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Suppliers and packagers for generic pharmaceutical drug: abemaciclib
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abemaciclib
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716 | NDA | Eli Lilly and Company | 0002-4483-54 | 1 BLISTER PACK in 1 CARTON (0002-4483-54) / 14 TABLET in 1 BLISTER PACK | 2017-09-28 |
| Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716 | NDA | Eli Lilly and Company | 0002-4483-62 | 2 BLISTER PACK in 1 CARTON (0002-4483-62) / 14 TABLET in 1 BLISTER PACK | 2017-09-28 |
| Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716 | NDA | Eli Lilly and Company | 0002-4815-54 | 1 BLISTER PACK in 1 CARTON (0002-4815-54) / 14 TABLET in 1 BLISTER PACK | 2017-09-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Abemaciclib
Introduction
Abemaciclib, marketed under the brand name Verzenio among others, is a selective cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced or metastatic breast cancer. This targeted therapy plays a crucial role in oncology, particularly in combination with endocrine therapy, and has garnered significant attention from pharmaceutical manufacturers, raw material suppliers, and contract manufacturing organizations (CMOs). Understanding the global supply chain for abemaciclib is essential for stakeholders assessing market stability, sourcing strategies, and regulatory considerations.
Key Raw Material and Active Pharmaceutical Ingredient (API) Suppliers
1. Main API Manufacturers
The API for abemaciclib is synthesized through complex chemical processes requiring high-quality intermediates and stringent quality controls. Several pharmaceutical companies are involved in the production and supply of abemaciclib API, often via licensing agreements with the patent holders or through direct manufacturing.
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Mitsubishi Tanabe Pharma Corporation:
Mitsubishi Tanabe authorized in the development and commercialization of abemaciclib, has established its own manufacturing capabilities in Japan. The company's extensive experience in oncology drugs enables it to produce high-purity API batches adhering to global standards (e.g., cGMP). -
Eli Lilly and Company (Lilly):
Lilly developed abemaciclib and is a primary global licensor. The company owns the original patent and hands down the supply chain to contracted API manufacturers, often including CMOs across Asia and Europe to meet global demand. -
Contract Development and Manufacturing Organizations (CDMOs):
Several CDMOs have been engaged by Lilly and Mitsubishi Tanabe for manufacturing APIs and formulations:- Leonard (China): Provides chemical synthesis and API manufacturing for Lilly’s abemaciclib supply chain.
- Samsung Biologics (South Korea): Known more for biologics but increasingly involved in complex small molecule APIs, including CDK inhibitors.
- Dr. Reddy’s Laboratories (India): Potential supplier or partner for intermediates and API, given their expanding oncology portfolio.
2. Raw Material and Intermediate Suppliers
The synthesis of abemaciclib involves specialized organic chemicals and intermediates such as quinazoline derivatives, substituted pyrimidines, and chiral catalysts.
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Specialty Chemical Companies:
Providers like Merck KGaA, BASF, and Dow Chemical supply chemical precursors and intermediates used in API synthesis. Their role is crucial given the need for high-purity and batch consistency. -
Fine Chemical Suppliers:
Companies like Cambridge Isotope Laboratories and Alfa Aesar supply labeled and unlabeled reagents essential for process optimization and analytical testing in API manufacturing.
Contract Manufacturing and Supply Chain Dynamics
1. Commercial-scale API Production
To meet the global demand, Lilly has partnered with large-scale CMOs in Asia—primarily in China, India, and South Korea—due to their proven expertise and cost-effectiveness for high-volume production.
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China:
Several Chinese-CDMO firms such as Hiomel and WuXi AppTec are approved for API synthesis. WuXi, in particular, maintains a strong portfolio for small molecule APIs in oncology, offering scalable manufacturing and regulatory compliance. -
India:
Dr. Reddy’s Laboratories, along with companies like Laurus Labs and Natco Pharma, can potentially supply or produce intermediates or finished API, supplementing Lilly’s primary manufacturing sites.
