ERGOTAMINE TARTRATE AND CAFFEINE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Anda Repository	ERGOTAMINE TARTRATE AND CAFFEINE	caffeine; ergotamine tartrate	TABLET;ORAL	040590	ANDA	Cintex Services, LLC	24470-917-10	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24470-917-10)	2016-11-23
Anda Repository	ERGOTAMINE TARTRATE AND CAFFEINE	caffeine; ergotamine tartrate	TABLET;ORAL	040590	ANDA	Cintex Services, LLC	24470-917-40	40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24470-917-40)	2016-11-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Ergotamine tartrate combined with caffeine remains a critical formulation in the treatment of acute migraines and cluster headaches. As a pharmaceutical compound with a long-standing therapeutic application, sourcing reliable and compliant suppliers is essential for manufacturers, distributors, and healthcare providers. This article offers an in-depth examination of global suppliers, highlights key manufacturing players, emphasizes regulatory considerations, and provides strategic insights for securing dependable supply channels.

Overview of Ergotamine Tartrate and Caffeine

Ergotamine tartrate is an ergot alkaloid derived from the Claviceps purpurea fungus, primarily used for its vasoconstrictive properties in migraine management. When paired with caffeine, which enhances absorption and potentiates vasoconstriction, it forms a synergistic combination widely prescribed under various brand names. The formulation's efficacy, however, hinges on the consistent quality and reliability of its raw materials and finished products.

Global Suppliers of Ergotamine Tartrate and Caffeine

1. Ergotamine Tartrate Suppliers

a. Micro Labs Limited (India)

Micro Labs is a leading Indian pharmaceutical manufacturer with a significant presence in the global generics market. The company produces high-quality ergotamine tartrate, adhering to stringent GMP standards and regulatory requirements of major markets such as the US FDA and EMA. Their excipient-quality products are supplied to various pharmaceutical companies worldwide, with a strong emphasis on compliance and affordability [1].

b. Hubei Bailing Group Pharmaceutical Co., Ltd. (China)

A notable Chinese manufacturer, Bailing Group offers ergotamine tartrate with comprehensive GMP certifications. Their products are often utilized in regional markets and are increasingly penetrating global supply chains due to competitive pricing and manufacturing capacity [2].

c. Yunnan Baiyao Group (China)

Known for their diversified pharmaceutical portfolio, Yunnan Baiyao produces ergotamine tartrate for regional markets. Their focus on quality control and regional distribution channels has positioned them as a reliable, if localized, supplier [3].

d. Sigmapharm Laboratories LLC (USA)

While primarily focused on generics, Sigmapharm supplies ergotamine tartrate formulated medicinal products that comply with US standards. They cater predominantly to the North American market and hold requisite FDA approvals [4].

2. Caffeine Suppliers

a. Jiangsu Xinde Pharmaceutical Co., Ltd. (China)

This manufacturer supplies pharmaceutical-grade caffeine used in various formulations, including combination products. They hold GMP certifications and possess extensive export licenses, making them a primary source for global markets [5].

b. Merck KGaA (Germany)

A premier pharmaceutical and chemical supplier, Merck produces pharmaceutical-grade caffeine with unwavering quality standards. Their products are globally recognized and supplied under strict regulatory compliance, especially for markets with high regulatory scrutiny [6].

c. Anhui Guolin Pharmaceutical Co., Ltd. (China)

Known for their wide spectrum of active pharmaceutical ingredients, Guolin supplies caffeine to many formulators worldwide. They emphasize quality control and have achieved certification by international regulatory agencies [7].

d. Sigma-Aldrich (part of Merck)

A leading provider of pharmaceutical raw materials, Sigma-Aldrich supplies caffeine and other excipients of pharmaceutical-grade quality. Their extensive distribution network ensures reliable supply and regulatory compliance [8].

3. Tiered Suppliers and Contract Manufacturing Organizations (CMOs)

In addition to primary manufacturers, numerous CMOs offer custom synthesis of ergotamine tartrate and caffeine or provide finished formulations for bulk purchase. These include companies like Almac Group, Catalent, and Recipharm, which possess the infrastructure and quality assurance protocols to meet stringent regulatory requirements globally.

Regulatory and Quality Considerations

Suppliers must meet various international standards, including GMP, ISO certifications, and specific regulatory approvals (FDA, EMA, PMDA, etc.). Ensuring traceability, batch-to-batch consistency, and adherence to pharmacopoeial specifications (USP, EP, JP) are prerequisites for reliable procurement.

