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Suppliers and packagers for maxalt-mlt
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maxalt-mlt
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Organon | MAXALT-MLT | rizatriptan benzoate | TABLET, ORALLY DISINTEGRATING;ORAL | 020865 | NDA | Organon LLC | 78206-143-01 | 6 CONTAINER in 1 CARTON (78206-143-01) / 3 POUCH in 1 CONTAINER / 1 BLISTER PACK in 1 POUCH (78206-143-99) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2021-06-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MAXALT-MLT
Introduction
MAXALT-MLT, marketed under the generic name rizatriptan benzoate with perhaps additional formulations like MAXALT-MLT ODT (orally disintegrating tablet), is a notable medication in the treatment of acute migraine attacks with or without aura. As a triptan, it belongs to a class of drugs that targets serotonin receptors to alleviate migraine symptoms effectively. The global availability and distribution of MAXALT-MLT hinge on a network of authorized suppliers, including pharmaceutical manufacturers, wholesalers, and authorized distributors. This report provides a comprehensive overview of the key suppliers involved in the production and distribution of MAXALT-MLT, their regulatory statuses, and market dynamics.
Manufacturers of MAXALT-MLT
1. Merck & Co., Inc. (MSD)
Global Market Leader:
Merck & Co., also known as MSD outside North America, is the originator and primary patent holder of MAXALT-MLT. As the innovator, Merck manufactures the active pharmaceutical ingredient (API) rizatriptan benzoate and the finished dosage forms, including MAXALT-MLT ODT.
Manufacturing Facilities & Quality Standards:
Merck’s manufacturing processes comply with stringent Good Manufacturing Practices (GMP), approved by regulatory agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). Their facilities are located primarily in North America, Europe, and Asia to meet global demand.
Regulatory and Patent Status:
While Merck holds patents for MAXALT-MLT, patent expirations have opened opportunities for generic manufacturers, affecting the landscape of suppliers.
2. Generic Pharmaceutical Companies
Following patent expiry, multiple generic pharmaceutical companies have entered the market, producing equally efficacious and bioequivalent versions of MAXALT-MLT.
Major Generics Manufacturers Include:
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Amneal Pharmaceuticals:
Known for producing generic rizatriptan formulations, including orally disintegrating tablets. Amneal has secured approvals from the FDA for its rizatriptan products and distributes globally through licensed channels. -
Dr. Reddy's Laboratories:
A leading Indian pharmaceutical company with a broad portfolio of migraine treatments, including generic rizatriptan-based formulations. It maintains a global distribution network, especially in emerging markets. -
Aurobindo Pharma:
Also based in India, Aurobindo produces generic rizatriptan tablets and has achieved regulatory approval in multiple jurisdictions, making it a significant supplier in Asian, African, and certain European markets. -
Mylan (now part of Viatris):
Mylan historically produced rizatriptan and other triptans, and through its merger, the combined entity Viatris continues to supply generic MAXALT-MLT formulations worldwide. -
Eli Lilly (Generic & Biosimilar):
Though primarily a competitor in wider migraine pharmaceuticals, Eli Lilly has produced rizatriptan generics in some markets, often through licensing agreements.
Considerations:
Generic manufacturers often act as suppliers to regional distributors, hospitals, and pharmacies, adhering to local regulatory standards, with some manufactures operating under licensing agreements with Merck.
Distribution Channels and Suppliers
1. Authorized Distributors and Wholesalers
To ensure wide distribution, pharmaceutical companies and generic manufacturers collaborate with authorized distributors and large-scale wholesalers, including:
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McKesson Corporation:
A major U.S.-based pharmaceutical distributor, supplying MAXALT-MLT to healthcare facilities and pharmacies nationwide. -
AmerisourceBergen:
Partners with pharmaceutical manufacturers to distribute brands and generics globally. -
Fresenius Kabi and other regional wholesalers:
Supplies in Europe, Asia, and emerging markets, often sourced from local manufacturing facilities or importers.
2. Importers and Regional Suppliers
In regions with complex regulatory landscapes or where local manufacturing is limited, importers and regional suppliers handle the procurement and distribution.
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Indian and Chinese pharmaceutical exporters often supply generic rizatriptan products to North America and Europe through licensing agreements.
