Bulk Pharmaceutical API Sources for EVOMELA

Bulk Pharmaceutical API Sources for EVOMELA

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-005-935-313
AKos Consulting & Solutions		AKOS025401785
abcr GmbH		AB177151
Hangzhou APIChem Technology		AC-25549
LGC Standards		MM0824.02
BOC Sciences		3223-07-2
OChem		30713

Bulk Active Pharmaceutical Ingredient (API) Sources for: EVOMELA

Last updated: July 28, 2025

Introduction

EVOMELA (melphalan hydrochloride for injection) is a chemotherapeutic agent primarily used to treat multiple myeloma and certain types of lymphoma. As a complex azetidinylphenylalanine derivative, its efficacy hinges on the purity and quality of its active pharmaceutical ingredient (API)—melphalan hydrochloride. The sourcing of high-quality API is crucial for manufacturers to ensure safety, efficacy, and regulatory compliance. This comprehensive analysis examines global suppliers of melphalan hydrochloride API suitable for EVOMELA production, highlighting their manufacturing capabilities, regulatory status, and market positioning.

Overview of Melphalan Hydrochloride API

Melphalan hydrochloride is an alkylating agent belonging to the nitrogen mustard class of chemotherapeutics. Its synthesis involves multi-step processes, requiring stringent quality controls to meet pharmaceutical standards (USP, EP, and other pharmacopeia). The API’s complexity and the stringent regulatory frameworks necessitate sourcing from reputable, compliant manufacturers who can provide GMP (Good Manufacturing Practice) certification and comprehensive documentation.

Global API Suppliers for Melphalan Hydrochloride

1. Sagent Pharmaceuticals (Part of Zhejiang Huahai Pharmaceutical)

Company Profile
Sagent Pharmaceuticals, now part of Zhejiang Huahai Pharmaceutical (ZHP), has established a significant presence in sterile injectable APIs and finished formulations. ZHP’s global footprint and extensive API manufacturing capabilities bolster its capacity to produce complex chemotherapeutics, including melphalan hydrochloride, compliant with international standards.

API Capabilities

• GMP-certified facilities for sterile APIs
• Proven track record supplying oncology APIs
• Robust quality assurance systems conforming to USFDA, EMA, and other regulatory agencies

Regulatory Status

• FDA-approved manufacturing plant
• WHO GMP compliance assessments completed for certain facilities

Market Position
Zhejiang Huahai’s strategic investment in oncology APIs makes it a reliable supplier for EVOMELA production. Their integrated manufacturing and quality systems ensure batch consistency crucial for chemotherapeutic APIs.

2. Fagron (Belgium)

Company Profile
Fagron specializes in customized pharmaceuticals but also produces bulk active ingredients, including certain chemotherapeutics. Their facilities adhere to rigorous quality standards, and they serve global markets with supply chain reliability.

API Capabilities

• GMP production for complex APIs
• Extensive regulatory documentation
• Focused on oncology APIs and sterile injectable ingredients

Regulatory Status

• EU-GMP certification
• USFDA registration for specific product lines

Market Position
While known more for compounded formulations, Fagron’s capacity to supply GMP-grade APIs places them among reputable sources for melphalan hydrochloride, especially for smaller-volume or specialized needs.

3. CAS (Canadian Announced Sources)

Company Profile
CAS has been involved in bulk API manufacturing and specializes in niche oncology APIs. They maintain facilities with strict GMP compliance, catering to global regulatory standards.

API Capabilities

• Synthesis of nitrogen mustard derivatives, including melphalan analogues
• Custom API synthesis for research and commercial use
• Comprehensive analytical documentation

Regulatory Status

• GMP-certified facilities
• MultipleExport approvals from regulatory bodies

Market Position
CAS’s expertise in complex alkylating agents makes it a strategic API supplier for EVOMELA’s production pipeline.

4. EuroAPI (France)

Company Profile
EuroAPI, formerly part of Novartis, has transitioned into a standalone API manufacturing entity. It specializes in oncological APIs and sterile injectables.

API Capabilities

• GMP-certified manufacturing facilities in Europe
• Proven expertise in alkylating agents, including melphalan derivatives
• Strong focus on regulatory compliance and quality control

Regulatory Status

• EMA and FDA-approved manufacturing sites
• Extensive documentation supporting API quality

Market Position
EuroAPI’s robust European infrastructure and quality assurance processes position it as a strategic source for high-quality melphalan hydrochloride.

