Bulk Pharmaceutical API Sources for ERGAMISOL

Bulk Pharmaceutical API Sources for ERGAMISOL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		L9756_SIGMA
TCI (Tokyo Chemical Industry)		T1215
Molport		MolPort-003-666-467
TCI (Tokyo Chemical Industry)		L0231

Bulk Active Pharmaceutical Ingredient (API) Sources for: ERGAMISOL

Last updated: July 28, 2025

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Introduction

Ergamisol, marketed globally under the brand name Leucovorin, is a derivative of folic acid used primarily in oncology and hematology for its antineoplastic and rescue properties. Its efficacy depends heavily on the purity, stability, and quality of its active pharmaceutical ingredient (API). As demand for high-grade APIs accelerates, identifying reliable bulk sources becomes essential for pharmaceutical manufacturers, research institutions, and regulatory bodies.

This report provides a comprehensive analysis of bulk API sources for Ergamisol (Leucovorin), detailing reputable suppliers, geographic regions, manufacturing standards, and strategic procurement considerations.

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Overview of Ergamisol API

Leucovorin (Folinic acid) functions as a reduced form of folic acid, bypassing dihydrofolate reductase, thus restoring folate levels. It is pivotal in combination chemotherapy regimens, notably with methotrexate, and in treating folate deficiency. Ensuring consistent quality and supply of Leucovorin API is critical for clinical efficacy.

Global API Manufacturing Landscape

The industry for Leucovorin API predominantly resides in regions with advanced pharmaceutical manufacturing capabilities, notably:

• India
• China
• Europe (primarily Germany, Switzerland, and France)
• United States

Manufacturers adhere to Good Manufacturing Practices (GMP), with certifications from regulatory authorities like the FDA (USA), EMA (Europe), and WHO.

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Leading Bulk API Suppliers for Ergamisol (Leucovorin)

1. Zhejiang Rundu Pharmaceutical Co., Ltd. (China)

• Overview: Specializes in producing high-purity APIs, including folate derivatives.
• Compliance: GMP-certified and has FDA registration for several APIs.
• Strengths: Competitive pricing, consistent quality, and scalable production.
• Considerations: Regulatory approval processes might be longer for certain markets, requiring detailed validation.

2. Xi’an Tianyu Pharmaceutical Co., Ltd. (China)

• Overview: Recognized for robust API development, particularly in amino acid derivatives.
• Quality Assurance: Emphasizes rigorous testing, ISO certifications.
• Market Position: Supplies to multiple global pharmaceutical companies with a focus on export.

3. Dr. Reddy’s Laboratories (India)

• Overview: One of India’s leading pharmaceutical manufacturers with a broad portfolio.
• API Strengths: GMP-compliant manufacturing with strong R&D capabilities.
• Regulatory Status: Approved in various markets, including the US and Europe.
• Advantages: Reliable supply chain and substantial capacity.

4. Teva Pharmaceuticals (Israel/Global)

• Overview: Global generic pharmaceutical leader with manufacturing facilities worldwide.
• API Profile: Offers Leucovorin API with high purity standards.
• Strengths: Extensive regulatory approvals and historical reliability.

5. Polpharma Group (Poland)

• Overview: Polish pharmaceutical manufacturer with regional and export capabilities.
• API Quality: Meets international standards and has a strong focus on sterile and non-sterile APIs.
• Strategic Edge: Proximity to European markets supports faster supply.

6. Thermo Fisher Scientific (US)

• Overview: Provides research-grade Leucovorin APIs as well as pharmaceutical-grade materials.
• Use Cases: Predominantly for research and clinical development, with APIs meeting stringent standards.

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Criteria for Selecting API Suppliers

When evaluating API sources for Ergamisol, several factors must be considered:

• Regulatory Compliance: GMP certification, FDA, EMA approvals.
• Quality Standards: Certificates of Analysis (CoA), impurity profile, stability data.
• Supply Reliability: Production capacity, lead times, historical fulfillment.
• Pricing: Competitive pricing aligned with quality standards.
• Regulatory Support: Assistance with documentation for registration and audits.

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Emerging Trends and Considerations

• Manufacturing Digitization: Increasing adoption of digital quality tracking enhances supply security.
• Regional Diversification: To minimize geopolitical risks, companies are diversifying sources across different regions.
• Vertical Integration: Larger suppliers are establishing integrated manufacturing to control quality and supply.
• Bioequivalence and Generic Competition: As patents expire or weaken, more manufacturers enter the field, broadening API options.

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Supply Chain Dynamics and Risks

Global supply chains for APIs face several risks:

• Regulatory Hurdles: Variability in approval processes across regions.
• Quality Concerns: Contamination, impurity profiles, and batch-to-batch variability.
• Raw Material Shortages: Sourcing of precursor materials may be affected by geopolitical or environmental factors.
• Manufacturing Disruptions: COVID-19 highlighted risks due to pandemic-driven shutdowns.

Strategic procurement necessitates assessing supplier risk profiles, maintaining multiple sourcing options, and periodic audits to mitigate disruptions.

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Conclusion

Reliable sourcing of Ergamisol (Leucovorin) API is fundamental for consistent therapeutic outcomes. Leading manufacturers across China, India, Europe, and Israel offer high-quality, GMP-compliant APIs capable of supporting global clinical and commercial needs. Due diligence, including regulatory compliance, quality assurance, and supply chain robustness, remains critical in vendor selection.

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Key Takeaways

• The API landscape for Ergamisol is dominated by major players in China, India, and Europe with strict adherence to GMP standards.
• Supplier evaluation must focus on quality certifications, regulatory approvals, capacity, and stability.
• Diversification of sourcing regions reduces supply chain vulnerabilities.
• Emerging trends include digitalization and vertical integration, improving supply security.
• Continuous monitoring of regulatory changes and geopolitical factors is essential for long-term procurement strategies.

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FAQs

1. Are Chinese API manufacturers for Leucovorin GMP-certified?
Yes, several Chinese manufacturers, such as Zhejiang Rundu Pharmaceutical, hold GMP certifications compliant with international standards. However, verification of certifications and audits are advised prior to procurement.

2. What are the key quality parameters to assess in API suppliers?
Critical parameters include purity, potency, impurity profile, assay certification, stability data, and compliance with pharmacopeial standards (USP, EP, JP).

3. How does the regulatory landscape impact API sourcing?
Regulatory approval from authorities like the FDA or EMA can facilitate market access and reduce compliance risks. Suppliers with established regulatory approval streamline registration processes for finished drug products.

4. Can I source Leucovorin API from emerging markets?
Yes, but thorough due diligence is essential. Emerging markets like India and China offer competitive options, but evaluating quality management systems and regulatory track record is necessary.

5. What are the implications of API supply chain disruptions for Ergamisol manufacturing?
Disruptions can lead to shortages, impacting clinical supply and commercial distribution. Diversified sourcing, maintaining safety stock, and engaging with multiple reliable suppliers mitigate these risks.

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References

[1] U.S. Pharmacopeia, "Leucovorin," USP Monograph, 2022.
[2] European Pharmacopoeia, "Folinic acid (Leucovorin)," 11th Edition, 2021.
[3] Industry reports and supplier websites as of 2023.