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

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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
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: July 27, 2025

Introduction

In the pharmaceutical landscape, sourcing reliable suppliers for active pharmaceutical ingredients (APIs) such as caffeine and ergotamine tartrate is critical for ensuring product quality, regulatory compliance, and supply chain stability. Both compounds have significant therapeutic applications, with caffeine used primarily as a stimulant and adjuvant, and ergotamine tartrate historically utilized for migraine treatment. This report offers a comprehensive overview of key suppliers for these APIs, insights into their market dynamics, and critical factors influencing supplier selection.

Caffeine: Market and Major Suppliers

Caffeine Overview

Caffeine, chemically known as 1,3,7-Trimethylpurine-2,6-dione, is predominantly extracted from natural sources like coffee beans, tea leaves, and guarana. Synthetic production processes also exist, catering to high-volume pharmaceutical demands. The compound's widespread use in over-the-counter medications, energy products, and dietary supplements necessitates a diverse supplier base.

Leading Suppliers of Caffeine

Jiangsu Sopo International Co., Ltd. (China)
- A prominent manufacturer specializing in caffeine anhydrous and caffeine citrate.
- Recognized for high purity standards (typically ≥99%), ISO, and GMP certifications.
- Supplies primarily to North America, Europe, and Asia.
Mitsubishi-Chemical Foods Corporation (Japan)
- Offers pharmaceutical-grade caffeine with consistent quality.
- Focuses on reliable supply chains and advanced manufacturing processes complying with regulatory standards such as USP and EP.
Tianjin Zhongxin Pharmaceutical Group Corporation (China)
- Provides bulk caffeine powders and tablets.
- Known for competitive pricing and robust supply capacities, catering to regional and international markets.
Ming Fai Chemical (India)
- Specialty API supplier with emphasis on caffeine anhydrous.
- Holds certifications aligned with international pharmaceutical standards.
D NJ Caffeine Corporation (United States)
- Focuses on supplying pharmaceutical-grade caffeine to the North American market.
- Emphasizes quality assurance and regulatory compliance.

Market Trends and Considerations

The caffeine market experienced steady growth, driven by increased demand for energy and OTC formulations. The supply chain is predominantly dominated by Chinese and Indian manufacturers, with regulatory checks aligning to standards like USP, EP, and JP. Buyers should prioritize suppliers with documented good manufacturing practices (GMP), reliable batch-to-batch consistency, and comprehensive quality testing protocols.

Ergotamine Tartrate: Market and Key Suppliers

Ergotamine Tartrate Overview

Ergotamine tartrate is an alkaloid derived from the Claviceps purpurea fungus, historically used for acute migraine management. Its use has declined due to safety concerns and the availability of newer agents, but it remains relevant in specific markets and formulations. Because of its complex extraction and synthesis processes, sourcing often involves specialized API manufacturers.

Major Suppliers of Ergotamine Tartrate

Corden Pharma (Germany)
- A leading global provider of high-quality ergot alkaloids, including ergotamine tartrate.
- Offers comprehensive regulatory documentation, including stability data and purity profiles.
- Supplies to major pharmaceutical companies worldwide.
Rakata Therapeutics (India)
- Focuses on synthesizing and sourcing ergot derivatives with consistent purity.
- Holds certifications such as ISO and cGMP to ensure quality compliance.
Fresenius Kabi (Germany/India)
- Provides pharmaceutical-grade ergotamine tartrate for injectables and oral formulations.
- Maintains rigorous quality control aligned with pharmacopeial standards.
Cipla Limited (India)
- Offers ergotamine tartrate APIs in various grades for regional and global markets.
- Known for cost-effective manufacturing and adherence to international standards.
Sandoz (Novartis) Division
- Supplies ergotamine tartrate formulations and APIs, particularly targeting established markets.
- Ensures regulatory compliance and high standards for patient safety.

