Active Pharmaceutical Ingredient

Mannitol Pharmaceutical Excipient Supplier India

Also known as: D-Mannitol; Mannite

CAS: 69-65-8 Osmotic Diuretic / Excipient IP / BP / USP GMP Certified Aurangabad, Maharashtra, India
Mannitol API — Mediocon Inc
Mannitol — Pharmaceutical Grade API

Product Overview

CAS No: 69-65-8  |  MF: C₆H₁₄O₆  |  MW: 182.17 g/mol

Mannitol is a pharmaceutical-grade active ingredient classified as Osmotic Diuretic / Excipient. Mediocon Inc supplies high-purity Mannitol API conforming to IP / BP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Osmotic diuretic agent
  • IP/BP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • IV osmotic diuretic therapy
  • Cerebral edema treatment
  • Tablet direct compression excipient
  • Lyophilization bulking agent

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 NameMannitol
Also Known AsD-Mannitol; Mannite
CAS Number69-65-8
Chemical NameD-Mannitol
Molecular FormulaC₆H₁₄O₆
Molecular Weight182.17 g/mol
CategoryOsmotic Diuretic / Excipient
AppearanceWhite, crystalline powder or crystalline mass
SolubilityFreely soluble in water, slightly soluble in ethanol
GradeIP / BP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 99.0%
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 Mannitol Pharmaceutical Excipient (CAS 69-65-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Mannitol Pharmaceutical Excipient 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 — Mannitol Pharmaceutical Excipient API

What is the minimum order quantity for Mannitol Pharmaceutical Excipient API?
Mediocon Inc supplies Mannitol Pharmaceutical Excipient 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 Mannitol Pharmaceutical Excipient does Mediocon supply?
We supply Mannitol Pharmaceutical Excipient conforming to IP / BP / 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 Mannitol Pharmaceutical Excipient API?
Every shipment of Mannitol Pharmaceutical Excipient 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 Mannitol Pharmaceutical Excipient bulk orders?
Standard lead time for Mannitol Pharmaceutical Excipient 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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