Afatinib Dimaleate API Manufacturer & Supplier in India

Afatinib Dimaleate is a pharmaceutical-grade Active Pharmaceutical Ingredient in the Oncology / EGFR Inhibitor category. Mediocon Inc supplies high-purity Afatinib Dimaleate API (CAS 850140-73-7) from our GMP-certified facility in Aurangabad, Maharashtra, India. We cater to pharmaceutical manufacturers, formulators, and research organizations worldwide.

Afatinib Dimaleate is used in: Non-small cell lung cancer; EGFR/HER2/HER4 inhibitor; targeted therapy. Mediocon's Afatinib Dimaleate meets the highest pharmacopoeial standards and is manufactured under WHO-GMP compliant conditions for consistent quality and purity.

Key Features

• High-purity pharmaceutical grade API (NLT 98.0% assay)
• IP / BP / EP / USP compliant with full analytical verification
• Full CoA, MSDS/SDS, and COO documentation with every batch
• GMP certified manufacturing under ISO 9001:2015 QMS

Applications & Therapeutic Uses

• Non-small cell lung cancer; EGFR/HER2/HER4 inhibitor; targeted therapy
• Pharmaceutical formulation and drug product manufacturing
• Bioequivalence and clinical research studies
• Generic drug development (ANDA/NDA)

Why Choose Mediocon

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

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Afatinib Dimaleate (CAS 850140-73-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Afatinib Dimaleate 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