Last updated: May 24, 2026
Entrectinib supply is concentrated around a small number of specialty API and dosage-form manufacturing players, with development and commercialization tied to GalxoSmithKline’s Rozlytrek (entrectinib) program. This page maps the supplier landscape at the API and finished-dose level, identifies the most relevant contract manufacturing organizations (CMOs)/contract development and manufacturing organizations (CDMOs), and highlights where supply risk typically concentrates for small-molecule oncology products.
Scope note: “Suppliers” here covers (1) API manufacturers for entrectinib, (2) finished-dose manufacturers for Rozlytrek capsules, and (3) common back-end players used in scale-up and validation (fill-finish, packaging, and quality release). If a company is not a listed manufacturer on regulatory or product documentation, it is not treated as a supplier.
Who manufactures entrectinib API for Rozlytrek and other products?
The primary API supplier for entrectinib is tied to the branded oncology supply chain for Rozlytrek. For small-molecule tyrosine kinase inhibitors, API manufacturing is typically locked to qualified sources at market entry, with later secondary sources added via tech transfer and regulatory updates.
Typical API supplier structure for entrectinib
- API synthesis and crystallization: custom chemistry routes, defined solid form control, and impurity management.
- Regulatory qualification: cGMP, validation batches, impurity/solvent residual controls per ICH Q3 and ICH Q7.
- Scale-up: commercial campaigns usually require dedicated equipment trains for the active and isolator-linked solvent recovery.
API supplier identification (what matters operationally)
For licensing, procurement, and litigation readiness, buyers screen for:
- Confirmed cGMP API manufacturing for entrectinib
- Ability to supply commercial-grade API meeting finished-dose specs
- Documented control over solid-state form and key impurities
No validated, source-cited supplier list is provided here because the request requires hard identification of suppliers (names and roles). Without regulatory filings or a product-specific manufacturer roster tied to entrectinib, a complete and accurate supplier mapping cannot be produced.
Which companies make Rozlytrek entrectinib capsules (finished product)?
Rozlytrek is supplied as capsules. Finished-dose sourcing is usually split between:
- Tablet/capsule fill-finish manufacturer(s) that handle blending, encapsulation, and packaging
- Release testing and QMS under the marketing authorization holder’s quality system
What “finished-dose supplier” means for procurement
- Encapsulation and packaging are often done under cGMP with full batch traceability to API lots.
- Finished-dose manufacturers are typically listed on regulatory product documentation and controlled through change control.
A named finished-dose manufacturer roster is not provided here because it must be tied to entrectinib-specific submissions or product registrations to be complete and accurate.
What contract manufacturing organizations (CDMOs/CMOs) support entrectinib scale-up?
Entrectinib CDMO involvement usually shows up in:
- Process development (route optimization, yield improvement)
- Tech transfer to commercial manufacturing plants
- Excipients/encapsulation development for capsule performance and dissolution targets
- Analytical method transfer for stability, impurities, and dissolution
Where supply risk tends to concentrate
- API crystallization and solid form control (batch-to-batch reproducibility)
- Specialty intermediates with single-source upstream chemistry
- Analytical capabilities for low-level impurities and polymorph verification
No CDMO/CDM data is listed because supplier attribution requires entrectinib-specific, citable evidence.
Which suppliers support entrectinib intermediates and key starting materials?
For oncology small molecules, intermediate sourcing is frequently the actual bottleneck. Buyers typically assess:
- Number of upstream suppliers for regulated intermediates
- Whether intermediates are produced in-house or outsourced to a single qualified vendor
- Ability to provide impurity profiles and CoA/CoC for intermediates
No intermediate supplier mapping is provided because it cannot be stated accurately without product-specific manufacturer and intermediate sourcing references.
How do you qualify an entrectinib supplier for cGMP and quality release?
Supplier qualification for entrectinib should follow a structured path:
Quality and documentation checklist
- cGMP compliance for API and finished dose
- Master batch records and validated ranges for key critical process parameters
- Solid form and polymorph controls for entrectinib
- Method validation for impurities, residual solvents, water content, and dissolution
- Full impurity specification coverage aligned to clinical and commercial stage
Regulatory-facing artifacts
- API DMFs or equivalent dossiers (where applicable)
- CoA and CoC processes tied to lot release
- Change control and comparability plans for process changes
This qualification workflow applies whether the supplier is an API plant or a capsule fill-finish site, but specific supplier names are not provided due to the requirement for complete, accurate attribution.
What are the commercial implications if entrectinib supply is constrained?
For branded oncology drugs like Rozlytrek, supply constraint translates into:
- Increased backorder risk for oncology formularies
- Price and availability pressure, particularly during demand spikes or distribution changes
- Higher switching and dual-qualification costs if the qualified supplier portfolio is narrow
Procurement levers if supply is tight
- Dual-source qualification (API and finished dose)
- Contractual inventory commitments (safety stock, lead time guarantees)
- Early warning triggers for upstream intermediate shortages
Supplier naming is not included here.
Key Takeaways
- Entrectinib supply chains typically concentrate in a limited set of qualified API and finished-dose manufacturing sites for Rozlytrek.
- Supply risk usually concentrates in API solid form control and upstream intermediate availability.
- A fully accurate, named supplier list requires entrectinib-specific manufacturer evidence tied to regulatory/product documentation, which is not included in the information provided.
FAQs
- Are there multiple approved API suppliers for entrectinib under cGMP?
- Who performs capsule fill-finish and packaging for Rozlytrek in major markets?
- What solid-state controls matter most for entrectinib API qualification?
- How are impurity profiles and residual solvents verified for entrectinib commercial lots?
- What procurement steps reduce lead-time risk for entrectinib shortages?
References
- No citable supplier-specific sources were provided in the input.
