Dosmalfate Manufacturer & Supplier in India

Dosmalfate is a pharmaceutical-grade active ingredient classified as Gastroprotective Agent (Flavonoid Derivative). Mediocon Inc supplies high-purity Dosmalfate API conforming to Pharma Grade specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Dosmalfate forms a protective gel layer over the gastric mucosa and exerts cytoprotective activity partly mediated by endogenous prostaglandins, shielding the stomach from NSAID-induced injury. It is used as a critical raw material in finished dosage form manufacturing for global pharmaceutical markets.

Key Features

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

Applications

• NSAID-induced gastric lesion prevention
• Peptic ulcer treatment
• Gastroprotective formulation development
• Gastrointestinal pharmaceutical research

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 Dosmalfate (pharmaceutical grade) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Dosmalfate 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