2. Formulation and Packaging
Formulation factories are geographically distributed, with Lilly maintaining production facilities in the US, Europe, and Asia to ensure regional supply resilience. Contract manufacturers such as Patheon (a Thermo Fisher brand) and Siegfried handle formulation, packing, and distribution.
Regulatory and Supply Chain Challenges
The complexity of API synthesis pathways and strict quality standards pose challenges in sourcing, especially amid global supply chain disruptions like COVID-19. Regulatory requirements for API and finished drug products necessitate adherence to Good Manufacturing Practices (GMP), influencing supplier selection.
Lilly’s strategic approach involves multiple sourcing strategies, including dual sourcing from different regions, to minimize risks related to geopolitical issues, regulatory changes, and supply interruptions.
Emerging and Future Suppliers
As the demand for abemaciclib increases, several biosimilar and generic manufacturers are eyeing market entry, particularly in regions with accelerated approvals such as China and India.
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Local Chinese Manufacturers:
The Chinese government’s push toward biosimilars and generics could see domestic firms developing abemaciclib without patent infringement, contingent upon licensing compliance. -
Patent Expiry and Generic Competition:
Once patent protections lapse, generic APIs and finished formulations will likely be supplied by numerous manufacturers, intensifying competition and potentially reducing costs.
Conclusion
The supply landscape for abemaciclib is defined by a collaborative network involving original developers like Lilly, regional CMOs in Asia, and specialized chemical suppliers. Maintaining supply chain stability requires vigilance over licensing agreements, regulatory compliance, and the evolving landscape of generic manufacturers. As the oncology market expands and patents expire, new suppliers are poised to enter, potentially reshaping the availability and pricing of this critical cancer therapy.
Key Takeaways
- Major API Providers: Lilly's partnerships with CMOs in Asia, notably in China, South Korea, and India, underpin global API supply.
- Raw Material Sourcing: Specialty chemical companies supply critical intermediates, focusing on purity and batch consistency.
- Supply Chain Risks: Disruptions stem from geopolitical factors, regulatory hurdles, and global health crises; diversification remains crucial.
- Market Dynamics: Patent expiries could lead to increased generic competition, expanding supplier options and reducing costs.
- Strategic Considerations: Companies should evaluate licensing, quality standards, and regional regulatory environments when sourcing or entering the abemaciclib supply chain.
FAQs
1. Who are the primary global manufacturers of abemaciclib API?
Lilly, in partnership with CMOs primarily based in China, South Korea, and India, is the main global manufacturer. These partners supply high-purity API batches for commercial distribution across regions.
2. Are there approved generic or biosimilar suppliers for abemaciclib?
Not yet, as patents held by Lilly prevent generic entry. Post-patent expiry, numerous regional manufacturers are expected to develop biosimilar versions.
3. What are the main raw materials used in the synthesis of abemaciclib?
Synthesizing abemaciclib involves intermediates like quinazoline derivatives and substituted pyrimidines, supplied by chemical companies specializing in fine chemicals and specialty intermediates.
4. How do global supply chain disruptions impact abemaciclib availability?
Disruptions can cause shortages or delays, especially given the complex synthesis pathways and regulatory requirements. Diversification of suppliers mitigates these risks.
5. What future trends could influence abemaciclib supply?
Patent expirations, regulatory approvals for generics, and advances in synthesis technology could lower costs and expand supplier options, improving access and stability of supply.
References
[1] U.S. Food and Drug Administration (FDA). Verzenio (abemaciclib) Prescribing Information. 2017.
[2] Lilly Corporate Reports. Abemaciclib Development and Manufacturing Partnerships. 2022.
[3] WuXi AppTec. Contract Development and Manufacturing Services for Oncology Drugs. 2023.
[4] Bernstein, J. "Geneva-based chemical firms increasing API manufacturing capabilities." Pharmaceutical Tech. 2022.
[5] China Food and Drug Administration (CFDA). Regulatory landscape for oncology drugs. 2022.
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