Bulk Pharmaceutical API Sources for METYROSINE

Bulk Pharmaceutical API Sources for METYROSINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M8131_SIGMA
Molport		MolPort-001-792-900
Amadis Chemical		A835693
Synblock Inc		AB02561
Mcule		MCULE-5340647798
BOC Sciences		672-87-7
Glentham Life Sciences Ltd.		GC3195

Bulk Active Pharmaceutical Ingredient (API) Sources for Metyrosine

Last updated: July 30, 2025

Introduction

Metyrosine (α-methyltyrosine) is a synthetic amino acid derivative primarily used in the management of certain endocrine disorders, notably for the treatment of inoperable or malignant pheochromocytomas. Its mechanism centers on inhibiting catecholamine synthesis by blocking tyrosine hydroxylase, the rate-limiting enzyme in catecholamine biosynthesis. Given its specialized therapeutic applications, sourcing high-quality bulk APIs is critical to ensure drug efficacy, safety, and regulatory compliance. This report provides an in-depth overview of current sources, manufacturers, and considerations for sourcing bulk metyrosine.

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Global Market and Key API Manufacturers

1. Major API Manufacturers

The procurement of metyrosine relies on a select group of pharmaceutical manufacturers specializing in amino acid synthesis, specialty chemicals, and active pharmaceutical ingredients. Manufacturers are typically located in regions with advanced pharmaceutical manufacturing capabilities, including North America, Europe, and parts of Asia.

Key suppliers include:

• AbbVie Inc. (formerly Abbott Laboratories): Historically engaged in the development and supply of metyrosine, especially in North America. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP).
• Sigma-Aldrich/Merck KGaA: A prominent global supplier offering research-grade and GMP-grade metyrosine for clinical and manufacturing use. Their sourcing emphasizes high purity standards suitable for pharmaceutical production.
• Sanofi: Engages in the production and distribution of specialty APIs, including certain amino acid derivatives, with a focus on regulatory compliance.
• Global API Contract Manufacturers: Several contract development and manufacturing organizations (CDMOs) in India and China produce metyrosine under strict quality standards, often serving regional markets or custom synthesis needs.

2. Specialty and Contract Manufacturers

Due to the niche demand for metyrosine, many pharmaceutical companies rely on contract manufacturing organizations (CMOs) in Asia, especially India and China. These regions have shown significant growth in generic API production, offering competitive pricing with GMP compliance. Notable CMOs include:

• Hikal Ltd. (India): Produces amino acid APIs and offers custom synthesis services compliant with international standards.
• BIOVASTA and Aurobindo Pharma: Engage in amino acid API manufacturing, including possible methylated derivatives under contractual agreements.
• Shanghai CP Pharmaceutics Co., Ltd. (China): Offers amino acid APIs and custom synthesis options.

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Sources of Metyrosine: Synthesis and Procurement Considerations

1. Synthetic Route and Quality Standards

Metyrosine synthesis generally involves methylating L-tyrosine or its derivatives through controlled chemical processes, ensuring stereochemical purity and compliance with pharmacopeial standards. Suppliers with established synthetic pathways that demonstrate traceability and batch consistency are preferred.

• The API must meet stringent specifications such as assay (purity ≥ 98%), residual solvents, heavy metals, and microbial limits, compliant with pharmacopoeial standards (e.g., USP, EP, JP).

2. Regulatory and Quality Assurance

Regulatory authorities prioritize suppliers with comprehensive quality management systems: GMP certification, proper documentation, stability data, and validated manufacturing processes. Certifications such as ISO 9001, ISO 13485, and adherence to ICH guidelines underscore supplier reliability.

3. Regional Sources and Accessibility

• North America & Europe: Suppliers with established GMP facilities, often providing higher-cost but higher-regulation-compliant APIs.
• Asia: Major production hubs, offering cost-effective options with a broad range of quality levels. Buyers must verify certificates and audit reports to ensure compliance.

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Sourcing Strategies for Metyrosine

1. Direct Procurement from Established Manufacturers

Companies should prioritize direct engagement with recognized API producers or authorized distributors to ensure authenticity, traceability, and quality. Due diligence involves reviewing GMP certifications, Certificates of Analysis (CoA), and regulatory compliance documentation.