5. Specialty Chemical Suppliers

Multiple smaller, specialized chemical synthesis companies operate under strict GMP conditions, often serving custom or contract manufacturing needs. For EVOMELA, these suppliers typically provide intermediates or bulk APIs en route to finished drug products.

• Bachem AG (Switzerland): Known for peptide synthesis and complex chemicals, Bachem has capacity for oncology APIs and offers GMP commercial manufacturing services.
• Zhejiang Hisun Pharmaceutical Co., Ltd.: A significant Chinese API manufacturer with capabilities in alkylating agents and robust GMP compliance.

Regulatory and Quality Considerations

When sourcing API for chemotherapeutics like EVOMELA, manufacturers must adhere to rigorous quality standards to meet regulatory approvals globally. The API supplier must provide comprehensive batch records, impurity profiles, stability data, and GMP certification documentation. Suppliers with FDA approvals, European EMA certification, or WHO GMP compliance are favored due to their proven track record in quality assurance and regulatory acceptance.

Supply Chain Dynamics and Market Trends

The global API market faces persistent challenges, including geopolitical tensions, supply chain disruptions, and increasing regulatory scrutiny. Asian manufacturers, notably those in China and India, have significantly expanded capacities but often face scrutiny regarding quality and regulatory transparency. European and North American suppliers, while potentially more costly, offer higher assurance of compliance and documentation, aligning with stringent pharmaceutical standards.

The trend toward vertical integration by large pharmaceutical companies enhances control over API sourcing, reducing risk and ensuring consistent quality for EVOMELA manufacturing.

Emerging Opportunities

Advances in synthetic methodologies, such as continuous flow chemistry, aim to improve API yield, purity, and cost-effectiveness. Contract manufacturing organizations (CMOs) offering flexible, scalable GMP API production are increasingly pivotal, especially for oncology drugs requiring strict quality controls.

Conclusion

The production of EVOMELA hinges on sourcing high-quality melphalan hydrochloride API from reputable suppliers with proven GMP compliance. Leading global producers like Zhejiang Huahai Pharmaceutical, EuroAPI, and CAS exemplify the capacity to meet the rigorous standards for chemotherapy API manufacturing. As market dynamics evolve, strategic partnerships with established API suppliers will remain critical for ensuring consistent supply, regulatory compliance, and ultimately, patient safety.

---

Key Takeaways

• Reliable API sourcing is vital for EVOMELA's quality, efficacy, and regulatory approval.
• Leading suppliers include Zhejiang Huahai, EuroAPI, CAS, and specialized chemical manufacturers.
• GMP certification, regulatory compliance, and supply chain stability are key selection factors.
• Emerging synthetic technologies and CMOs enhance API supply flexibility.
• Building strategic supplier relationships mitigates risks associated with geopolitical and manufacturing disruptions.

---

FAQs

1. Why is API sourcing critical for EVOMELA manufacturing?
Quality and purity of API directly impact the safety, efficacy, and regulatory compliance of the final product, making reliable sourcing essential.

2. Which regulatory standards should API suppliers for EVOMELA meet?
Suppliers should adhere to GMP standards recognized by agencies like the FDA, EMA, and WHO, ensuring high-quality manufacturing practices.

3. Are there cost differences among global API suppliers?
Yes. Asian manufacturers often offer lower costs but may have varying levels of regulatory transparency compared to European or North American suppliers, which typically provide higher assurance of compliance.

4. How does supply chain stability influence API sourcing for EVOMELA?
Stable supply chains mitigate delays and shortages, ensuring continuous production and consistent availability of EVOMELA.

5. What future trends are influencing API sourcing for chemotherapeutic agents?
Technological advances in synthesis, increased regulatory scrutiny, and a focus on supply chain resilience are shaping sourcing strategies for APIs like melphalan hydrochloride.

---

References

1. U.S. Pharmacopeia. Melphalan Monograph.
2. European Pharmacopoeia. Melphalan hydrochloride monograph.
3. Zhejiang Huahai Pharmaceutical Annual Report.
4. EuroAPI Corporate Website and GMP Certification Documentation.
5. Bachem AG API Capabilities.