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Suppliers and packagers for tecfidera
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tecfidera
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 | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063 | NDA | Biogen Inc. | 64406-005-01 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-005-01) / 14 CAPSULE in 1 BOTTLE, PLASTIC | 2013-03-27 |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063 | NDA | Biogen Inc. | 64406-006-02 | 1 BOTTLE, PLASTIC in 1 CARTON (64406-006-02) / 60 CAPSULE in 1 BOTTLE, PLASTIC | 2013-03-27 |
| Biogen Inc | TECFIDERA | dimethyl fumarate | CAPSULE, DELAYED RELEASE;ORAL | 204063 | NDA | Biogen Inc. | 64406-007-03 | 1 KIT in 1 KIT (64406-007-03) * 14 CAPSULE in 1 BOTTLE, PLASTIC * 46 CAPSULE in 1 BOTTLE, PLASTIC | 2013-03-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TECFIDERA
Introduction
TeCFIDERA (dimethyl fumarate) is a prescription medication primarily used to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, TECFIDERA has gained widespread usage globally, driven by its oral administration route and favorable efficacy profile. Central to its supply chain are multiple manufacturers involved in active pharmaceutical ingredient (API) production, formulation, and distribution, ensuring consistent availability to meet global demand.
This analysis focuses on the key suppliers underpinning the production and distribution of TECFIDERA. Understanding these suppliers is critical for stakeholders involved in procurement, supply chain management, or market analysis within the pharmaceutical sector.
Active Pharmaceutical Ingredient (API) Supply Chain
Boehringer Ingelheim and Biogen's Role
The active pharmaceutical ingredient for TECFIDERA, dimethyl fumarate, is primarily supplied by Boehringer Ingelheim under a licensing agreement. Boehringer Ingelheim originates the API, which serves as the cornerstone of manufacturing for the final product. After licensing, Biogen Europe, the marketing authorization holder in many regions, handles formulation, packaging, and distribution.
Boehringer Ingelheim's API manufacturing is characterized by rigorous quality control and adherence to Good Manufacturing Practices (GMP). Their plants located in Germany and Austria are certified to produce high-purity API suitable for global regulation standards. These facilities possess advanced synthesis technology, ensuring consistent API quality critical for efficacy and safety.
Contract Manufacturing Organizations (CMOs)
In addition to Boehringer Ingelheim, several CMOs are engaged by pharmaceutical companies to scale API production, especially during spikes in demand or to mitigate supply chain risks. These CMOs often possess GMP-certified facilities capable of large-scale API synthesis, providing redundancy and capacity expansion.
Formulation and Finished Product Manufacturing
Once API is produced, several generic and branded manufacturers undertake formulation, filling, and packaging. The manufacturing landscape for TECFIDERA's finished dosage form involves:
- Biogen: As the original developer and marketer, Biogen manages the final formulation, packaging, and distribution for USA and select markets, often utilizing their network of manufacturing partners.
- Contract Manufacturers: Numerous global CMOs, including Selene America and others in India, Europe, and North America, produce generic equivalents and branded formulations.
The production process involves converting API into film-coated tablets, which require specialized equipment to ensure uniformity, stability, and patient safety. These manufacturing entities operate under strict quality controls aligned with regional regulatory standards, including FDA regulations in the USA, EMA standards in Europe, and other local authorities.
Distribution and Supply Chain Considerations
The supply chain of TECFIDERA extends beyond manufacturing, involving warehousing, logistics, and regional distributors. Biogen maintains a global distribution network to meet regional regulatory and supply demands, including:
- Distribution Centers: Strategically located in North America, Europe, and Asia to facilitate rapid delivery.
- Wholesale Distributors: Key distributors include McKesson and Cardinal Health in the North American market, and regional wholesalers worldwide.
Supply chain disruptions have been historically managed through diversified manufacturing sources and regional warehousing, minimizing risks associated with geopolitical issues, manufacturing delays, or raw material shortages.
Emerging and Generic Suppliers
Generic manufacturers have entered the TECFIDERA market, leveraging the expiration of patent rights in multiple jurisdictions (e.g., in the US, patent expirations occurred around 2028). These companies source API and finished formulations from existing suppliers or develop their own synthesis pathways for dimethyl fumarate, adhering to regulatory standards.
