Who manufactures Augtyro (Repotrectinib)?

Repotrectinib bulk supplier for pharma manufacturers

Repotrectinib 40mg, 160mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 40mg, 160mg

Reference Brands: Augtyro (USA)

Repotrectinib is a targeted cancer therapy used to treat ROS1-positive non-small cell lung cancer (NSCLC) and NTRK fusion-positive solid tumors. It works as a tyrosine kinase inhibitor, blocking key enzymes that promote tumor growth and survival. Available as oral capsules in strengths of 40 mg and 160 mg, Repotrectinib is designed for patients with advanced or metastatic cancers who have limited treatment options.

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Product Description:

Repotrectinib is a next-generation inhibitor of ROS1, TRK and ALK, designed compactly so that it still fits the kinase pocket when a solvent-front mutation has narrowed it. That mutation is the standard escape route from first-generation drugs in these tumours: the target remains addicted to the same pathway, but the older inhibitor no longer fits. A smaller, rigid macrocyclic structure continues to bind.

It is used for ROS1-positive advanced non-small cell lung cancer, both in patients never treated with a targeted agent and in those who have progressed on one, and for NTRK fusion-positive solid tumours regardless of where they arise. Central nervous system penetration is good, which matters because brain progression is a common pattern of failure. Dizziness is the most frequent adverse effect and is dose-related; dysgeusia, paraesthesia, ataxia, anaemia and transaminase elevation occur, and patients are warned about driving.

Sourcing notes. Originator product, on patent, approved in a limited set of territories — confirm before quoting. Two capsule strengths support the step-up schedule and both are needed. Requires ROS1 or NTRK fusion testing by next-generation sequencing at the destination. Oral capsules, room temperature.

How Repotrectinib is supplied today, and licensing ahead of patent expiry

Repotrectinib is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Repotrectinib, hold a dossier for it or want to license it, talk to us.

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

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Frequently Asked Questions

Augtyro (Repotrectinib) is developed and sold by Bristol Myers Squibb. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.