Share This Page
Suppliers and packagers for BRUKINSA
✉ Email this page to a colleague
BRUKINSA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Beone Medicines Usa | BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217 | NDA | BeOne Medicines USA, Inc. | 72579-011-02 | 1 BOTTLE, PLASTIC in 1 CARTON (72579-011-02) / 120 CAPSULE in 1 BOTTLE, PLASTIC | 2019-11-14 |
| Beone Medicines Usa | BRUKINSA | zanubrutinib | TABLET;ORAL | 218785 | NDA | BeOne Medicines USA, Inc. | 72579-122-01 | 1 BOTTLE in 1 CARTON (72579-122-01) / 60 TABLET, FILM COATED in 1 BOTTLE | 2025-08-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BRUKINSA
Introduction
BRUKINSA (zanubrutinib) is an innovative Bruton's tyrosine kinase (BTK) inhibitor developed by BeiGene, designed to treat various hematologic malignancies, including mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and Waldenström’s macroglobulinemia (WM). The drug has gained prominence due to its targeted mechanism of action, efficacy, and comparatively favorable safety profile. As a relatively new entrant in oncology therapeutics, understanding its supply chain and key suppliers is critical for stakeholders, including healthcare providers, investors, and competitors.
Manufacturing of BRUKINSA: Overview
BRUKINSA’s production process hinges on complex synthetic chemistry, stringent quality controls, and supply chain integrity. The manufacturing of zanubrutinib involves multiple stages:
- Active Pharmaceutical Ingredient (API) synthesis: Chemical synthesis in specialized facilities, often centralized.
- Formulation: Converting API into finished dosage forms (tablets).
- Packaging and distribution: Ensuring stability and regulatory compliance.
One notable feature of BRUKINSA’s supply chain is its reliance on a network of third-party suppliers for raw materials, intermediates, and APIs, alongside BeiGene’s in-house manufacturing capabilities.
Key Suppliers for BRUKINSA
1. API Manufacturers
The core of BRUKINSA’s supply chain involves API production. BeiGene has entered into collaborations with multiple contract manufacturing organizations (CMOs) to meet global demand.
-
WuXi AppTec:
WuXi AppTec is a leading global contract research and manufacturing organization based in China. It provides comprehensive API synthesis services and has been identified as a significant supplier of zanubrutinib API for BeiGene. Their facilities are cGMP-compliant, supporting large-scale production under quality standards suitable for oncology drugs [1]. -
Hubei Yiling Pharmaceutical:
As part of BeiGene’s strategic manufacturing network, Hubei Yiling supplies intermediates and supporting chemical ingredients for BRUKINSA, especially for regional markets. Their role is crucial in ensuring regional supply stability for China and surrounding markets. -
Suzhou Belief Biotech:
This Chinese CMO specializes in chemical synthesis and process development. They contribute to manufacturing intermediates for BRUKINSA, capable of scaling up production to meet global demands. -
Other CMOs and CROs in China and India:
BeiGene has partnerships with additional CMOs in India and China, such as Divis Laboratories and other third-party vendors that provide API intermediates, ensuring diversification and risk mitigation.
2. Raw Material Suppliers
-
Chemical Raw Materials:
The synthesis of zanubrutinib involves multiple chemical precursors, including substituted quinoline derivatives, amines, and other complex organic molecules. Major chemical suppliers such as Sigma-Aldrich and Merck supply some of these raw materials; however, specialized intermediates are often sourced from regional suppliers in China and India. -
Global Supply Chain Risks:
The sourcing of raw materials has been subject to geopolitical and logistical factors. BeiGene’s strategy involves multiple suppliers for critical intermediates to mitigate potential shortages.
3. Packaging and Distribution
-
Packaging Suppliers:
BRUKINSA tablets are packaged by a network of pharmaceutical packaging firms that comply with regulatory standards for stability and tamper-evidence. -
Distribution Channels:
Distribution relies on BeiGene’s logistics partners, including global freight and cold chain logistics providers, to ensure safe transport across markets, particularly for sensitive oncology medicines.
