Active Pharmaceutical Ingredient

Metaxalone API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 1665-48-1 Active Pharmaceutical Ingredient USP / Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Metaxalone API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Metaxalone API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 1665-48-1 | Grade: USP / Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Metaxalone API

Metaxalone is a pharmaceutical-grade Active Pharmaceutical Ingredient (API) belonging to the centrally acting skeletal muscle relaxant class. It is used in pharmaceutical formulations for the symptomatic relief of acute, painful musculoskeletal conditions and is generally administered as an oral medicine. MEDIOCON INC supplies quality-focused Metaxalone API for pharmaceutical formulation, product development, analytical requirements and bulk API applications.

Metaxalone is also known as Metaxalone, Metaxalon, Methaxalonum, Zorane, Skelaxin, Methoxolone and AHR-438. Its CAS number is 1665-48-1, molecular formula is C₁₂H₁₅NO₃, and molecular weight is 221.25 g/mol. PubChem identifies Metaxalone as an aromatic ether and confirms its chemical identity and associated identifiers.

The systematic chemical name of Metaxalone is 5-[(3,5-dimethylphenoxy)methyl]-1,3-oxazolidin-2-one. The molecule contains an oxazolidinone ring linked through a methylene group to a 3,5-dimethylphenoxy moiety. PubChem provides the corresponding IUPAC name, molecular structure, SMILES and InChI identifiers.

Metaxalone is a white to almost white crystalline powder in pharmaceutical-grade material. It is used as the active ingredient in oral muscle-relaxant formulations. Its pharmacological effect is centrally mediated, and the exact mechanism of action has not been fully established.

The current USP-NF monograph defines Metaxalone as containing NLT 98.0% and NMT 102.0% of C₁₂H₁₅NO₃, calculated on the dried basis. USP also identifies USP Metaxalone RS, USP Metaxalone Related Compound B RS and USP Metaxalone Related Compound C RS as reference standards for the monograph.

MEDIOCON INC supplies Metaxalone API for pharmaceutical formulation, analytical development and commercial pharmaceutical requirements. Supporting documentation such as Certificate of Analysis (COA), MSDS/SDS and applicable technical specifications can be provided according to product specification and customer requirements.

Metaxalone should be handled and stored according to the applicable pharmaceutical quality system and validated manufacturer specifications. Appropriate packaging and environmental controls should be used to maintain API quality throughout storage and transportation.

MEDIOCON INC focuses on quality-oriented supply of Metaxalone API for domestic and international pharmaceutical customers.

Product Specifications

Product NameMetaxalone API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number1665-48-1
CategoryActive Pharmaceutical Ingredient
GradeUSP / Pharmaceutical Grade
AppearanceWhite to Almost White Crystalline Powder
StandardsUSP Pharmaceutical Standard

Analytical Specifications

ParameterSpecification
AppearanceWhite to Almost White Crystalline Powder
IdentificationIR & HPLC Complies
Assay (HPLC)98.0% – 102.0%
Melting Point121°C – 124°C

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 Metaxalone API Manufacturer & Supplier in India | MEDIOCON INC (CAS 1665-48-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Metaxalone API Manufacturer & Supplier in India | MEDIOCON INC 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Metaxalone API Manufacturer & Supplier in India | MEDIOCON INC

What is Metaxalone?
Metaxalone is a pharmaceutical active ingredient belonging to the centrally acting skeletal muscle relaxant class and is used for symptomatic relief of acute painful musculoskeletal conditions.
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