Suppliers and packagers for alecensa

alecensa

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434	NDA	Genentech, Inc.	50242-130-01	1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTIC	2015-12-11
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434	NDA	Genentech, Inc.	50242-130-86	1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTIC	2015-12-11

Suppliers for the Pharmaceutical Drug: Alecensa

Last updated: July 29, 2025

Introduction
Alecensa (alectinib) is a targeted therapy developed by Genentech, a Roche subsidiary, for the treatment of ALK-positive non-small cell lung cancer (NSCLC). As an oral ALK inhibitor, Alecensa has gained prominence in oncology therapeutics, emphasizing the importance of a reliable and well-established supply chain. Understanding the landscape of suppliers involved in the manufacturing, formulation, and distribution of Alecensa is crucial for stakeholders in the pharmaceutical industry, healthcare providers, and investors.

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Manufacturing of Active Pharmaceutical Ingredient (API)

Global API Suppliers

The foundational component of Alecensa, its active pharmaceutical ingredient (API) alectinib, is produced by specific high-quality API manufacturers, often operating under stringent regulatory standards such as Good Manufacturing Practice (GMP).

• Roche's Internal Manufacturing
  Genentech, the manufacturer of Alecensa, sources the API from its internal facilities or approved external suppliers that meet regulatory compliance, ensuring consistent quality and supply chain integrity [1].

• External API Suppliers
  While Roche maintains proprietary control over its API, industry reports suggest partnerships with specialized chemical manufacturing firms. These firms are often located in North America, Europe, or Asia, particularly capable of producing complex small-molecule APIs at scale.

Key Considerations in API Supply Chain

Supply chain resilience is critical, especially given the complex synthesis pathways for ALK inhibitors. Any disruption at the API production level, whether due to raw material shortages, manufacturing issues, or regulatory delays, can impact product availability.

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Formulation and Final Product Assembly

Contract Manufacturing Organizations (CMOs)

Alecensa's formulation, encapsulation, and final packaging are typically managed by CMOs with specialized expertise in oral solid-dose pharmaceuticals.

• Major CMO Partners
  Several global CMOs, such as Patheon (a FDA-licensed CDMO now part of Thermo Fisher Scientific), Lonza, and Jubilant Biosys, are known to partner with pharmaceutical companies for the formulation and fill-finish processes of targeted cancer therapies [2].

• Regulatory Compliance
  These facilities must adhere to GMP standards mandated by regulatory agencies like the FDA and EMA, ensuring drug safety and efficacy.

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Distribution and Supply Chain Partners

Global Distribution Networks

Once manufactured, Alecensa is distributed worldwide through a network of logistics providers specializing in temperature-sensitive pharmaceuticals.

• Global Logistics Providers
  FedEx, DHL, and UPS often manage the global shipping of Alecensa, implementing cold-chain logistics where necessary to maintain stability across transit.

• Regional Distributors
  In various countries, local distributors and specialty pharmacies manage supply channels, coordinate with healthcare institutions, and ensure patient access.

Supply Chain Challenges and Mitigation Strategies

The complexity of distributing an oncology drug like Alecensa underscores the need for robust supply chain management, contingency planning, and real-time inventory monitoring to mitigate shortages and delays.

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Key Players in Alecensa Supply Chain

Role	Companies/Institutions	Notes
API Manufacturing	Roche (internal), External suppliers	Focused on high-purity alectinib synthesis
Formulation & Final Product	Patheon, Lonza, Jubilant Biosys	CMOs with solid regulatory track records
Logistics & Distribution	FedEx, DHL, UPS	Ensuring temperature control and security

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Regulatory and Quality Assurance

Ensuring the reliability of suppliers involves rigorous qualification and audit processes aligned with Good Manufacturing Practices (GMP). Regulatory oversight by agencies such as the FDA, EMA, and PMDA stipulates strict standards for each node in the supply chain.

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Emerging Trends and Future Outlook

• Diversification of Suppliers
  To reduce dependency risks, Roche is expected to diversify its API and formulation suppliers, possibly engaging additional firms in Asia-Pacific regions.

• Supply Chain Digitization
  Enhanced tracking, blockchain-based traceability, and AI-driven demand forecasting could optimize Alecensa’s supply chain in the future.

• Manufacturing Capacity Expansion
  As Alecensa’s global adoption increases, Roche and its partners are likely to expand manufacturing capacity, ensuring supply continuity amid rising demand.

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Key Takeaways

• Alecensa’s supply chain involves high-complexity synthesis, primarily managed by Roche and specialized external API manufacturers.
• The formulation and final packaging are outsourced to reputable CMOs with experience in oncology drugs.
• Distribution networks leverage global logistics companies with advanced cold chain capabilities to ensure product integrity.
• Supply chain resilience hinges on diversified API sources, robust quality assurance, and advanced logistics management.
• Future strategies include capacity expansion, supplier diversification, and technological enhancements in supply chain monitoring.

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FAQs

1. Who are the primary API suppliers for Alecensa?
Roche primarily manufactures the API in-house, supplemented by select external suppliers capable of producing high-purity alectinib under GMP standards.

2. Are there multiple manufacturers involved in Alecensa’s formulation?
Yes, Roche partners with multiple CDMOs like Patheon, Lonza, and Jubilant Biosys for formulation, filling, and packaging.

3. How does Roche ensure supply chain resilience for Alecensa?
Through supplier diversification, strict GMP compliance, strategic inventory management, and advanced logistics systems.

4. Where is Alecensa primarily distributed?
Globally, including North America, Europe, Asia-Pacific, and other regions, with regional distributors managing local supply chains.

5. What are future trends influencing Alecensa’s supply chain?
Increased automation, digitization, capacity expansion, and diversification of supply sources to mitigate disruptions and meet growing demand.

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Sources
[1] Roche Annual Reports and Public Disclosures [2] Industry reports on pharmaceutical Contract Manufacturing Organizations (CMOs)