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Suppliers and packagers for XADAGO
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XADAGO
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145 | NDA | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. | 27505-110-14 | 1 BLISTER PACK in 1 CARTON (27505-110-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 2017-05-08 |
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145 | NDA | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. | 27505-110-30 | 1 BOTTLE in 1 CARTON (27505-110-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 2017-05-08 |
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145 | NDA | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. | 27505-110-90 | 1 BOTTLE in 1 CARTON (27505-110-90) / 90 TABLET, FILM COATED in 1 BOTTLE | 2017-05-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Xadago (Safinamide)
Introduction
Xadago (generic name: safinamide) is an advanced pharmacological treatment approved primarily for managing Parkinson’s disease, particularly as an adjunct therapy in patients experiencing motor fluctuations. Developed and marketed by Zelapar, its unique dual mechanism—reversible monoamine oxidase B (MAO-B) inhibition coupled with modulation of glutamate release—has garnered significant attention within neurology and pharmaceutical sectors. With its increasing global acceptance, understanding the supply landscape of safinamide is crucial for stakeholders including healthcare providers, pharmaceutical distributors, and investors.
Manufacturing and Proprietary Development
Initial Development and Patent Holders
Safinamide was developed by Newron Pharmaceuticals, an Italy-based biopharmaceutical company, and subsequently licensed to other entities for broader production and commercialization. As of 2022, Newron holds key patents protecting safinamide's formulation and use, which are critical in maintaining exclusivity and supply chain stability [[1]].
Manufacturing Facilities
The primary manufacturing facilities are operated by Newron Pharmaceuticals and licensed subcontractors. These facilities must meet stringent Good Manufacturing Practices (GMP) standards mandated by regulatory agencies such as the FDA and EMA. Outsourcing to Contract Manufacturing Organizations (CMOs) enhances scalability but requires robust quality assurance protocols.
Global Suppliers and Market Dynamics
Key Suppliers in the Pharmaceutical Supply Chain
Multiple pharmaceutical companies are involved in the distribution and import/export of safinamide. The landscape varies significantly across regions.
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Zelapar (U.S. Market): In the United States, exclusive rights were granted to specialty pharmacies and licensed distributors affiliated with Zambon, which secured approval from the FDA in 2017. Zambon is a major player in the safinamide supply chain for North America [[2]].
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Europe: In the European Union, Neuraxpharm AG acts as an authorized distributor, sourcing safinamide directly from Newron or licensed manufacturers. Several regional distributors in countries like Germany, France, and Italy procure safinamide from licensed European manufacturers [[3]]].
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Asia-Pacific: Companies such as Sandoz (a Novartis division) and local generic manufacturers in India and Japan have either licensed or are in negotiations to produce safinamide under license agreements. These regional suppliers often engage in importing finished formulations or active pharmaceutical ingredients (APIs) for local manufacturing.
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Emerging Markets: Manufacturing is increasingly occurring in China and India, with local generic producers obtaining licenses under different regulatory frameworks. However, the consistency of supply and regulatory post-market surveillance varies [[4]].
Active Pharmaceutical Ingredient (API) Suppliers
The core of safinamide supply hinges on high-quality API production. Major API suppliers include:
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Reputed Chinese API Manufacturers: Several Chinese firms produce safinamide API under license, often linked to prominent global pharmaceutical companies' supply chains.
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Indian API Producers: Companies such as ACG Associated Capsules and Sun Pharma have reported API manufacturing capacity for safinamide, either via licensing or proprietary development.
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European API Suppliers: Limited European API manufacturers are involved, primarily linked to the original developers.
The API's synthesis involves complex aromatic amine and benzamide derivatives, requiring stringent quality controls to meet pharmacopeia standards.
Regulatory Approval and Licensing Impact
The regulatory environment influences supplier dynamics. Approved markets (US, Europe, Japan) typically require compliance with strict GMP standards, limiting the pool of qualified manufacturers. Licensing agreements often stipulate manufacturing under specific facilities, affecting the number of active suppliers.
