Active Pharmaceutical Ingredient

Roflumilast — CAS 162401-32-3

Also known as: Daliresp; Daxas; BY 217

GMP Certified IP / BP / EP / USP PDE4 Inhibitor / Anti-inflammatory Agent Aurangabad, India
Roflumilast API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Roflumilast IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 162401-32-3

Product Overview

Roflumilast is a high-purity Active Pharmaceutical Ingredient (API) classified under PDE4 Inhibitor / Anti-inflammatory Agent. Mediocon Inc manufactures GMP-compliant Roflumilast at its state-of-the-art facility in Aurangabad, Maharashtra, India, supplying pharmaceutical companies worldwide with consistent quality and full regulatory documentation.

Therapeutic Applications
  • Chronic obstructive pulmonary disease (COPD)
  • Phosphodiesterase-4 (PDE4) inhibition
  • Reduction of COPD exacerbations
  • Plaque psoriasis treatment

Technical Specifications

ParameterSpecification
CAS Number162401-32-3
Molecular FormulaC₁₇H₁₄Cl₂F₂N₂O₃
Molecular Weight403.21 g/mol
GradeIP / BP / EP / USP
CategoryPDE4 Inhibitor / Anti-inflammatory 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 NoROF/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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