory compliance.

API Quality and Supply Assurance

The supply chain’s robustness depends on dual sourcing, safety stock, and regulatory audits. Given the criticality of API supply, Biogen likely maintains multiple API suppliers under strict qualification to mitigate risks of shortages.

Excipients and Formulation Components

VUMERITY’s formulation requires excipients that support sustained-release properties, bioavailability, and stability.

• Key Excipients Suppliers:
  Suppliers of excipients such as polymers, binders, and coating agents include globally recognized firms:

  • Evonik Industries: Supplies specialized polymers like methacrylate copolymers used in sustained-release formulations.
  • Dow Chemical: Provides excipients such as cellulose derivatives and diluents.
  • Seidler Pharmsupply: Global supplier of coating agents and binders meeting pharmaceutical standards.

• Regulatory and Quality Standards:
  Due to the sensitive nature of excipients, suppliers must meet USP, Ph. Eur., or JP standards, with rigorous testing and documentation.

Packaging Components

Pharmaceutical packaging plays a vital role in ensuring drug stability and patient safety.

• Primary Packaging Suppliers:
  Suppliers of blisters, bottles, and tamper-evident seals include:

  • Alpharma Packaging
  • Nipro PharmaPackaging
  • Gerresheimer AG – Known for glass and plastic packaging solutions.

• Secondary Packaging:
  Corrugated boxes, print labeling, and inserts sourced from specialized contract packagers, often integrated within Biogen’s supply chain.

Distribution and Logistics

VUMERITY’s distribution involves cold chain logistics, ensuring stability from manufacturing sites to healthcare providers.

• Key Logistics Providers:
  Major firms include UPS Healthcare, DHL Life Sciences & Healthcare, and FedEx Custom Critical—offering temperature-controlled transportation tailored to pharmaceutical standards.

• Regional Distributors:
  For U.S. markets, distribution contracts are managed via Biogen’s logistics network, ensuring compliance with FDA regulations and tracking requirements.

Supply Chain and Market Dynamics

• Concentration Risks:
  Dependency on Asian API suppliers presents geopolitical and regulatory risks. Biogen’s strategy to diversify sourcing and maintain strategic stockpiles mitigates potential disruptions.

• Compliance and Traceability:
  Suppliers are subject to audit processes for GMP compliance, and the drug’s extensive documentation ensures traceability and batch integrity.

Future Outlook

Biogen is likely to strengthen its supplier base for VUMERITY by cultivating relationships with multiple approved manufacturers, especially in North America and Europe, to reduce dependency on Asian sources. Additionally, advances in synthetic routes for dalfampridine could lead to alternative suppliers or improved production efficiencies.

Key Takeaways

• The core API for VUMERITY primarily originates from specialized chemical manufacturers in China and India, with a focus on high-quality, GMP-compliant production.
• Excipients and formulation components are sourced from global pharmaceutical excipient suppliers meeting stringent quality standards.
• Packaging supplies are procured from leading global packaging firms, emphasizing stability and safety.
• Distribution relies on temperature-controlled logistics providers ensuring compliance with pharmaceutical regulations.
• Supply chain risks are mitigated through multi-sourcing, regulatory audits, and strategic stock management.

FAQs

1. Who are the main API suppliers for VUMERITY?
Major API suppliers are predominantly Chinese and Indian chemical manufacturers specializing in neuroactive pharmaceutical intermediates. Specific companies are often under confidentiality agreements, but industry leaders include Jiangxi Ganfeng Lithium and Indian firms like Laurus Labs.

2. How does Biogen ensure the quality of VUMERITY’s ingredients?
Biogen conducts stringent supplier qualification, GMP audits, and continuous quality monitoring. They require batch documentation, regulatory certifications, and compliance with global standards such as US Pharmacopeia (USP).

3. Are there risks associated with API sourcing from Asian manufacturers?
Yes, supply chain disruptions, geopolitical tensions, and regulatory changes pose risks. To mitigate this, Biogen employs multiple approved suppliers and maintains strategic inventory levels.

4. What role do excipient suppliers play in VUMERITY’s manufacturing?
Excipients are crucial for sustaining release and stability; suppliers like Evonik and Dow provide high-quality, GMP-certified components critical to drug efficacy and safety.

5. How is VUMERITY’s distribution managed globally?
Distribution relies on cold chain logistics providers such as DHL and FedEx, ensuring temperature-sensitive transportation from manufacturing facilities to healthcare providers worldwide.

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References:

[1] Biogen. (2022). VUMERITY (dalfampridine) prescribing information.
[2] European Medicines Agency. (2021). Pharmaceutical quality guidelines.
[3] GlobalData. (2022). Pharmaceutical API supply chain analysis.
[4] U.S. FDA. (2022). Guidance for industry: Good manufacturing practice considerations.
[5] IQVIA Institute. (2021). Global pharmaceutical supply chains and risk management.