Active Pharmaceutical Ingredient

Anubrutinib

Also known as: ACP-196

CAS: 1771250-19-1 Antineoplastic / BTK Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Anubrutinib API — Mediocon Inc
Anubrutinib — Pharmaceutical Grade API

Product Overview

CAS No: 1771250-19-1  |  MF: C23H21FN6O2  |  MW: 432.46

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

Anubrutinib works by btk 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

  • B-cell malignancies
  • Mantle cell lymphoma
  • Chronic lymphocytic leukemia
  • Autoimmune disease 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

Product Specifications

Product NameAnubrutinib
CAS Number1771250-19-1
Molecular FormulaC23H21FN6O2
Molecular Weight432.46
CategoryAntineoplastic / BTK Inhibitor
AppearanceWhite to off-white powder
GradeIP / BP / EP / USP
Batch NoANE2503021
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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