Active Pharmaceutical Ingredient

Reteplase — CAS 133652-38-7

Also known as: r-PA; Rapilysin; Retavase

GMP Certified IP / BP / EP / USP Thrombolytic / Fibrinolytic Agent Aurangabad, India
Reteplase API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Reteplase IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 133652-38-7

Product Overview

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

Therapeutic Applications
  • Acute myocardial infarction (AMI) thrombolysis
  • Pulmonary embolism treatment
  • Peripheral arterial thrombosis
  • Cardiac catheterisation adjunct therapy

Technical Specifications

ParameterSpecification
CAS Number133652-38-7
Molecular FormulaRecombinant deletion mutant of t-PA
Molecular Weight39,571 Da
GradeIP / BP / EP / USP
CategoryThrombolytic / Fibrinolytic 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 NoRET/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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