Active Pharmaceutical Ingredient

Ketamine API Manufacturer & Supplier in India

Also known as: Ketalar / Calypsol

CAS: 6740-88-1 Dissociative Anesthetic / NMDA Antagonist IP / BP / EP / USP Bulk Supply Available
Ketamine API Manufacturer India | Mediocon Inc
Ketamine — Pharmaceutical Grade API

Product Overview

CAS No: 6740-88-1  |  MF: C₁₃H₁₆ClNO  |  MW: 237.73 g/mol

Ketamine is a rapid-acting dissociative anesthetic and NMDA receptor antagonist used for induction and maintenance of anesthesia. It is also being explored for treatment-resistant depression. Mediocon Inc supplies pharmaceutical-grade Ketamine HCl API meeting IP/BP/EP/USP standards for injectable formulations.

Key Features

  • Rapid-acting dissociative anesthetic
  • IP/BP/EP/USP compliant quality
  • NMDA receptor antagonist
  • Suitable for injectable and nasal formulations

Applications

  • General anesthesia induction and maintenance
  • Procedural sedation and analgesia
  • Treatment-resistant depression (off-label)
  • Veterinary anesthesia

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 NameKetamine
Also Known AsKetalar / Calypsol
CAS Number6740-88-1
Molecular FormulaC₁₃H₁₆ClNO
Molecular Weight237.73 g/mol
CategoryDissociative Anesthetic / NMDA Antagonist
AppearanceWhite Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay99.0% – 101.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
pH3.5 – 5.5 (HCl salt solution)
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 Ketamine (CAS 6740-88-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ketamine 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 — Ketamine API

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