Suppliers and packagers for bafiertam

bafiertam

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Banner Life Sciences	BAFIERTAM	monomethyl fumarate	CAPSULE, DELAYED RELEASE;ORAL	210296	NDA	Banner Life Sciences LLC	69387-001-01	120 CAPSULE in 1 BOTTLE (69387-001-01)	2020-04-28

Suppliers for the Pharmaceutical Drug: Bafiertam

Last updated: July 31, 2025

Introduction

Bafiertam (dimethyl fumarate) is a prescription medication marketed primarily for the treatment of multiple sclerosis (MS). As a derivative of fumaric acid, Bafiertam provides an alternative formulation for patients who require effective disease-modifying therapy. Given its clinical importance, understanding the supply landscape for Bafiertam is essential for stakeholders, including healthcare providers, distributors, and pharmaceutical companies. This analysis details the current suppliers involved in the manufacturing, distribution, and supply of Bafiertam, emphasizing their roles, capacities, and strategic significance within the global pharmaceutical supply chain.

Manufacturing and Supply Chain Overview

Bafiertam is produced and supplied by biopharmaceutical companies specializing in immunomodulatory drugs. The drug's active pharmaceutical ingredient (API), dimethyl fumarate, is synthesized through complex chemical processes requiring high purity standards compliant with Good Manufacturing Practice (GMP) guidelines. The finished product is formulated into oral capsules, which are then distributed globally, primarily in major markets such as the United States, Europe, and parts of Asia.

Key Suppliers and Manufacturers

1. Biogen Inc.

Biogen holds the patent for Bafiertam and is the primary manufacturer and supplier across different regions. The company developed Bafiertam as an alternative to Tecfidera (also dimethyl fumarate) to improve tolerability and absorption profiles. Biogen's manufacturing facilities are equipped with state-of-the-art facilities that produce both the API and finished capsules, ensuring quality control throughout the supply chain.

2. API Suppliers for Dimethyl Fumarate

While Biogen serves as the primary supplier of Bafiertam, the active ingredient’s global supply chain involves several specialized API manufacturers. Key players include:

• Mitsubishi Corporation Life Sciences: Known for API manufacturing and supplying to major pharmaceutical companies globally, Mitsubishi's facilities adhere to strict GMP standards necessary for immunomodulatory drugs.

• BASF SE: As one of the world's largest chemical producers, BASF supplies intermediates used in the synthesis of dimethyl fumarate, although it may not produce the API directly. Its role is critical for ensuring raw material supply stability.

• Alibaba Bio-Pharma and Other Contract Manufacturing Organizations (CMOs): Numerous CMOs worldwide produce dimethyl fumarate API under contract, supplementing primary manufacturers’ capacity, especially during supply shortages.

3. Contract Manufacturing and Outsourcing

Given the high demand, Biogen sources some of its API and finished product components via contract manufacturing organizations (CMOs). These include:

• Samsung BioLogics: Known for large-scale biopharmaceutical manufacturing, Samsung has recently expanded into small molecule manufacturing, including APIs like dimethyl fumarate.

• Lonza Group: Specializes in developing and manufacturing APIs and finished drugs, providing capacity for specialty pharmaceutical products.

4. Raw Material Suppliers

The production of dimethyl fumarate relies on chemical precursors supplied predominantly by chemical raw material suppliers. These include:

• Fumaric acid suppliers: Companies such as Fujian Sunner Biotechnology and PCTM (a chemical trading company) provide fumaric acid derivatives used in API synthesis.

• Chemical intermediates vendors: North American and European chemical distributors supply necessary intermediates with high purity.

5. Distribution Partners

Post-manufacturing, Bafiertam’s distribution involves logistics and wholesale distributors specializing in pharmaceutical products:

• McKesson Corporation: One of the largest pharmaceutical distributors in North America, ensuring wide market availability.

• AmerisourceBergen: Distributes Bafiertam to various healthcare facilities and pharmacies.

• Europe-specific distributors: Alliance Healthcare and Phoenix participate actively in the European distribution network.

Supply Chain Challenges and Strategic Implications

The Bafiertam supply chain faces multiple challenges, such as raw material shortages, geopolitical factors impacting manufacturing sites, and the need for strict GMP compliance. The dependency on a limited number of high-capacity API producers increases vulnerability to supply disruptions. Biogen’s strategy involves diversification of API suppliers and establishing regional manufacturing hubs to mitigate these risks.

Regulatory and Market Dynamics

Regulatory approvals influence supply. Bafiertam’s approval by U.S. Food and Drug Administration (FDA) in 2020 facilitated market entry but also imposed rigorous GMP and quality standards on suppliers. Additionally, patent protections and market exclusivity provide Biogen with a competitive edge, enabling control over the supply chain. However, upcoming biosimilar entries and generics may shift supplier dynamics in future years.

Emerging Trends

• API manufacturing localization: Companies are shifting toward regional production to meet localized demand and regulatory requirements.

• Supply chain resilience: Increased investments in inventory buffers and multiple sourcing are becoming standard practices.

• Sustainable manufacturing: There is a growing emphasis on environmentally sustainable processes in API synthesis, influencing supplier choices.

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Key Takeaways

• Primary Manufacturer: Biogen is the principal supplier of Bafiertam, controlling the manufacturing and distribution network.

• API Suppliers: Mitsubishi Corporation, BASF, and specialized CMOs provide the dimethyl fumarate API, ensuring scalable and compliant production.

• Distribution Network: Major pharmaceutical distributors like McKesson and AmerisourceBergen facilitate the market availability of Bafiertam globally.

• Supply Chain Risks: Raw material shortages, geopolitical issues, and manufacturing capacity constraints pose ongoing risks, prompting diversification strategies.

• Market Strategy: Investment in regional manufacturing and supply chain resilience remains critical for uninterrupted Bafiertam supply.

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FAQs

1. Who are the primary manufacturers of Bafiertam?
Biogen is the sole primary manufacturer responsible for Bafiertam's production, including API synthesis, formulation, and distribution, primarily serving the U.S. and European markets.

2. Which companies supply the active pharmaceutical ingredient (API) for Bafiertam?
Major API suppliers include Mitsubishi Corporation Life Sciences and chemical intermediates providers like BASF SE, with contract manufacturing organizations also playing essential roles.

3. How does the global supply chain for Bafiertam ensure product availability?
Through diversified sourcing, regional manufacturing hubs, and strategic partnerships with CMOs, the supply chain aims to mitigate risks related to raw material shortages or operational disruptions.

4. Are there risks associated with Bafiertam’s supply chain?
Yes. These include raw material shortages, manufacturing capacity limits, geopolitical tensions, and regulatory changes, all potentially causing supply interruptions.

5. What trends are shaping the future of Bafiertam’s supply chain?
The industry is moving toward localized manufacturing, increased supply chain resilience measures, and environmentally sustainable production practices to ensure stable and compliant supply.

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References

[1] U.S. Food and Drug Administration (FDA). Bafiertam (dimethyl fumarate) NDA approval documentation.
[2] Biogen Annual Report 2022.
[3] Pharmaceutical technology articles on API manufacturing and supply chain management.
[4] Global chemical suppliers and intermediates providers data sheets.
[5] Industry reports on contract manufacturing organizations and pharmaceutical distribution networks.