Ambamustine API Manufacturer & Supplier in India

Ambamustine is a pharmaceutical-grade Active Pharmaceutical Ingredient in the Antineoplastic / Nitrogen Mustard Conjugate category. Mediocon Inc supplies high-purity Ambamustine API (CAS 80168-70-3) from our GMP-certified facility in Aurangabad, Maharashtra, India. We cater to pharmaceutical manufacturers, formulators, and research organizations worldwide.

Antineoplastic nitrogen mustard conjugate designed for targeted cytotoxic delivery in cancer therapy. Mediocon's Ambamustine 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)
• Pharma Grade 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

• Cancer chemotherapy formulations
• Alkylating agent-based therapy
• Oncology research applications
• Antineoplastic compound synthesis

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 Ambamustine (CAS 80168-70-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ambamustine is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP / BP / EP / USP). 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