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Suppliers and packagers for generic pharmaceutical drug: RIMEGEPANT SULFATE
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RIMEGEPANT SULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | NURTEC ODT | rimegepant sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 212728 | NDA | Pfizer Laboratories Div Pfizer Inc | 72618-3000-2 | 1 BLISTER PACK in 1 CARTON (72618-3000-2) / 8 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2020-03-05 |
| Pfizer | NURTEC ODT | rimegepant sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 212728 | NDA | Pfizer Laboratories Div Pfizer Inc | 72618-3001-2 | 4 DOSE PACK in 1 CARTON (72618-3001-2) / 1 BLISTER PACK in 1 DOSE PACK (72618-3001-1) / 2 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2020-03-05 |
| Pfizer | NURTEC ODT | rimegepant sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 212728 | NDA | Sportpharm, Inc. dba Sportpharm | 85766-096-08 | 1 BLISTER PACK in 1 CARTON (85766-096-08) / 8 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2020-03-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Rimegepant Sulfate
Introduction
Rimegepant sulfate represents a vital advancement in the landscape of migraine treatment. As a calcitonin gene-related peptide (CGRP) receptor antagonist, it offers both acute and preventive therapy options, enhancing patient outcomes and expanding therapeutic paradigms. This medication is developed and marketed by pharmaceutical giants such as Eli Lilly and Co., which secured approval for its use mainly in North America and select global markets. The procurement of Rimegepant sulfate requires understanding its various sourcing avenues, including raw material suppliers, manufacturing partnerships, and regional distributors. This article explores the landscape of suppliers involved in the production and supply of Rimegepant sulfate, providing a comprehensive overview for industry stakeholders, healthcare providers, and business strategists.
Chemical Profile and Manufacturing Context
Rimegepant sulfate, the active pharmaceutical ingredient (API), is synthesized via complex organic processes, involving advanced medicinal chemistry techniques. The API's production demands high-purity chemical intermediates and specialized manufacturing conditions compliant with Good Manufacturing Practice (GMP) standards. Suppliers for these intermediates and finished APIs are strategically located across Asia, Europe, and North America, with a focus on ensuring quality, regulatory compliance, and supply chain robustness.
Key Raw Material Suppliers
1. Specialty Chemical Manufacturers
The synthesis of Rimegepant sulfate depends on high-quality starting materials, including complex intermediates such as pyridine derivatives, amides, and sulfonyl chlorides. Leading suppliers for these materials include:
- BASF – A global chemical leader supplying a range of pharmaceutical intermediates and specialty chemicals utilized in Rimegepant synthesis. BASF’s expertise in research-driven chemical production ensures compliance with pharmaceutical standards.
- Sigma-Aldrich (Merck KGaA) – Offers a broad portfolio of raw materials, including pyridine derivatives and coupling agents essential for API synthesis.
- Jubilant Organosys – An Indian manufacturer providing custom synthesis services for complex intermediates at GMP standards.
2. Custom Synthesis and Contract Manufacturing Organizations (CMOs)
Partnering with CMOs experienced in small molecule APIs offers flexibility and scalability in API production:
- Lonza – Specializes in custom synthesis with capabilities aligned to GMP, providing R&D, pilot, and commercial scale manufacturing of APIs like Rimegepant sulfate.
- Glenmark Life Sciences – An Indian-based CMO producing specialized intermediates under stringent regulatory regimes, contributing to supply chain diversification.
- Therapure – Focused on complex small molecule API manufacturing, including chemical intermediates necessary for Rimegepant synthesis.
Active Pharmaceutical Ingredient (API) Suppliers
While Eli Lilly manufactures Rimegepant sulfate internally for its commercial formulations, some regional markets may source the API from third-party suppliers under licensing or supply agreements. Notably:
- Cerbios-Pharma SA – A Swiss API manufacturer with capabilities in complex small molecules, including licensed production of certain calcitonin gene-related peptide antagonists or similar CNS-active compounds.
- APIs from China and India – Several manufacturers in these regions possess capacity for bulk API production due to a mature generic pharmaceutical sector. However, sourcing from these markets emphasizes quality assurance and regulatory compliance.
