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Tepotinib bulk supplier for pharma manufacturers

Tepotinib 225 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 225 mg

Reference Brands: Tepmetko (USA/EU)

Category: Oncology Cancer Care

Tepotinib 225 mg film-coated tablets, an oral MET kinase inhibitor for non-small cell lung cancer with MET exon 14 skipping. For hospital oncology pharmacies, importers and specialist distributors.

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Product Description:

Tepotinib is an oral, selective inhibitor of the MET receptor tyrosine kinase. In some lung cancers a mutation causes MET exon 14 to be skipped when the gene is read, producing a receptor that escapes normal breakdown and keeps signalling for growth. Blocking MET shuts that signal down. It comes as a 225 mg film-coated tablet, and the standard daily dose is two tablets taken together with food, which helps absorption.

It is used for adults with advanced or metastatic non-small cell lung cancer whose tumours carry MET exon 14 skipping alterations, identified by a validated tissue or plasma test. Swelling of the legs and other parts of the body is the most common effect and often drives dose reductions. Interstitial lung disease or pneumonitis can occur, so new cough or breathlessness needs prompt review. Liver enzymes are checked regularly, and blood creatinine may rise without a real fall in kidney function. Tepotinib inhibits P-glycoprotein, so drugs such as dabigatran and digoxin need monitoring.

Sourcing notes. Registration covers the United States, the European Union, Japan and a number of other markets; elsewhere supply runs through special-access import. The tablets are stored at room temperature in their blisters, with no cold chain. Because the daily dose is two tablets, plan stock in tablets per patient month. Ask for the batch CoA, the GMP certificate and a CoPP, or the named-patient import permit where it is unregistered. It is a prescription-only targeted oncology medicine; insist on original serialised packs with the approved leaflet.

Tepotinib — third party manufacturing & bulk supply

Tepotinib 225 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

Tepotinib 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 Tepotinib 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

Tepotinib is used to treat non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations by inhibiting MET receptor signaling and slowing tumor progression.

Tepotinib mesylate is a synthetic small-molecule MET kinase inhibitor that specifically targets MET-driven cancer cell growth pathways.

The trade name of tepotinib is Tepmetko.

Tepotinib (Tepmetko) is developed and marketed by Merck KGaA (EMD Serono in the USA).

The generic name is tepotinib mesylate.


The brand name is Tepmetko.

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