Suppliers and packagers for migranal

migranal

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-357-10	8 VIAL in 1 KIT (68682-357-10) / 1 mL in 1 VIAL	2013-03-18

Suppliers for the Pharmaceutical Drug: MIGRANAL

Last updated: July 29, 2025

Introduction

MIGRANAL, known generically as dihydroergotamine mesylate, is an intravenous, intranasal, or subcutaneous medication primarily used for the acute treatment of migraines. As a member of the ergot alkaloid class, MIGRANAL is significant in neurology and pain management sectors. Its market presence relies heavily on reliable supply chains from pharmaceutical manufacturers and authorized suppliers. This report explores the key suppliers of MIGRANAL, their market roles, regulatory considerations, and implications for healthcare providers and investors.

Overview of MIGRANAL as a Pharmaceutical Product

MIGRANAL was originally developed by pharmaceutical companies specializing in neurology and migraine therapies. Its pharmacological efficacy stems from vasoconstriction of cranial blood vessels, alleviating migraine symptoms. The formulation's stability, safety profile, and production complexity influence supplier options and availability.

Despite its clinical importance, MIGRANAL’s market is characterized by limited manufacturers due to manufacturing complexities, strict regulatory controls, and patent considerations. Consequently, the supply landscape is relatively concentrated, requiring scrutiny for continuity and quality assurance.

Key Manufacturers of MIGRANAL

1. Medicis Pharmaceutical (Endo Pharmaceuticals)
   Historically, Endo Pharmaceuticals has been a primary supplier for MIGRANAL, manufacturing dihydroergotamine formulations for various routes of administration. Their facilities maintain strict compliance with regulatory standards, including FDA Good Manufacturing Practices (GMP).

2. Egalet Corporation
   Specializing in developing and manufacturing complex drugs, Egalet has historically provided formulations of dihydroergotamine, focusing on nasal sprays and injectable forms. Their expertise in formulation technology positions them as a potential supplier or partner for MIGRANAL production, especially considering recent industry trends toward innovative delivery methods.

3. Teva Pharmaceutical Industries
   Teva, a leading generic drug manufacturer, has the capability to produce dihydroergotamine products, often under different brand names or as authorized generics. Their global manufacturing footprint offers distribution advantages, though specific licensing agreements influence MIGRANAL supply.

4. Specialty Compounding Pharmacies
   While not traditional large-scale manufacturers, certain specialized compounding pharmacies prepare dihydroergotamine formulations. These are often used in research settings, clinical trials, or personalized medicine. However, their products lack the regulatory approval status enjoyed by licensed manufacturers.

Regulatory and Patent Considerations

MIGRANAL’s manufacturing and supply are tightly regulated by the FDA and equivalent regulatory bodies worldwide. Any manufacturing entity wishing to produce dihydroergotamine must demonstrate compliance with stringent quality standards, including facility inspections, validation protocols, and product stability testing.

Patent life and exclusivity periods impact supplier entry. Once patents expire or are challenged, generic manufacturers can enter the market, expanding the supply base and potentially reducing costs.

Market Dynamics and Supplier Risks

• Supply Concentration: Despite multiple potential manufacturers, the market remains concentrated. Limited dedicated manufacturing facilities and complex formulation requirements restrict rapid scaling or entry by new suppliers.
• Regulatory Risks: Changes in FDA regulations or manufacturing standards can cause supply disruptions or necessitate costly facility upgrades.
• Quality Assurance: Given the medication’s critical role, buyers prioritize suppliers with robust quality management systems, comprehensive traceability, and proven track records.
• Price Volatility: Fluctuating raw material costs, especially for ergot alkaloids derived from natural sources, influence pricing and supply stability.

Emerging Supply Considerations

• Partnerships and Licensing Agreements: Large pharmaceutical firms often secure licensing arrangements with specialized manufacturers to ensure product availability.
• Alternative Formulations: Developing new formulations, such as nasal sprays or auto-injectors, diversifies the supply chain and caters to patient preferences.
• Regional Manufacturing: Expanding manufacturing capacity within emerging markets enhances supply resilience but introduces regulatory and quality challenges.

Implications for Stakeholders

Healthcare providers depend on consistent, high-quality supply for patient safety and treatment efficacy. Disruptions in MIGRANAL’s supply chain can lead to treatment gaps, motivating procurement strategies that involve multiple suppliers, inventory management, and quality assurance.

Investors and industry analysts should monitor regulatory developments, patent statuses, and manufacturer capacities to anticipate market shifts. Collaborations or licensing arrangements reveal strategic priorities and potential market entry barriers.

Conclusion

The supply ecosystem for MIGRANAL is characterized by a limited number of manufacturers operating within a stringent regulatory framework. Major players include Endo Pharmaceuticals, Egalet Corporation, and Teva. Each navigates regulatory, manufacturing, and market risks that influence drug availability and pricing. While the potential for expanding the supplier base exists with technological innovations and patent expiries, current market conditions favor a concentrated supply landscape. Ensuring stability requires strategic partnerships, rigorous quality controls, and proactive monitoring of regulatory environments.

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Key Takeaways

• MIGRANAL's current supply is primarily dominated by established manufacturers like Endo Pharmaceuticals, Egalet, and Teva.
• Manufacturing complexities and regulatory barriers limit rapid entry of new suppliers, maintaining market concentration.
• Quality assurance and regulatory compliance are critical factors for procurement decisions, given the medication’s clinical importance.
• Patent expiries and technological innovations could diversify and expand the supplier ecosystem.
• Healthcare providers should adopt robust supply chain management practices to mitigate risks of disruptions.

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FAQs

1. Who are the primary manufacturers of MIGRANAL?
Historically, Endo Pharmaceuticals and Egalet Corporation have been key suppliers. Teva also manufactures dihydroergotamine formulations, often as authorized generics or under licensing agreements.

2. Can new suppliers enter the MIGRANAL market easily?
Entry is challenging due to strict regulatory requirements, complex formulation standards, and limited manufacturing capacity. Patents and exclusivity agreements also influence market entry.

3. Are there generic versions of MIGRANAL available?
Yes, once patents expire, generic manufacturers can produce dihydroergotamine products, expanding supply options and reducing costs.

4. What risks exist in the current MIGRANAL supply chain?
Risks include supply concentration, regulatory delays, manufacturing disruptions, and quality issues. These factors can lead to shortages and price fluctuations.

5. How might the supply of MIGRANAL evolve in the future?
Technological advances, patent expiries, and strategic licensing could diversify and strengthen the supply chain, ensuring broader access and stability.

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Sources
[1] US Food and Drug Administration, “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).”
[2] Industry reports on ergot alkaloid manufacturing, 2022.
[3] Company websites and press releases from Endo Pharmaceuticals, Egalet Corporation, and Teva Pharmaceutical Industries.