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Osimertinib Tablets bulk supplier for pharma manufacturers

Osimertinib Tablets 40 mg, 80 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 40 mg, 80 mg

Reference Brands: Tagrisso (USA/EU)

Category: Oncology Cancer Care

Osimertinib (40 mg, 80 mg tablets) is a third-generation EGFR inhibitor for non-small cell lung cancer with EGFR mutations, including the T790M resistance mutation, and as adjuvant therapy after surgery. It is made by AstraZeneca as Tagrisso. Supply is through authorised distribution or named-patient import; ask us which route fits your country.

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Product Description:

Osimertinib is a third-generation EGFR inhibitor built to solve the problem that defeated the first generation. Tumours treated with gefitinib or erlotinib escape after about a year, most often by acquiring the T790M gatekeeper mutation, which blocks those drugs from binding. Osimertinib binds irreversibly and is active against T790M while sparing wild-type receptor, which is why it causes markedly less rash and diarrhoea than its predecessors despite greater potency.

It is now used first line in EGFR-mutant advanced non-small cell lung cancer rather than held in reserve, as adjuvant treatment after resection of EGFR-mutant disease, and after progression on earlier inhibitors in T790M-positive tumours. It penetrates the central nervous system well and controls brain metastases, a decisive advantage in this population. Diarrhoea, rash, paronychia and stomatitis are usually manageable; QT prolongation, reduced ejection fraction and rare interstitial lung disease need monitoring.

Sourcing notes. Originator product, on patent in the major markets, with two tablet strengths — the lower one exists for dose reduction, not as an alternative starting dose. EGFR mutation testing is mandatory at the destination. Oral solid, room temperature.

How Osimertinib Tablets 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

As first-line treatment for advanced EGFR-mutated non-small cell lung cancer, for T790M-positive disease after earlier EGFR inhibitors, and as adjuvant therapy after surgery.

Tagrisso (AstraZeneca) is patented in the US and EU. Generic versions are marketed in some countries, such as Bangladesh, so we confirm patent status for your destination.

40 mg and 80 mg film-coated tablets, taken once daily.

Tagrisso (Osimertinib) is developed and sold by AstraZeneca. 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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