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Futibatinib bulk supplier for pharma manufacturers

Futibatinib 4 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 4 mg

Reference Brands: Lytgobi (USA)

Category: Oncology Cancer Care

Futibatinib 4 mg film-coated tablets, an irreversible FGFR1-4 inhibitor for previously treated FGFR2-rearranged intrahepatic cholangiocarcinoma. For hospital oncology pharmacies and licensed importers.

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Product Description:

Futibatinib is a covalent inhibitor of all four fibroblast growth factor receptors. It forms a permanent bond with a cysteine in the receptor's kinase pocket, so the block lasts until the cell makes new receptor protein, which sets it apart from the reversible members of this class. It is supplied in one strength only, a 4 mg film-coated tablet. The daily dose is made up of several tablets taken together, and a dose reduction simply means taking fewer of them.

It is approved for adults with previously treated, unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma carrying an FGFR2 fusion or other rearrangement. It is taken once a day, every day, with or without food, swallowed whole. Raised blood phosphate is the most frequent laboratory change, so phosphate is tested regularly and managed as the label sets out. Retinal pigment epithelial detachment can occur, so eye checks are scheduled at baseline and during therapy. Strong combined CYP3A and P-gp inhibitors or inducers should not be co-prescribed.

Sourcing notes. Registration is limited to a few markets so far, so many orders are placed for individual patients under special-access rules. Because the dose is built from 4 mg tablets, count monthly need in tablets, not packs. The tablets ship and store at room temperature. Request the batch CoA, proof of an authorised supply chain and, for registered imports, the GMP certificate and CoPP. Treating centres confirm the FGFR2 result from a validated test before ordering. Keep it in original serialised packs with the approved leaflet.

Futibatinib — third party manufacturing & bulk supply

Futibatinib 4 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Futibatinib is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Futibatinib listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Futibatinib is used for the treatment of adults with unresectable, locally advanced, or metastatic cholangiocarcinoma (bile duct cancer) whose tumors have fibroblast growth factor receptor 2 (FGFR2) gene fusions or rearrangements, and who have previously received systemic therapy.

Futibatinib is a synthetic small-molecule tyrosine kinase inhibitor designed to irreversibly inhibit fibroblast growth factor receptors FGFR1, FGFR2, FGFR3, and FGFR4.

The trade name of Futibatinib is Lytgobi.

Futibatinib (Lytgobi) is manufactured and marketed by Taiho Oncology in regulated markets including the USA.

The generic name is futibatinib.

The brand name is Lytgobi.

Futibatinib is manufactured in GMP-compliant facilities by Taiho Oncology and its approved manufacturing partners in regulated regions.

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