Last updated: June 3, 2026
ROZLYTREK (entrectinib) is manufactured through a commercial supply chain centered on active pharmaceutical ingredient (API) production and contract manufacturing for the final oral dosage form. Publicly available, regulator-facing and market data do not support a complete, single “supplier list” covering every upstream API and finished-goods vendor across all jurisdictions. Below are the supplier entities that can be tied to ROZLYTREK’s US commercial distribution and to the documented manufacturers appearing in public regulatory and product documentation.
Who supplies ROZLYTREK in the US market?
Answer: The US supply is coordinated by the ROZLYTREK brand owner and marketed through the US distribution network; finished-goods supply is executed by contract manufacturing and/or R-Pharm production sites used by the brand owner.
Brand owner and US commercial role
- Hoffmann-La Roche (Genentech in the US) is the brand owner for ROZLYTREK and controls supplier qualification, quality agreements, and commercial supply allocation.
Finished-dose manufacturing and distribution footprint
ROZLYTREK is an oral capsule product. For US commercial use, finished dosage supply typically comes from qualified manufacturing sites listed in regulatory submissions and inspections. Public documents used in antitrust and procurement contexts routinely cite contract manufacturing arrangements rather than a single vertically integrated vendor for all sites.
What companies manufacture entrectinib capsules (ROZLYTREK) under contract?
Answer: Contract manufacturing typically supplies ROZLYTREK capsules, and the plant network can include multiple CMOs across dosage manufacturing and packaging.
Key CMO patterns for ROZLYTREK
- Capsule manufacturing sites that execute bulk blending, encapsulation/filling, and packaging under Roche/Genentech supply agreements.
- Quality-controlled packaging and distribution under supply chain serialization and cold-chain requirements where applicable (ROZLYTREK is not typically cold-chain, but market-specific handling rules apply).
How to interpret “supplier” in regulatory terms
- API supplier: produces entrectinib or key intermediates.
- DS manufacturer: makes drug substance (API) under a GMP controlled process.
- DP manufacturer: produces drug product (capsule, packaging).
- Secondary packaging/distribution: repackaging, bundling, and shipment through US wholesalers and specialty channels.
Which raw-materials suppliers provide the ROZLYTREK API supply chain?
Answer: ROZLYTREK API suppliers are part of the Roche/Genentech qualified DS vendor network and are not consistently published as a full upstream list in public-facing channels.
API supply chain structure for oncology small molecules
For small-molecule oncology drugs like entrectinib, the supplier network commonly includes:
- One or more API manufacturing sites (DS plants).
- One or more intermediate suppliers for key steps in synthesis.
- Backup suppliers for key intermediates to mitigate supply disruptions.
Publicly accessible documents often list finished product and quality control release data, but not always the full upstream intermediate vendor map.
What is the sourcing and quality control pathway for ROZLYTREK?
Answer: ROZLYTREK follows a Roche-controlled quality system with release testing and GMP oversight across DS and DP manufacturing.
Release and GMP controls
- DS and DP are released under Roche/Genentech quality oversight.
- Lot release and stability programs support continued commercial supply.
- Suppliers operate under quality agreements addressing deviations, change control, and audit schedules.
Change control and site transfers
Supplier changes are governed by:
- comparability protocols for DS and DP,
- regulatory notifications/approvals for site or process changes,
- labeling and distribution coordination for lot-specific manufacturing history.
Does ROZLYTREK have any regulatory-listed manufacturing sites on US labels or submissions?
Answer: US regulatory documentation contains the manufacturing site roster, but those site names are not consistently exposed in public label text used for market searches.
Where manufacturing sites show up
Manufacturing site and packaging information are typically found in:
- FDA drug master file (DMF) contexts (for API),
- FDA CMC sections in NDA/BLA review packages,
- approved labeling components (when explicitly disclosed),
- inspection histories.
How can procurement teams map ROZLYTREK suppliers for contracting or contingency supply?
Answer: Procurement should map suppliers by role: API/DS, DP capsule manufacturing, and packaging, then verify qualification status per Roche/Genentech quality agreement.
Supplier mapping workflow used in pharma contracting
- Identify DS and DP sites from regulatory submissions and inspection databases.
- Confirm lot release responsibility and quality agreement scope.
- Validate backup supply pathways for both DS and capsule bottlenecks (encapsulation/filling, granulation, packaging line capacity).
- Secure change control triggers and transition timelines for interruption scenarios.
Key Takeaways
- ROZLYTREK is supplied through a Roche-controlled network covering API (DS), capsule manufacturing (DP), and secondary packaging and distribution.
- A complete upstream “supplier list” across all API and intermediate vendors is not consistently published in public consumer-facing channels; procurement-grade supplier mapping requires using regulator-facing manufacturing site information and quality-verified vendor rosters.
- For contingency planning, supplier role segmentation (DS vs DP vs packaging) is the most actionable way to build a reliable ROZLYTREK supply map.
FAQs
1) Who is the US brand owner for ROZLYTREK?
Hoffmann-La Roche/Genentech is the brand owner and commercial controller of the supply chain.
2) Is ROZLYTREK supplied by a single API manufacturer?
Supply is typically multi-site for oncology small molecules, with at least one qualified DS manufacturing site and backup arrangements as part of Roche’s vendor strategy.
3) How do you identify the exact capsule manufacturing sites for ROZLYTREK?
Use FDA CMC documentation and inspection histories to confirm qualified DP sites for capsule manufacturing and packaging.
4) Are entrectinib API suppliers publicly listed on ROZLYTREK labeling?
Not reliably. API suppliers are usually identified through DMFs, CMC submissions, and procurement-quality vendor rosters rather than consumer labeling.
5) What supply risk exists if a ROZLYTREK manufacturing site is disrupted?
Risks concentrate in DP capsule encapsulation/filling and packaging line capacity; DS backup capacity mitigates upstream shortages but does not eliminate DP line bottlenecks.
References
- FDA. Drug labeling and product information for ROZLYTREK (entrectinib). U.S. Food and Drug Administration.
- FDA. Orange Book: Approved Drug Products for ROZLYTREK (entrectinib) (product and applicant listings). U.S. Food and Drug Administration.
- FDA. Drug approvals and CMC/labeling records for entrectinib. U.S. Food and Drug Administration.
