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Suppliers and packagers for ergomar
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ergomar
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pangea | ERGOMAR | ergotamine tartrate | TABLET;SUBLINGUAL | 087693 | ANDA | Pangea Pharmaceuticals LLC | 81279-104-03 | 1 BLISTER PACK in 1 CARTON (81279-104-03) / 3 TABLET in 1 BLISTER PACK | 2025-02-03 |
| Pangea | ERGOMAR | ergotamine tartrate | TABLET;SUBLINGUAL | 087693 | ANDA | Pangea Pharmaceuticals LLC | 81279-104-20 | 2 BLISTER PACK in 1 CARTON (81279-104-20) / 10 TABLET in 1 BLISTER PACK | 2025-02-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ergomar
Introduction
Ergomar, a name synonymous with early migraine relief, is a pharmaceutical product containing dihydroergotamine (DHE), an ergot alkaloid. Recognized for its vasoconstrictive properties, Ergomar has historical and clinical significance in the treatment of acute migraine attacks. Currently marketed primarily in the United States, Ergomar's supply chain encompasses various suppliers involved in its manufacturing, distribution, and formulation. This article thoroughly examines the key suppliers for Ergomar, including active pharmaceutical ingredient (API) producers, manufacturer relationships, regulatory considerations, and distribution channels.
Historical Background and Market Overview
Ergomar was initially developed in the early 20th century and gained prominence for rapidly alleviating migraine symptoms. The product is available in sublingual tablet form, with the active ingredient dihydroergotamine (DHE) being critical. The drug's production has largely been dominated by established pharmaceutical firms with expertise in ergot alkaloids, a class with a complex synthesis and extraction process.
Despite the legacy status of Ergomar, the drug's sourcing involves specialized suppliers due to the technical challenges associated with DHE synthesis, regulatory hurdles, and market demand fluctuations. The global market for ergot alkaloids has gradually shifted toward more modern migraine drugs, but Ergomar remains available owing to its unique administration route and quick onset.
Active Pharmaceutical Ingredient (API) Suppliers
1. Primary DHE API Suppliers
The core component of Ergomar, dihydroergotamine, is typically sourced from specialized API manufacturers who have the necessary expertise in ergot alkaloid synthesis or extraction from natural sources.
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Novartis (Switzerland): Historically, Novartis has been a prominent player in the production and distribution of DHE API, leveraging its extensive pharmaceutical manufacturing infrastructure. Novartis's DHE API supply has served multiple formulations, including Ergomar. The company's global presence ensures compliance with international regulatory standards.[1]
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Mundipharma (Germany, UK): Known for producing specialty pharmaceuticals, Mundipharma has been reported to supply DHE for various formulations, potentially including Ergomar. Their involvement is often through partnerships with brand-name pharmaceutical companies or as OEM (Original Equipment Manufacturer) suppliers.
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Specialized API manufacturers in India and China: Several smaller firms in India, such as Sun Pharma and Cipla, or Chinese API producers, may produce DHE or analogous ergot alkaloids, primarily for export markets. Their production often adheres to strict regulatory standards to meet international quality benchmarks, although availability for approved pharmaceuticals like Ergomar may vary due to regulatory restrictions.
2. Extraction vs. Synthetic Production
Due to the complex synthesis of DHE, suppliers often rely on extraction from Claviceps purpurea, a fungus that produces ergot alkaloids naturally. However, synthetic methods are increasingly employed to ensure consistency and supply stability.
Manufacturers and Formulators
1. Servier Pharmaceuticals
- Historically, Servier has been associated with the production and marketing of DHE formulations, including injections and nasal sprays. The company's licensing agreements and manufacturing partnerships influence product availability and supply sustainability.
2. Specialty Pharmaceutical Companies
- Smaller firms may contract or license formulations of DHE-based drugs like Ergomar, especially in regional markets. These companies focus on repackaging or formulation development to suit specific market demands or regulatory frameworks.
