Tolvaptan API Manufacturer & Supplier in India

Tolvaptan is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Tolvaptan is a selective, oral vasopressin V₂-receptor antagonist (vaptant) that blocks the effects of vasopressin (antidiuretic hormone) in the kidney. It promotes aquaresis (free water excretion) without significant electrolyte loss and is approved for hyponatremia and autosomal dominant polycystic kidney disease (ADPKD).

Key Features

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

Applications

• Hyponatremia treatment (SIADH)
• Autosomal dominant polycystic kidney disease (ADPKD)
• Euvolemic and hypervolemic hyponatremia
• Heart failure-related fluid retention

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 Tolvaptan (CAS 150683-30-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Tolvaptan 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