Active Pharmaceutical Ingredient

Darolutamide

Also known as: Nubeqa

CAS: 1297538-32-9 Antineoplastic / Androgen Receptor Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Darolutamide API — Mediocon Inc
Darolutamide — Pharmaceutical Grade API

Product Overview

CAS No: 1297538-32-9  |  MF: C27H29N3O2F4  |  MW: 513.54

Darolutamide is a pharmaceutical-grade active ingredient classified as Antineoplastic / Androgen Receptor Inhibitor. Mediocon Inc supplies high-purity Darolutamide API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Darolutamide works by androgen receptor inhibitor mechanism to provide therapeutic efficacy. 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

  • Non-metastatic castration-resistant prostate cancer
  • Metastatic hormone-sensitive prostate cancer
  • Androgen receptor targeting
  • Urology-oncology formulations

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

Product Specifications

Product NameDarolutamide
CAS Number1297538-32-9
Molecular FormulaC27H29N3O2F4
Molecular Weight513.54
CategoryAntineoplastic / Androgen Receptor Inhibitor
AppearanceWhite to off-white powder
GradeIP / BP / EP / USP
Batch NoDAR2503021A
Mfg DateMAR 2025
Exp DateFEB 2030
Quantity25.00 Kg
Gross Weight26.00 Kg

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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