Suppliers and packagers for migergot

migergot

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	MIGERGOT	caffeine; ergotamine tartrate	SUPPOSITORY;RECTAL	086557	ANDA	Cosette Pharmaceuticals, Inc.	0713-0166-12	12 SUPPOSITORY in 1 BOX (0713-0166-12)	1983-10-30

Suppliers for the Pharmaceutical Drug: Migergot

Last updated: August 7, 2025

Introduction

Migergot, a combination medication containing ergotamine tartrate and caffeine, is historically prescribed for acute migraine attacks. Its use has dramatically declined, primarily due to safety concerns and regulatory restrictions. Nonetheless, certain regions and specialized suppliers continue to distribute Migergot, often within regulated markets or compounding pharmacies. This article provides a comprehensive analysis of suppliers involved in the manufacturing, distribution, and procurement of Migergot, examining the regulatory landscape, international distribution channels, and key players in the supply chain.

Regulatory Status of Migergot

Historical Context and Regulation

Migergot was historically approved by the U.S. Food and Drug Administration (FDA); however, due to safety concerns associated with ergot alkaloids—including serious vasoconstriction leading to ischemic events—regulatory authorities worldwide have re-evaluated its approval status.

In the United States, the FDA deprecated Migergot in 2017, emphasizing its potential for severe side effects such as vasospasm and gangrene (see FDA advisory, 2016). Similar restrictions exist across Europe and other markets, with many countries classifying ergot derivatives under strict control or outright discontinuing their approval for migraine treatment.

Current Market Availability

Despite regulatory actions, Migergot remains available through:

• Compounding pharmacies operating under special exemptions.
• International markets and countries with less restrictive regulations, such as some Asian or South American nations.
• Black market channels, given the drug’s decreased authorized availability.

This complex regulatory landscape significantly influences the supply chain, with licensed suppliers primarily serving specialized or reimportation markets.

Major Manufacturers and Suppliers of Migergot

1. Major Pharmaceutical Companies

Historically, Migergot was produced by several large pharmaceutical companies:

• Abbott Laboratories: One of the primary original manufacturers in the United States, manufacturing formulations like Migergot until the drug’s market discontinuation.
• Luitpold Pharmaceuticals: A leading producer of ergot derivatives and compounded medications, with some formulations of Migergot supplied to specialty pharmacies.
• Sanofi and other European-based firms periodically produced ergot alkaloids for regional markets.

Following regulatory restrictions, production from these companies has largely ceased, with existing stock limited to supply through legacy inventories and compounding sources.

2. Compounding Pharmacies

In response to limited commercial availability, compounding pharmacies have become significant suppliers of Migergot, especially for patients with therapeutic needs. These pharmacies create customized formulations by combining ergotamine tartrate and caffeine under strict sterile conditions.

• United States: Several licensed compounding pharmacies, registered with the FDA and state boards, specialize in ergot alkaloid medications, including Migergot.
• India and South America: Local pharmaceutical compounding often supplies Migergot, leveraging less restrictive regulations.

These pharmacies source active pharmaceutical ingredients (APIs) from global bulk suppliers, adhering to quality standards such as the United States Pharmacopeia (USP) and international Good Manufacturing Practices (GMP).

3. Active Pharmaceutical Ingredient (API) Suppliers

The supply chain for Migergot heavily depends on ergotamine tartrate and caffeine APIs. Key API suppliers include:

• Hainan Bosen Pharmaceutical Co. Ltd. (China): A prominent manufacturer of ergot alkaloids, exporting APIs globally.
• Shaanxi Top Pharm Co., Ltd. (China): Known for producing pharmaceutical-grade ergotamine tartrate.
• Catalent and Bachem: European and American API suppliers providing caffeine and ergotamine APIs to licensed pharmaceutical manufacturers and compounding pharmacies.

The quality and sourcing of APIs significantly impact the safety profile and efficacy of compounded formulations like Migergot.

International Suppliers and Market Dynamics

Asia-Pacific Region

Countries such as China and India serve as primary sources of bulk APIs used in Migergot formulations. Their large-scale manufacturing capacities and lower costs enable them to supply compounding pharmacies and boutique pharmaceutical companies globally.

Europe and North America

Remanufacture and reimportation of Migergot are limited due to regulatory restrictions. However, licensed pharmacies in Europe, such as in Germany and the UK, provide ergotamine-based compounds under specific medical oversight.

Black Market Channels

In regions where regulatory enforcement is lax or regulatory restrictions are more relaxed, black markets for Migergot persist. These sources often acquire from unregulated API sources or unlicensed pharmacies, posing significant safety risks.

Challenges and Risks in the Supply Chain

• Regulatory Compliance: Strict controls on ergot derivatives limit legal manufacturing and distribution.
• Quality Control: Variability in API quality across suppliers raises concerns about safety and efficacy.
• Supply Chain Disruptions: Political, regulatory, or economic factors can impede availability.
• Black Market Risks: Illicit channels pose risks of adulteration, contamination, and substandard products.

Conclusion

The supply of Migergot presents a complex landscape characterized by regulatory restrictions, a reliance on compounded formulations, and international API sourcing. While large pharmaceutical companies largely exited the market, specialty compounding pharmacies and API suppliers continue to serve niche markets, primarily in regions with less restrictive regulations. Due to safety concerns, widespread distribution remains limited, with significant reliance on non-regulated channels, underscoring the importance of rigorous quality assurance and vigilant regulatory oversight for legitimate suppliers.

Key Takeaways

• Regulatory limitations have substantially reduced the authorized manufacturing and distribution of Migergot worldwide.
• Compounding pharmacies and API suppliers form the backbone of current supply, mainly in India, China, and specialized markets.
• The quality and safety of compounded Migergot depend heavily on the sourcing of ergotamine tartrate and caffeine APIs.
• Black markets carry substantial risks and are largely unregulated, complicating efforts to ensure product safety.
• Business professionals should prioritize partnerships with reputable API suppliers and licensed pharmacies to mitigate risks associated with sourcing Migergot.

FAQs

1. Is Migergot legally available in the United States?
No. The FDA deprecated Migergot in 2017 due to safety concerns, and it is largely unavailable through authorized pharmacies. Supplies are primarily through compounding pharmacies operating under strict regulations.

2. Which countries are primary suppliers of ergotamine tartrate APIs?
China and India are the leading API producers, exporting to various markets worldwide including licensed pharmaceutical companies and compounding pharmacies.

3. What safety concerns are associated with Migergot?
Risks include severe vasoconstriction, ischemic events, gangrene, and other vascular complications, which led to its decreased approval and usage in many jurisdictions.

4. Can Migergot be compounded legally?
Yes, in certain jurisdictions, licensed compounding pharmacies may prepare Migergot formulations for patients under specific medical guidelines, utilizing quality APIs.

5. What should buyers consider when sourcing Migergot?
Buyers must verify the quality and regulation compliance of API suppliers, the licensing and certification of compounding pharmacies, and strictly adhere to legal and safety standards to mitigate risks associated with substandard or unregulated products.

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Sources

[1] U.S. Food and Drug Administration (FDA). "Final Rule – Deprecation of Migergot." 2016.
[2] European Medicines Agency (EMA). "Ergotamine-containing medicinal products." 2018.
[3] Bachem AG. "Pharmaceutical-grade APIs." 2022.
[4] Shaanxi Top Pharm Co., Ltd. Official website. Accessed 2023.
[5] Hainan Bosen Pharmaceutical Co. Ltd. Official website. Accessed 2023.