Active Pharmaceutical Ingredient

Saruplase API Manufacturer & Supplier in India

Also known as: Single-chain Urokinase; Pro-urokinase; scuPA

CAS: 305841-29-6 Thrombolytic / Plasminogen Activator IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Saruplase API — Mediocon Inc, Aurangabad Maharashtra India
Saruplase — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 305841-29-6  |  MF: Recombinant glycoprotein  |  MW: ~54,000 Da

Saruplase (pro-urokinase) is a single-chain recombinant urokinase-type plasminogen activator (scuPA) used as a thrombolytic agent. Mediocon Inc supplies pharmaceutical-grade Saruplase conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Saruplase acts as a fibrin-selective thrombolytic by converting plasminogen to plasmin at the thrombus site. It offers advantages of relative clot selectivity over earlier non-selective thrombolytics.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Acute myocardial infarction thrombolysis
  • Ischaemic stroke treatment
  • Deep vein thrombosis management
  • Thrombolytic drug R&D

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 NameSaruplase
Also Known AsSingle-chain Urokinase; Pro-urokinase; scuPA
CAS Number305841-29-6
Molecular FormulaRecombinant glycoprotein
Molecular Weight~54,000 Da
CategoryThrombolytic / Plasminogen Activator
AppearanceLyophilised white powder
SolubilitySoluble in aqueous buffer
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2025
Exp DateFEB 2030
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 Saruplase (CAS 305841-29-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Saruplase 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 — Saruplase API

What is the minimum order quantity for Saruplase API?
Mediocon Inc supplies Saruplase 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 Saruplase does Mediocon supply?
We supply Saruplase 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 Saruplase API?
Every shipment of Saruplase 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 Saruplase bulk orders?
Standard lead time for Saruplase 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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