Lazertinib bulk supplier for pharma manufacturers

Lazertinib 240 mg, 80 mg Suppliers & Bulk Manufacturers

Q: What is Lazertinib made from?

Lazertinib is a smallâmolecule EGFR tyrosine kinase inhibitor. It selectively and irreversibly binds to mutant EGFR proteins in cancer cells, blocking signals that promote tumor cell proliferation and survival. It is formulated with excipients suitable for oral administration.

Available Forms: Tablets

Available Strengths: 240 mg, 80 mg

Reference Brands: Lazcluze (USA)

Category: Oncology Cancer Care

Lazertinib is a third‑generation EGFR tyrosine kinase inhibitor used to treat advanced or metastatic non‑small cell lung cancer (NSCLC) in adults whose tumors carry certain EGFR mutations (exon 19 deletions or exon 21 L858R substitution). It blocks abnormal EGFR signaling in cancer cells, inhibiting growth and helping shrink tumors.

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Product Description:

Lazertinib is a third-generation EGFR tyrosine kinase inhibitor. Like others in its generation it binds irreversibly and spares wild-type receptor, which limits the rash and diarrhoea that constrained the earlier drugs, and it covers the T790M resistance mutation. It also penetrates the central nervous system well, which matters because brain metastases are common in EGFR-mutant lung cancer and were historically a point where systemic treatment failed while the rest of the disease stayed controlled.

It is used for advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or the L858R substitution, notably in combination with amivantamab, a bispecific antibody against EGFR and MET — the pairing attacks the receptor from inside and outside the cell and closes the MET-mediated escape route. Rash, paronychia, diarrhoea, stomatitis and venous thromboembolism occur, the last frequently enough that prophylactic anticoagulation is used early in the combination.

Sourcing notes. Originator product, on patent, approved in a limited number of territories to date. A 240 mg tablet provides the standard once-daily dose and an 80 mg tablet the reduced doses, so a supply plan needs both. Demand is tied to amivantamab availability. EGFR mutation testing is mandatory at the destination. Oral solid, room temperature.

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

Lazertinib is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Lazertinib, hold a dossier for it or want to license it, talk to us.

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

Lazertinib is used for the treatment of advanced or metastatic Non‑Small Cell Lung Cancer (NSCLC) in adult patients whose tumors have specific mutations in the Epidermal Growth Factor Receptor (EGFR) gene, such as exon 19 deletion or exon 21 L858R substitution. It is often prescribed in combination with Amivantamab as a first‑line chemotherapy‑free regimen for eligible patients.

Lazertinib is a small‑molecule EGFR tyrosine kinase inhibitor. It selectively and irreversibly binds to mutant EGFR proteins in cancer cells, blocking signals that promote tumor cell proliferation and survival. It is formulated with excipients suitable for oral administration.

The trade names for lazertinib include Lazcluze and Leclaza (region-specific).

Lazcluze (lazertinib) is manufactured by Janssen-Cilag, part of Johnson & Johnson.

The generic name is lazertinib.

Brand names include Lazcluze and Leclaza.

Lazertinib is manufactured in GMP-certified facilities by Janssen-Cilag for global distribution.

Lazcluze (Lazertinib) is developed and sold by Johnson & Johnson, and by discovered by Yuhan (Leclaza in Korea). 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.