Ranitidine API Manufacturer & Supplier in India

Ranitidine is a pharmaceutical-grade active ingredient classified as an H₂ Receptor Antagonist Antiulcer agent. Mediocon Inc supplies high-purity Ranitidine API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Ranitidine is an H2-receptor antagonist that competitively inhibits histamine at the H2 receptors of gastric parietal cells, reducing basal and stimulated acid secretion. It is used in the treatment of peptic ulcers, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. Ranitidine HCl is the pharmaceutical salt form widely used in tablet and injection formulations.

Key Features

• High-purity pharmaceutical grade API
• IP/BP/EP/USP compliant
• Full CoA and MSDS documentation
• GMP certified manufacturing

Applications

• Duodenal and gastric ulcer treatment
• GERD and erosive esophagitis
• Zollinger-Ellison syndrome
• Prevention of stress-related mucosal bleeding

Why Choose Mediocon

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

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Ranitidine (CAS 66357-35-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ranitidine 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