Active Pharmaceutical Ingredient

Colchicine (CAS 64-86-8) API Manufacturer & Supplier in India

Also known as: Colcrys, Mitigare (brand)

CAS: 64-86-8 Anti-Gout Alkaloid USP / BP / IP Bulk Supply Available
Colchicine API Manufacturer India | Mediocon Inc
Colchicine — Pharmaceutical Grade API

Product Overview

CAS No: 64-86-8  |  MF: C₂₂H₂₅NO₆  |  MW: 399.44 g/mol

Colchicine is a natural alkaloid derived from Colchicum autumnale (autumn crocus) that inhibits microtubule polymerization. It is used for acute gout flares, gout prophylaxis, familial Mediterranean fever (FMF), and pericarditis. It disrupts the inflammatory cascade by preventing neutrophil migration. Mediocon Inc supplies pharmaceutical-grade Colchicine meeting IP/BP/EP/USP standards.

Key Features

  • Natural anti-inflammatory alkaloid – tubulin binder
  • IP/BP/EP/USP compliant, Assay 99.0% Min.
  • First-line treatment for acute gout and FMF
  • Suitable for oral tablet formulations

Applications

  • Acute gout flare treatment
  • Gout attack prophylaxis
  • Familial Mediterranean fever management
  • Pericarditis prevention and treatment

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 NameColchicine
Also Known AsColcrys, Mitigare (brand)
CAS Number64-86-8
Molecular FormulaC₂₂H₂₅NO₆
Molecular Weight399.44 g/mol
CategoryAnti-Gout / Anti-inflammatory Alkaloid
AppearanceYellow Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 1.0%
Heavy MetalsNMT 10 ppm
Related SubstancesComplies
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 Colchicine (CAS 64-86-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Colchicine 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 — Colchicine API

What is the minimum order quantity for Colchicine API?
Mediocon Inc supplies Colchicine 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 Colchicine does Mediocon supply?
We supply Colchicine 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 Colchicine API?
Every shipment of Colchicine 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 Colchicine bulk orders?
Standard lead time for Colchicine 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.
💬
Mediocon AI
Hello 👋 How can I help you today?