High-purity Epalrestat API — GMP Certified
Epalrestat is an aldose reductase inhibitor used in the management of diabetic peripheral neuropathy. Mediocon Inc manufactures Epalrestat API conforming to IP/BP/EP/USP pharmacopoeial standards in its GMP-certified facility in Aurangabad, Maharashtra, India.
Our Epalrestat API is widely used in diabetic neuropathy treatment formulations and is supplied with comprehensive quality documentation including CoA, MSDS, and Certificate of Origin.
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 Epalrestat (CAS 82159-09-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Epalrestat 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