Active Pharmaceutical Ingredient

Propofol API Manufacturer & Supplier in India

Also known as: Diprivan; Fresofol

CAS: 2078-54-8 Intravenous Anesthetic Agent IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Propofol API — Mediocon Inc
Propofol — Pharmaceutical Grade API

Product Overview

CAS No: 2078-54-8  |  MF: C₁₂H₁₈O  |  MW: 178.27 g/mol

Propofol is a pharmaceutical-grade active ingredient classified as an Intravenous Anesthetic Agent. Mediocon Inc supplies high-purity Propofol API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Propofol is a short-acting phenolic intravenous anesthetic that enhances GABA-mediated chloride influx in the CNS, producing rapid sedation and anesthesia. Its rapid onset and short duration of action, with minimal accumulation, have made it the most widely used induction and maintenance anesthetic globally.

Key Features

  • High-purity pharmaceutical grade API
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • General anesthesia induction and maintenance
  • ICU sedation in mechanically ventilated patients
  • Procedural sedation (endoscopy, etc.)
  • Post-operative antiemetic effect

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 NamePropofol
Also Known AsDiprivan; Fresofol
CAS Number2078-54-8
Molecular FormulaC₁₂H₁₈O
Molecular Weight178.27 g/mol
CategoryIntravenous Anesthetic Agent
AppearanceColorless to pale yellow liquid
SolubilityPractically insoluble in water; formulated as oil-in-water emulsion
GradeIP / BP / EP / USP

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 Propofol (CAS 2078-54-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Propofol 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 — Propofol API

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