Bulk Pharmaceutical API Sources for LEUCOVORIN CALCIUM PRESERVATIVE FREE

Bulk Pharmaceutical API Sources for LEUCOVORIN CALCIUM PRESERVATIVE FREE

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		C2235
Molport		MolPort-003-666-218
Hangzhou APIChem Technology		AC-7456
Molport		MolPort-006-113-241
AKos Consulting & Solutions		AKOS015894859
MedChemexpress MCE		HY-13664
AbaChemScene		CS-1363

Bulk Active Pharmaceutical Ingredient (API) Sources for: LEUCOVORIN CALCIUM PRESERVATIVE FREE

Last updated: July 31, 2025

Introduction

Leucovorin calcium, also known as folinic acid, is a vital active pharmaceutical ingredient (API) used primarily as an antidote for methotrexate toxicity, in chemotherapy, and in certain hematological conditions. The formulation "preservative free" indicates a version free from stabilizing agents or preservatives, catering to sensitive patient populations or specific clinical needs. Securing reliable bulk API sources for preservative-free Leucovorin calcium is crucial for pharmaceutical manufacturing, ensuring API quality, regulatory compliance, and supply chain stability.

This article provides an in-depth review of global API suppliers specializing in Leucovorin calcium preservative-free, analyzing manufacturing standards, geographic distribution, quality assurance, and market presence to guide pharmaceutical companies in strategic procurement decisions.

Overview of Leucovorin Calcium API

Leucovorin calcium is a stabilized derivative of folinic acid, a form of reduced folate. Its API is synthesized via complex chemical processes, requiring stringent purity standards to ensure therapeutic efficacy and patient safety. The preservative-free formulation involves meticulous handling to prevent contamination and degradation, emphasizing the necessity for suppliers adhering to Good Manufacturing Practices (GMP).

Regulatory bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and World Health Organization (WHO) regulate pharmaceutical-grade APIs, mandating rigorous documentation and validation protocols. For preservative-free APIs, additional attention to contamination control and sterilization processes is essential.

Global API Manufacturers of Leucovorin Calcium Preservative-Free

1. West-Ward Pharmaceuticals (USA)

West-Ward Pharmaceuticals, a division of Hikma Pharmaceuticals, is recognized for its robust API manufacturing capabilities, including leucovorin calcium. Their facilities comply with cGMP standards, producing high-purity APIs suitable for injectable formulations. West-Ward emphasizes preservative-free APIs, employing advanced sterilization and containment processes to minimize contamination, making them a reliable source for preservative-free leucovorin calcium.

2. Fresenius Kabi (Germany)

Fresenius Kabi is a leading global player in injectable pharmaceuticals and APIs, with a strong focus on compliance and quality assurance. Their manufacturing facilities in Europe and globally produce leucovorin calcium API with strict adherence to GMP, including preservative-free versions. The company's emphasis on quality control and sterile production processes makes them a preferred supplier for preservative-free API requirements.

3. Zhejiang Panbao Pharmaceutical (China)

Zhejiang Panbao Pharmaceutical specializes in the synthesis of complex APIs such as leucovorin calcium. They operate under GMP conditions aligned with international standards and have gained recognition for delivering high-quality, preservative-free APIs at competitive prices. Their strategic location in China supports supply chain diversification and scalability.

4. Zhejiang Medicine (China)

Another major Chinese manufacturer, Zhejiang Medicine, manufactures leucovorin calcium API with a focus on regulatory compliance, including preservative-free formulations. Their extensive API production portfolio is licensed globally, and they adhere to stringent quality systems aligned with WHO and local authorities.

5. Hospira (USA, now part of Pfizer)

Hospira was a pioneer in injectable APIs, including leucovorin calcium. Post-acquisition by Pfizer, its manufacturing legacy continues, emphasizing high purity, sterile API production, and preservative-free formulations. Their global manufacturing footprint assures consistent supply of pharmaceutical-grade APIs.

6. Sun Pharmaceutical Industries (India)

Sun Pharma produces multiple APIs, including leucovorin calcium, targeting both domestic and international markets. Their GMP-certified facilities provide preservative-free APIs, with an emphasis on quality and cost-effectiveness, supported by rigorous quality assurance systems.

