Suppliers and packagers for generic pharmaceutical drug: ERGOTAMINE TARTRATE

ERGOTAMINE TARTRATE

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

Suppliers for the Pharmaceutical Drug: Ergottamine Tartrate

Last updated: November 7, 2025

Introduction

Ergotamine tartrate remains a critical therapeutic agent used primarily for the treatment of acute migraine attacks. Its efficacy in vasoconstriction and alleviation of migraine symptoms has sustained its market relevance despite emerging therapies. Ensuring a consistent supply of ergottamine tartrate depends on sourcing from reliable suppliers with approved manufacturing processes. This article explores the key suppliers globally, the regulatory landscape, and factors influencing procurement decisions for this essential pharmaceutical ingredient.

Overview of Ergottamine Tartrate

Ergotamine tartrate is an ergot alkaloid derivative extracted from the Claviceps species, historically used for migraine management. Its pharmacological action involves vasoconstrictive effects on intracranial blood vessels, providing relief from severe headaches. Despite its age, the drug persists in formulations such as tablets, suppositories, and injections, often compounded into combination medications. The complex synthesis and strict regulatory controls underpin supplier selection, emphasizing quality, compliance, and supply stability.

Global Suppliers and Manufacturing Hubs

1. European Manufacturers

Europe hosts a significant number of pharmaceutical raw material producers specializing in alkaloid extraction and synthesis. Notably, Fresenius Kabi and BASF have established operations in this sector.

• Fresenius Kabi: Known for its comprehensive portfolio of active pharmaceutical ingredients (APIs), it sources ergottamine tartrate from both internal capacity and trusted third-party manufacturers. The company emphasizes GMP-compliant processes, ensuring high-quality standards aligned with EMA regulations.

• BASF: A global chemical giant, BASF supplies a broad range of specialty chemicals and APIs, including ergot derivatives. Their manufacturing facilities in Germany and the UK are equipped to produce high-grade ergottamine tartrate under stringent regulatory oversight.

2. Indian Manufacturers

India remains a prominent player in generic pharmaceuticals and APIs, with several companies engaged in ergot alkaloid production.

• Vifor Pharma India: Although primarily a specialty pharmaceutical company, Vifor sources and supplies ergot alkaloids, including ergottamine tartrate, through partnerships with local producers adhering to WHO-GMP standards.

• Shree Ram Pharmacy: A regional manufacturer that produces ergottamine tartrate for export markets, certified by Indian regulators (DCGI), meeting international quality benchmarks.

3. Chinese Suppliers

China is a notable source of bulk APIs, with many companies offering ergottamine tartrate. However, due diligence regarding quality control and regulatory compliance remains essential.

• Hubei Pharmaceutical Group: Reports indicate the production of ergot alkaloid APIs, including ergottamine tartrate, primarily for export. Certification and inspection reports are crucial when considering sourcing from Chinese suppliers.

• Jiangsu Hengrui Medicine Co.: While mostly known for downstream pharmaceuticals, Hengrui has been expanding its API portfolio, potentially including ergot derivatives. Regulatory approval status on specific APIs varies and warrants verification.

4. South American Producers

Latin American companies offer localized sourcing options, mainly serving regional markets.

• BIO-BALSA: An Argentine pharmaceutical company producing ergottamine tartrate, compliant with local and international guidelines, primarily for formulations within South America.

Regulatory Considerations and Supply Chain Risks

Compliance with regulatory standards—including those mandated by the EMA, FDA, or regional health authorities—is critical. Suppliers must adhere to GMP guidelines, and many require certifications such as party approvals or Third-Party Certification audits.

Supply chain risks encompass geopolitical factors, manufacturing disruptions, or regulatory reclassification. For example, some manufacturers ceased production due to regulatory non-compliance or economic issues, affecting availability. Due diligence, including supplier audits and validation of quality systems, remains paramount for procurement.

Emerging Trends and Alternatives

As novel migraine therapies gain approval, such as CGRP antagonists, the demand for ergottamine tartrate faces future uncertainties. Nevertheless, it remains pivotal in specific settings and formulations, especially compounded medications. Suppliers expanding capacities or diversifying their product portfolios are positioning themselves to serve evolving market demands.

Factors Influencing Supplier Selection

• Quality Assurance: Validated manufacturing processes, consistent batch quality, and adherence to international standards.
• Regulatory Compliance: Certifications under GMP, ISO, and regional EUGMP standards.
• Supply Stability: Proven track record of steady supply, capacity for scale-up, and contingency planning.
• Cost and Lead Time: Competitive pricing combined with reliable delivery timelines.
• Reputation and Track Record: Industry reputation, audits, and past compliance history.

Conclusion

Securing reliable suppliers for ergottamine tartrate requires navigating a complex landscape of global manufacturers, regulatory frameworks, and supply chain dynamics. Manufacturers and procurement professionals must prioritize quality, compliance, and supply chain resilience to sustain pharmaceutic availability. The evolving regulatory environment and emerging therapeutics influence market dynamics, emphasizing the necessity for diligent sourcing strategies.

---

Key Takeaways

• Europe and India are primary sources for ergottamine tartrate, with strict GMP compliance being integral to quality assurance.
• Chinese suppliers offer competitive options but require rigorous vetting due to variability in regulatory adherence.
• Supplier selection hinges on quality, regulatory certification, supply reliability, and reputation.
• Regulatory changes and market shifts influence long-term availability; diversification reduces procurement risks.
• Continuous monitoring of suppliers’ compliance and market developments is essential for informed decision-making.

---

FAQs

1. Are there any FDA-approved suppliers of ergottamine tartrate?
   Currently, ergottamine tartrate is often compounded or sourced from international suppliers with GMP certifications. Specific approvals depend on regional regulatory pathways, and many suppliers focus on exports rather than local FDA approval.

2. What certifications should I verify when sourcing ergottamine tartrate?
   Verify GMP compliance, ISO certifications, and supplier audits. Certificates of suitability, manufacturing licenses, and third-party audit reports bolster supplier credibility.

3. Is ergottamine tartrate still widely available in the global market?
   Availability varies due to regulatory reclassification and shifting demand. Although still in use, it faces declining prominence with newer migraine therapies emerging.

4. How does geopolitical risk impact ergottamine tartrate supply?
   Political stability and trade relations influence supply chains. Disruptions, tariffs, or sanctions can impede procurement from specific regions or manufacturers.

5. Are there synthetic alternatives to ergottamine tartrate?
   Currently, no direct synthetic replacements offer the same efficacy, making reliable sourcing of natural or semi-synthetic ergottamine tartrate essential for certain formulations.

---

References

[1] European Medicines Agency. (2022). List of authorized medicinal products.
[2] FDA. (2023). Guidelines for Active Pharmaceutical Ingredient Manufacturing.
[3] WHO. (2020). Good Manufacturing Practices for Pharmaceuticals.
[4] Indian Drug Regulatory Agency. (2021). Pharmaceutical Manufacturing Standards.
[5] Industry reports on the global ergot alkaloids market.