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Taletrectinib bulk supplier for pharma manufacturers

Taletrectinib 200 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 200 mg

Reference Brands: Ibtrozi (USA)

Category: Oncology Cancer Care

Taletrectinib is a next-generation tyrosine kinase inhibitor that targets ROS1 and NTRK fusion proteins. It is used to treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. It works by blocking the abnormal ROS1 signaling that drives cancer cell growth and proliferation. Because it is taken once daily, on an empty stomach (2 hours before or after food), it has specific administration requirements.

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Product Description:

Taletrectinib inhibits ROS1 and TRK kinases, and was developed to address the two problems that limit the older ROS1 drugs: resistance mutations at the solvent front, and off-target inhibition of TRKB in the brain, which produces the dizziness and gait disturbance that lead patients to reduce or stop treatment. Greater selectivity for ROS1 over TRKB is intended to preserve efficacy while sparing those central effects.

It is used for locally advanced or metastatic ROS1-positive non-small cell lung cancer, both in previously untreated patients and after a prior ROS1 inhibitor, with activity against the G2032R resistance mutation and against brain metastases. It is taken once daily on an empty stomach, two hours away from food, which is a real adherence consideration. Transaminase elevation is frequent and requires liver monitoring; diarrhoea, nausea and vomiting are common, usually early and manageable.

Sourcing notes. Recently approved originator product, on patent, with registration so far in a limited number of territories — verify before quoting. Requires ROS1 fusion testing at the destination, generally by next-generation sequencing. Small but growing patient population with long treatment duration. Oral capsules, room temperature.

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

Where taletrectinib is approved

Checked 3 Oct 2026
MarketStatusBrand · regulator · date
China Approved Dovbleron · NMPA · Jan 2025
United States Approved Ibtrozi · FDA · Jun 2025
Japan Approved MHLW · Sep 2025
Generic / biosimilar None None approved as of the check date

Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →

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

Taletrectinib is used to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a ROS1 gene fusion. It helps slow or stop the growth of cancer cells by blocking ROS1 and certain NTRK pathways.

Taletrectinib is a small-molecule kinase inhibitor formulated as taletrectinib adipate. It works by inhibiting ROS1 and NTRK receptors that drive the growth of certain cancer cells.

The trade name is Ibtrozi.

It is developed and marketed by Nuvation Bio along with partnered manufacturers for distribution.

The generic name is taletrectinib, commonly available as taletrectinib adipate.

The brand name is Ibtrozi.

It is manufactured in authorized facilities in the United States and partner regions for global supply.

Ibtrozi (Taletrectinib) is developed and sold by Nuvation Bio (Innovent in China). 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.

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