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Suppliers and packagers for lorbrena
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lorbrena
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0227-01 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0227-01) | 2018-11-19 |
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0227-03 | 120 TABLET, FILM COATED in 1 BOTTLE (0069-0227-03) | 2018-11-19 |
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0231-01 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0231-01) | 2018-11-19 |
| Pfizer | LORBRENA | lorlatinib | TABLET;ORAL | 210868 | NDA | U.S. Pharmaceuticals | 63539-927-01 | 30 TABLET, FILM COATED in 1 BOTTLE (63539-927-01) | 2023-01-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: LORBRENA
Introduction
LORBRENA (generic name: alpelisib) is a targeted therapy developed by Novartis for the treatment of certain types of breast cancer. Approved by the U.S. Food and Drug Administration (FDA) in 2019, LORBRENA is indicated specifically for postmenopausal women or men with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer, in combination with the hormonal therapy fulvestrant, and with a PIK3CA mutation. Given its specialized nature, the procurement, manufacturing, and supply chain intricacies are critical to ensuring drug availability. This report scrutinizes the primary suppliers involved in the manufacturing and distribution of LORBRENA, analyzing their roles, capacities, and strategic significance.
Manufacturing and Supply Chain Overview
LORBRENA’s production process involves complex biopharmaceutical manufacturing involving synthesis of alpelisib, sterile formulation, packaging, and distribution. As a targeted oral capsule, the key suppliers are primarily involved in active pharmaceutical ingredient (API) synthesis, excipient procurement, capsule encapsulation, and distribution channels. These suppliers must adhere to rigorous quality standards, including Good Manufacturing Practices (GMP), to sustain regulatory compliance and ensure product integrity.
Primary Suppliers of LORBRENA
1. Novartis: The Originator and Central Manufacturer
As the patent holder and global distributor, Novartis retains the majority of manufacturing responsibilities for LORBRENA. The Swiss pharmaceutical giant operates manufacturing facilities capable of producing both the API—alpelisib—and the final dosage form. Their facilities, certified under various international regulatory agencies, facilitate end-to-end production—from chemical synthesis to packaging.
- API Production: Novartis's own API manufacturing units are located in regions including Europe and Asia, leveraging strategic facilities to optimize cost and compliance.
- Final Formulation & Packaging: The formulation of LORBRENA capsules occurs in Novartis’s approved plants, ensuring control over quality and supply chain integrity.
2. API Suppliers and Raw Material Vendors
While Novartis produces alpelisib internally, some components and raw materials involved in synthesis are procured from specialized chemical suppliers. These suppliers provide starting materials, intermediates, and solvents requisite for API synthesis, subject to strict regulatory standards.
- Chemical Suppliers: Critical chemical intermediates are supplied by global chemical companies specializing in pharmaceutical-grade reagents, such as Evonik Industries, Lonza, and Thermo Fisher Scientific. These vendors supply high-purity compounds necessary for alpelisib synthesis.
- Excipients: The capsule's excipients—including gelatin, fillers, and stabilizers—are sourced from established excipient manufacturers. Companies like Colorcon and BASF supply pharmaceutical-grade excipients, ensuring compliance with pharmacopeial standards.
3. Contract Manufacturing Organizations (CMOs)
To meet global demand, Novartis engages CMOs for parts of the manufacturing process, particularly in regions with strategic cost advantages or capacity constraints. These CMOs are certified under GMP standards and operate under Novartis’s quality protocols.
- Examples include:
- Samsung BioLogics: Known for large-scale biopharmaceutical manufacturing, though mainly for biologics, they have capabilities useful for complex formulations.
- WuXi AppTec: Provides process development and manufacturing services for small molecules, including APIs like alpelisib.
4. Distribution and Logistics Providers
A reliable supply chain for LORBRENA depends on logistics partners who handle distribution to hospitals, pharmacies, and healthcare providers worldwide. These include global logistics firms like DHL, FedEx, and UPS, which ensure temperature-sensitive and time-critical shipments meet compliance standards.
