Bulk Pharmaceutical API Sources for ABITREXATE

Bulk Pharmaceutical API Sources for ABITREXATE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		Yh\QJ@@D@fickg`PMCHdlbbTTRTRjTTNbRfTQT\fVn~Z`hFbfj@@BHB@c@@
NovoSeek		126941
MolPort		MolPort-003-665-521
ISpharm		I06-2098

Bulk Active Pharmaceutical Ingredient (API) Sources for: ABITREXATE

Last updated: July 27, 2025

Introduction

Abitrexate, the brand name for methotrexate, is a cornerstone chemotherapeutic agent widely utilized in oncology, autoimmune diseases, and other medical indications. As an antimetabolite, methotrexate inhibits dihydrofolate reductase, impeding DNA synthesis, which underpins its efficacy. Ensuring reliable sourcing of high-quality bulk methotrexate API is vital for pharmaceutical manufacturers, regulators, and healthcare providers. This report delineates key global sources of bulk methotrexate API, analyzing supplier credentials, manufacturing standards, and potential sourcing considerations.

Global API Manufacturing Landscape for Methotrexate

The production of methotrexate API is concentrated primarily in regions with established pharmaceutical manufacturing infrastructures, notably India, China, and Europe. These regions host multiple GMP-compliant facilities accredited by international regulators such as the US FDA, EMA, and WHO. The complexity of methotrexate synthesis—requiring multistep chemical processes—demands rigorous control over quality parameters, including purity, residual solvents, and impurity profiles.

Leading API Suppliers for Methotrexate

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

Zhejiang Hisun Pharmaceutical is a major Chinese pharmaceutical group with extensive API manufacturing capabilities, including methotrexate. The company operates GMP-certified facilities aligned with international standards (FDA, EMA, WHO), offering competitive pricing and reliable supply chains. Hisun's methotrexate API is used in both generic and specialty formulations. Their comprehensive documentation, including stability data and impurity profiles, supports regulatory submissions worldwide.

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Hengrui is a prominent global pharmaceutical manufacturer, with robust API production infrastructure. Their methotrexate API manufacturing facilities meet rigorous GMP standards, with certifications from multiple global agencies. Hengrui emphasizes quality control, employing advanced analytical techniques to ensure batch-to-batch consistency. Their extensive experience in oncology APIs positions them as a preferred supplier for large-volume needs.

3. Pfizer Inc. (USA)

Pfizer, one of the original developers of methotrexate, maintains an active API manufacturing division. Though primarily known for finished drug products, Pfizer's API manufacturing unit supplies bulk methotrexate to approved partners. Their controlled processes and GMP compliance ensure high purity and consistent supply. However, access may be restricted due to proprietary considerations and supply chain confidentiality.

4. Dr. Reddy’s Laboratories (India)

Dr. Reddy’s, a leading Indian pharmaceutical company, produces GMP-compliant methotrexate API used in a broad range of indications. Their facility meets US FDA and EU GMP standards, with proven scalability for large orders. Dr. Reddy’s focuses on cost-effective sourcing without compromising quality, making them a preferred partner for generic formulations globally.

5. Sandoz (Novartis division) (Switzerland/India/Global)

Sandoz, the generics arm of Novartis, supplies high-quality methotrexate API through their global manufacturing network. Their manufacturing complies with stringent international standards, and their delivery reliability is well-regarded. Sandoz's focus on comprehensive quality management ensures API suitability for regulatory approval worldwide.

6. Aurobindo Pharma Ltd. (India)

Aurobindo Pharma is a key player in API manufacturing, with a dedicated portfolio of oncology APIs, including methotrexate. Their GMP-certified facilities and consistent quality outputs make them a reliable bulk supplier. The company's large-scale production capacity minimizes supply disruptions, which is critical during high-demand periods or shortages.

Emerging and Contract Manufacturing Options

Contract manufacturing organizations (CMOs) with specialized capabilities also serve as sources of methotrexate API, often providing flexible supply arrangements. Companies such as Heilongjiang Chinese Pharmaceutical, Hainan Yew Pharmatech, and other regional players increasingly engage in bulk API production for export purposes, often under licensors or third-party certifications. These sources may offer competitive pricing but require rigorous qualification and quality audits.

