Suppliers and packagers for TAFINLAR

TAFINLAR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806	NDA	Novartis Pharmaceuticals Corporation	0078-0681-66	120 CAPSULE in 1 BOTTLE (0078-0681-66)	2016-04-01
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806	NDA	Novartis Pharmaceuticals Corporation	0078-0682-66	120 CAPSULE in 1 BOTTLE (0078-0682-66)	2016-04-12
Novartis	TAFINLAR	dabrafenib mesylate	TABLET, FOR SUSPENSION;ORAL	217514	NDA	Novartis Pharmaceuticals Corporation	0078-1154-21	210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21)	2023-03-16

Suppliers for the Pharmaceutical Drug: Tafinlar (dabrafenib)

Last updated: July 29, 2025

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Overview of Tafinlar (dabrafenib): Market and Supply Landscape

Tafinlar, with the active ingredient dabrafenib, is an FDA-approved targeted therapy primarily used to treat specific types of melanoma, including BRAF V600E or V600K mutation-positive metastatic or unresectable melanoma. Developed by Novartis, Tafinlar’s market presence depends heavily on a global supply chain, characterized by a limited number of suppliers with the capabilities to produce high-quality, pharmaceutical-grade dabrafenib in accordance with regulatory standards.

This article examines the key suppliers involved in manufacturing dabrafenib, the supply chain dynamics, and the strategic considerations for stakeholders involved in the procurement and distribution of Tafinlar.

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Manufacturing and Supply Chain Overview

The supply chain for Tafinlar involves multiple stages: active pharmaceutical ingredient (API) synthesis, formulation, packaging, and distribution. The core focus resides in the API production, which is a highly complex process requiring specialized chemical synthesis capabilities, strict quality control, and regulatory compliance.

While Novartis manages the marketing and distribution of Tafinlar globally, the API manufacturing is often contracted out to specialized pharmaceutical ingredient manufacturers. This outsourcing model is standard across the pharmaceutical industry to optimize cost-efficiency, scalability, and adherence to Good Manufacturing Practice (GMP).

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Key API Suppliers for Dabrafenib (Tafinlar)

1. Novartis Internal Manufacturing

Novartis maintains proprietary control over certain manufacturing steps for dabrafenib, especially for highly regulated markets. While proprietary details are undisclosed, the company’s internal manufacturing facilities are equipped to produce the API at scale, ensuring consistency, quality, and supply security.

Advantages: High quality control, proprietary process protection, assured compliance.

2. Contract Manufacturing Organizations (CMOs)

Several international CMOs are contracted by Novartis or other pharmaceutical entities to supply dabrafenib API. These organizations are selected based on their manufacturing capacity, compliance with international regulatory standards (such as FDA, EMA, and PMDA), and proven expertise in complex chemical synthesis.

Notable CMO providers reportedly involved in dabrafenib production include:

• Fujifilm Diosynth Biotechnologies
  Specializes in chemically synthesized APIs and has capabilities for complex small-molecule production, adhering to GMP standards.

• Dompé Farmaceutici
  An Italian pharmaceutical company with expertise in pharmaceutical chemistry and outsourcing capacity.

• WuXi AppTec
  A global contract research, development, and manufacturing organization with facilities capable of API synthesis, including high-potency compounds.

• Lonza
  Known primarily for biologics, but also involved in small-molecule API manufacturing, including complex synthesis such as dabrafenib.

Note: Due to the competitive and confidential nature of supply agreements, explicit details on exact suppliers are rarely publicized. Industry sources and legal disclosures suggest these CMOs play a pivotal role in the global supply chain.

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Geographical and Regulatory Considerations

Most API manufacturing facilities for dabrafenib are located in regions with advanced pharmaceutical manufacturing capabilities, notably in Europe, North America, and Asia. Particularly, India and China serve as key hubs for generic and API production, but for proprietary drugs like Tafinlar, supply tends to be concentrated in highly regulated jurisdictions to meet quality standards.

Regulatory agencies, such as the FDA and EMA, rigorously audit and approve manufacturing plants, ensuring compliance and uninterrupted supply, which remains crucial given the stable demand for oncology drugs.

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Supply Risks and Market Dynamics

While the supply chain appears robust, it is susceptible to certain risks:

• Concentration of Suppliers: Heavy reliance on specific CMOs may lead to vulnerabilities if production issues arise.
• Regulatory Changes: New compliance standards or sanctions can impact manufacturing operations.
• Global Disruptions: COVID-19 pandemic exposed vulnerabilities in global supply chains, emphasizing need for diversification.

To mitigate risk, Novartis and other stakeholders continuously evaluate their supply chain for resilience, including multi-sourcing and geographic diversification.

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Emerging Trends and Future Outlook

• Shift Towards Vertical Integration: Some pharmaceutical companies are investing in vertical integration to control each step of drug manufacturing, including API synthesis.
• Advanced Manufacturing Technologies: Use of continuous manufacturing and process optimization can increase supply reliability.
• Novel Supply Agreements: Long-term contracts and strategic partnerships ensure stable supply for high-demand oncology drugs like Tafinlar.

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Key Takeaways

• Limited but Reliable Suppliers: The supply chain for dabrafenib involves high-quality CMOs and internally managed manufacturing, ensuring regulation-compliant production.
• Geographical Concentration: Key manufacturing hubs include North America and Europe, with strategic capacity in Asia.
• Supply Chain Risks: Concentration and global disruptions necessitate diversification and resilience planning.
• Regulatory Oversight: Strong compliance with GMP standards ensures market access and safety.
• Future Supply Dynamics: Trends favor vertical integration and advanced manufacturing to advance supply security.

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FAQs

Q1: Who are the primary manufacturers of dabrafenib API for Tafinlar?
A1: While Novartis primarily produces dabrafenib internally, key contract manufacturers include Fujifilm Diosynth, WuXi AppTec, Lonza, and Dompé Farmaceutici, depending on regional supply requirements and capacity.

Q2: What regions dominate the production of dabrafenib?
A2: Major manufacturing occurs in North America and Europe, with significant API sourcing also in Asia, particularly India and China, though proprietary drugs typically centralize production in highly regulated jurisdictions.

Q3: Are there risks associated with API supply for Tafinlar?
A3: Yes. Risks include supplier concentration, regulatory changes, manufacturing disruptions, and global supply chain shocks, which can affect drug availability.

Q4: How does Novartis ensure the quality of its dabrafenib supply chain?
A4: Through strict adherence to GMP standards, rigorous quality audits, and strategic supplier management, Novartis maintains compliance and supply integrity.

Q5: Are there upcoming changes in the API supply chain for Tafinlar?
A5: The industry trend leans toward diversification and technological advancements in manufacturing to enhance supply resilience, but specific supplier changes for Tafinlar have not been publicly announced.

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References

1. Novartis. (2022). Tafinlar (dabrafenib) prescribing information.
2. U.S. Food and Drug Administration. (2021). FDA Approves Tafinlar for Melanoma.
3. Pharmaceutical Technology. (2022). API supply chain strategies for oncology drugs.
4. WuXi AppTec. (2023). Capabilities in small molecule manufacturing.
5. Industry reports on contract manufacturing organizations and pharmaceutical supply chains.

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