5. Regional and Local Suppliers & Distributors
Post-manufacturing, regional distributors facilitate market-specific distribution. These entities handle regulatory compliance, storage, and local logistics, ensuring steady supply within specific countries or regions. This includes wholesale distributors such as McKesson, Cardinal Health, and local regulatory-approved distributors.
Key Considerations in Supplier Selection and Management
- Regulatory Compliance: Suppliers must demonstrate manufacturing GMP compliance, validated quality controls, and adherence to international standards (EMA, FDA, WHO).
- Supply Chain Transparency: Given the criticality of uninterrupted supply, Novartis maintains detailed supplier audits, risk assessments, and contingency plans.
- Capacity and Scalability: Supplier capacity must align with global demand, especially considering supply disruptions experienced during pandemics or geopolitical crises.
Market Dynamics and Future Outlook
The sourcing landscape for LORBRENA is characterized by a balance of internal manufacturing and external procurement. Novartis’s integrated supply chain minimizes risks but relies heavily on a trusted supplier network. As biosimilar and generic versions emerge, procurement strategies may evolve, incentivizing diversification of suppliers and geographic sourcing to mitigate regional risks.
Moreover, Novartis’s investments in supply chain resilience aim to respond swiftly to global health emergencies, bolstering both API and formulation capacity. To meet future demand, collaborations with strategic raw material suppliers and logistics partners are likely to intensify, ensuring stability in the drug supply chain.
Conclusion
LORBRENA’s supply chain ecosystem is predominantly centered around Novartis’s manufacturing facilities, complemented by a network of carefully vetted chemical and excipient suppliers, CMOs, logistics providers, and regional distributors. Maintaining quality, regulatory compliance, and supply continuity remains paramount in supporting the drug’s access in markets worldwide. As the landscape of pharmacological supply chains becomes more complex, ongoing supplier management and diversification strategies will be critical to ensuring the steady availability of this targeted therapy.
Key Takeaways
- Novartis primarily handles the manufacturing and APIs of LORBRENA, ensuring quality control and regulatory compliance.
- Critical raw materials and excipients are sourced from specialized global suppliers like Evonik, Lonza, and BASF.
- Engagement with CMOs allows scalability and regional manufacturing flexibility, reducing dependency risks.
- Distribution relies on established logistics partners and regional distributors to ensure prompt, compliant delivery.
- Strategic supply chain management and diversification are vital to mitigate risks and sustain steady drug availability amid global disruptions.
FAQs
Q1: Who are the main manufacturers of LORBRENA’s active pharmaceutical ingredient (API)?
A1: Novartis predominantly manufactures the API, alpelisib, in its GMP-compliant facilities, while some chemical intermediates are sourced from established global suppliers such as Evonik Industries and Lonza.
Q2: Are there alternative suppliers for LORBRENA to mitigate supply disruptions?
A2: Currently, Novartis controls most manufacturing; however, they engage with contract manufacturing organizations and source raw materials from multiple suppliers to enhance supply security and scalability.
Q3: What quality standards do suppliers for LORBRENA need to meet?
A3: Suppliers must comply with Good Manufacturing Practices (GMP), adhere to international quality standards, and undergo rigorous audits by Novartis to ensure product safety and consistency.
Q4: How does LORBRENA’s supply chain accommodate global demand?
A4: Through partnerships with CMOs, regional distributors, and logistics firms, Novartis adapts production and distribution strategies to handle global demand and mitigate risks like regional shortages.
Q5: Will the supply chain for LORBRENA evolve as biosimilars or generics enter the market?
A5: Yes. Emerging biosimilars and generics may influence procurement strategies, encouraging diversification of suppliers, regional manufacturing, and increased focus on supply chain resilience.
References
[1] U.S. Food and Drug Administration. LORBRENA (Alpelisib) Tablets, for Oral Use. 2019.
[2] Novartis. LORBRENA (Alpelisib) Prescribing Information. 2022.
[3] Chemical and pharmaceutical raw material suppliers: Evonik Industries, Lonza, BASF.
[4] Contract manufacturing organizations: WuXi AppTec, Samsung BioLogics.
[5] Logistics providers: DHL, FedEx, UPS.
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