High-purity Epirubicin Hydrochloride API — GMP Certified
Epirubicin Hydrochloride is the hydrochloride salt of Epirubicin, a widely used anthracycline chemotherapy agent for breast, gastric, and other cancers. Mediocon Inc manufactures Epirubicin Hydrochloride API to IP/BP/EP/USP standards in its GMP-certified facility in Aurangabad, Maharashtra, India.
Our Epirubicin Hydrochloride API is supplied to oncology pharmaceutical manufacturers worldwide with complete quality documentation. Mediocon provides full regulatory support including DMF for global submissions.
Key Features
Applications
Why Choose Mediocon
| Parameter | Specification |
|---|---|
| Assay | NLT 98.0% |
| Loss on Drying | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Residue on Ignition | NMT 0.1% |
| Microbial Limits | Complies with pharmacopoeia |
| Identification | IR, HPLC Compliant |
| Packing | 25 kg HDPE drums / as per requirement |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Epirubicin Hydrochloride (CAS 56390-09-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Epirubicin 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
Quality & Compliance