Bulk Pharmaceutical API Sources for IXAZOMIB CITRATE

Bulk Pharmaceutical API Sources for IXAZOMIB CITRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
AbaChemScene		CS-1720
MedChemexpress MCE		HY-10452
ChemShuttle		139039
AbovChem LLC		HY-10452
AKos Consulting & Solutions		AKOS030632768

Bulk Active Pharmaceutical Ingredient (API) Sources for: Ixazomib Citrate

Last updated: July 30, 2025

Introduction

Ixazomib citrate is an oral proteasome inhibitor used primarily in the management of multiple myeloma, either as a standalone therapy or in combination regimens. As a critical component in pharmaceutical manufacturing, securing reliable API sources is vital for pharmaceutical companies to ensure consistent supply, quality, and regulatory compliance. This report provides a comprehensive overview of bulk API sources for ixazomib citrate, including key manufacturers, geographic considerations, supply chain dynamics, and quality assurance considerations.

Understanding Ixazomib Citrate as an API

Ixazomib citrate (chemical name: (2S)-1-[(2S)-3-methyl-2-[(2-aminophenyl)amino]propanoyl]pyrrolidine-2-carboxylic acid citrate) functions as a reversible proteasome inhibitor. Its synthesis involves complex processes requiring high-purity raw materials, advanced synthetic routes, and stringent quality management to meet pharmaceutical standards (e.g., USP, EP, EP 3.1.5).

Demand for ixazomib citrate has surged since its approval by regulatory authorities such as the FDA and EMA, prompting a focus on sourcing, especially amid geopolitical and supply chain complexities.

Leading API Manufacturers for Ixazomib Citrate

1. Takeda Pharmaceutical Company

Takeda, as the innovator and patent holder of ixazomib citrate, is the primary manufacturer and supplier of the API. The company's integrated manufacturing facilities and technology platforms enable high-quality production, critical for maintaining therapeutic efficacy and regulatory compliance. Takeda generally supplies the API directly to global partners under licensing or contractual arrangements, ensuring product integrity and traceability.

Advantages:

• Certified manufacturing facilities aligned with international standards (e.g., cGMP).
• Proven track record of supply stability.
• Ongoing commitment to api production scale-up to meet global demand.

Considerations:

• Limited third-party supplier presence; typically, Takeda manages API availability directly.

2. Contract Manufacturing Organizations (CMOs)

Given the high technical complexity and regulatory stringency, several CMOs have developed capabilities to synthesize ixazomib citrate either as an OEM (original equipment manufacturing) or under licensing agreements. These include:

• Therapure Biopharma: Known for complex small molecule synthesis and API manufacturing, with a focus on oncology compounds.
• CordenPharma (part of the IDT Biologika Group): Offers advanced GMP manufacturing for complex APIs, including proteasome inhibitors, leveraging extensive process development expertise.
• Wuxi AppTec: Globally recognized for chemical synthesis and API production, expanding capacity in oncology APIs.
• Hainan Yanglaite Biological Pharmaceutical Co. (China): Focused on producing APIs for domestic markets, with increasing FDA inspection compliance.

Advantages:

• Increased capacity and geographic diversification.
• Competitive pricing and flexible supply arrangements.
• Potential for regional supply to mitigate geopolitical risks.

Considerations:

• Variability in regulatory approval status for APIs sourced from certain CMOs.
• The need for rigorous quality assessments and validation documentation to ensure APIs meet specifications.

3. Emerging and Regional Suppliers

In response to rising demand, several regional producers in China, India, and Southeast Asia have entered the market:

• Hainan Yezhimei Chemical Co. (China): Offers synthetic APIs with GMP certification, targeting domestic and export markets.
• Sun Pharmaceutical Industries: Has developed capabilities for complex APIs, including proteasome inhibitors, leveraging their extensive API manufacturing infrastructure.
• Covalent Laboratories: An Indian API manufacturer with a growing portfolio of oncology APIs, aiming to supply to domestic and international markets.

Advantages:

• Cost efficiencies and regional proximity.
• Potentially quicker turnaround for localized supply.