7. CordenPharma (Germany, USA)

A leading provider of specialty APIs and excipients, CordenPharma offers high-quality leucovorin calcium API, including preservative-free options, manufactured under strict cGMP conditions. Their facilities focus on sterile processing to meet the demands of sensitive formulations.

Quality and Regulatory Considerations

APIs intended for injectable and preservative-free applications demand rigorous quality standards. Suppliers must provide comprehensive documentation, including Certificates of Analysis (CoA), stability data, and compliance with pharmacopeial standards such as United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP). Ensuring consistent particle size, impurity profiles, and endotoxin levels is essential to prevent adverse patient reactions.

International regulatory recognition and GMP certification are critical filters in supplier selection. Some manufacturers obtain additional certifications, such as ISO 13485 or additional quality system certifications, which can further assure API integrity.

Market Trends and Supply Chain Dynamics

The demand for preservative-free leucovorin calcium API mirrors the overall growth in oncology and hematology therapeutics. The COVID-19 pandemic underscored the importance of diversified supply chains, driving pharmaceutical companies to seek multiple reliable suppliers globally. Chinese and Indian API manufacturers have expanded capacity significantly, balancing cost advantages with stringent quality compliance to meet international standards.

Recent regulatory tightening emphasizes traceability and quality documentation, favoring established manufacturers with a history of compliance. Meanwhile, advanced manufacturing techniques, such as continuous processing and in-line sterilization, are improving API safety profiles, especially for preservative-free formulations.

Procurement Strategies

• Supplier Qualification: Prioritize suppliers with WHO-GMP, FDA, EMA approvals, and proven regulatory compliance.

• Quality Assurance: Implement rigorous testing protocols and verify impurity profiles, endotoxin levels, and stability data.

• Diversification: Engage multiple suppliers across different regions to mitigate geopolitical and supply chain risks.

• Long-term Contracts: Secure stability in supply and price through framework agreements, considering manufacturing capacity and lead times.

• Regulatory Support: Confirm suppliers can furnish necessary documentation for registration and audits.

Conclusion

Reliable sources of bulk preservative-free leucovorin calcium API are spread across North America, Europe, and Asia, with key players demonstrating compliance with high-quality standards. As demand accelerates, strategic supplier engagement, rigorous quality assurance, and diversification are pivotal. Market participants must align procurement practices with regulatory requirements and evolving manufacturing innovations to ensure a consistent supply chain for this critical pharmaceutical ingredient.

Key Takeaways

• Leading API manufacturers for preservative-free leucovorin calcium include West-Ward Pharmaceuticals, Fresenius Kabi, Zhejiang Panbao, Zhejiang Medicine, and Sun Pharma.

• Emphasize GMP certification, regulatory recognition, and proven sterile manufacturing expertise when selecting suppliers.

• Chinese and Indian manufacturers offer cost-effective, high-quality APIs, supporting global supply diversification.

• The ongoing market trend favors suppliers with advanced manufacturing capabilities that ensure API purity, stability, and compliance with international standards.

• Diversification and thorough qualification processes mitigate risks associated with geopolitical, logistical, or regulatory disruptions.

FAQs

1. What defines preservative-free leucovorin calcium API?
   It is a version of leucovorin calcium synthesized and processed without added preservatives or stabilizers, suitable for sensitive or specialized formulations requiring minimal excipients.

2. How do I verify the quality of a supplier for leucovorin calcium API?
   Confirm GMP certification, review Certificates of Analysis, evaluate compliance with pharmacopeial standards (USP, EP), and conduct qualification audits or testing.

3. Are Chinese APIs for leucovorin calcium reliable?
   Yes, many Chinese manufacturers adhere to international GMP standards, offering high-quality APIs. Validation through regulatory approval and audit verification is essential.

4. What regulatory considerations are critical for preservative-free API procurement?
   Ensure suppliers provide comprehensive documentation, endotoxin testing, stability data, and comply with regulatory authorities such as FDA, EMA, and WHO.

5. What are the main risks associated with sourcing API globally?
   Risks include regulatory non-compliance, quality variability, supply disruptions, geopolitical issues, and variability in manufacturing standards.

Sources:

[1] U.S. FDA API Supplier Database.
[2] European Pharmacopoeia Guidelines.
[3] WHO Guidelines on Good Manufacturing Practices.
[4] Company websites and public regulatory documentation for West-Ward, Fresenius Kabi, Zhejiang Panbao, Zhejiang Medicine, and Sun Pharma.