Erlotinib Hydrochloride API Manufacturer & Supplier in India

Erlotinib Hydrochloride is a selective EGFR (HER1/EGFR) tyrosine kinase inhibitor used in the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer. Mediocon Inc manufactures Erlotinib Hydrochloride API to IP/BP/EP/USP pharmacopoeial standards in its GMP-certified facility in Aurangabad, Maharashtra, India.

Our Erlotinib Hydrochloride API is supplied to oncology pharmaceutical manufacturers globally with comprehensive quality documentation and regulatory support including DMF for FDA and EMA filings.

Key Features

• High-purity pharmaceutical grade API
• IP / BP / EP / USP compliant
• Full CoA and MSDS documentation
• GMP certified manufacturing

Applications

• Non-small cell lung cancer (NSCLC) treatment
• Pancreatic cancer therapy
• EGFR-positive cancer targeted therapy
• Oncology oral tablet formulation manufacturing

Why Choose Mediocon

• ISO 9001:2015 & GMP certified manufacturing
• Consistent batch-to-batch quality with full CoA
• Export-ready documentation: COO, MSDS, DMF
• Flexible MOQ for both R&D and commercial scale
• Dedicated QA support for regulatory filings

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Erlotinib Hydrochloride (CAS 183321-74-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Erlotinib Hydrochloride 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 — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — 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
• Stability data available (ICH Q1A guidelines) for regulatory submissions
• Dedicated QA team for customer audits and regulatory queries