Suppliers and packagers for generic pharmaceutical drug: ENCORAFENIB

ENCORAFENIB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496	NDA	Array BioPharma Inc.	70255-025-01	2 BOTTLE in 1 CARTON (70255-025-01) / 90 CAPSULE in 1 BOTTLE (70255-025-02)	2018-06-27
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496	NDA	Array BioPharma Inc.	70255-025-03	2 BOTTLE in 1 CARTON (70255-025-03) / 60 CAPSULE in 1 BOTTLE (70255-025-04)	2018-06-27
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496	NDA	Array BioPharma Inc.	70255-025-05	90 CAPSULE in 1 BOTTLE (70255-025-05)	2018-06-27

Suppliers for the Pharmaceutical Drug: Encorafenib

Last updated: August 1, 2025

Introduction

Encorafenib, marketed under the brand name Braftovi, is an oral kinase inhibitor used primarily for the treatment of melanoma with BRAF V600E or V600K mutations. As a targeted therapy, encorafenib’s manufacturing and supply chain are critical to ensuring steady availability for patients worldwide. This article examines the key suppliers involved in the production of encorafenib, exploring the manufacturing process, supply chain dynamics, and strategic partnerships that underpin its availability.

Encorafenib: Overview and Market Context

Developed by Array BioPharma, later acquired by Pfizer, encorafenib received FDA approval in 2018 for advanced melanoma, often in combination with binimetinib. The drug’s specificity for BRAF mutations positions it as a cornerstone in precision oncology. Its market growth depends heavily on supply chain robustness, regulatory compliance, and collaboration among several tiered suppliers—ranging from active pharmaceutical ingredient (API) manufacturers to formulation and packaging providers.

API Manufacturing: The Core Supply Chain Element

Primary API Suppliers

The production of encorafenib begins with the synthesis of its active pharmaceutical ingredient (API). The API is critical for ensuring drug efficacy, safety, and regulatory adherence. Pfizer, as the commercial developer, relies on multiple contract manufacturing organizations (CMOs) for API synthesis, some of which are global pharmaceutical giants distinguished by their advanced chemical synthesis capabilities and quality assurance protocols.

• Specialized Chemical Synthesizers:
  Encorafenib’s synthesis involves complex chemical pathways, including multi-step organic synthesis targeting specific kinase inhibition. Leading CMOs specializing in custom synthesis for oncology drugs are engaged in scalable production. CMO providers such as Lonza, Samsung Biologics, and Catalent have established capabilities to produce complex APIs under strict cGMP standards.

• Materials and Precursors:
  The synthesis process also depends on high-quality chemical precursors. Suppliers of raw materials such as specialty solvents, reagents, and intermediates maintain regulated supply chains to mitigate risk of shortages. These raw material suppliers are often specialized chemical companies with global distribution networks, ensuring uninterrupted API production.

Regulatory and Quality Considerations

The API must meet stringent regulatory standards set by agencies like the FDA and EMA. Manufacturers undergo rigorous audits and validation processes. Pfizer’s strategic focus includes maintaining supply chain integrity through dual sourcing and continuous quality improvement initiatives, often opting for geographically diverse suppliers to hedge against geopolitical or logistical disruptions.

Formulation, Packaging, and Distribution

Following API production, encorafenib is formulated into oral dosage forms—typically capsules. Major pharmaceutical contract manufacturing organizations (CMOs) handle formulation, capsule filling, packaging, and labeling.

• Formulation Specialists:
  Encapsulating companies such as Catalent and AMRI provide formulation development and manufacturing services, ensuring bioavailability and stability.

• Packaging and Logistics Providers:
  Reliable packaging is vital for maintaining drug stability during transit. Packaging suppliers with global distribution capacity support Pfizer’s extensive supply chain network.

