Overview

Entrectinib is an oral tyrosine kinase inhibitor that targets the tropomyosin receptor kinase proteins TRKA, TRKB and TRKC (encoded by NTRK genes), as well as ROS1 and ALK. It is approved for ROS1-positive metastatic non-small cell lung cancer and for NTRK gene fusion-positive solid tumors. For B2B buyers such as distributors, hospital pharmacies and procurement teams, the molecule's handling, packaging and documentation requirements are as important as the clinical profile. This article covers practical sourcing considerations for entrectinib capsules without making commitments a supplier cannot guarantee.

Procurement Specifications and Packaging

Entrectinib is supplied as hard capsules in 100 mg and 200 mg strengths, with 50 mg oral pellets also available for patients who cannot swallow capsules. In B2B sourcing, confirming the exact strength, count per carton and lot traceability is essential. Genuine product should ship in the original manufacturer carton with intact tamper-evident seals and legible batch and expiry labeling. Buyers should request a Certificate of Analysis for each lot and, where relevant, a Drug Master File reference so quality can be verified against the registered specification. Matching the ordered strength to the intended regimen, adult dosing is weight-independent at 600 mg once daily, prevents costly returns.

Cold-Chain and Storage Considerations

Entrectinib does not require frozen storage, but stability depends on controlled room-temperature handling. Labeling directs storage at 20 to 25 degrees C (68 to 77 degrees F), with permitted excursions between 15 and 30 degrees C, always in the original container to protect from moisture. For international procurement this means avoiding prolonged exposure to high humidity and heat during transit, using desiccant-protected secondary packaging and monitoring thermal exposure on long routes. A documented chain-of-custody and temperature log protects both product integrity and regulatory defensibility at the point of import.

FAQ

Q: What strengths should a distributor stock for entrectinib? A: The two capsule strengths are 100 mg and 200 mg, plus 50 mg oral pellets; stocking both capsule strengths supports flexible dispensing, though the final mix depends on local demand.

Q: Does entrectinib need refrigerated transport? A: No. It is stored at controlled room temperature (20 to 25 degrees C, excursions 15 to 30 degrees C) in the original container, so the priority is moisture protection and avoiding heat exposure rather than active refrigeration.

Q: Which documents confirm genuine entrectinib quality? A: A per-lot Certificate of Analysis and, where applicable, a Drug Master File reference let buyers verify identity, assay and impurities against the registered specification.