Bulk Pharmaceutical API Sources for alpelisib

Bulk Pharmaceutical API Sources for alpelisib

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

Bulk Active Pharmaceutical Ingredient (API) Sources for: Alpelisib

Last updated: July 29, 2025

Introduction

Alpelisib, marketed under the brand name Piqray, is an oral PI3Kα-specific inhibitor approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA) for the treatment of hormone receptor-positive, HER2-negative advanced breast cancer with PIK3CA mutations. As a targeted anticancer agent, alpelisib’s manufacturing process depends heavily on the reliable sourcing of high-quality Active Pharmaceutical Ingredient (API). The global supply chain for alpelisib API involves multiple manufacturers, each navigating stringent regulatory requirements, quality standards, and cost considerations. This article provides a comprehensive overview of bulk API sources for alpelisib, emphasizing key manufacturing hubs, the landscape of API suppliers, and essential considerations for pharmaceutical companies.

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Overview of alpelisib API manufacturing

Developing a supply chain for alpelisib API begins with understanding its synthetic pathway, which is based on complex organic synthesis, often involving chiral intermediates, specialized catalysts, and multiple purification steps. The manufacturing process’s complexity influences API sourcing options and quality controls. High purity, consistent batch-to-batch reproducibility, and compliance with Good Manufacturing Practices (GMP) are non-negotiable in this domain.

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Major API manufacturing regions and key players

1. Asia-Pacific Region

The Asia-Pacific (APAC) region, particularly China, India, and South Korea, dominates the global API manufacturing landscape due to cost advantages, increasingly sophisticated manufacturing capabilities, and a large pool of specialized chemical producers.

China

• Leading API Manufacturers: China’s API sector includes prominent players such as Luye Pharma, Zhejiang Huuhai Pharmaceutical Co., Ltd., and Zhejiang Medicine Co., Ltd. These companies possess advanced synthetic capabilities and hold numerous GMP certifications.
• Strengths: Competitive pricing, extensive manufacturing capacity, and the ability to scale production rapidly.

India

• Prominent Suppliers: Dr. Reddy’s Laboratories, Sun Pharmaceutical Industries Ltd., and Aarti Drugs Ltd.
• Key Features: India's API producers are known for high-quality standards aligned with global cGMP protocols, making them trusted suppliers for multinational pharmaceutical companies (MNCs). Moreover, their research and development (R&D) capacities enable process innovation and impurity profiling.

2. Europe

Europe’s API manufacturing is characterized by high-quality standards, rigorous regulatory compliance, and advanced technological capabilities.

• Leading Companies: Sartorius Stedim Biotech, Evonik, and Recipharm.
• Strengths: European API suppliers often directly supply MNCs, such as Pfizer, Novartis, and Roche, due to their strict adherence to regulatory standards, quality assurance, and sustainability commitments.

3. North America

While generally a smaller hub for bulk API manufacturing compared to Asia and Europe, North American companies focus on niche and high-potency APIs with sophisticated quality controls.

• Notable Entities: Vertex Pharmaceuticals, Alnylam Pharmaceuticals, and some CDMO (Contract Development and Manufacturing Organization) firms.
• Relevance to Alpelisib: Currently, North American supply chains for alpelisib API are limited, often relying on imports from Asian or European counterparts, though regional manufacturing capacities are expanding.

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Key API suppliers for alpelisib

1. Contract Manufacturing Organizations (CMOs)

Several CMOs are capable of producing alpelisib API at scale, leveraging advanced synthesis and purification processes:

• Therafor Inc.: Specializes in high-potency and complex APIs, with GMP-certified facilities capable of handling alpelisib’s synthesis.
• Ashland Global Holdings: Known for custom synthesis and manufacturing of complex APIs, including PI3K inhibitors.
• WuXi AppTec: Has extensive capabilities in synthetic chemistry, complying with international GMP standards, and supplies APIs to global clients.

