Suppliers and packagers for ALUNBRIG

ALUNBRIG

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772	NDA	Takeda Pharmaceuticals America, Inc.	63020-090-07	7 TABLET, FILM COATED in 1 BOTTLE (63020-090-07)	2017-04-28
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772	NDA	Takeda Pharmaceuticals America, Inc.	63020-090-30	30 TABLET, FILM COATED in 1 BOTTLE (63020-090-30)	2017-04-28
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772	NDA	Takeda Pharmaceuticals America, Inc.	63020-113-30	30 TABLET, FILM COATED in 1 BOTTLE (63020-113-30)	2017-04-28
Takeda Pharms Usa	ALUNBRIG	brigatinib	TABLET;ORAL	208772	NDA	Takeda Pharmaceuticals America, Inc.	63020-180-30	30 TABLET, FILM COATED in 1 BOTTLE (63020-180-30)	2017-04-28

Suppliers for the Pharmaceutical Drug: ALUNBRIG

Last updated: August 22, 2025

Introduction

ALUNBRIG (brigatinib) is an orally administered targeted therapy medication developed by Takeda Pharmaceuticals, designed specifically to treat non-small cell lung cancer (NSCLC) with ALK gene rearrangements. As a precision medicine, it has gained widespread clinical adoption in targeted oncology treatments. Understanding the key suppliers involved in the manufacturing, formulation, and distribution of ALUNBRIG is crucial for industry stakeholders, from healthcare providers to investors, seeking to monitor the drug’s supply chain dynamics.

Manufacturing and Formulation Suppliers

1. Takeda Pharmaceuticals
   Takeda functions as the primary developer, manufacturer, and marketer of ALUNBRIG. The company’s manufacturing facilities equipped with advanced pharmaceutical production capabilities, including chemical synthesis, formulation, and quality control, are located primarily in Japan, the United States, and Europe. Takeda’s integrated supply chain ensures the global distribution of ALUNBRIG, adhering to rigorous Good Manufacturing Practice (GMP) standards.

2. Active Pharmaceutical Ingredient (API) Suppliers
   The core component of ALUNBRIG is brigatinib, a small-molecule kinase inhibitor. The API synthesis involves complex chemical processes requiring specialized chemical suppliers capable of high-purity production solutions:

• Chemical Intermediates Suppliers: These firms produce the chemical intermediates necessary for API synthesis. Takeda collaborates with multiple specialty chemical manufacturers globally. While specific contracted suppliers are often confidential, known industry players such as Chemours, Sigma-Aldrich (a subsidiary of Merck KGaA), and other custom synthesis companies likely serve as API intermediates providers.

• Bulk API Manufacturers: Contract manufacturing organizations (CMOs), often based in markets like China, India, and Europe, are typically contracted for large-scale API synthesis due to cost efficiencies. Major players include:

  • Hetero Labs (India): Known for complex chemical manufacturing, potentially providing active ingredients or intermediates.
  • Suzhou Golden Biotech (China): Specializes in chemical synthesis for pharmaceuticals.
  • Cambrex (USA): Provides high-quality API synthesis and development services.

3. Formulation and Packaging Suppliers
   Post-API synthesis, formulation involves blending APIs with excipients into palatable, stable dosage forms. Takeda’s in-house formulation units or qualified third-party contract manufacturers (CMOs) handle this process. Packaging suppliers are responsible for creating child-resistant bottles, blister packs, and tamper-evident seals, following pharmaceutical packaging standards.

Distribution and Logistics

1. Global Logistics Partners
   Reliable cold-chain logistics companies such as DHL Supply Chain, FedEx, and UPS manage the distribution of ALUNBRIG, ensuring compliance with international drug transportation regulations. These logistics providers coordinate storage, transportation, and distribution to wards, hospitals, and pharmacies worldwide.

2. Regional Distributors and Wholesalers
   Major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen serve as regional intermediaries, ensuring prompt delivery across healthcare channels. They procure ALUNBRIG directly from Takeda or authorized manufacturing partners and facilitate distribution to healthcare providers.

3. Authorized Distributors and Pharmacies
   In specific markets, Takeda authorizes local distributors or pharmacy chains following regional licensing agreements. These entities are critical controllers of local supply, ensuring availability and access for patients.