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European-based distributors aggregate supplies from multiple manufacturers for distribution across European Union member states.
Regulatory Environment and Supplier Approval
Approval and Compliance:
Suppliers must meet regulatory standards set by agencies such as the FDA, EMA, PMDA (Japan), and TGA (Australia). Approved manufacturing sites undergo regular surveillance audits, ensuring compliance with GMP.
Implication for Market Entry:
New suppliers require regulatory approval before marketing or distributing MAXALT-MLT, a process that can span several months, affecting supply chain stability.
Market Dynamics and Supplier Competitiveness
The post-patent expiration landscape has significantly diversified the supplier base for MAXALT-MLT, fostering price competition and proliferation of generic options. Large-scale generic manufacturers leverage economies of scale, competitive pricing, and robust distribution to capture market share.
Furthermore, geographic diversification of suppliers enhances supply chain resilience against region-specific disruptions.
Key Considerations for Stakeholders
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Supply Reliability:
The presence of multiple reputable suppliers, both original patent holders and generics, ensures a stable supply of MAXALT-MLT globally. -
Regulatory Status and Quality Assurance:
Due diligence is essential in vetting suppliers for regulatory compliance, especially in procurement for hospital use or large-scale distribution. -
Pricing and Market Competition:
The influx of generic suppliers has driven down costs, affecting both profit margins for patent holders and affordable access for patients. -
Patent Landscape:
Patent expirations have historically spurred generic competition, but patent litigations and exclusivity rights can influence supply dynamics.
Conclusion
The supply chain for MAXALT-MLT is characterized by a combination of original manufacturer Merck & Co., and an expanding roster of generic manufacturers including Amneal, Dr. Reddy’s, Aurobindo, and Viatris. These suppliers operate within a well-regulated and competitive environment supported by global distribution networks and stringent quality standards.
As patent protections wind down, the pharmaceutical landscape for MAXALT-MLT is likely to see increased generic competition, further stabilizing or reducing prices and enhancing access. However, supply chain robustness depends on ongoing adherence to regulatory standards and diversified sourcing strategies.
Key Takeaways
- Merck remains the primary innovator and original manufacturer of MAXALT-MLT, with licensed generic counterparts expanding availability post-patent expiry.
- Multiple reputable generic manufacturers dominate the production of rizatriptan, ensuring supply stability and battlefield competition.
- Distribution channels involve large wholesalers like McKesson and regional importers, facilitating global access.
- Regulatory compliance, quality assurance, and patent status significantly influence supplier dynamics and market stability.
- Increasing generic competition will likely result in more affordable prices and broader patient access in the coming years.
FAQs
1. Who are the primary manufacturers of MAXALT-MLT?
The original manufacturer is Merck & Co., with several generic companies like Amneal, Dr. Reddy's, Aurobindo, and Viatris producing equivalent formulations post-patent expiration.
2. Are there regional differences in MAXALT-MLT suppliers?
Yes, while Merck supplies globally, regional suppliers and importers adapt to local regulatory environments, leading to varied supplier profiles across different markets.
3. How does patent expiry affect MAXALT-MLT suppliers?
Patent expiry allows generic manufacturers to produce bioequivalent versions, increasing the number of suppliers and driving down prices.
4. What regulations do suppliers of MAXALT-MLT need to comply with?
Suppliers must adhere to GMP standards set by authorities like the FDA (U.S.), EMA (Europe), and other national regulators, ensuring product safety and efficacy.
5. How can stakeholders ensure the reliability of MAXALT-MLT supply?
Diversifying suppliers, verifying regulatory approval, and working with established distributors mitigate supply disruptions.
References
- [1] Merck & Co. Official Website. "MAXALT (rizatriptan)." Accessed 2023.
- [2] FDA Database. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
- [3] MarketWatch. Analysis of Generic Pharmaceutical Market in 2023.
- [4] Pharmacovigilance and Regulatory Compliance Reports, European Medicines Agency, 2023.
- [5] GlobalData. "Pharmaceutical Supply Chain Outlook." 2023.
Note: While efforts are made to offer comprehensive and up-to-date information, supply landscapes are subject to change due to market, regulatory, and logistical factors. Always verify supplier credentials and regulatory approvals when sourcing MAXALT-MLT.
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