Regional Distributors and Supply Chain Dynamics
Once manufactured, Rimegepant sulfate is distributed via regional wholesalers and distributors, often through partnerships aligned with the pharmaceutical company:
- McKesson and Cardinal Health – Major North American distributors handling pharmaceutical logistics, including specialty drug supply chains for Rimegepant sulfate formulations.
- API Trading Companies – Entities such as Tianjin Chempharm and Chemtrade Asia serve as bulk API traders, providing regional supply to generic manufacturers or compounding pharmacies.
Supply Chain Challenges and Considerations
The supply chain for Rimegepant sulfate faces unique challenges:
- Regulatory Compliance: Sourcing from GMP-compliant suppliers is paramount to meet FDA, EMA, and other regulatory standards.
- Quality Consistency: Ensuring batch-to-batch consistency requires rigorous supplier qualification and continuous quality oversight.
- Geopolitical Factors: Dependence on Asian suppliers introduces risks related to trade tensions, tariffs, and transportation disruptions, notably highlighted during the COVID-19 pandemic.
- Intellectual Property: Securing licensing agreements and navigating patent landscapes influence supplier selection and sourcing strategies.
Emerging Trends and Future Directions
As demand for Rimegepant sulfate grows, new suppliers are entering the pipeline, particularly in emerging markets. Contract manufacturing partnerships continue to evolve, with increased emphasis on sustainable, cost-effective, and quality-assured sourcing. Additionally, vertical integration strategies by pharmaceutical firms aim to secure key raw materials and APIs internally, reducing reliance on external suppliers.
Key Players Summary
| Category | Leading Entities | Notes |
|---|---|---|
| Raw Material Suppliers | BASF, Sigma-Aldrich, Jubilant | Provide key intermediates and raw materials |
| Custom Synthesis & CMOs | Lonza, Glenmark, Therapure | Facilitate scalable and GMP-compliant manufacturing |
| API Manufacturers | Eli Lilly (internal), Cerbios-Pharma, Chinese/Indian vendors | Supply bulk APIs via licensing agreements or third-party manufacturing |
| Distributors | McKesson, Cardinal Health, regional API traders | Regional and global distribution channels |
Conclusion
The supply ecosystem for Rimegepant sulfate involves a complex network of specialized chemical manufacturers, contract manufacturing organizations, and regional distributors, all operating within a framework of regulatory compliance and quality assurance. Success in sourcing hinges on strategic supplier partnerships, rigorous quality oversight, and adaptability to geopolitical and market dynamics. As demand continues to escalate, diversification and supply chain resilience will be top priorities for stakeholders involved in Rimegepant sulfate’s production and distribution.
Key Takeaways
- Sourcing high-quality raw materials for Rimegepant sulfate involves engagement with leading specialty chemical manufacturers and CMOs like BASF and Lonza.
- Ensuring GMP compliance and consistent quality standards is critical across the entire supply chain.
- Dependence on Asian API manufacturers introduces geopolitical and logistical risks; diversification is vital.
- Pharmaceutical companies often leverage licensing agreements to access APIs from regional or third-party suppliers.
- Growing demand necessitates strategic supply chain management, including the development of new suppliers and potential vertical integration.
FAQs
1. Who are the top raw material suppliers for Rimegepant sulfate?
Major chemical companies like BASF and Sigma-Aldrich supply key intermediates, while Indian firms such as Jubilant Organosys offer custom synthesis services.
2. Can third-party manufacturing organizations produce Rimegepant sulfate commercially?
Yes, CMOs like Lonza and Glenmark are capable of GMP-compliant production at commercial scale, often under licensing agreements with patent holders.
3. How does regulatory compliance impact supplier selection?
Suppliers must meet GMP standards and regulatory approvals (FDA, EMA), ensuring the API's safety, efficacy, and quality.
4. Are regional distributors involved in the supply of Rimegepant sulfate?
Yes, regional distributors like McKesson facilitate the transportation and distribution of the finished drug to healthcare providers.
5. What future supply chain trends are anticipated for Rimegepant sulfate?
Increased localization, strategic diversification, and potential vertical integration are expected to address supply chain vulnerabilities as demand expands.
Sources
[1] Eli Lilly’s official Rimegepant product information.
[2] Pharmaceutical chemical market reports (e.g., Grand View Research).
[3] API manufacturing and supply chain case studies.
[4] Regulatory standards documents (FDA, EMA).
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