Active Pharmaceutical Ingredient

Lisdexamfetamine Dimesylate API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 608137-33-3 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Lisdexamfetamine Dimesylate API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Lisdexamfetamine Dimesylate API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 608137-33-3 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Lisdexamfetamine Dimesylate API is the dimesylate salt of lisdexamfetamine, a chemically designed prodrug of dextroamphetamine belonging to the central nervous system stimulant class. Lisdexamfetamine consists of dextroamphetamine covalently linked to the naturally occurring amino acid L-lysine. Following administration, enzymatic cleavage releases dextroamphetamine, which produces the principal pharmacological activity.

Lisdexamfetamine Dimesylate is chemically identified as (2S)-2,6-diamino-N-[(2S)-1-phenylpropan-2-yl]hexanamide; methanesulfonic acid, representing lisdexamfetamine associated with two molecules of methanesulfonic acid. The substance has the molecular formula C₁₇H₃₃N₃O₇S₂, molecular weight approximately 455.59 g/mol, and CAS No. 608137-33-3. It contains two defined stereocenters, making stereochemical identity and enantiomeric purity important analytical characteristics.

Lisdexamfetamine is used therapeutically as a CNS stimulant, including in the treatment of attention-deficit/hyperactivity disorder (ADHD) and moderate-to-severe binge-eating disorder in applicable jurisdictions. Its pharmacological activity is primarily attributable to the dextroamphetamine released from the prodrug.

From a pharmaceutical-development perspective, Lisdexamfetamine Dimesylate is relevant to CNS pharmaceutical formulations, stimulant drug development, analytical research, pharmaceutical quality control and formulation development. Because the molecule is a chiral prodrug and contains two mesylate equivalents, appropriate analytical controls for identity, assay, organic impurities, enantiomeric purity and mesylate-related impurities are particularly important.

MEDIOCON INC supplies Lisdexamfetamine Dimesylate for applicable pharmaceutical research, analytical and formulation-development requirements, subject to product availability, applicable regulatory requirements, controlled-substance regulations and supporting documentation. The exact grade, assay, impurity profile, stereochemical purity, water content, packaging and Certificate of Analysis should be confirmed for the specific batch.

Key Applications

  • CNS pharmaceutical research
  • ADHD pharmaceutical development
  • Binge-eating-disorder pharmaceutical research
  • Stimulant drug development
  • Pharmaceutical formulation development
  • Analytical research
  • Quality-control testing
  • Medicinal chemistry
  • API research

Product Specifications

Product NameLisdexamfetamine Dimesylate API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number608137-33-3
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to off-white powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white powder

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 Lisdexamfetamine Dimesylate API Manufacturer & Supplier in India | MEDIOCON INC (CAS 608137-33-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Lisdexamfetamine Dimesylate API Manufacturer & Supplier in India | MEDIOCON INC 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Lisdexamfetamine Dimesylate API Manufacturer & Supplier in India | MEDIOCON INC

What is Lisdexamfetamine Dimesylate?
Lisdexamfetamine Dimesylate is the dimesylate salt of lisdexamfetamine, a prodrug that is converted to dextroamphetamine after administration.
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