Considerations:

• Regulatory acceptance and documentation quality may vary.
• Supply chain stability needs thorough vetting.

Supply Chain Dynamics and Procurement Strategies

Regulatory and Quality Assurance

Ensuring API authenticity, purity, and compliance with pharmacopeial standards (USP, EP) remains paramount. Due diligence involves auditing manufacturing sites, reviewing batch records, and validating analytical data. Companies should prioritize suppliers with established regulatory track records and documented quality systems.

Supply Chain Risks

• Geopolitical risks: Trade restrictions and tariffs may impact regions like China and India.
• Raw material availability: The complex synthesis of ixazomib citrate depends on high-purity intermediates, which can face supply shortages.
• Manufacturing capacity constraints: Rapid growth in demand may cause supply bottlenecks.

Diversified sourcing, long-term supply agreements, and establishing inventory buffers are recommended to mitigate risks.

Cost and Lead Times

Pricing varies based on geographic origin, purity levels, and production scales. Lead times can range from 3 to 12 months depending on supplier readiness and regulatory clearance, underscoring the importance of early engagement and strategic procurement planning.

Regulatory and Quality Considerations

Compliance with international standards is non-negotiable in API sourcing for oncology drugs like ixazomib citrate. Suppliers must provide comprehensive analytical data, stability studies, and certificates of analysis. Additionally, adherence to ICH Q7 guidelines for good manufacturing practices (GMP) is essential.

Regulatory agencies such as the FDA, EMA, and PMDA scrutinize API batch records, impurity profiles, and process validation. Companies should prioritize suppliers with well-documented regulatory filings and robust quality management systems.

Future Outlook

The global API market for ixazomib citrate is poised for growth, driven by increased oncology treatment needs and expanding regional manufacturing capabilities. Innovations in synthetic methodologies and continuous manufacturing are expected to streamline production, reduce costs, and improve supply resilience.

Furthermore, strategic collaborations between innovator companies and third-party API producers are likely to facilitate broader access and stability in the supply chain.

Key Takeaways

• Primary source: Takeda remains the dominant and most reliable API manufacturer for ixazomib citrate, with strict quality control and regulatory compliance.
• Secondary sources: Contract manufacturing organizations and regional suppliers are increasingly important as supply chain diversification strategies.
• Quality and regulatory focus: Due diligence, site audits, and documentation rigor are critical for qualified API procurement.
• Supply chain resilience: Diversification, early procurement planning, and inventory management mitigate geopolitical, logistical, and raw material risks.
• Market outlook: Growth in demand and technological advancements will enhance API manufacturing capacity, fostering more stable and cost-effective supply options.

FAQs

1. What factors should I consider when selecting an API supplier for ixazomib citrate?
Focus on regulatory compliance, quality control measures, manufacturing capabilities, track record of on-time delivery, and geographical considerations to ensure supply stability and regulatory acceptance.

2. Are there alternative API sources for ixazomib citrate outside of Takeda?
Yes, several CMOs and regional manufacturers are developing or providing APIs, but thorough vetting of their regulatory standing and quality systems is essential before procurement.

3. How does regulatory compliance impact API sourcing for oncology drugs like ixazomib citrate?
Regulatory compliance ensures the API meets purity, potency, and safety standards, which is critical to maintaining drug efficacy and avoiding clinical or market approval delays.

4. What are typical lead times for sourcing ixazomib citrate API?
Lead times usually range from 3 to 12 months depending on the supplier’s production capacity, regulatory approval status, and logistical factors.

5. How can manufacturers mitigate risks associated with supply chain disruptions?
By establishing multiple sourcing relationships, engaging in long-term contracts, maintaining safety stock, and verifying supplier compliance with quality standards.

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Sources:

[1] Takeda Pharmaceutical. (2022). Ixazomib citrate product monograph.
[2] European Pharmacopoeia. (2021). Monographs on proteasome inhibitors.
[3] Contract Pharma. (2023). API manufacturing landscape for oncology drugs.
[4] ICH Q7 Guidelines. (2016). Good Manufacturing Practices for Active Pharmaceutical Ingredients.
[5] IMS Health Reports. (2022). Global API market analysis.