Active Pharmaceutical Ingredient

Chloramphenicol API Manufacturer & Supplier in India

Also known as: Chloromycetin (brand)

CAS: 56-75-7 Broad-Spectrum Antibiotic USP / BP / IP Bulk Supply Available
Chloramphenicol API Manufacturer India | Mediocon Inc
Chloramphenicol — Pharmaceutical Grade API

Product Overview

CAS No: 56-75-7  |  MF: C₁₁H₁₂Cl₂N₂O₅  |  MW: 323.13 g/mol

Chloramphenicol is a broad-spectrum antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. It is used for serious infections where other antibiotics are contraindicated, including typhoid fever, bacterial meningitis, and ocular infections. Mediocon Inc supplies pharmaceutical-grade Chloramphenicol meeting IP/BP/EP/USP standards.

Key Features

  • Broad-spectrum bacteriostatic antibiotic
  • IP/BP/EP/USP compliant, Assay 99.0% Min.
  • Effective against gram-positive and gram-negative bacteria
  • Suitable for oral, ophthalmic, and topical formulations

Applications

  • Ophthalmic eye drops and ointments
  • Typhoid fever treatment
  • Bacterial meningitis therapy
  • Topical skin infection formulations

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 NameChloramphenicol
Also Known AsChloromycetin (brand)
CAS Number56-75-7
Molecular FormulaC₁₁H₁₂Cl₂N₂O₅
Molecular Weight323.13 g/mol
CategoryAntibiotic / Broad-Spectrum
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 0.5%
Melting Point149°C – 153°C
Heavy MetalsNMT 10 ppm
Microbial LimitsComplies with pharmacopoeia
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 Chloramphenicol (CAS 56-75-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Chloramphenicol 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 — Chloramphenicol API

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