Active Pharmaceutical Ingredient

Linezolid API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 165800-03-3 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Linezolid API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Linezolid API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 165800-03-3 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Linezolid API is a synthetic antibacterial active pharmaceutical ingredient belonging to the oxazolidinone class of antibiotics. It is a potent protein-synthesis inhibitor used primarily against susceptible Gram-positive bacterial infections, including infections caused by organisms that may be resistant to several other antibacterial classes.

Chemically, Linezolid is an oxazolidinone derivative containing a fluorophenyl group, morpholine ring and acetamide side chain. It is identified by CAS No. 165800-03-3, with molecular formula C₁₆H₂₀FN₃O₄ and molecular weight approximately 337.35 g/mol.

Linezolid exerts its antibacterial activity by binding to a specific site on 23S ribosomal RNA of the 50S bacterial ribosomal subunit. This prevents formation of the functional 70S initiation complex required for bacterial protein synthesis, thereby inhibiting bacterial growth.

Linezolid has important applications in pharmaceutical formulations intended for infections caused by susceptible Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus faecium (VRE) in appropriate clinical settings. Its distinctive mechanism and oxazolidinone structure make it an important compound in antibacterial pharmaceutical research and formulation development.

MEDIOCON INC supplies Linezolid API for pharmaceutical manufacturing, formulation development, analytical research, quality-control applications and applicable bulk API requirements, subject to product availability, applicable regulatory requirements and supporting documentation. The exact grade, assay, related-substance profile, water content, particle characteristics, packaging and Certificate of Analysis should be confirmed for the specific batch.

USP maintains an official Linezolid drug-substance monograph, including identification, assay and related reference standards. USP states that Linezolid contains NLT 98.0% and NMT 102.0% of Linezolid on an anhydrous, solvent-free basis.

Key Applications

  • Antibacterial pharmaceutical formulations
  • Oxazolidinone antibiotic development
  • Gram-positive bacterial infection research
  • Pharmaceutical formulation development
  • Antimicrobial research
  • Analytical research
  • Quality-control testing
  • Bulk API sourcing

Product Specifications

Product NameLinezolid API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number165800-03-3
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to off-white crystalline powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder
Assay (HPLC)98.0% – 102.0%

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 Linezolid API Manufacturer & Supplier in India | MEDIOCON INC (CAS 165800-03-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Linezolid 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 — Linezolid API Manufacturer & Supplier in India | MEDIOCON INC

What is Linezolid?
Linezolid is a synthetic oxazolidinone antibiotic that inhibits bacterial protein synthesis.
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