Active Pharmaceutical Ingredient

Ramelteon — CAS 196597-26-9

Also known as: TAK-375; Rozerem

GMP Certified IP / BP / EP / USP Melatonin Receptor Agonist Aurangabad, India
Ramelteon API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Ramelteon IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 196597-26-9

Product Overview

Ramelteon is a melatonin receptor agonist that binds with high selectivity to MT1 and MT2 receptors in the suprachiasmatic nucleus. It is approved for the treatment of insomnia characterized by difficulty with sleep onset. Mediocon Inc manufactures GMP-compliant Ramelteon at its Aurangabad facility.

Therapeutic Applications
  • Treatment of insomnia characterized by difficulty with sleep onset
  • Melatonin receptor (MT1/MT2) agonist
  • Circadian rhythm sleep disorder treatment
  • Non-habit-forming sleep aid

Technical Specifications

ParameterSpecification
CAS Number196597-26-9
Molecular FormulaC₁₆H₂₁NO₂
Molecular Weight259.34 g/mol
GradeIP / BP / EP / USP
CategoryMelatonin Receptor Agonist
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 NoRMTN/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
💬
Mediocon AI
Hello 👋 How can I help you today?