Active Pharmaceutical Ingredient

Amidox API Manufacturer & Supplier in India

Also known as: 3-AP analogue

CAS: 2395-92-8 Antineoplastic / Ribonucleotide Reductase Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Amidox API — Mediocon Inc, GMP certified manufacturer Aurangabad India
Amidox — Pharmaceutical Grade API | CAS 2395-92-8

Product Overview

CAS No: 2395-92-8  |  MF: C3H7N3O2  |  MW: 117.11 g/mol

Amidox is a pharmaceutical-grade Active Pharmaceutical Ingredient in the Antineoplastic / Ribonucleotide Reductase Inhibitor category. Mediocon Inc supplies high-purity Amidox API (CAS 2395-92-8) from our GMP-certified facility in Aurangabad, Maharashtra, India. We cater to pharmaceutical manufacturers, formulators, and research organisations worldwide.

Primary uses include: Investigational cancer treatment; inhibits ribonucleotide reductase, affecting DNA synthesis. Mediocon's Amidox meets the highest pharmacopoeial standards and is manufactured under WHO-GMP compliant conditions for consistent quality and purity.

Key Features

  • High-purity pharmaceutical grade API (NLT 98.0% assay)
  • IP / BP / EP / USP compliant with full analytical verification
  • Full CoA, MSDS/SDS, and COO documentation with every batch
  • GMP certified manufacturing under ISO 9001:2015 QMS

Applications & Therapeutic Uses

  • Investigational cancer treatment; inhibits ribonucleotide reductase, affecting DNA synthesis
  • Bulk pharmaceutical raw material for formulation manufacturers
  • R&D and analytical reference grade supply available
  • Export-ready for regulated markets (US FDA, EU EMA, WHO)

Why Choose Mediocon

  • ISO 9001:2015 & WHO-GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF support
  • Flexible MOQ — 1 kg minimum (R&D samples available)
  • Dedicated QA support for regulatory filings (FDA, EMA, WHO)

Product Specifications

Product NameAmidox
Also Known As3-AP analogue
CAS Number2395-92-8
Molecular FormulaC3H7N3O2
Molecular Weight117.11 g/mol
CategoryAntineoplastic / Ribonucleotide Reductase Inhibitor
AppearanceWhite crystalline powder
GradeIP / BP / EP / USP
StorageStore in a cool, dry place; protected from light and moisture

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
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 Amidox (CAS 2395-92-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Amidox is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP / BP / EP / USP). 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 — Amidox API

What is the minimum order quantity for Amidox API?
Mediocon Inc supplies Amidox 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 Amidox does Mediocon supply?
We supply Amidox conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Amidox API?
Every shipment of Amidox 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 Amidox bulk orders?
Standard lead time for Amidox is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging.
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