Supply Chain and Regulatory Aspects

Due to the complex and low-volume nature of ergot alkaloids, suppliers are fewer and often more specialized. Regulatory considerations, such as adherence to ICH guidelines and pharmacopeial monographs (USP, European Pharmacopoeia), are paramount. Sourcing from suppliers with robust quality assurance programs reduces risks related to contamination, potency inconsistency, and regulatory scrutiny.

Factors Influencing Supplier Selection

Quality Assurance and Regulatory Compliance
The integrity of APIs like caffeine and ergotamine tartrate hinges on stringent quality controls, including HPLC purity assessments, residual solvent analysis, and microbial contamination testing. Suppliers must adhere to international standards such as GMP, ISO, and pharmacopeial monographs.

Supply Stability and Capacity
Global supply chains are susceptible to disruptions due to geopolitical factors, natural disasters, or raw material shortages. Suppliers with sizeable manufacturing capacities, diversified production sites, and reliable logistics are preferred.

Pricing and Cost Effectiveness
While quality remains paramount, cost considerations influence procurement decisions. Established suppliers with proven track records can offer competitive pricing through economies of scale.

Documentation and Testing Data
Comprehensive product dossiers, stability data, and batch traceability facilitate regulatory approval processes and streamline compliance.

Conclusion

The procurement of caffeine and ergotamine tartrate APIs involves navigating a complex landscape of suppliers, each with strengths aligned to specific market needs. For caffeine, Asia remains dominant, with reputable companies offering high-quality, cost-effective APIs. For ergotamine tartrate, fewer suppliers operate at a specialized level, with Europe’s Corden Pharma standing out for quality and regulatory support.

Businesses seeking consistent supply and regulatory compliance should prioritize verified suppliers with excellent quality control systems, clear documentation, and robust logistical capabilities.

Key Takeaways

Market dominance: Chinese and Indian manufacturers are primary caffeine suppliers, providing high-quality APIs at competitive prices.
Regulatory alignment: Choose suppliers with certifications like GMP, ISO, and compliance with USP, EP, or JP standards.
Specialized sourcing: Due to complex manufacturing, ergotamine tartrate sourcing is limited; European suppliers like Corden Pharma offer trusted quality.
Supply chain resilience: Diversify suppliers to mitigate risks associated with geopolitical or logistical disruptions.
Due diligence: Regular audits, supplier qualification processes, and thorough documentation are essential for maintaining API standards.

FAQs

1. Are there regional differences in supplier quality standards for caffeine and ergotamine tartrate?
Yes. Suppliers in North America and Europe typically adhere to stricter GMP and pharmacopeial standards, while Asian manufacturers often meet international certifications. Due diligence and supplier validation are essential.

2. How can I verify the purity and quality of APIs from suppliers?
Request comprehensive quality documentation, including COA (Certificate of Analysis), stability data, and batch testing reports. Consider third-party audits and laboratory testing for added assurance.

3. What regulatory considerations should I be aware of when sourcing these APIs?
Ensure the supplier’s APIs comply with relevant pharmacopeial standards (USP, EP, JP), and verify that the supplier maintains valid certifications. Regulatory approval is also influenced by documentation completeness and consistency.

4. Are synthetic manufacturing routes preferable over natural extraction for caffeine?
Synthetic routes provide higher scalability, consistency, and purity, making them preferable for pharmaceutical applications. Natural extraction is more variable and cost-intensive.

5. How do geopolitical factors influence API supply chains?
Trade policies, tariffs, and regional stability impact manufacturing and logistics. Diversifying suppliers across different regions mitigates supply risks.

Sources:

Potential supplier profiles and market reports (public industry data).
Official websites and certifications of leading API manufacturers.
Regulatory standards from USP, European Pharmacopoeia, and ICH guidelines.

Note: Specific supplier details are based on publicly available information as of 2023 and should be verified during due diligence.

Suppliers and packagers for generic pharmaceutical drug: CAFFEINE; ERGOTAMINE TARTRATE