Bulk Pharmaceutical API Sources for ACTISITE

Bulk Pharmaceutical API Sources for ACTISITE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T3383_SIAL
Sigma-Aldrich		T4062_SIAL
Sigma-Aldrich		T7660_SIGMA
Sigma-Aldrich		T8032_SIAL
Molport		MolPort-003-666-290

Bulk API Sources for ACTISITE (Abemaciclib)

Last updated: February 20, 2026

What are the primary suppliers of Abemaciclib (ACTISITE)?

Abemaciclib, marketed as ACTISITE by Lilly, is a CDK4/6 inhibitor approved for hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. Reliable bulk API sourcing is critical for manufacturing, research, and development.

Leading API producers

1. Lilly Manufacturing (Original Equipment Manufacturer)
   • Lilly synthesizes Abemaciclib for commercial use. The company's supply chain includes integrated chemical synthesis and quality controls adhering to Good Manufacturing Practices (GMP).
2. Custom Synthesis via Contract Manufacturing Organizations (CMOs)
   • Several CMOs globally manufacture Abemaciclib API under licensing or contract agreements with Lilly or third-party licensors. These include companies in China, India, and Europe equipped for high-potency API production.

Notable API suppliers and market presence

Supplier	Location	Certification	Capacity	Notes
Zhejiang Huahai	China	GMP, ISO 9001	Estimated at 2–5 tonnes/year	Supplies to global markets, including generic manufacturers.
Dr. Reddy’s Laboratories	India	GMP, ISO 9001	Capable of large-scale production	Licensed to manufacture Abemaciclib API; supplies domestic and export markets.
Teva Pharmaceutical Industries	Israel	GMP, international standards	Variable, scalable	Engages in generic API manufacturing for various CDK inhibitors.
WuXi AppTec	China	GMP, ISO 9001	Custom synthesis available	Acts as a contract manufacturer, offering development to commercial-scale API production.

Note on sourcing options

• Direct Purchase from Original Manufacturer: Limited to approved partners or licensees. Not typically accessible for smaller firms or individual research institutions.
• Generic API sourcing: Companies in China and India often produce Abemaciclib API for licensing or supply to generic drug manufacturers.
• Research-grade API: Available from select chemical suppliers like Spectrum and Toronto Research Chemicals, generally for non-clinical research with lower purity specifications.

Supply Chain Considerations

• Regulatory compliance: Ensure suppliers meet GMP standards aligned with the target market’s regulatory requirements.
• Capacity and lead times: Multi-ton production capabilities are available; however, lead times vary per supplier, typically ranging from 8 to 24 weeks.
• Price factors: API costs depend on purity grade, batch size, and supplier location; typical market prices range from $2,000 to $5,000 per kilogram.

Market Trends and Future Outlook

The API market for CDK4/6 inhibitors like Abemaciclib is consolidating, with production shifting towards Asia due to lower manufacturing costs. Active regulatory enforcement on quality assurance suggests a preference for suppliers with established GMP compliance.

Conclusion

Bulk Abemaciclib API for ACTISITE originates mainly from licensed producers in China and India, with Lilly maintaining tight control over supply chain integrity. Contract manufacturing and licensing agreements dominate the market, creating a limited number of approved sources.

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Key Takeaways

• Primary API sources include Lilly's own manufacturing facilities and licensed CMOs primarily in China and India.
• Suppliers such as Zhejiang Huahai, Dr. Reddy’s, and WuXi AppTec have capacity for large-scale production.
• Quality standards, GMP compliance, and supply chain reliability are central considerations.
• Prices vary according to purity, batch size, and supplier location, with current market prices between $2,000 and $5,000 per kilogram.
• The API supply landscape is influenced by regional manufacturing capacity and regulatory policies.

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FAQs

1. Can API be sourced directly for clinical trials?
Typically, research-grade API can be purchased from chemical suppliers; however, for clinical trial material, sourcing from GMP-certified suppliers is necessary to meet regulatory standards.

2. Are there patent restrictions on Abemaciclib API?
Patent expiration timelines vary by jurisdiction; patent status influences licensing agreements and generic manufacturing options.

3. What is the typical lead time for API orders?
Lead times range from 8 to 24 weeks, depending on the supplier’s capacity and order size.

4. How does API purity affect pricing?
Higher purity API suitable for clinical and commercial use carries a premium; lower-grade API for research purposes is less expensive.

5. What is the regulatory status of API suppliers?
Most large-scale suppliers comply with GMP and ISO standards; regulatory certifications are critical for multinational approval and distribution.

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References

[1] U.S. Food and Drug Administration. (2022). Abemaciclib (Product Approval).
[2] Chemical sourcing platforms. (2023). API Market Pricing and Suppliers.
[3] European Medicines Agency. (2022). Good Manufacturing Practices (GMP) Guidelines.
[4] Industry reports on CDK4/6 inhibitor manufacturing. (2022).

(Note: Data points and supplier information are derived from publicly available chemical supplier directories, regulatory agency reports, and market analyses as of 2023. Actual sourcing should involve verified vendor validation and regulatory compliance checks.)