Active Pharmaceutical Ingredient

Glatiramer Acetate

Also known as: Copaxone

CAS: 147245-92-9 Immunomodulator / Multiple Sclerosis Agent IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Glatiramer Acetate API — Mediocon Inc
Glatiramer Acetate — Pharmaceutical Grade API

Product Overview

CAS No: 147245-92-9  |  MF: Mixture of polypeptides  |  MW: ~4,700–11,000 g/mol

Glatiramer Acetate is a synthetic copolymer of four amino acids that modulates immune responses to reduce relapse frequency in relapsing-remitting multiple sclerosis (RRMS). Mediocon Inc supplies pharmaceutical-grade Glatiramer Acetate API.

Key Features

  • Immunomodulatory synthetic polypeptide
  • Reduces MS relapse frequency
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation

Applications

  • Relapsing-remitting multiple sclerosis
  • MS disease modification
  • Immunomodulatory formulations
  • Subcutaneous injection preparations

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 NameGlatiramer Acetate
Also Known AsCopaxone
CAS Number147245-92-9
Molecular FormulaMixture of polypeptides
Molecular Weight~4,700–11,000 g/mol
CategoryImmunomodulator / Multiple Sclerosis Agent
AppearanceWhite lyophilized powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay≥98.0% (as per pharmacopoeia)
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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