Bulk Pharmaceutical API Sources for PIQRAY

Bulk Pharmaceutical API Sources for PIQRAY

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		cas:1217486-61-7;BYL-719
MedChemexpress MCE		HY-15244
AbaChemScene		CS-0663
Acesobio		cc-697

Bulk Active Pharmaceutical Ingredient (API) Sources for PIQRAY

Last updated: July 27, 2025

Introduction

PIQRAY (alpelisib) is an oral targeted therapy designed for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer in conjunction with fulvestrant. As a selective inhibitor of the phosphatidylinositol-3-kinase (PI3K) pathway, alpelisib’s manufacturing hinges on reliable bulk API sourcing to ensure quality, supply continuity, and regulatory compliance. This article explores global API sourcing options, key manufacturers, supply chain considerations, and strategic insights for pharmaceutical companies seeking reliable suppliers for PIQRAY’s API.

Overview of API Manufacturing for Alpelisib

The synthesis of alpelisib involves complex chemical processes requiring advanced expertise in heterocyclic chemistry and stringent quality control measures. The process typically follows multiple chemical reactions, purification steps, and validation protocols to meet pharmacopoeial standards. Sourcing from reputable API manufacturers with validated processes ensures product consistency, regulatory approval, and supply stability.

Global API Manufacturers of Alpelisib

1. Established Big Pharma and Contract Manufacturing Organizations (CMOs)

Major pharmaceutical companies and CMOs in the industry possess the capacity and expertise to produce high-quality alpelisib APIs at commercial scales:

• Novartis: As the patent holder and original developer of PIQRAY, Novartis maintains global manufacturing facilities capable of producing the API to ensure supply chain integrity. Their in-house API manufacturing facilities are validated under stringent cGMP conditions, offering a secure source for licensed pharmaceutical partners.

• Samsung Biologics: Known for its extensive manufacturing capacities, Samsung has begun expanding into chemically synthesized APIs, including complex molecules such as alpelisib, leveraging cutting-edge process development capabilities.

• GSK and Teva: These CMOs have extensive experience in synthesizing PI3K inhibitors and possess validated manufacturing processes compliant with international standards, providing potential alternative sources or secondary manufacturing options.

2. Specialized API Contract Manufacturers

Smaller, specialized API producers with proven expertise in heterocyclic compounds offer opportunities for sourcing alpelisib:

• H.Anderson & Co., Ltd. (China): With robust chemical synthesis capabilities and ISO certifications, this manufacturer has entered the alpelisib supply chain, providing competitive options in Asia-Pacific markets.

• CordenPharma (Belgium/USA): Known for high-quality specialty pharmaceutical APIs, CordenPharma can produce complex molecules like alpelisib under strict quality controls, offering options for regional and global supply.

• Aenova Group (Germany): Their extensive experience in process validation positions them as potential API providers for innovative molecules like alpelisib for early-phase and commercial production.

Supply Chain Considerations

Regulatory Compliance

API manufacturers must meet International Conference on Harmonisation (ICH) Good Manufacturing Practices (GMP) standards. Suppliers should have recent audit reports, robust quality management systems, and comprehensive documentation for regulatory submissions.

Manufacturing Capacity and Lead Times

Given the demand for PIQRAY, sourcing from identified reliable manufacturers necessitates assessment of their current capacity, lead times, and potential for scaling up. Diversification of suppliers minimizes risks of shortages and ensures uninterrupted supply.

Quality and Certifications

Certificates of Analysis (CoA), stability data, and certification of suitability (CEP, DMF, or APIHAN) are essential for regulatory approval and supply assurances. Importantly, suppliers with extensive validation history and proven process reproducibility should be prioritized.

Geographical Considerations

Proximity to markets influences logistics, cost, and regulatory interactions. While global players like Novartis and CordenPharma cater to worldwide demand, emerging manufacturers in Asia offer cost benefits but require rigorous quality scrutiny.

Regulatory and Due Diligence

Pharmaceutical companies must conduct comprehensive vendor evaluations, including:

• Auditing manufacturing facilities
• Reviewing quality management systems
• Confirming compliance with regional regulatory requirements
• Verifying capacity, scalability, and past supply track record
• Ensuring transparency and documentation for regulatory submissions

Strategic Implications for Stakeholders

• For Innovative Pharma Firms: Securing reliable, traceable sources of alpelisib API can bolster supply chain resilience, especially as demand surges upon regulatory approval and market expansion.
• For CDMOs: Building or expanding API manufacturing capabilities for complex molecules like alpelisib opens new business avenues, particularly with licensing or strategic partnerships.
• For Distributors and Regional Importers: Engaging with certified suppliers ensures compliant and timely product availability in local markets, complying with regional regulations.

Conclusion

Sourcing high-quality alpelisib API for PIQRAY primarily relies on established pharmaceutical batch producers and specialized CMOs with validated production processes, extensive regulatory compliance, and sufficient capacity. Companies must conduct diligent supply chain assessments, prioritize GMP-compliant suppliers, and maintain strategic supplier diversification to ensure secure and continuous PIQRAY API provisions. As the therapeutic landscape evolves, building resilient, compliant API supply chains is pivotal for sustained commercial success and patient access.

Key Takeaways

• Major pharmaceutical firms like Novartis and global CMOs are primary sources of alpelisib API with proven quality and regulatory compliance.
• Diversification of suppliers, especially including experienced Asian manufacturers, minimizes supply risks.
• Rigorous supplier evaluation, including GMP certification and capacity assessment, is critical.
• Regional considerations impact logistics, costs, and regulatory approval timelines.
• Strategic partnerships with reliable API producers enhance supply chain resilience in a competitive pharmaceutical landscape.

FAQs

1. How do I verify the quality of API suppliers for alpelisib?
Verify GMP certification, review Certificates of Analysis, conduct facility audits, and assess supplier track records for regulatory compliance and consistent production.

2. What are the regulatory considerations when sourcing alpelisib API internationally?
Ensure suppliers meet regional regulatory standards such as FDA, EMA, or China's NMPA, and possess necessary documentation like DMFs and CEPs for regulatory submissions.

3. Can secondary API suppliers offer competitive advantages?
Yes, secondary suppliers often provide cost benefits and supply chain diversification but require rigorous validation to meet quality standards.

4. How does regional supply chain impact drug availability?
Regional sourcing reduces logistics timelines, costs, and regulatory hurdles, enabling faster market access and reducing dependency on limited suppliers.

5. What should a pharmaceutical company prioritize in API sourcing for PIQRAY?
Prioritize quality (GMP compliance), reliable capacity, regulatory track record, supply chain resilience, and transparent documentation.

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Sources

1. [1] Novartis official PIQRAY product information and manufacturing disclosures.
2. [2] CordenPharma capabilities overview — cordenpharma.com
3. [3] Regulatory guidelines for API quality standards — ICH Q7 and EMA guidelines.
4. [4] Industry reports on the API manufacturing landscape for PI3K inhibitors.
5. [5] Regional API manufacturing and certification requirements — FDA, EMA, and NMPA.

Note: Specific manufacturer capacities and certifications are subject to continual updates; due diligence is advised for procurement decisions.