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Fedratinib bulk supplier for pharma manufacturers

Fedratinib 100mg, 200mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 100mg, 200mg

Reference Brands: Inrebic (USA/EU)

Category: Oncology Cancer Care

Fedratinib is an oral JAK2 inhibitor used for the treatment of adults with intermediate-2 or high-risk primary or secondary myelofibrosis. It helps reduce spleen size and improves disease-related symptoms by selectively targeting the JAK2 pathway involved in abnormal blood cell production.

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Product Description:

Fedratinib inhibits JAK2, the kinase that is constitutively activated in most myeloproliferative neoplasms, and it also inhibits FLT3. Its practical significance lies in what happens after ruxolitinib fails: patients whose spleens regrow and whose symptoms return have historically had nothing to move to, and fedratinib produces spleen volume reduction and symptom response in a meaningful proportion of them.

It is indicated for intermediate-2 or high-risk primary myelofibrosis and for post-polycythaemia vera or post-essential thrombocythaemia myelofibrosis, taken once daily. The critical safety issue is Wernicke encephalopathy, reported in early trials and the reason for a boxed warning: thiamine levels must be measured before treatment and monitored during it, and deficiency corrected before dosing. Anaemia and thrombocytopenia are common and often require transfusion support. Diarrhoea, nausea and vomiting are frequent early and warrant prophylactic antiemetics.

Sourcing notes. Originator product, on patent, with two capsule strengths supporting dose reduction. Approval is not universal and the thiamine monitoring requirement means the receiving market needs laboratory access — confirm both before quoting. Oral capsules, room temperature, no special handling beyond standard cytotoxic precautions.

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

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

Fedratinib is used for treating intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. It works as a selective JAK2 inhibitor that helps reduce spleen size and improve associated disease symptoms.

Fedratinib is made from the active ingredient fedratinib hydrochloride, a targeted small-molecule JAK2 inhibitor designed to block dysregulated signaling involved in myeloproliferative disorders.

The trade name is Inrebic.

Inrebic is manufactured and marketed by Celgene, which is now a part of Bristol-Myers Squibb (BMS).

The generic name is fedratinib hydrochloride.

The brand name is Inrebic.

Fedratinib is manufactured in the United States and Europe under Bristol-Myers Squibb’s regulated production facilities.

Inrebic (Fedratinib) 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.

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