Active Pharmaceutical Ingredient

Sugammadex API Manufacturer & Supplier in India

Also known as: Bridion; Org 25969

CAS: 343306-79-6 Neuromuscular Reversal Agent IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Sugammadex API — Mediocon Inc, Aurangabad Maharashtra India
Sugammadex — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 343306-79-6  |  MF: C₇₂H₁₀₄N₈O₄₈S₈  |  MW: 2178.01 g/mol

Sugammadex is a modified gamma-cyclodextrin used as a selective reversal agent for neuromuscular blockade induced by rocuronium and vecuronium. Mediocon Inc supplies pharmaceutical-grade Sugammadex conforming to IP / BP / EP / USP specifications.

Sugammadex works by encapsulating and inactivating free steroidal muscle relaxants in plasma, providing rapid reversal of neuromuscular blockade. It is widely used in anaesthetic practice globally.

Key Features

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

Applications

  • Neuromuscular reversal formulations
  • Anesthesia drug manufacturing
  • Rocuronium/vecuronium reversal
  • Perioperative care preparations

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 NameSugammadex
Also Known AsBridion; Org 25969
CAS Number343306-79-6
Molecular FormulaC₇₂H₁₀₄N₈O₄₈S₈
Molecular Weight2178.01 g/mol
CategoryNeuromuscular Reversal Agent
AppearanceWhite to almost white powder
SolubilityFreely soluble in water
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
Mfg DateMAR 2025
Exp DateFEB 2031
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 Sugammadex (CAS 343306-79-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sugammadex 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 — Sugammadex API

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