For example, after FDA approval, Zambon secured exclusive distribution rights in the US, potentially limiting the number of domestic suppliers but ensuring quality control [[2]].
Supply Chain Challenges
Several considerations influence safinamide's supplier landscape:
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Regulatory Hurdles: Certification and continuous GMP adherence restrict the number of capable suppliers.
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Patent Expirations: While the patent protection remains active, generic manufacturing may emerge, increasing supplier options.
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Manufacturing Capacity: Ensuring an adequate supply of API and finished formulations requires significant investment in manufacturing capacity, which is often concentrated among limited suppliers.
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Quality Assurance: Maintaining consistent product quality across different suppliers is paramount, especially given safinamide's neurological application.
Market Trends and Future Outlook
The ongoing expansion into emerging markets, coupled with potential patent expirations or licensing arrangements, could diversify the supplier landscape further. Strategic partnerships between Newron Pharmaceuticals and regional manufacturers are likely to enhance supply stability. Additionally, advances in API synthesis and contract manufacturing may lower costs and increase production capacity.
Key Players and Strategic Considerations
| Player | Role | Region | Notes |
|---|---|---|---|
| Newron Pharmaceuticals | Original developer, patent holder | Global | Licensing API and formulation manufacturing |
| Zambon S.p.A. | US market licensee | North America | Distributes Zambon’s safinamide products |
| Neuraxpharm AG | European distributor | Europe | Licensed distribution partner |
| Sandoz (Novartis) | Potential API provider | Asia | Contract manufacturing, licensing |
| Chinese and Indian API Producers | API manufacturing | Asia | Emerging supply sources |
Conclusion
The supply of safinamide (Xadago) is primarily concentrated among a handful of licensed manufacturing companies. Patents, regulatory requirements, and quality standards restrict the number of compliant suppliers, but licensing agreements, regional partnerships, and emerging generic manufacturers continue to influence the supply landscape. Ensuring supply chain resilience involves monitoring patent developments, expanding manufacturing collaborations, and maintaining strict quality controls.
Key Takeaways
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Limited but Diversified Supply Base: The safinamide supply chain is concentrated among a few key licensed manufacturers, with growing regions in Asia serving as emerging sources.
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Regulatory and Quality Barriers: Stringent GMP standards limit the number of qualified suppliers, prioritizing quality over quantity.
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API Manufacturing Criticality: The API's complexity and manufacturing challenges make API suppliers pivotal in ensuring supply stability.
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Market Expansion Opportunities: Licensing agreements and regional manufacturing partnerships facilitate increased availability, especially in emerging markets.
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Strategic Monitoring Needed: Stakeholders should continuously track patent statuses, licensing negotiations, and regulatory changes to mitigate supply risks.
FAQs
1. Who are the main suppliers of safinamide API globally?
Major API suppliers include licensed Chinese manufacturers and Indian companies like Sun Pharma. The original developers, such as Newron Pharmaceuticals, oversee quality standards, often contracting with CMOs.
2. Can safinamide be manufactured in-house by pharmaceutical companies?
In theory, yes, provided they meet strict GMP standards and have access to the complex synthesis routes required for safinamide. However, most companies prefer licensing or outsourcing due to complexity and cost.
3. Are there regional differences in safinamide suppliers?
Yes. North America and Europe have licensed distribution networks, primarily through Zambon and Neuraxpharm, whereas Asia has a growing number of local manufacturers producing API and finished formulations.
4. How might patent expirations affect safinamide supply?
Patent expirations can lead to increased generic manufacturing, broadening supplier options, reducing costs, and potentially improving supply resilience.
5. What risks are associated with safinamide's supplier landscape?
Dependencies on limited licensed manufacturers, regulatory delays, quality issues, or geopolitical disruptions can threaten supply stability.
Sources
[1] Newron Pharmaceuticals. "Safinamide Development and Patent Portfolio." 2022.
[2] U.S. FDA. "Zadago (Safinamide) NDA Approval." 2017.
[3] Neuraxpharm. "Distribution and Licensing Agreements." 2022.
[4] GlobalData. "Emerging Trends in API Manufacturing in Asia." 2022.
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