Last updated: May 26, 2026
TAFINLAR suppliers: who makes the drug, APIs, and key components for production?
Who supplies TAFINLAR (dabrafenib) for US and global markets?
TAFINLAR is dabrafenib, a small-molecule BRAF inhibitor. Market supply is organized around (1) the branded manufacturer that holds FDA label responsibility, (2) the API supply chain that produces dabrafenib API, and (3) formulation and packaging sites producing the oral capsules. Public-facing “supplier” information is typically captured through:
- FDA labeling (manufacturer/distributor and sometimes site addresses)
- Orange Book “listed drug” manufacturer details
- NDA/ANDA facility listings in FDA databases
- Contract manufacturing arrangements reported in regulatory submissions and litigation discovery
Branded US label supply (marketing authorization holder)
- NDA/label holder for TAFINLAR in the US: Novartis Pharmaceuticals Corporation (Novartis is the US marketing authorization holder for branded TAFINLAR).
What this means for suppliers
- Novartis is the primary commercial supplier-of-record for the marketed product.
- Actual production is executed via one or more Novartis manufacturing sites and/or contract manufacturers supplying drug product, plus API manufacturers supplying dabrafenib API.
What contract manufacturers and manufacturing sites supply TAFINLAR capsules?
Featured-supplier intelligence for manufacturing sites usually comes from:
- the TAFINLAR FDA label (drug product manufacturer/distributor addresses)
- the product’s listed drug details in the Orange Book (manufacturer names tied to the NDA/BLA)
- facility inspection and establishment listings on FDA databases (registration and drug establishment records)
Missing element constraint
A complete supplier map (API firms + drug-product CMOs + packaging suppliers) requires exact facility and establishment data tied to dabrafenib API and to the specific capsule strengths (50 mg and 75 mg) with the currently marketed label configuration. That label-linked facility list is not present in the provided prompt content, so a complete, accurate supplier roster cannot be produced.
Who supplies dabrafenib API for TAFINLAR?
Dabrafenib API is a specialized intermediate-heavy synthesis product. API suppliers are typically one or more:
- bulk API manufacturers registered with FDA (drug establishment registration)
- specialized chemical suppliers with validated routes for the dabrafenib scaffold
Missing element constraint
A verified list of dabrafenib API suppliers requires tying the TAFINLAR NDA manufacturing data or FDA establishment registration entries to the API. No NDA manufacturing-site/API-supplier listing is included in the prompt content.
How do strength-specific formulations affect the supplier chain for TAFINLAR?
TAFINLAR is marketed in capsule strengths (notably 50 mg and 75 mg). Supplier chains can differ across strengths due to:
- separate blending, encapsulation, and strength-specific fill-finish runs
- packaging materials and counting systems
- validated dissolution and stability programs per strength
Missing element constraint
A strength-by-strength supplier list requires the specific drug product manufacturer details from the current US label for each strength.
What Orange Book status says about TAFINLAR manufacturing suppliers?
Orange Book is the best source for identifying the “listed drug” manufacturer names for the reference product and any related patents/exclusivity context. It can also indicate whether a generic or NDA supplement references that manufacturer record.
Missing element constraint
No Orange Book entry data (listing number, manufacturer name as recorded, NDA number, submission link) is included in the prompt content, so the supplier roster derived from Orange Book cannot be stated accurately.
Key Takeaways
- Novartis is the US label/marketing authorization holder for TAFINLAR (dabrafenib) and is the branded supplier-of-record.
- A complete, accurate list of dabrafenib API suppliers, drug-product contract manufacturers, and packaging suppliers requires label-linked manufacturing-site and FDA establishment data that is not contained in the prompt input.
- Strength-specific supply chains for 50 mg vs 75 mg can involve different manufacturing and fill-finish runs, but the exact site list cannot be produced without the label/site records.
FAQs
- Who is the manufacturer of record for TAFINLAR in the US?
- Are there separate manufacturing sites for different TAFINLAR capsule strengths?
- Which companies supply dabrafenib API used in TAFINLAR?
- Does the Orange Book list TAFINLAR drug product manufacturing sites?
- What supplier-chain risks exist for dabrafenib (API synthesis, intermediates, and fill-finish capacity)?
References
No sources were provided in the prompt content, and no verifiable supplier list can be produced without cited label/Orange Book/FDA establishment data.
