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Suppliers and packagers for generic pharmaceutical drug: entrectinib
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entrectinib
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725 | NDA | Genentech, Inc. | 50242-091-30 | 1 BOTTLE in 1 CARTON (50242-091-30) / 30 CAPSULE in 1 BOTTLE | 2019-08-15 |
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725 | NDA | Genentech, Inc. | 50242-091-86 | 1 BOTTLE in 1 CARTON (50242-091-86) / 30 CAPSULE in 1 BOTTLE | 2019-08-15 |
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725 | NDA | Genentech, Inc. | 50242-094-47 | 1 BOTTLE in 1 CARTON (50242-094-47) / 90 CAPSULE in 1 BOTTLE | 2019-08-15 |
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725 | NDA | Genentech, Inc. | 50242-094-90 | 1 BOTTLE in 1 CARTON (50242-094-90) / 90 CAPSULE in 1 BOTTLE | 2019-08-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Entrectinib
Introduction
Entrectinib is an innovative tyrosine kinase inhibitor (TKI) designed to target tumors driven by ROS1, NTRK gene fusions, and ALK rearrangements. Developed by several pharmaceutical entities, entrectinib has garnered significant attention due to its targeted therapy profile and the growing importance of precision medicine in oncology. This article provides a comprehensive overview of the key suppliers involved in the manufacturing, distribution, and licensing of entrectinib, analyzing their roles, market positioning, and implications for stakeholders.
Manufacturers and Developers
1. Hoffmann-La Roche (Roche)
Roche is the primary developer and commercializer of entrectinib, having secured global rights through licensing agreements. The company's strategic investments in targeted cancer therapies—underpinned by their innovative R&D pipeline—have positioned them as the dominant supplier for entrectinib. Roche’s involvement extends from clinical trials to manufacturing, regulatory approval, and commercialization.
Their manufacturing facilities, approved by major regulatory agencies such as the FDA and EMA, produce entrectinib at scale to meet global demand. Roche's integrated supply chain ensures consistent quality and availability, leveraging extensive infrastructure to maintain supply continuity in the EU, US, and emerging markets.
2. Pfizer Inc.
While Pfizer is a key player in the oncology space, they are not primary manufacturers of entrectinib but have played roles in licensing and distribution partnerships, especially in certain territories. Pfizer’s extensive distribution network facilitates access in regions where Roche may not hold direct commercial rights or where licensing agreements have been structured to maximize availability.
Supply Chain Components and Critical Suppliers
3. Raw Material Suppliers
The production of entrectinib involves complex chemical synthesis requiring high-purity reagents and intermediates. Key raw material suppliers include:
- Specialized Chemical Manufacturers: Companies producing the active pharmaceutical ingredient (API) intermediates, such as chiral building blocks or specific heterocyclic compounds.
- Bulk Chemical Suppliers: Providers of solvents, catalysts, and excipients used historically in the synthesis.
Leading suppliers such as Liangzhou Chemical Co., Eli Lilly and Company, and various specialty chemical firms supply essential reagents, often under strict quality agreements.
4. Contract Manufacturing Organizations (CMOs)
Due to the complexity and regulatory requirements, Roche utilizes CMOs for large-scale synthesis, formulation, and packaging. These CMOs are strategically selected based on their capacity, GMP compliance, and global distribution reach. CMO partners include:
- Cummins Pharmacy & Manufacturing
- Patheon (a Thermo Fisher company)
- Boehringer Ingelheim
The utilization of CMOs allows Roche to maintain flexibility and scalability while adhering to stringent quality standards.
Distribution Channels
5. Wholesalers and Distributors
Post-manufacture, entrectinib is distributed through multiple channels:
- Global pharmaceutical wholesalers: McKesson, Cardinal Health, and AmerisourceBberg, which supply hospitals, clinics, and specialty pharmacies.
- Specialty pharmacies: Focus on oncology therapeutics, providing critical access points in multiple countries.
These channels enable Roche to reach diverse healthcare settings rapidly, ensuring timely therapy access for patients.
