Active Pharmaceutical Ingredient

Sucralfate API Manufacturer & Supplier in India

Also known as: Carafate; Ulcyte; Sucrose octasulfate aluminum complex

CAS: 54182-58-0 Gastroprotective / Antiulcer Agent IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Sucralfate API — Mediocon Inc, Aurangabad Maharashtra India
Sucralfate — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 54182-58-0  |  MF: C₁₂H₅₄Al₁₆O₇₅S₈  |  MW: 2086.71 g/mol

Sucralfate is a gastrointestinal protective agent that forms a paste-like substance over ulcers in an acidic environment. It is used for the treatment of gastric and duodenal ulcers. Mediocon Inc supplies pharmaceutical-grade Sucralfate conforming to IP / BP / EP / USP specifications.

Sucralfate acts locally in the stomach by binding to proteins at ulcer sites to form a protective barrier against acid, pepsin, and bile. It is not systemically absorbed in significant amounts.

Key Features

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

Applications

  • Antiulcer tablet and suspension formulations
  • Gastric protection preparations
  • Duodenal ulcer therapy
  • Gastroprotective drug manufacturing

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 NameSucralfate
Also Known AsCarafate; Ulcyte; Sucrose octasulfate aluminum complex
CAS Number54182-58-0
Molecular FormulaC₁₂H₅₄Al₁₆O₇₅S₈
Molecular Weight2086.71 g/mol
CategoryGastroprotective / Antiulcer Agent
AppearanceWhite to off-white amorphous powder
SolubilityPractically insoluble in water and most organic solvents
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 Sucralfate (CAS 54182-58-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Sucralfate 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 — Sucralfate API

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