Active Pharmaceutical Ingredient

Baclofen (CAS 1134-47-0) API Manufacturer & Supplier in India

Also known as: Lioresal (brand)

CAS: 1134-47-0 Muscle Relaxant USP / BP / IP Bulk Supply Available
Baclofen API Manufacturer India | Mediocon Inc
Baclofen — Pharmaceutical Grade API

Product Overview

CAS No: 1134-47-0  |  MF: C₁₀H₁₂ClNO₂  |  MW: 213.66 g/mol

Baclofen is a GABA-B receptor agonist used as a muscle relaxant and antispastic agent. It is primarily used to treat spasticity resulting from multiple sclerosis, spinal cord injuries, and other neurological disorders. Mediocon Inc supplies pharmaceutical-grade Baclofen meeting IP/BP/EP/USP standards.

Key Features

  • GABA-B receptor agonist
  • IP/BP/EP/USP compliant quality
  • Muscle relaxant for spasticity
  • Suitable for tablet and intrathecal formulations

Applications

  • Oral tablets for muscle spasticity
  • Intrathecal pump formulations
  • Neurological disorder treatment
  • Rehabilitation medicine

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 NameBaclofen
Also Known AsLioresal (brand)
CAS Number1134-47-0
Molecular FormulaC₁₀H₁₂ClNO₂
Molecular Weight213.66 g/mol
CategoryMuscle Relaxant / GABA-B Agonist
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay98.5% – 101.5%
Loss on DryingNMT 0.5%
Melting Point206°C – 210°C
Heavy MetalsNMT 20 ppm
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 Baclofen (CAS 1134-47-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Baclofen 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 — Baclofen API

What is the minimum order quantity for Baclofen API?
Mediocon Inc supplies Baclofen 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 Baclofen does Mediocon supply?
We supply Baclofen 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 Baclofen API?
Every shipment of Baclofen 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 Baclofen bulk orders?
Standard lead time for Baclofen 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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