Daratumumab API Manufacturer & Supplier in India

Daratumumab is a human IgG1κ monoclonal antibody targeting CD38, a glycoprotein highly expressed on multiple myeloma cells. It induces tumor cell death via multiple mechanisms including complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). Mediocon Inc supplies pharmaceutical-grade Daratumumab for bulk pharma manufacturing.

Key Features

• Analgesic, antipyretic & anti-inflammatory
• USP/BP/IP compliant quality
• Widely used in cardiovascular therapy
• Suitable for tablet and effervescent formulations

Applications

• Multiple myeloma (relapsed/refractory)
• First-line multiple myeloma combination regimens
• Smoldering multiple myeloma (investigational)
• Oncology biologic formulation R&D

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 Daratumumab (CAS 945721-28-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Daratumumab 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