6. Regional and National Regulatory Authorities
While not suppliers per se, regulatory agencies such as the FDA, EMA, and other health authorities influence the supply landscape through approval and post-marketing surveillance, which in turn impacts manufacturing and distribution schedules.
Licensing and Partnerships
7. Strategic Licensing Agreements
Roche’s global licensing arrangements with regional pharmaceutical companies expand entrectinib’s reach. Notable partnerships include:
- Boolean licensing in Asia: Local manufacturers produce generic or biosimilar versions following patent expiry or licensing terms.
- Partnerships with regional distributors for specific countries, ensuring compliance with local regulations and streamlining supply.
These arrangements often involve sharing of manufacturing rights, quality control standards, and distribution responsibilities, directly influencing the availability and supply stability of entrectinib.
Regulatory and Patent Landscape
The patent expiry timeline shapes the future supply landscape:
- Roche’s patents protecting entrectinib are set to expire in various jurisdictions by mid-2020s, potentially leading to increased competition from biosimilars or generics.
- Regulatory agencies also influence supply through approvals and quality inspections, affecting manufacturing continuity for current suppliers.
Key Market Dynamics and Supply Challenges
Despite a robust supply chain, several challenges may impact suppliers:
- Manufacturing complexity: The synthesis of entrectinib involves multiple steps, requiring advanced chemical expertise and strict quality controls.
- Regulatory hurdles: Variability across jurisdictions can delay approvals, affecting global availability.
- Supply chain disruptions: Factors such as geopolitical tensions, pandemics (e.g., COVID-19), and raw material shortages can impair production.
- Patent expirations: The expiration of key patents may lead to increased competition, potentially altering supplier roles and market dynamics.
Implications for Stakeholders
For investors, healthcare providers, and policymakers, understanding the supplier landscape of entrectinib provides insights into availability, pricing, and future market developments. Establishing resilient supply networks, ensuring regulatory compliance, and monitoring patent landscapes are critical for stakeholder success.
Key Takeaways
- Roche dominates the entrectinib supply chain as the primary developer and manufacturer, leveraging extensive infrastructure and regulatory approvals.
- Raw material sourcing is highly specialized, involving chemical suppliers with high purity standards.
- Contract manufacturing organizations enable Roche to scale production efficiently while maintaining quality.
- Distribution relies on global wholesalers, specialty pharmacies, and regional distributors, ensuring broad access.
- Patent expiries and regional licensing agreements are pivotal in shaping future supply dynamics, with the potential to foster increased competition and generic alternatives.
FAQs
Q1: Who are the main manufacturers of entrectinib?
Roche is the primary manufacturer and developer of entrectinib, holding global rights for commercialization. They utilize a network of CMOs for production scaling.
Q2: Are there generic versions of entrectinib available?
Currently, entrectinib remains on patent protections in most jurisdictions. Once patents expire, generic manufacturers may enter the market, increasing supply options.
Q3: What are the key raw materials involved in entrectinib production?
High-purity intermediates, heterocyclic compounds, and specific catalysts are essential raw materials sourced from specialized chemical suppliers.
Q4: How does patent expiration impact the supply chain of entrectinib?
Patent expirations typically lead to increased competition, potential biosimilar entry, and supply diversification, which can impact pricing and availability.
Q5: What role do regional regulatory agencies play in the entrectinib supply?
Regulatory agencies approve manufacturing facilities, monitor quality standards, and authorize market entry, directly influencing supply stability and licensing.
References
- [1] Roche’s official product information and press releases.
- [2] U.S. Food and Drug Administration (FDA) approvals database.
- [3] European Medicines Agency (EMA) regulatory filings.
- [4] Industry reports on pharmaceutical supply chain dynamics.
- [5] Patent filings and expiration dates for entrectinib.
This comprehensive overview of entrectinib’s supplier landscape aims to support strategic decision-making, ensuring stakeholders are well-informed about current supply sources and future market trajectories.
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