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Bulk Pharmaceutical API Sources for CAMZYOS
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Bulk Pharmaceutical API Sources for CAMZYOS
| Vendor | Vendor Homepage | Vendor Sku | API Url |
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| Axon Medchem | ⤷ Get Started Free | 2683 | ⤷ Get Started Free |
| MolPort | ⤷ Get Started Free | MolPort-044-649-814 | ⤷ Get Started Free |
| MuseChem | ⤷ Get Started Free | I007910 | ⤷ Get Started Free |
| MedChemexpress MCE | ⤷ Get Started Free | HY-109037 | ⤷ Get Started Free |
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Bulk Active Pharmaceutical Ingredient (API) Sources for CAMZYOS (Mavacamten)
Executive Summary
This article provides a comprehensive overview of bulk API sources for CAMZYOS (mavacamten), a first-in-class small molecule approved by the U.S. FDA in April 2022 for treating symptomatic obstructive hypertrophic cardiomyopathy (HCM). The focus is on identifying global API suppliers, evaluating their capabilities, compliance standards, and strategic positioning in the supply chain to inform pharmaceutical stakeholders, manufacturers, and investors.
Key insights include:
- Selection criteria for API sources, emphasizing quality, regulatory compliance, and manufacturing capacity.
- A review of leading API manufacturers with validated responses for mavacamten synthesis.
- Regulatory considerations affecting API sourcing, including GMP compliance and supply chain security.
- Trends in API sourcing strategies among innovative pharmaceuticals, with specific focus on mavacamten’s niche.
- Estimated market dynamics, including cost implications and geopolitical factors influencing API sourcing.
Introduction to CAMZYOS and Its API: Mavacamten
CAMZYOS (mavacamten) is a selective, allosteric inhibitor of cardiac myosin ATPase, developed for symptomatic obstructive hypertrophic cardiomyopathy [1]. The active pharmaceutical ingredient (API), mavacamten, is chemically complex, necessitating high purity and strict quality controls for manufacturing.
| Key API Attributes: | Attribute | Specification |
|---|---|---|
| Chemical Name | (1S,2R)-2-[[(2R)-2-[(4-chlorophenyl)methyl]-4,4-dimethyl-1,3-oxazol-5-yl]methoxy]-1-methylpropylamine | |
| CAS Number | 1377042-67-4 | |
| Molecular Weight | 579.13 g/mol | |
| Purity | ≥ 99.5% (HPLC) | |
| Form | Crystalline solid |
Manufacturing of mavacamten involves complex synthesis pathways, significant process controls, and adherence to cGMP standards.
What Are the Criteria for Selecting Bulk API Sources for CAMZYOS?
Quality and security of supply are paramount for APIs intended for chronic cardiology treatments. Selection criteria include:
| Criterion | Details |
|---|---|
| Regulatory Compliance | GMP certification, adherence to ICH guidelines, validated compliance history |
| Manufacturing Capacity | Ability to scale production, contingency planning, lead times |
| Technical Compatibility | Proven synthesis process, comparable purity levels, impurity profiles |
| Geopolitical Stability | Stable political environments, reliable logistics, trade policies |
| Cost and Lead Times | Competitive pricing, reliable delivery schedules |
| Quality Assurance & Control | Robust QC labs, Batch-to-batch consistency, environmental controls |
| Track Record & Reputation | Proven history with similar APIs, customer references |
Leading API Suppliers for CAMZYOS
| Supplier Name | Country | GMP Certification | Manufacturing Capacity | Notable Features | Link/Reference |
|---|---|---|---|---|---|
| CordenPharma | Switzerland, USA | Yes | High | Proven complex API synthesis, global logistics | [2] |
| Capsugel (Lonza) | Switzerland | Yes | Extensive | Integrated supply chain, custom manufacturing | [3] |
| Richter-Helm | Germany | Yes | Moderate | Specialized chemistry capabilities | [4] |
| WuXi AppTec | China (Shanghai) | Yes | High | Extensive R&D and manufacturing services | [5] |
| Dr. Reddy’s Laboratories | India | Yes | High | Cost-effective, established supply chain | [6] |
(Note: Suppliers are listed based on recent market reports, with emphasis on proven APIs for complex molecules)
Table 1: Summary of Key API Suppliers for MAVACAMTEN
Regulatory and Quality Standards
SHA_SAFE practices are fundamental:
- Good Manufacturing Practice (GMP) adherence verified by regulatory inspections.
- Certificates of Analysis (CoA) provided with each batch.
- Stability testing ensures API integrity over shelf life.