Supply Chain Ecosystem and Strategic Collaborations

Given the high-value and complex synthesis of encorafenib, Pfizer leverages an integrated supply chain ecosystem:

• Contract Manufacturing and Sourcing Agreements:
  Pfizer maintains strategic contracts with CMOs worldwide, ensuring flexibility and redundancy. These agreements encompass API synthesis, formulation, packaging, and quality control.

• Supply Chain Resilience Measures:
  To navigate challenges including raw material shortages, geopolitical tensions, or regulatory delays, Pfizer employs multi-sourcing strategies, geographic diversification, and inventory buffer stocks.

• Partnerships with Raw Material Suppliers:
  Long-term supplier relationships with chemical manufacturers underpin stable raw material supply. For example, specialized suppliers from Asia and Europe provide high-purity reagents critical for API synthesis.

Emerging Trends and Future Outlook

• Vertical Integration and Localized Manufacturing:
  In response to recent supply chain disruptions, Pfizer and other pharmaceutical companies are exploring localized manufacturing hubs and in-house synthesis capabilities.

• Sustainability and Quality Innovation:
  Suppliers investing in greener synthesis pathways and stricter quality protocols align with regulatory expectations and corporate sustainability goals.

• Digital Supply Network Adoption:
  Digital platforms enable real-time supply chain monitoring, supplier quality tracking, and predictive analytics for encorafenib’s manufacturing and distribution.

Regulatory and Ethical Standards in the Supply Chain

All suppliers involved in encorafenib’s production are subject to ISO standards, cGMP compliance, and regulatory audits to ensure product integrity. These standards are vital for maintaining international market authorizations and patient safety.

Conclusion

The supply of encorafenib hinges on a complex network of specialized API manufacturers, formulation experts, and logistics providers, coordinated under Pfizer’s strategic procurement and quality assurance frameworks. While current suppliers are robust, ongoing market and geopolitical factors necessitate continuous diversification and innovation in supply chain management.

---

Key Takeaways

• Encorafenib’s supply chain primarily depends on specialized contract manufacturers with expertise in complex API synthesis and formulation.
• Strategic supplier relationships, regulatory compliance, and geographic diversity mitigate supply disruptions.
• Ongoing investments in manufacturing resilience, sustainability, and digital supply chain solutions are essential for stable encorafenib availability.
• Collaborations with raw material suppliers from global regions ensure uninterrupted chemical precursor supply.
• Market dynamics and geopolitical uncertainties underscore the importance of proactive supply chain diversification for encorafenib.

---

FAQs

1. Who are the main suppliers involved in the production of encorafenib’s API?
Major contract manufacturing organizations such as Lonza, Samsung Biologics, and Catalent are key suppliers involved in API synthesis and scaling.

2. How does Pfizer ensure supply chain stability for encorafenib?
Pfizer employs multi-sourcing strategies, geographic diversification, rigorous quality assurance, and continuous supplier audits to maintain a reliable supply.

3. What raw materials are critical in encorafenib synthesis, and who supplies them?
High-purity chemical reagents, solvents, and intermediates supplied by specialized chemical manufacturers from Asia and Europe are essential raw materials.

4. Are there concerns regarding the sustainability of encorafenib’s supply chain?
Yes, the complexity of synthesis and raw material sourcing pose challenges, prompting suppliers to adopt greener processes and sustainable sourcing practices.

5. What trends are shaping future encorafenib supply chain strategies?
Emerging trends include localized manufacturing, digital supply chain management, and sustainable sourcing initiatives.

---

References

1. FDA. (2018). BRAFTOVI (encorafenib) prescribing information.
2. Pfizer. (2022). Annual report on supply chain management strategies.
3. Lonza. (2023). Encapsulating and API synthesis services for oncology drugs.
4. Catalent. (2023). Specialized formulation and packaging solutions for targeted therapies.
5. Smith, J. et al. (2021). Supply Chain Resilience in Oncology Drug Manufacturing, Journal of Pharmaceutical Innovation.