Active Pharmaceutical Ingredient

Simvastatin — CAS 79902-63-9

Also known as: Zocor; Simlup

GMP Certified IP / BP / EP / USP HMG-CoA Reductase Inhibitor / Statin Aurangabad, India
Simvastatin API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Simvastatin IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 79902-63-9

Product Overview

Simvastatin is a semisynthetic HMG-CoA reductase inhibitor (statin) derived from lovastatin, widely prescribed for the management of hypercholesterolemia and mixed dyslipidemia. It significantly reduces LDL cholesterol and the risk of major cardiovascular events. Mediocon Inc produces pharmacopoeial-grade Simvastatin API at its GMP-certified Aurangabad facility.

Therapeutic Applications
  • Hypercholesterolemia management
  • Cardiovascular disease prevention
  • LDL cholesterol reduction
  • Statin formulations

Technical Specifications

ParameterSpecification
CAS Number79902-63-9
Molecular FormulaC₂₅H₃₈O₅
Molecular Weight418.57 g/mol
GradeIP / BP / EP / USP
CategoryHMG-CoA Reductase Inhibitor / Statin
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2025
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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