High-purity Epinastine Hydrochloride API — GMP Certified
Epinastine Hydrochloride is a second-generation antihistamine and mast cell stabiliser used for allergic conjunctivitis and allergic rhinitis. Mediocon Inc manufactures Epinastine Hydrochloride API to IP/BP/EP/USP pharmacopoeial standards in its GMP-certified facility in Aurangabad, Maharashtra, India.
Our Epinastine Hydrochloride API is widely used in ophthalmic and oral allergy formulations and is supplied with complete quality documentation. We supply to 40+ countries for both R&D and commercial manufacturing.
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 Epinastine Hydrochloride (CAS 80012-43-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Epinastine 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