Key generic suppliers include:
- India-based manufacturers: Companies like Natco Pharma, Cipla, and Sun Pharmaceutical Industries manufacture generic dimethyl fumarate or finished formulations, targeting markets with lower regulatory barriers or cost-sensitive regions.
- European manufacturers: Some firms have developed their own API synthesis capability for regional markets, often tied to licensing agreements or partnerships with originator companies.
Regulatory Impact on Supplier Selection
Regulations impact supplier strategies significantly. For instance, the FDA and EMA impose stringent quality standards for APIs and finished products, influencing supplier selection. Companies often prefer suppliers with established regulatory approval histories, robust quality assurance programs, and proven ability to produce APIs at scale.
Emerging regional regulators, like the Central Drugs Standard Control Organization (CDSCO) in India, are tightening standards, compelling suppliers to upgrade manufacturing facilities. This dynamic influences the global sourcing landscape for TECFIDERA raw materials and formulations.
Market Dynamics and Future Supply Trends
The demand for TECFIDERA remains stable, but there is increasing competition from newer MS treatments and generic options. This pressure encourages manufacturers to optimize their supply chains, often leading to:
- Diversification of API sources to mitigate risks.
- Investment in new manufacturing capacity.
- Collaborations between originators and CMOs for increased flexibility.
The expiration of patents and regulatory pathways for biosimilars and generics will likely expand the supplier base. Consequently, companies involved in API development, formulation, and distribution must maintain high-quality standards to secure regulatory approval and streamline global supply.
Key Suppliers Summary
| Supplier Type | Key Companies | Region | Role |
|---|---|---|---|
| API Manufacturer | Boehringer Ingelheim, Contract Manufacturing Organizations | Germany, Austria, Global | API production for TECFIDERA |
| Formulation & Fini. Product | Biogen, Selene America, Indian generic manufacturers | USA, India, Europe | Final drug formulation, packaging, distribution |
| Distributors | McKesson, Cardinal Health, Regional Distributors | North America, Europe, Asia | Supply chain logistics |
Key Takeaways
- Boehringer Ingelheim is the primary originator of TECFIDERA's API, with robust manufacturing capabilities in Europe.
- Biogen oversees formulation, packaging, and global distribution, working with multiple CMOs to ensure supply reliability.
- The evolving generic market, especially post-patent expiry, introduces diverse suppliers from India, Europe, and other regions.
- Regulatory standards significantly influence supplier choices, emphasizing quality assurance and compliance.
- Supply chain resilience hinges on diversified sourcing, regional manufacturing, and strategic partnerships to prevent disruptions.
FAQs
1. Who is the primary supplier of the API for TECFIDERA?
Boehringer Ingelheim supplies the active pharmaceutical ingredient (dimethyl fumarate) for TECFIDERA, leveraging their GMP-certified manufacturing facilities in Europe.
2. How do generic manufacturers produce TECFIDERA?
Generic companies source API from established suppliers or produce their own, then carry out formulation, coating, and packaging, adhering to regional regulatory standards.
3. Are there alternative suppliers to Boehringer Ingelheim for TECFIDERA API?
Yes, several CMOs and regional API producers, especially in India and Europe, are developing or licensing synthesis pathways to supply dimethyl fumarate.
4. How does patent expiry influence the supplier landscape for TECFIDERA?
Patent expiry opens the market for generics, leading to new suppliers entering the market with their own API synthesis capabilities, increasing competition and supply options.
5. What role do regulatory standards play in supplier selection?
Regulatory compliance ensures API safety, efficacy, and quality. Suppliers with proven GMP certification and regulatory approval histories are favored to mitigate risk.
References
[1] FDA Drug Approvals Database. (2013). Tecfidera (dimethyl fumarate) approval.
[2] Boehringer Ingelheim Annual Report. (2022). API manufacturing overview.
[3] Biogen Official Website. (2023). Global supply chain and formulation facilities.
[4] Market analyses on patent expirations and generics in MS drugs. (2022).
[5] European Medicines Agency (EMA). (2023). Regulatory standards for API production.
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