Criteria for Selecting API Suppliers

• Regulatory Compliance: GMP certification from reputable agencies (FDA, EMA, PMDA, WHO) is essential.
• Quality Assurance: Verification of batch consistency, impurity profiles, and stability data.
• Supply Chain Reliability: Proven track record of timely delivery and capacity to meet volume demands.
• Pricing and Terms: Competitive pricing aligned with procurement budgets, with consideration for lead times and minimum order quantities.
• Transparency: Clear documentation on manufacturing processes, quality control, and audit reports.

Quality Considerations and Due Diligence

Given methotrexate's therapeutic importance and narrow therapeutic window, sourcing from an approved, validated manufacturing site remains critical. Regular auditing, review of Certificates of Analysis (CoA), and alignment with pharmacopoeial standards (USP, EP, JP) safeguard product quality. Additionally, potential for impurities—such as 7-hydroxymethotrexate or residual solvents—must be meticulously evaluated to ensure regulatory compliance and patient safety.

Regulatory and Supply Chain Dynamics

The geopolitical landscape influences API sourcing strategies. Trade policies, tariffs, and export restrictions can impact availability, costs, and lead times. Diversification of sources is recommended to mitigate supply chain disruptions, especially considering recent global supply chain vulnerabilities highlighted during the COVID-19 pandemic. Strategic stockpiling and multi-source agreements enhance resilience.

Conclusion

The procurement of bulk methotrexate API depends on multiple factors including regulatory compliance, quality standards, cost, and supply stability. Leading global suppliers such as Zhejiang Hisun, Jiangsu Hengrui, Dr. Reddy’s, and Sandoz boast GMP-certified facilities capable of meeting international demand. As market dynamics evolve, continuous supplier qualification and supply chain risk management will remain vital for pharmaceutical companies relying on methotrexate API.

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Key Takeaways

• GMP Certification is Paramount: Prioritize suppliers with proven GMP compliance from recognized agencies.
• Diverse Supply Sources Reduce Risks: Engage multiple vendors, particularly in regions less susceptible to geopolitical or pandemic-related disruptions.
• Thorough Quality Evaluation: Regular audits, CoA reviews, and impurity testing ensure API quality and regulatory adherence.
• Cost and Capacity Balance: Large-volume orders favor suppliers with proven scalability; negotiate terms favorably but ensure quality is not compromised.
• Stay Informed on Regulatory Changes: Evolving regulations or import/export policies can impact sourcing; maintain active communication with suppliers and regulators.

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FAQs

1. What are the key regulatory considerations when sourcing methotrexate API?

Ensuring API suppliers comply with GMP standards and possess relevant certifications (FDA, EMA, WHO) is critical. Validation of impurity profiles and batch consistency supports approval and safety profiles.

2. How does geographic diversification improve supply chain resilience for methotrexate API?

Diversification spreads risk, reduces dependence on a single region, and buffers against geopolitical, logistical, or pandemic disruptions—ensuring continuous supply.

3. Can smaller or regional suppliers meet high-volume demands for methotrexate API?

Yes, provided they have GMP-certified, scalable manufacturing facilities. Due diligence and direct validation are advisable before engagement.

4. What quality parameters are most critical for methotrexate API?

Purity, residual solvents, impurity profiles (e.g., 7-hydroxymethotrexate), and stability are paramount to ensure safety and efficacy.

5. How do trade policies influence methotrexate API sourcing?

Trade restrictions, tariffs, and export controls can impact availability and costs. Staying informed and establishing multi-source supply agreements mitigate these risks.

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Sources

[1] Global API Manufacturers Directory, API Factory Certifications (2022).

[2] U.S. Food and Drug Administration, Drug Master Files, https://www.fda.gov.

[3] European Medicines Agency, Good Manufacturing Practice Guidelines, https://www.ema.europa.eu.

[4] World Health Organization, WHO Expert Committee on Specifications for Pharmaceutical Substances, 2021.

[5] Industry Reports on Oncology API Market, Pharmacopoeias, and Regulatory Updates (2022).