Active Pharmaceutical Ingredient

Prasugrel API Manufacturer & Supplier in India

Also known as: DB289; Prasugrel hydrochloride

GMP Certified IP / BP / USP Antiplatelet Agent Aurangabad, India
Prasugrel API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Prasugrel IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 150322-43-3

Product Overview

Prasugrel is a thienopyridine antiplatelet agent that irreversibly inhibits the P2Y12 receptor on platelets, thereby preventing ADP-mediated platelet aggregation. It is used to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). Mediocon Inc manufactures Prasugrel API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Reduction of atherothrombotic events in acute coronary syndrome (ACS)
  • Used alongside aspirin in dual antiplatelet therapy post-PCI
  • Management of unstable angina and non-ST-elevation myocardial infarction
  • Prevention of stent thrombosis after coronary stent placement

Technical Specifications

ParameterSpecification
CAS Number150322-43-3
Molecular FormulaC20H24NO4S
Molecular Weight456.51 g/mol
GradeIP / BP / USP
CategoryAntiplatelet Agent
AppearanceWhite to off-white, crystalline powder
SolubilityFreely soluble in methanol, soluble in ethanol and slightly soluble in water
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 NoPRAS/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 / 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

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 Prasugrel — CAS 150322-43-3 (CAS 150322-43-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Prasugrel — CAS 150322-43-3 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 — Prasugrel — CAS 150322-43-3 API

What is the minimum order quantity for Prasugrel — CAS 150322-43-3 API?
Mediocon Inc supplies Prasugrel — CAS 150322-43-3 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 Prasugrel — CAS 150322-43-3 does Mediocon supply?
We supply Prasugrel — CAS 150322-43-3 conforming to IP / BP / 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 Prasugrel — CAS 150322-43-3 API?
Every shipment of Prasugrel — CAS 150322-43-3 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 Prasugrel — CAS 150322-43-3 bulk orders?
Standard lead time for Prasugrel — CAS 150322-43-3 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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