Active Pharmaceutical Ingredient

Cilostazol API Manufacturer & Supplier in India

Also known as: Pletal (brand)

CAS: 73963-72-1 PDE3 Inhibitor USP / BP / IP Bulk Supply Available
Cilostazol API Manufacturer India | Mediocon Inc
Cilostazol — Pharmaceutical Grade API

Product Overview

CAS No: 73963-72-1  |  MF: C₂₀H₂₇N₅O₂  |  MW: 369.46 g/mol

Cilostazol is a selective PDE3 inhibitor that inhibits platelet aggregation and causes vasodilation. It is used for the treatment of intermittent claudication in peripheral arterial disease and for prevention of secondary stroke. Mediocon Inc supplies pharmaceutical-grade Cilostazol meeting IP/BP/EP/USP standards.

Key Features

  • Selective PDE3 inhibitor with antiplatelet activity
  • IP/BP/EP/USP compliant, Assay 99.0% Min.
  • Treats intermittent claudication & prevents stroke
  • Suitable for oral tablet formulations

Applications

  • Intermittent claudication tablets
  • Secondary stroke prevention
  • Peripheral arterial disease therapy
  • Cardiovascular drug manufacturing

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameCilostazol
Also Known AsPletal (brand)
CAS Number73963-72-1
Molecular FormulaC₂₀H₂₇N₅O₂
Molecular Weight369.46 g/mol
CategoryCardiovascular / PDE3 Inhibitor / Antiplatelet
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Cilostazol (CAS 73963-72-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Cilostazol is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Cilostazol API

What is the minimum order quantity for Cilostazol API?
Mediocon Inc supplies Cilostazol with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Cilostazol does Mediocon supply?
We supply Cilostazol conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Cilostazol API?
Every shipment of Cilostazol comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Cilostazol bulk orders?
Standard lead time for Cilostazol is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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