Active Pharmaceutical Ingredient

Galantamine API Manufacturer & Supplier in India

Also known as: Galanthamine

CAS: 357-70-0 Cholinesterase Inhibitor / Anti-Alzheimer IP / BP / USP Bulk Supply Available
Galantamine API Manufacturer India | Mediocon Inc
Galantamine — Pharmaceutical Grade API

Product Overview

CAS No: 357-70-0  |  MF: C₁₇H₂₁NO₃  |  MW: 287.35 g/mol

Galantamine is a reversible, competitive acetylcholinesterase inhibitor and allosteric potentiating ligand of nicotinic receptors used for the symptomatic treatment of mild-to-moderate Alzheimer's disease and dementia. It enhances cholinergic neurotransmission in the brain.

Mediocon Inc supplies Galantamine IP/BP/USP as a pharmaceutical-grade active ingredient for manufacturers producing anti-dementia and cognitive health formulations. Our GMP-certified manufacturing ensures batch-to-batch consistency and full regulatory compliance.

Key Features

  • Dual-mechanism AChE inhibitor
  • Allosteric potentiating ligand (APL)
  • For mild-to-moderate Alzheimer's therapy
  • Meets IP/BP/USP pharmacopoeial standards

Applications

  • Alzheimer's disease symptom management
  • Vascular dementia formulations
  • Cognitive enhancement neurological products
  • Geriatric pharmaceutical 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 NameGalantamine
CAS Number357-70-0
Molecular FormulaC₁₇H₂₁NO₃
Molecular Weight287.35 g/mol
CategoryCholinesterase Inhibitor / Anti-Alzheimer
AppearanceWhite to Almost White Crystalline Powder
GradeIP / BP / USP
Packaging25 kg HDPE Drums / Aluminium Bags
StorageCool, Dry & Ventilated Place

Analytical Specifications

ParameterSpecification
AssayNLT 98.0% & NMT 102.0%
Water ContentNMT 1.0%
Heavy MetalsNMT 10 ppm
Residual SolventsComplies ICH Q3C
Microbial LimitsComplies
IdentificationHPLC & IR Compliant
Specific Rotation-120° to -128°
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 Galantamine (CAS 357-70-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Galantamine 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 — Galantamine API

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