Active Pharmaceutical Ingredient

Rotigotine — CAS 92206-54-7

Also known as: Neupro; SPM-962; N-0923

GMP Certified IP / BP / EP / USP Dopamine Agonist / Anti-Parkinsonian Agent Aurangabad, India
Rotigotine API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Rotigotine IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 92206-54-7

Product Overview

Rotigotine is a high-purity Active Pharmaceutical Ingredient (API) classified under Dopamine Agonist / Anti-Parkinsonian Agent. Mediocon Inc manufactures GMP-compliant Rotigotine at its state-of-the-art facility in Aurangabad, Maharashtra, India, supplying pharmaceutical companies worldwide with consistent quality and full regulatory documentation.

Therapeutic Applications
  • Parkinson's disease (early and advanced stage)
  • Restless legs syndrome (RLS)
  • Transdermal dopaminergic therapy
  • Monotherapy or adjunct in Parkinson's management

Technical Specifications

ParameterSpecification
CAS Number92206-54-7
Molecular FormulaC₁₉H₂₅NOS
Molecular Weight315.47 g/mol
GradeIP / BP / EP / USP
CategoryDopamine Agonist / Anti-Parkinsonian Agent
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoROT/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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