Suppliers and packagers for generic pharmaceutical drug: VEMURAFENIB

VEMURAFENIB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429	NDA	Genentech, Inc.	50242-090-02	1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2011-08-17

Suppliers and packagers for generic pharmaceutical drug: VEMURAFENIB

Last updated: April 26, 2026

Who Supplies Vemurafenib (API, Intermediates, and Finished Product) and How the Supply Chain Is Typically Structured

What does the Vemurafenib supply chain look like in practice?

Vemurafenib supply is generally split into three layers:

• Finished dose drug product (tablets) sourced from branded and generic manufacturers.
• Active pharmaceutical ingredient (API) produced under cGMP, typically by dedicated API makers and/or licensed generic API producers.
• Key intermediates and synthesis steps produced by fine-chemical and custom synthesis suppliers supporting the API route.

In the absence of a single global “exclusive” supply map for all geographies, business users usually triangulate supply via: (i) regulatory listings (e.g., FDA Orange Book for drug product, EUDRACT/EMA sources for EU), (ii) API manufacturer name disclosure in regulatory submissions when available, and (iii) supplier disclosure in commercial tendering and DMF-linked manufacturing networks.

Which companies supply vemurafenib finished drug product?

Vemurafenib is marketed under the brand Zelboraf (Roche/Genentech). In markets outside the originator, generic vemurafenib tablets are typically supplied by multiple manufacturers depending on country-specific approvals, pack strength, and patent status.

Because “finished product suppliers” vary by jurisdiction and approval pathway, the only stable, non-ambiguous anchor in the public domain is the originator brand:

Category	Supplier	Product	Notes
Originator finished drug product	Genentech, Inc. (Roche)	Zelboraf (vemurafenib)	Branded reference product for most filings and supply contracts

Which companies supply vemurafenib API and intermediates?

Vemurafenib API supply usually comes from a small set of API manufacturers that sell to branded and generic tablet makers, plus intermediate and custom synthesis vendors. In practice, contract manufacturing and DMF (Drug Master File) networks obscure “who made the API” at the retail level, while procurement teams work from: (i) DMF references, (ii) CoA and GMP certificate trails, and (iii) audited vendor lists.

Given the requirement for hard, verifiable supplier identification, only the originator finished product supplier can be stated without jurisdiction-specific gaps.

Hard-anchored supplier (verifiable from public brand labeling)

Supply layer	Supplier	Evidence basis
Finished product	Genentech, Inc.	Originator brand “Zelboraf” is linked to Genentech in public drug labeling and regulatory reference material

What procurement paths do sourcing teams use for vemurafenib?

Typical procurement structures in oncology small-molecule drugs:

• Brand-origin supplies: direct contracting from the originator brand supply chain for commercial continuity.
• Generic route: procurement via tendered generic tablet supply where the API source is validated through incoming QC + supplier audit.
• API-only procurement: for re-packers or secondary manufacturers, purchase of API is tracked by batch traceability and GMP documentation (CoA, GMP certificate, and DMF-linked manufacturing statements where available).

How do APIs for vemurafenib get validated in vendor qualification?

Vendor qualification for vemurafenib API commonly focuses on:

• CQA alignment: identity (chromatographic profile), assay, impurities, residual solvents, polymorph/solid form if applicable.
• Impurity control: ragged synthesis routes increase impurity risk; vendors must show impurity trend stability over consecutive batches.
• Supply continuity: multi-site manufacturing where possible to reduce single-point failure risk.
• Regulatory documentation: GMP compliance evidence, DMF cross-references when used.

Key Takeaways

• Vemurafenib supply is structured as finished drug product, API, and intermediates/custom synthesis.
• The only consistently and unambiguously identifiable supplier from public reference points is the originator finished product supplier: Genentech, Inc. (Zelboraf).
• API and intermediate suppliers vary by jurisdiction, DMF linkage, and contract manufacturing networks, and are not reliably determinable without drug- and region-specific regulatory detail.

FAQs

1) Who is the originator supplier for vemurafenib tablets?
Genentech, Inc. supplies the branded finished product Zelboraf.

2) Is there a single global API manufacturer for vemurafenib?
No. Vemurafenib API supply is handled through multiple API manufacturers and contract networks that vary by jurisdiction and filing strategy.

3) How do buyers verify vemurafenib API source?
Through incoming documentation (CoA, GMP certificates), impurity/assay release testing, and audit trails tied to the manufacturing site and batch traceability.

4) Does API supply depend on the generic or brand market?
Yes. Brand and generic tablet makers use different contracted API sources depending on cost, availability, and regulatory strategy.

5) What typically determines whether an intermediate supplier is used?
The compatibility of intermediate specifications with the approved impurity profile and the ability to meet cGMP process validation requirements.

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References (APA)

[1] Genentech, Inc. (n.d.). Zelboraf (vemurafenib) prescribing information / product labeling reference. U.S. Food and Drug Administration (FDA) drug labeling materials.