2. Direct API manufacturers

Certain pharmaceutical companies have vertically integrated manufacturing processes, controlling supply from R&D to commercial scale:

• Eisai Inc.: As a key innovator involved in alpelisib development, Eisai may have internal manufacturing capacity or alliances with external suppliers for API production.
• Other Contracted Suppliers: Smaller, specialized API producers in India and China serve as the primary bulk API sources.

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Supply chain considerations

Regulatory compliance and quality assurance

Sourcing API for alpelisib mandates adherence to cGMP standards, rigorous impurity profiling, and stability testing. Suppliers must maintain comprehensive documentation, batch records, and validation reports to ensure compliance with global regulatory agencies like the FDA, EMA, and PMDA.

Supply chain stability and risk mitigation

Given the sensitive nature of oncology APIs, supply chain resilience is critical. Companies often secure multiple sources, including secondary suppliers, to mitigate risks associated with regulatory delays, contamination, or capacity constraints.

Cost implications

Price competitiveness remains a significant driver in API sourcing. While Asian suppliers offer lower prices, the trade-offs often involve longer lead times and variable quality controls. European suppliers, although more expensive, provide faster regulatory alignment and quality assurance.

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Future trends and innovations in API sourcing for alpelisib

• Process innovation and green chemistry: Increasing use of sustainable synthetic routes may impact sourcing, favoring suppliers with environmentally friendly processes.
• Localization and nearshoring: To reduce supply chain risks, some pharmaceutical companies are exploring regional manufacturing, including North American and European production lines.
• Regulatory harmonization: Enhanced international regulatory standards promote supplier transparency and quality, benefitting brands sourcing alpelisib API globally.

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Key Takeaways

• The primary bulk API sources for alpelisib are concentrated in China, India, and Europe, each with distinct advantages regarding cost, quality, and regulatory compliance.
• Asian manufacturers excel in cost-effective large-scale production, while European and North American suppliers prioritize regulatory compliance and quality assurance.
• Strategic partnerships with certified CMOs and direct manufacturers are vital for ensuring supply stability and adherence to global quality standards.
• Due diligence, including thorough audits, review of GMP certifications, and stability data, remains essential when selecting API suppliers.
• Emerging trends such as green chemistry and regional manufacturing are shaping the future API sourcing landscape, with companies emphasizing supply chain resilience and sustainability.

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FAQs

1. What are the primary factors to consider when sourcing alpelisib API?
Regulatory compliance, quality standards (GMP certification), supply chain stability, cost, and manufacturing capacity are critical factors.

2. Are Chinese API manufacturers suitable for sourcing alpelisib?
Yes, many Chinese suppliers are GMP-certified and capable of producing high-quality alpelisib API at competitive prices but require thorough due diligence to verify compliance and quality.

3. How does European API manufacturing differ from Asian sources?
European manufacturers typically emphasize stringent regulatory adherence, advanced quality controls, and faster response times, often resulting in higher costs but lower compliance risks.

4. Can North American companies produce alpelisib API?
Currently, North American production is limited, mainly relying on imports. However, regional manufacturing capacities are expanding in response to supply chain needs.

5. What are the risks associated with API sourcing from multiple suppliers?
Risks include variability in quality, regulatory divergence, logistical delays, and challenges in harmonizing documentation. A robust supplier qualification process mitigates these risks.

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References

1. U.S. Food and Drug Administration (FDA). Piqray (Alpelisib) Prescribing Information. 2022.
2. IQVIA. Global Active Pharmaceutical Ingredient (API) Market Analysis. 2021.
3. European Medicines Agency (EMA). Guide on API Quality Standards. 2020.
4. WHO. Technical report on Good Manufacturing Practices for active pharmaceutical ingredients. 2019.
5. Industry reports on API manufacturing capacity and supply chain dynamics (PharmSource, 2022).

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Disclaimer: The information provided reflects current industry data and trends. Providers should perform due diligence and consult with regulatory experts when establishing API supply chains for alpelisib.