Lutetium Lu 177 Dotatate API Manufacturer & Supplier in India

Lutetium Lu 177 Dotatate is a pharmaceutical-grade active ingredient classified as Radiopharmaceutical / Peptide Receptor Radionuclide Therapy. Mediocon Inc supplies high-purity Lutetium Lu 177 Dotatate API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

• Targeted radiopharmaceutical for IV use
• For radiopharmaceutical use only
• Full CoA and MSDS documentation
• GMP certified manufacturing

Applications

• Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
• Midgut neuroendocrine tumors
• PRRT — Peptide Receptor Radionuclide Therapy

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 Lutetium Lu 177 Dotatate (CAS 140462-76-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Lutetium Lu 177 Dotatate 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