2. Partnerships with Contract Manufacturing Organizations (CMOs)

For custom synthesis or large-volume procurement, partnering with CMOs experienced in amino acid APIs enables flexibility and reliability. CMOs can often adapt manufacturing processes to specific regulatory requirements or formulation needs.

3. Import and Regulatory Considerations

Entering the metyrosine supply chain involves understanding import regulations, documentation, and tariff requirements in target markets. Proper documentation, including CoA, Material Safety Data Sheets (MSDS), and registration dossiers, facilitates smooth customs clearance and regulatory approval.

4. Quality Verification and Audits

Prospective buyers should conduct supplier audits, verify capacity for GMP compliance, and assess quality systems. Sample testing and stability studies provide further validation before scale-up.

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Pricing and Market Trends

Due to the specialized nature of metyrosine, pricing varies based on purity, scale, supplier location, and regulatory compliance. Asian suppliers often offer competitive prices, with costs ranging approximately from $100 to $300 per gram (subject to quality and batch size). North American and European suppliers tend to command premium pricing but align closely with regulatory expectations.

The growing demand for personalized medicine and targeted therapies could influence future supply, pushing innovation in synthesis and sourcing channels. Moreover, increasing regulatory stringency emphasizes the need for supply chain transparency and compliance.

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Supply Chain Challenges

• Limited Number of Suppliers: The niche demand for metyrosine limits widespread manufacturing, increasing dependency on a small pool of suppliers.
• Regulatory Variability: Differences in quality standards and documentation practices across regions necessitate rigorous due diligence.
• Supply Disruptions: Political, economic, or logistical issues in key manufacturing countries could impact availability.
• Intellectual Property: While metyrosine is generally off-patent, specific synthesis methods might be proprietary, influencing sourcing options.

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Conclusion

Sourcing high-quality bulk metyrosine involves navigating a complex landscape of regional manufacturers, regulatory requirements, and quality standards. The most reliable sources are established GMP-certified suppliers in North America, Europe, and Asia, with Asian CMOs playing a pivotal role due to cost-effectiveness and capacity. Ensuring compliance through thorough supplier evaluation, quality verification, and understanding regional regulatory frameworks is vital for pharmaceutical companies seeking to incorporate metyrosine into their product portfolio.

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Key Takeaways

• Limited but Critical Supply: Metyrosine is produced by a select group of manufacturers, making supplier qualification essential.
• Quality and Compliance: Prioritize GMP-certified suppliers with transparent documentation and consistent quality standards.
• Regional Dynamics: Asian manufacturers are prominent in providing cost-effective metyrosine; however, North American and European suppliers offer higher assurance of regulatory compliance.
• Supply Chain Vigilance: Due diligence, including audits and sample testing, helps mitigate risks of substandard or counterfeit APIs.
• Strategic Partnerships: Collaborating with experienced CMOs enhances sourcing flexibility, customization, and regulatory adherence.

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FAQs

1. What are the primary regions producing metyrosine APIs?
Major production occurs in North America, Europe, India, and China, with Asian regions serving as cost-effective sources through established CMOs.

2. How can I verify the quality of metyrosine from a supplier?
Request Certificates of Analysis, GMP certifications, and perform independent testing of samples. Auditing suppliers and reviewing their quality management systems is also recommended.

3. Is metyrosine production suitable for small-scale manufacturing?
Yes, but due to specialized synthesis, most suppliers prefer bulk orders. Small-scale production may involve custom synthesis agreements with CMOs.

4. What regulatory considerations should be accounted for when sourcing metyrosine?
Ensure suppliers comply with GMP standards, provide all necessary documentation, and the API meets pharmacopeial specifications for its intended market.

5. Are there synthetic alternatives to metyrosine?
Currently, metyrosine is typically synthesized via methylation of tyrosine derivatives; no direct synthetic alternatives replicate its exact mechanism. Biosynthesis pathways are not commonly used commercially for this API.

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Sources:

1. US Pharmacopeia (USP). Monographs and manufacturing standards.
2. Sigma-Aldrich product catalog and technical datasheets.
3. Industry reports on amino acid API production, Market Research Future.
4. Company websites and regulatory filings for manufacturers like Aurobindo Pharma, Hikal, and others.
5. International trade databases and API export/import records.