Active Pharmaceutical Ingredient

Abciximab API Manufacturer & Supplier in India

Also known as: ReoPro; c7E3 Fab Antibody Fragment

CAS: 143653-53-6 Cardiology / GPIIb-IIIa Receptor Antagonist (Biologic) Pharma Grade / Injectable Biologic GMP Certified Aurangabad, Maharashtra, India
Abciximab API — Mediocon Inc
Abciximab — Pharmaceutical Grade API

Product Overview

CAS No: 143653-53-6  |  Recombinant Fab Antibody Fragment (Biologic)  |  ~47.6 kDa

Abciximab is a pharmaceutical-grade Active Pharmaceutical Ingredient in the Cardiology / GPIIb-IIIa Receptor Antagonist (Biologic) category. Mediocon Inc supplies high-purity Abciximab API (CAS 143653-53-6) from our GMP-certified facility in Aurangabad, Maharashtra, India. We cater to pharmaceutical manufacturers, formulators, and research organizations worldwide.

Abciximab is primarily associated with: GPIIb/IIIa platelet receptor antagonist for percutaneous coronary intervention. Mediocon's Abciximab meets the highest pharmacopoeial standards and is manufactured under WHO-GMP compliant conditions for consistent quality and purity.

Key Features

  • High-purity pharmaceutical grade API (NLT 95.0% assay)
  • Pharma Grade / Injectable Biologic compliant with full analytical verification
  • Full CoA, MSDS/SDS, and COO documentation with every batch
  • GMP certified manufacturing under ISO 9001:2015 QMS

Applications & Therapeutic Uses

  • Adjunct therapy during percutaneous coronary intervention (PCI)
  • Prevention of acute cardiac ischemic complications
  • Acute coronary syndrome management protocols
  • Platelet aggregation inhibition research

Why Choose Mediocon

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

Product Specifications

Product NameAbciximab
Also Known AsReoPro; c7E3 Fab Antibody Fragment
CAS Number143653-53-6
Molecular FormulaRecombinant Fab Antibody Fragment (Biologic)
Molecular Weight~47.6 kDa
CategoryCardiology / GPIIb-IIIa Receptor Antagonist (Biologic)
AppearanceSterile lyophilized powder / clear colourless solution for injection
GradePharma Grade / Injectable Biologic
StorageStore at 2-8°C (do not freeze); protect from light

Analytical Specifications

ParameterSpecification
Purity (SEC-HPLC)NLT 95.0%
EndotoxinNMT 5 EU/mg (LAL test)
AggregatesWithin validated limits
IdentitySDS-PAGE / Peptide Mapping Compliant
SterilityComplies with pharmacopoeia
BioburdenComplies with pharmacopoeia
PackingCold-chain packaging / single-use vials, 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 Abciximab (CAS 143653-53-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Abciximab is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (Pharma Grade / Injectable Biologic). 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 — Abciximab API

What is the minimum order quantity for Abciximab API?
Mediocon Inc supplies Abciximab with a minimum order quantity of 100 mg (cold-chain sample available). 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 Abciximab does Mediocon supply?
We supply Abciximab conforming to Pharma Grade / Injectable Biologic pharmacopoeial standards. Each batch is tested against full specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Abciximab API?
Every shipment of Abciximab 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 Abciximab bulk orders?
Standard lead time for Abciximab is 2-4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging.
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