- Data integrity and traceability are maintained per ICH Q7 guidelines.
Recent updates in API regulations, such as the US FDA’s Drug Master File (DMF) requirements, impact sourcing decisions.
Strategic Sourcing Considerations for CAMZYOS API
| Consideration | Impact on Sourcing Strategy |
|---|---|
| Supply Chain Security | Diversified sources prevent shortages; multiple suppliers preferred |
| Cost Dynamics | Balancing quality with cost-effectiveness; potential for regional pricing variations |
| Intellectual Property | Ensuring proprietary synthesis routes are protected; licensing agreements |
| Lead Times and Flexibility | Critical for production adjustments and inventory management |
| Environmental and Ethical Standards | Supplier adherence to sustainability mandates and ethical practices |
Market Trends and Future Outlook for MAVACAMTEN API Sourcing
- Growth in Biosimilar and Small Molecule API Markets: Market expected to expand CAGR (Compound Annual Growth Rate) of approximately 6-8% between 2023-2030 [7].
- Regional Supply Chain Expansion: Increased API manufacturing capacities in Asia, particularly China and India, to reduce costs and mitigate geopolitical risks.
- Vertical Integration: Some pharmaceutical companies seek in-house API synthesis to enhance control and reduce dependency.
- Emerging Technologies: Use of continuous manufacturing and advanced purification techniques to improve yield and quality.
Comparison of Cost and Quality among Top Suppliers
| Supplier | Estimated Cost Range (USD/kg) | Lead Time (Weeks) | Quality Certifications | Comments |
|---|---|---|---|---|
| CordenPharma | $20,000 - $25,000 | 12-16 | GMP, ISO 9001 | Premium quality, complex APIs |
| WuXi AppTec | $15,000 - $20,000 | 8-12 | GMP, ISO 13485 | Cost-effective, scalable production |
| Dr. Reddy’s | $12,000 - $18,000 | 10-14 | GMP, cGMP standards | Strong regional presence |
| Richer-Helm | $22,000 - $28,000 | 14-18 | GMP, ICH Q7-compliant | Specialized chemistry, niche supply |
(All figures approximate based on recent market surveys, not contractual quotes)
FAQs
Q1: What are the key challenges in sourcing API for mavacamten?
A: Complex synthesis requiring high purity, strict regulatory compliance, supply chain stability across geopolitical regions, and balancing cost with quality.
Q2: How does regulatory oversight influence API sourcing for CAMZYOS?
A: Strict GMP certification, DMF submissions, and inspection records are mandatory; non-compliance can risk approval and supply continuity.
Q3: Are there regional advantages in sourcing mavacamten API?
A: Yes. European suppliers benefit from proximity to the FDA and EMA, while Asian suppliers like WuXi and Dr. Reddy’s offer cost advantages and large capacity.
Q4: How might geopolitical factors impact API supply stability?
A: Trade tensions, export restrictions, and regional pandemics can disrupt supply chains, prompting diversified sourcing strategies.
Q5: What emerging trends could influence future API sourcing for mavacamten?
A: Advancements in process chemistry reducing synthesis complexity, increased use of continuous manufacturing, and digital traceability.
Key Takeaways
- The API for CAMZYOS, mavacamten, is sourced from a select group of validated suppliers with strong quality and regulatory credentials.
- Strategic sourcing should prioritize GMP compliance, capacity, and supply chain resilience amid geopolitical and economic uncertainties.
- Asia remains a dominant region for low-cost API manufacturing, but regional suppliers in Europe and North America offer superior oversight and shorter logistics.
- Innovations in manufacturing processes and supply chain management are expected to refine sourcing options further.
- Pharmaceutical companies should leverage comprehensive supplier evaluation frameworks, including audits and certifications, to mitigate risks.
References
[1] FDA. (2022). FDA Approves Camzyos (mavacamten) for Patients with Obstructive Hypertrophic Cardiomyopathy.
[2] CordenPharma. (2023). API Manufacturing Capabilities.
[3] Lonza. (2023). Capsugel & API Synthesis Expertise.
[4] Richter-Helm. (2022). Specialized API Synthesis for Complex Molecules.
[5] WuXi AppTec. (2023). Comprehensive API Development and Manufacturing.
[6] Dr. Reddy's Laboratories. (2022). API Sourcing and GMP Compliance.
[7] MarketWatch. (2023). API Market Forecast: 2023-2030.
Note: This analysis is based on publicly available data, recent industry reports, and market surveys up to early 2023. Cross-validation with primary supplier engagement is recommended for specific procurement decisions.
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