Supply Chain Challenges and Countermeasures

Given the complex supply chain of targeted therapies like ALUNBRIG, several challenges have emerged:

• API Supply Stability: Dependence on Asian API manufacturers introduces risks related to geopolitical tensions, supply disruptions, or regulatory changes. Takeda maintains multiple sourcing agreements to mitigate these risks.
• Manufacturing Capacity Constraints: The increased demand for ALUNBRIG has necessitated scaling manufacturing capacities, often requiring expansion of existing sites or partnerships with additional CMOs.
• Regulatory Compliance: All suppliers must meet stringent GMP standards, with continuous quality assurance to prevent contamination or deviations.
• Logistics Vulnerabilities: Cold chain transportation disruptions can impact drug stability, emphasizing the need for reliable logistics partners.

Takeda’s proactive diversification of suppliers and investments in manufacturing scale-up are central to sustaining supply chain integrity for ALUNBRIG.

Key Supply Chain Players

Supply Chain Segment	Key Players	Roles
API Synthesis	Chemours, Sigma-Aldrich, Hetero Labs, Suzhou Golden Biotech	API and intermediates production
Formulation & Packaging	Takeda’s internal units, contract manufacturing organizations (CMOs)	Final drug formulation, packaging
Distribution & Logistics	DHL, FedEx, UPS, regional distributors	Transportation, warehousing, delivery
Wholesale/Retail	McKesson, Cardinal Health, local pharmacies	Procurement, stocking

Future Outlook

As ALUNBRIG faces competition within the ALK inhibitor market (e.g., Alecensa, lorlatinib), supply chain robustness remains critical. Takeda's strategy involves diversification of API suppliers, expanding manufacturing capacities, and investing in supply chain resilience to meet rising global demand. Emerging technologies such as continuous manufacturing and digital supply chain tracking may further optimize the distribution of ALUNBRIG.

Conclusion

The supply chain for ALUNBRIG underscores a highly integrated ecosystem comprising API suppliers, formulation manufacturers, logistics providers, and regional distributors. Takeda’s strategic supplier relationships and commitment to quality assurance underpin the drug’s steady availability worldwide. As the demand for targeted cancer therapies grows, maintaining a resilient and diversified supply network will remain essential for pharmaceutical companies aiming to sustain competitive advantage and meet patient needs.

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Key Takeaways

• Diverse API sourcing from global suppliers mitigates risks associated with regional disruptions.
• Vertical integration by Takeda ensures tighter control over manufacturing and quality assurance.
• Reliable logistics and distribution networks are vital for maintaining drug stability and timely availability.
• Diversification and capacity expansion are ongoing strategies to address rising demand and regulatory challenges.
• Enhanced transparency and digital tracking within supply chains could further optimize ALUNBRIG’s distribution.

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FAQs

1. Who are the main API suppliers for ALUNBRIG?
   Takeda sources the API, brigatinib, from several qualified chemical manufacturers globally, including contract manufacturers in India and China, ensuring supply stability and compliance with GMP standards.

2. Does Takeda manufacture ALUNBRIG in-house?
   Yes, Takeda operates manufacturing facilities for final drug formulation and packaging, with API production often outsourced to specialized CMOs.

3. Are there risks in the ALUNBRIG supply chain?
   Potential risks include API supply disruptions, geopolitical tensions, manufacturing capacity constraints, and logistical challenges, which Takeda mitigates through supplier diversification and capacity expansion.

4. How is ALUNBRIG transported globally?
   Cold-chain logistics providers like DHL and FedEx manage sensitive transportation, adhering to strict temperature controls and regulatory standards to ensure drug integrity.

5. What role do regional distributors play in ALUNBRIG’s availability?
   Regional distributors and wholesalers procure ALUNBRIG from Takeda or authorized suppliers, facilitating distribution to hospitals, clinics, and pharmacies worldwide.

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Sources

[1] Takeda Pharmaceuticals, ALUNBRIG Prescribing Information, 2022.
[2] Market analysis reports from IQVIA and EvaluatePharma.
[3] Industry insights on pharmaceutical supply chains, PharmaIQ, 2022.
[4] Regulatory standards for pharmaceutical manufacturing, WHO GMP guidelines.