Potential regulatory hurdles include import/export restrictions, tariffs, and regional licensing obligations. Suppliers compliant with the Drug Supply Chain Security Act (DSCSA) in the US or FMD regulations in Europe facilitate seamless distribution pathways.

Strategic Supplier Selection and Risk Management

Given the criticality of this active pharmaceutical ingredient (API), companies should diversify their supplier base to mitigate risks like supply interruptions, quality deviations, or geopolitical disruptions. Establishing long-term partnerships with verified vendors, thoroughly auditing manufacturing facilities, and maintaining rigorous testing protocols are essential practices.

Furthermore, supply chain transparency can be enhanced via digital platforms and supplier audits, reinforcing compliance and operational resilience. Strategic geographical diversification, especially sourcing from regions with robust regulatory oversight, reduces dependency on single-region producers.

Emerging Trends and Future Outlook

The demand for ergotamine tartrate and caffeine continues to be influenced by innovations in migraine therapy and evolving regulatory landscapes. The growing focus on generic drug manufacturing, coupled with intensified scrutiny on supply chain integrity, prompts manufacturers to seek high-quality, compliant suppliers.

The shift towards biosimilar and alternative therapies may impact demand dynamics; however, the longstanding clinical efficacy of ergotamine-caffeine formulations sustains their relevance. Future supply chains will increasingly incorporate integrated inventory management, digital procurement platforms, and regional manufacturing hubs to ensure uninterrupted supply.

Conclusion

Securing reliable suppliers for ergotamine tartrate and caffeine requires a comprehensive understanding of global manufacturing landscapes, quality standards, and regulatory frameworks. Key suppliers from India, China, and Europe dominate the market, offering cost-effective, compliant API options. Manufacturers and distributors must prioritize quality assurance, compliance, and supply chain resilience to optimize their drug manufacturing pipelines.

Key Takeaways

The primary global suppliers of ergotamine tartrate are Micro Labs (India), Hubei Bailing Group (China), and Sigmapharm (USA); for caffeine, Merck KGaA (Germany), Jiangsu Xinde (China), and Sigma-Aldrich are prominent.
Regulatory compliance, GMP certification, and rigorous quality controls are non-negotiable when selecting suppliers for APIs.
Diversification of supplier sources reduces procurement risks and ensures continuity of supply.
Contract manufacturing organizations offer flexible solutions for custom synthesis and finished product formulation.
Staying engaged with emerging regional manufacturing hubs and digital procurement channels enhances supply chain resilience.

FAQs

1. Are generic suppliers of ergotamine tartrate and caffeine reliable?
Yes. Many reputable manufacturers in India, China, and Europe provide high-quality generic APIs that comply with international standards, assuming proper due diligence and supplier qualification are performed.

2. What regulatory considerations should I prioritize when sourcing these APIs?
Ensure suppliers hold GMP certifications, possess relevant regulatory approvals (FDA, EMA), and comply with pharmacopoeial standards such as USP or EP. Regular audits and batch testing are recommended.

3. Can I source these APIs from regional suppliers for domestic and regional markets?
Certainly. Many regional suppliers in Asia and Europe cater to local markets, often offering cost advantages and faster lead times, provided they meet quality and regulatory standards.

4. How can manufacturers mitigate supply chain disruptions for these APIs?
By diversifying suppliers across different regions, establishing long-term strategic partnerships, maintaining safety stock, and implementing robust quality management protocols.

5. What are the emerging trends affecting suppliers of ergotamine tartrate and caffeine?
Increasing regulatory scrutiny, digital procurement platforms, regional manufacturing hubs, and a trend toward integrating supply chain transparency are shaping the future landscape for these APIs.

References

[1] Micro Labs Limited official website. (2023). Product Portfolio.
[2] Hubei Bailing Group Pharmaceutical Co., Ltd. Certifications and Product Data. (2023).
[3] Yunnan Baiyao Group annual report. (2022).
[4] Sigmapharm Laboratories LLC FDA approval documents. (2023).
[5] Jiangsu Xinde Pharmaceutical Co., Ltd. GMP Certification. (2022).
[6] Merck KGaA product catalog. (2023).
[7] Anhui Guolin Pharmaceutical Co., Ltd. Certification information. (2023).
[8] Sigma-Aldrich, Caffeine Product Details. (2023).

Suppliers and packagers for ERGOTAMINE TARTRATE AND CAFFEINE