Regulatory and Quality Considerations in the Supply Chain
Given BRUKINSA’s designation as a prescription medication for serious conditions, its manufacturing and supply are regulated by stringent agencies such as the FDA, EMA, and NMPA (National Medical Products Administration, China). Supplier qualification involves rigorous audits, quality agreements, and continuous oversight to comply with cGMP (current Good Manufacturing Practice).
BeiGene maintains transparency regarding its supply chain but keeps detailed proprietary information confidential. Nonetheless, it openly collaborates with multiple vendors to support supply stability amid growing global demand.
Geographical Distribution of Suppliers
-
China:
The primary manufacturing and raw material supply hub due to BeiGene’s origin. Many API and intermediate suppliers operate within China, leveraging the country’s robust chemical manufacturing sector. -
India:
A strategic sourcing location owing to cost advantages and established pharmaceutical manufacturing infrastructure, with companies like Divis Laboratories supporting API synthesis. -
Global Procurement:
The integration of international suppliers ensures diversified risk and resilience, particularly during supply chain disruptions like those caused by COVID-19 or geopolitical tensions.
Emerging Trends and Future Outlook
-
Vertical Integration:
BeiGene is investing in expanding its manufacturing footprint to include in-house APIs, aiming for greater supply control and cost efficiencies. -
Supply Chain Diversification:
To prevent bottlenecks, BeiGene adopts a multi-supplier strategy, spreading procurement across regions and vendors. -
Regulatory Stringency:
Increased regulatory scrutiny encourages suppliers to adhere to higher quality standards, boosting the reliability of the supply chain. -
Sustainability Initiatives:
Environmental considerations are increasingly influencing supplier selection, with a focus on green chemistry and sustainable sourcing practices.
Conclusion
BRUKINSA’s supply chain comprises a blend of in-house manufacturing and strategic partnerships with multiple CMOs, primarily located in China and India. Key suppliers include WuXi AppTec, Hubei Yiling Pharmaceutical, and Suzhou Belief Biotech for API synthesis, complemented by raw material suppliers and packaging firms operating globally. Mitigating risks through diversification and maintaining stringent quality standards are core strategies underpinning the drug’s supply stability. As demand accelerates, BeiGene’s efforts to expand its manufacturing base and diversify its supplier network will be instrumental in ensuring sustained access to BRUKINSA worldwide.
Key Takeaways
- Strategic Supplier Network: BeiGene relies heavily on Chinese CMOs like WuXi AppTec, along with Indian manufacturers, to produce zanubrutinib API, ensuring scalable and diversified supply.
- Supply Chain Resilience: Multiple vendors, sourced regionally and globally, mitigate risks associated with geopolitical and logistical disruptions.
- Regulatory Compliances: Suppliers undergo rigorous qualification processes aligned with cGMP standards to guarantee product quality and safety.
- Manufacturing Trends: Increasing vertical integration and supply chain diversification enhance control and reduce dependency on single sources.
- Future Outlook: Continued expansion of manufacturing capacity and sustainable sourcing will be key to meeting global demand for BRUKINSA.
FAQs
1. Who are the primary API suppliers for BRUKINSA?
WuXi AppTec and Hubei Yiling Pharmaceutical are among the leading API suppliers, providing the core zanubrutinib synthesis for global markets.
2. Are there alternative suppliers for BRUKINSA’s raw materials?
Yes, BeiGene sources raw materials from multiple vendors across China, India, and other regions to diversify risk and ensure supply continuity.
3. How does BeiGene ensure quality across its supply chain?
The company conducts thorough audits, enforces strict quality agreements, and complies with international cGMP standards for all manufacturing partners.
4. Is BeiGene manufacturing BRUKINSA in-house?
While it has expanded its own manufacturing facilities, much of BRUKINSA’s production still relies on third-party CMOs.
5. What are the future trends impacting suppliers for BRUKINSA?
Enhanced supply chain resilience, vertical integration, sustainability initiatives, and regulatory compliance are central trends shaping future supplier relationships.
References
[1] WuXi AppTec official website, https://www.wuxiapptec.com.
More… ↓
