Active Pharmaceutical Ingredient

Sulbactam (CAS 68373-14-8) API Manufacturer & Supplier in India

Also known as: Penicillanic acid sulfone; CP-45,899

CAS: 68373-14-8 Beta-Lactamase Inhibitor / Antibiotic Adjunct IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Sulbactam API — Mediocon Inc, Aurangabad Maharashtra India
Sulbactam — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 68373-14-8  |  MF: C₈H₁₁NO₅S  |  MW: 233.24 g/mol

Sulbactam is a beta-lactamase inhibitor used in combination with beta-lactam antibiotics to overcome bacterial resistance. Mediocon Inc supplies pharmaceutical-grade Sulbactam conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

When combined with ampicillin or other penicillins, Sulbactam inhibits beta-lactamase enzymes produced by resistant bacteria, restoring antibiotic efficacy. It is used in treating a wide range of serious infections.

Key Features

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

Applications

  • Antibiotic combination formulations
  • Beta-lactamase inhibitor preparations
  • IV injection manufacturing
  • Broad-spectrum antibacterial therapy

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 NameSulbactam
Also Known AsPenicillanic acid sulfone; CP-45,899
CAS Number68373-14-8
Molecular FormulaC₈H₁₁NO₅S
Molecular Weight233.24 g/mol
CategoryBeta-Lactamase Inhibitor / Antibiotic Adjunct
AppearanceWhite to off-white crystalline 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 Sulbactam (CAS 68373-14-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sulbactam 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 — Sulbactam API

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