Active Pharmaceutical Ingredient

Mirtazapine — CAS 61337-67-5

Also known as: Remeron; Avanza; Zispin

GMP Certified IP / BP / EP / USP Noradrenergic and Specific Serotonergic Antidepressant (NaSSA) Aurangabad, India
Mirtazapine API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Mirtazapine IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 61337-67-5

Product Overview

Mirtazapine is a high-purity Active Pharmaceutical Ingredient (API) classified as a Noradrenergic and Specific Serotonergic Antidepressant (NaSSA). Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 61337-67-5.

Therapeutic Applications
  • Major depressive disorder (MDD)
  • Generalized anxiety disorder (GAD)
  • Post-traumatic stress disorder (PTSD)
  • Insomnia and sleep disturbances associated with depression
  • Nausea and appetite stimulation in oncology patients

Technical Specifications

ParameterSpecification
CAS Number61337-67-5
Molecular FormulaC₁₇H₁₉N₃
Molecular Weight265.35 g/mol
GradeIP / BP / EP / USP
CategoryNoradrenergic and Specific Serotonergic Antidepressant (NaSSA)
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water; freely soluble in methanol and chloroform
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 NoMIR/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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