Lazertinib Intermediate Manufacturer & Supplier: Europe & UK

Lazertinib Intermediate Supplier | CAS NO:  26033-20-5

Following the European Medicines Agency (EMA) marketing authorization of Lazcluze™ (Lazertinib) in combination with amivantamab for first-line treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) across the European Union, pharmaceutical manufacturers, CDMOs, and generic developers in Germany, the United Kingdom, Switzerland, Ireland, France, and Italy face rapidly increasing demand for validated, regulatory-compliant starting materials.

At Lifechem Pharma (lifechempharma.com), we are an established chemical manufacturer of high-purity API intermediates and Key Starting Materials (KSMs). We specialize in commercial-scale supply of the essential chemical building blocks required to synthesize Lazertinib (CAS: 1903008-80-9) and Lazertinib Mesylate, supporting European and UK pharmaceutical innovators and generic filers with full regulatory dossiers, REACH-compliant documentation, and direct temperature-controlled export.

Lazertinib Intermediates Portfolio for European & UK Sourcing

Lifechem Pharma manufactures and directly exports the following three critical Lazertinib building blocks adhering to European Pharmacopoeia (Ph. Eur.) and ICH Q7/Q3A standards:

Technical Specifications & Role in Industrial Lazertinib Synthesis

1. 3-Phenyl-1H-pyrazole-4-carbaldehyde (CAS: 26033-20-5) — Pyrazole Core

• Chemical Identifiers: Molecular Formula: C10H8N2O | Molecular Weight: 172.18 g/mol
• Synthetic Role: Primary heterocyclic starting material establishing the core 3-phenyl-1H-pyrazole scaffold that provides potent, mutant-selective inhibition against EGFR activating mutations and T790M resistance. The C4-carbaldehyde group is aminated via reductive amination in downstream steps to install the dimethylaminomethyl tail.
• Lifechem Export Spec: Chromatographic Purity >= 99.0% by HPLC, Single Impurity <= 0.3%, Moisture (KF) < 0.5%, heavy metals < 10 ppm. Supplied from multi-kilogram R&D quantities to metric-ton commercial batches for European formulation plants.

2. 4-Fluoro-2-methoxy-5-nitroaniline (CAS: 1075705-01-9) — Aniline Fragment

• Chemical Identifiers: Molecular Formula: C7H7FN2O3 | Molecular Weight: 186.14 g/mol
• Synthetic Role: The core fluorinated aniline precursor. The aromatic fluorine undergoes clean nucleophilic aromatic substitution (SNAr) with morpholine to install the 4-morpholino pharmacophore, while the nitro group is subsequently reduced to a primary amine for pyrimidine coupling.
• Lifechem Export Spec: Purity >= 98.5% by HPLC, Melting Point 140–144°C, Loss on Drying < 0.5%, tightly controlled regioisomer levels.

3. 4-Chloro-2-(methylthio)pyrimidine (CAS: 49844-90-8) — Pyrimidine Linker

• Chemical Identifiers: Molecular Formula: C5H5ClN2S | Molecular Weight: 160.62 g/mol
• Synthetic Role: The bifunctional pyrimidine linker. The C4-chloro group selectively couples with the pyrazole core; oxidation of the thiomethyl group gives the activated sulfone intermediate for subsequent coupling with the morpholino-aniline fragment.
• Lifechem Export Spec: Purity >= 98.0% by GC/HPLC, low residual moisture, packaged under inert nitrogen in UN-certified drums.

European Regulatory Compliance: Supporting EMA & UK MHRA Filings

European pharmaceutical buyers in Germany, Switzerland, the UK, and Ireland operate under strict European Medicines Agency (EMA) and UK MHRA compliance mandates. Lifechem Pharma provides full regulatory alignment:

• EU REACH & CLP Compliance: Our intermediates comply with EU REACH Regulation (EC No 1907/2006) and CLP Regulation (EC No 1272/2008), supplied with extended Safety Data Sheets (eSDS).
• ICH Q3A(R2) Impurity Control: Ultra-low impurity profiles in our starting materials prevent formation of downstream process impurities (Lazertinib Impurity 1, 2, 4) in crude API batches, ensuring compliance with ICH Q3A(R2).
• ICH M7 Genotoxic Assessment: Screened for potential DNA-reactive alkylating reagents and nitrosamine precursors under ICH M7 guidelines.
• Complete Analytical Dossiers: Batch-specific Route of Synthesis (ROS), elemental impurity reports (ICH Q3D by ICP-MS), residual solvent testing (ICH Q3C by Headspace-GC), and BSE/TSE-free certification for smooth QP (Qualified Person) release in Europe.

Fast European & UK Logistics & Packaging

We ensure unbroken supply chain security with direct air and sea freight logistics to major European distribution centers:

• Major European Hubs: Direct air shipments to Frankfurt Airport (FRA), London Heathrow (LHR), Amsterdam Schiphol (AMS), Dublin Airport (DUB), Milan Malpensa (MXP), and Zurich (ZRH) with typical customs delivery within 3–6 business days.
• Pharmaceutical Packaging: UN-approved 25 kg fiber drums with double anti-static polyethylene liners, moisture barrier foil bags, and temperature logging devices for sensitive shipments.

Frequently Asked Questions for European Procurement Teams

Q1: Does Lifechem Pharma export Lazertinib intermediates directly to Germany, UK, and Switzerland?

Yes. Lifechem Pharma regularly exports commercial-scale Lazertinib starting materials (CAS: 26033-20-5, 1075705-01-9, 49844-90-8) directly to pharmaceutical manufacturers and CDMOs across Germany, the UK, Switzerland, Ireland, France, and Italy with complete export documentation (DDP, CIF, FOB terms).

Q2: Does Lifechem Pharma manufacture Lazertinib finished tablets or impurity standards?

No. Lifechem Pharma (lifechempharma.com) is strictly an intermediate and Key Starting Material (KSM) manufacturer. We do not produce finished formulation products or analytical impurity reference standards.

Q3: How do your intermediate specifications support European regulatory audits?

Every batch is supplied with validated analytical documentation including 1H/13C NMR, HPLC/GC chromatograms, KF moisture, residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), enabling European QP release and seamless ASMF/DMF preparation.