Active Pharmaceutical Ingredient

Glatiramer Acetate (CAS 147245-92-9) API Manufacturer & Supplier in India

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

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Glatiramer Acetate (CAS 147245-92-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Glatiramer Acetate 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

Frequently Asked Questions — Glatiramer Acetate API

What is the minimum order quantity for Glatiramer Acetate API?
Mediocon Inc supplies Glatiramer Acetate with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Glatiramer Acetate does Mediocon supply?
We supply Glatiramer Acetate conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Glatiramer Acetate API?
Every shipment of Glatiramer Acetate comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Glatiramer Acetate bulk orders?
Standard lead time for Glatiramer Acetate is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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