Active Pharmaceutical Ingredient

Lapatinib API Manufacturer and Supplier in India

CAS: 231277-92-2 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Lapatinib API Manufacturer and Supplier in India — Mediocon Inc
Lapatinib API Manufacturer and Supplier in India

Product Overview

CAS No: 231277-92-2 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Lapatinib is a synthetic 4-anilinoquinazoline tyrosine kinase inhibitor that selectively inhibits the intracellular kinase domains of human epidermal growth factor receptor (EGFR/HER1) and human epidermal growth factor receptor 2 (HER2/ErbB2). It is an established oncology pharmaceutical active ingredient.

Lapatinib API

Lapatinib is a small-molecule kinase inhibitor belonging to the 4-anilinoquinazoline class. It inhibits phosphorylation of EGFR and HER2 receptor tyrosine kinases, interfering with signaling pathways involved in tumor-cell proliferation and survival.

The pharmaceutical product lapatinib is supplied as the ditosylate monohydrate salt; however, the active parent compound Lapatinib has the chemical identity CAS 231277-92-2, molecular formula C₂₉H₂₆ClFN₄O₄S and molecular weight approximately 581.1 g/mol.

Chemical Information

Product Name: Lapatinib
CAS Number: 231277-92-2
Molecular Formula: C₂₉H₂₆ClFN₄O₄S
Molecular Weight: Approximately 581.1 g/mol
Chemical Class: 4-Anilinoquinazoline tyrosine kinase inhibitor
Synonyms: GW572016, GW 572016, GSK 572016
PubChem CID: 208908
ChEMBL ID: CHEMBL554
DrugBank ID: DB01259

Mechanism of Action

Lapatinib is an intracellular tyrosine kinase inhibitor that inhibits the kinase domains of both EGFR (ErbB1) and HER2 (ErbB2). FDA information reports estimated apparent inhibition constants of approximately 3 nM for EGFR and 13 nM for HER2.

By inhibiting receptor phosphorylation, Lapatinib interferes with downstream ErbB signaling and inhibits ErbB-driven tumor-cell growth in experimental models.

Manufacturing and Quality

MEDIOCON INC focuses on supplying pharmaceutical and specialty chemical ingredients with emphasis on quality, consistency, technical documentation and reliable supply.

Lapatinib API quality evaluation may include identity, assay, chromatographic purity, related substances, residual solvents, water content, residue on ignition, elemental impurities and other parameters according to the applicable product specification.

The exact analytical acceptance criteria should be confirmed against the current approved specification and batch-specific Certificate of Analysis.

Applications

Lapatinib is an antineoplastic tyrosine kinase inhibitor used in oncology. It has been used in treatment regimens for certain HER2-positive breast cancers, including in combination with other anticancer therapies according to applicable prescribing information.

The specific approved indication, dosage form and combination regimen should always be confirmed against the regulatory requirements applicable to the intended market.

Product Characteristics

Lapatinib is a defined synthetic small molecule with molecular formula C₂₉H₂₆ClFN₄O₄S and molecular weight approximately 581.1 g/mol.

Lapatinib itself should be distinguished from Lapatinib Ditosylate Monohydrate. Lapatinib Ditosylate Monohydrate has CAS 388082-78-8 and molecular weight approximately 943.5 g/mol.

Packaging and Documentation

Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications and other documentation should be confirmed with MEDIOCON INC according to the intended application and customer requirements.

Product Specifications

Product NameLapatinib API Manufacturer and Supplier in India
CAS Number231277-92-2
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceYellow solid
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceYellow solid

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Lapatinib API Manufacturer and Supplier in India (CAS 231277-92-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Lapatinib API Manufacturer and Supplier in India is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Lapatinib API Manufacturer and Supplier in India

What is Lapatinib?
Lapatinib is a 4-anilinoquinazoline tyrosine kinase inhibitor that targets the intracellular kinase domains of EGFR/HER1 and HER2/ErbB2.
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