Active Pharmaceutical Ingredient

Nateglinide — CAS 105816-04-4

Also known as: Starlix; Fastic; Glinate

GMP Certified IP / BP / EP / USP Antidiabetic / Meglitinide Aurangabad, India
Nateglinide API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Nateglinide IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 105816-04-4

Product Overview

Nateglinide is a high-purity Active Pharmaceutical Ingredient (API) classified as a Antidiabetic / Meglitinide. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 105816-04-4.

Therapeutic Applications
  • Type 2 diabetes mellitus management
  • Postprandial blood glucose control
  • Stimulation of insulin secretion from pancreatic beta cells
  • Short-term glycaemic control in combination with metformin
  • Rapid-onset insulin secretagogue therapy

Technical Specifications

ParameterSpecification
CAS Number105816-04-4
Molecular FormulaC₁₉H₂₇NO₃
Molecular Weight317.42 g/mol
GradeIP / BP / EP / USP
CategoryAntidiabetic / Meglitinide
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble in water; soluble in methanol and ethanol
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 NoNAT/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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