Last Updated: May 12, 2026

Suppliers and packagers for generic pharmaceutical drug: ENCORAFENIB


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

Suppliers and packagers for generic pharmaceutical drug: ENCORAFENIB

Last updated: April 25, 2026

What Suppliers Provide Encorafenib for Pharmaceutical Use?

Encorafenib is supplied through a mix of branded-manufacturing supply chains (for commercial drug product), and specialized chemical supply chains (for bulk drug substance and intermediate chemistry). The supplier set depends on whether you need finished dosage form (capsules) or API (drug substance).

Which companies supply Encorafenib as a finished drug product (capsules)?

In practice, finished-dose supply is handled by the company that holds the commercial product license in each market, with secondary logistics through contract manufacturing and distribution partners.

Market Branded product Label status (key point) Practical supplier implication
Global BRAFTOVI (encorafenib) Branded product referenced across oncology BRAF testing pathways Brand holder supply chain governs bulk allocations and distribution

Product naming: Encorafenib is the active ingredient in BRAFTOVI.

Who supplies Encorafenib API (bulk drug substance) and intermediates?

Encorafenib API manufacturing is typically conducted by specialized API manufacturers and chemical synthesis providers under development and commercial supply agreements. However, a complete, company-by-company “supplier list” is not determinable from the information provided in this request.

If you require a supplier roster that is suitable for procurement or investment diligence, the supplier list must be sourced from verifiable public filings (regulatory databases, DMFs, product labels, or official inspection and listing sources). Those datasets are not provided here, and producing a supplier list without sourcing would be non-actionable.

What supply-chain documents are typically used to identify Encorafenib suppliers?

Procurement-grade supplier identification relies on the following evidence types:

  • Regulatory registrations: drug product labels and prescribing information (to tie to the marketing authorization holder and listed manufacturers).
  • API traceability: DMF holders or listed manufacturers in regulatory submissions (for each jurisdiction).
  • Quality and inspection linkage: GMP inspection records that name the API site.
  • Contract manufacturing disclosures: sometimes listed in regulatory summaries and product documentation.

Where does “encorafenib supplier” data most often show up in public sources?

The reliable locations are:

  • National medicines agency product pages and label PDFs (finished product)
  • Regulatory submission databases (API, DMF holders)
  • Corporate annual reports and manufacturing site announcements (site-level)
  • Quality agreements and listing references (where publicly accessible)

What procurement choices do buyers usually make for Encorafenib?

Buyer objective Typical sourcing route What you verify in diligence
Commercial distribution Brand supply chain (finished product) Label manufacturers, MAH, distribution partners by country
API procurement API manufacturing and/or toll manufacturing DMF-linked site, GMP status, impurity profile controls, stability package
Intermediate procurement Route-specific intermediate suppliers Route IP boundaries, impurity carryover controls, CoA traceability

Key Takeaways

  • Encorafenib’s finished-dose supply is tied to the branded product supply chain (encorafenib is marketed as BRAFTOVI).
  • A complete and accurate supplier list for API/intermediates requires regulatory traceability (DMF/site disclosures) or label-identified manufacturers by jurisdiction.
  • Without jurisdiction-specific regulatory documents or filed DMF/site references, you cannot produce a defensible supplier roster suitable for procurement.

FAQs

  1. Is BRAFTOVI the branded product for encorafenib?
    Yes. Encorafenib is the active ingredient in BRAFTOVI.

  2. Can I buy encorafenib only as API?
    Yes, but API availability depends on DMF-linked manufacturers and contractual supply arrangements.

  3. How do buyers identify the true encoarafenib API manufacturer?
    They confirm the listed API manufacturer via regulatory submissions or DMF-linked disclosures, then cross-check with GMP inspection evidence.

  4. Do encoarafenib suppliers differ by country?
    Yes. Finished product manufacturers and distributors can change by market even when the MAH is the same.

  5. What evidence supports procurement-grade supplier selection for encorafenib?
    Regulatory labels (finished product), DMF and submission references (API), and GMP inspection or site documentation.


References

[1] U.S. Food and Drug Administration. BRAFTOVI (encorafenib) prescribing information. FDA label information.
[2] European Medicines Agency. BRAFTOVI (encorafenib) product information and assessment materials. EMA.

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