Active Pharmaceutical Ingredient

Pitavastatin — CAS 147526-32-7

Also known as: Livalo; Itavastatin; NK-104

GMP Certified IP / BP HMG-CoA Reductase Inhibitor (Statin) Aurangabad, India
Pitavastatin API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Pitavastatin IP / BP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 147526-32-7

Product Overview

Pitavastatin is a synthetic HMG-CoA reductase inhibitor (statin) used for the treatment of hypercholesterolemia and mixed dyslipidemia. It competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol biosynthesis, reducing LDL-C and triglycerides while increasing HDL-C. Mediocon Inc manufactures Pitavastatin API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Treatment of primary hypercholesterolemia and mixed dyslipidemia
  • Reduction of LDL cholesterol, total cholesterol, and triglycerides
  • Cardiovascular risk reduction in patients with dyslipidemia
  • Prevention of atherosclerosis progression

Technical Specifications

ParameterSpecification
CAS Number147526-32-7
Molecular FormulaC25H24FNO4
Molecular Weight421.46 g/mol
GradeIP / BP
CategoryHMG-CoA Reductase Inhibitor (Statin)
AppearanceWhite to off-white, crystalline powder
SolubilityPractically insoluble in water, slightly soluble in methanol, freely soluble in ethanol and in methylene chloride
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 NoPTV/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 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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