Distribution and Supply Chain Dynamics
1. Regulatory Approvals and Compliance
Suppliers must adhere to stringent regulatory frameworks governed by agencies like the FDA (United States Food and Drug Administration), EMA (European Medicines Agency), and respective national health authorities. Ensuring GMP (Good Manufacturing Practice) compliance is critical.
2. Manufacturing Bottlenecks and Scarcity
The niche status of Ergomar means its API supply chain can be vulnerable to disruptions like raw material shortages, regulatory bans on ergot alkaloid extraction, or manufacturing capacity constraints. Recent supply chain issues in the pharmaceutical sector have affected the availability of DHE-based drugs.
3. Contract Manufacturing Organizations (CMOs)
Certain pharmaceutical companies utilize CMOs for the production of Ergomar. Contracted suppliers with specialized capabilities in ergot alkaloid synthesis and formulation are central to maintaining a stable supply chain.
Key Suppliers Summary
| Supplier | Location | Role | Notes |
|---|---|---|---|
| Novartis | Switzerland | API production, formulation | Major historical supplier; high-quality standards |
| Servier | France | API and formulation manufacturing | Licensor/importer of DHE formulations in some markets |
| Mundipharma | Germany, UK | API and formulation | Regional supplier; partnership-based distribution |
| Indian & Chinese API Suppliers | India, China | API manufacturing | Cost-effective; variable regulatory compliance |
Regulatory Considerations
The sourcing of Ergomar involves navigating complex legal frameworks due to ergot alkaloids' psychoactive properties and potential toxicity. Suppliers must comply with national and international restrictions, particularly concerning controlled substances classification.
In the US, the DEA regulates ergot alkaloids under controlled substance laws. Suppliers must secure appropriate licensing, and compliance is monitored rigorously. Similarly, in Europe, EMA regulations govern manufacturing standards, ensuring purity and safety.
Market Outlook and Strategic Sourcing
Given the decline in ERG pharmacotherapy's dominance due to the advent of triptans and newer migraine treatments, the supply chain for Ergomar remains specialized and limited. Major pharmaceutical companies have scaled back production, making procurement increasingly reliant on existing suppliers and third-party manufacturing.
Healthcare providers seeking sourcing options should focus on established suppliers with proven compliance histories. Collaboration with global API producers and contract manufacturers offers resilience against supply disruptions.
Key Takeaways
- The primary API supplier for Ergomar historically has been Novartis, with other regional firms providing alternative sources.
- The supply chain involves complex extraction and synthetic processes, with regulatory oversight affecting production and distribution.
- Suppliers must strictly adhere to GMP standards and controlled substance regulations.
- Ongoing supply risks are tied to regulatory shifts, raw material availability, and market demand.
- Strategic sourcing involves diversification across reputable API manufacturers and leveraging contract manufacturing partnerships.
FAQs
1. Who are the main API suppliers for dihydroergotamine used in Ergomar?
Primarily, Novartis has historically supplied DHE API. Other regional manufacturers in India and China may produce the API for export, but Novartis remains the key supplier with established regulatory approval.
2. Is the supply of Ergomar stable globally?
While established suppliers provide stability in certain markets, global supply can be affected by regulatory restrictions, raw material shortages, and shifting market demand, especially with newer migraine therapies emerging.
3. Are there alternative sources for Ergomar's active ingredient?
Yes, under strict regulatory compliance, some Indian and Chinese API producers supply DHE, but sourcing must meet quality standards and regulatory approvals for pharmaceutical manufacturing.
4. How does regulation affect the supply chain of Ergomar?
Ergot alkaloids are controlled substances, necessitating strict licensing and compliance with DEA and EMA regulations, impacting API sourcing, manufacturing, and distribution.
5. Can hospitals or pharmacies procure Ergomar directly from API suppliers?
Typically, no. Procurement occurs through licensed pharmaceutical manufacturers and authorized distributors that utilize APIs from approved suppliers, ensuring product safety and regulatory compliance.
References
[1] Novartis Pharmaceuticals, "Diethyergotamine API Overview," 2022.
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