Active Pharmaceutical Ingredient

Lepirudin API Manufacturer and Supplier in India

CAS: 138068-37-8 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Lepirudin API Manufacturer and Supplier in India — Mediocon Inc
Lepirudin API Manufacturer and Supplier in India

Product Overview

CAS No: 138068-37-8 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Lepirudin is a recombinant hirudin analogue and a highly specific direct thrombin inhibitor. It is a 65-amino-acid polypeptide produced using recombinant technology and is structurally related to natural hirudin. Lepirudin has been used as an anticoagulant, particularly in the management of heparin-induced thrombocytopenia (HIT) with thromboembolic complications.

Lepirudin API

Lepirudin is a recombinant peptide anticoagulant belonging to the direct thrombin inhibitor class. It selectively inhibits free and clot-bound thrombin and prevents thrombin-mediated conversion of fibrinogen to fibrin. The molecule contains three disulfide bridges and consists of 65 amino acids.

Chemical Information

Product Name: Lepirudin
CAS Number: 138068-37-8
Molecular Formula: C₂₈₇H₄₄₀N₈₀O₁₁₁S₆
Molecular Weight: Approximately 6979 g/mol
Chemical Type: Recombinant polypeptide / peptide
Synonyms: Lepirudin recombinant, Refludan, recombinant hirudin
Mechanism: Direct thrombin inhibitor

Manufacturing and Quality

MEDIOCON INC provides pharmaceutical and nutraceutical ingredients with a focus on quality, consistency, documentation, and reliable supply. Lepirudin is a complex recombinant peptide, and its quality assessment may include identity, purity, content/potency, peptide integrity, related proteins, microbial quality, and bacterial endotoxin controls, depending on the intended application and applicable specification. EMA documentation for Refludan describes controls including RP-HPLC, amino-acid composition, peptide mapping, purity, pH, lepirudin-related proteins, microbial contamination, bacterial endotoxins, content, activity, and specific activity.

Applications

Lepirudin has been used as an anticoagulant and direct thrombin inhibitor, particularly for anticoagulation in patients with heparin-induced thrombocytopenia and associated thromboembolic disease. Its use is subject to applicable regulatory, medical, and quality requirements.

Packaging and Documentation

Product availability, packaging configuration, batch documentation, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), and other technical documentation should be confirmed with MEDIOCON INC according to the intended application and applicable regulatory requirements.

 

Product Specifications

Product NameLepirudin API Manufacturer and Supplier in India
CAS Number138068-37-8
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
StandardsPharmaceutical Specifications

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 Lepirudin API Manufacturer and Supplier in India (CAS 138068-37-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Lepirudin API Manufacturer and Supplier in India 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Lepirudin API Manufacturer and Supplier in India

What is Lepirudin?
Lepirudin is a recombinant hirudin analogue consisting of 65 amino acids and acts as a highly specific direct thrombin inhibitor.
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