Active Pharmaceutical Ingredient

Irinotecan API Manufacturer and Supplier in India

CAS: 97682-44-5 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Irinotecan API Manufacturer and Supplier in India — Mediocon Inc
Irinotecan API Manufacturer and Supplier in India

Product Overview

CAS No: 97682-44-5 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Irinotecan is a topoisomerase I inhibitor and antineoplastic pharmaceutical active ingredient used in cancer treatment. It is a semisynthetic derivative of camptothecin and is widely associated with chemotherapy regimens for colorectal cancer and other malignancies.

Irinotecan API

Irinotecan is a water-soluble camptothecin derivative developed as an anticancer agent. It functions as a prodrug that is converted in the body to its active metabolite, SN-38.

SN-38 inhibits DNA topoisomerase I, an enzyme involved in relieving DNA torsional stress during replication. This results in DNA damage and ultimately contributes to the death of rapidly dividing cancer cells.

Irinotecan is commonly administered as Irinotecan Hydrochloride, particularly as the hydrochloride trihydrate pharmaceutical form.

Chemical Information

Product Name: Irinotecan
CAS Number: 97682-44-5
Molecular Formula: C₃₃H₃₈N₄O₆
Molecular Weight: 586.68 g/mol
Chemical Class: Camptothecin Derivative
Pharmacological Class: Antineoplastic / Topoisomerase I Inhibitor
Active Metabolite: SN-38
Development Code: CPT-11
Synonyms: Irinotecan, Irinotecanum, CPT-11

Mechanism of Action

Irinotecan is converted by carboxylesterase enzymes to its active metabolite SN-38.

SN-38 inhibits DNA topoisomerase I, stabilizing the transient DNA-topoisomerase I complex. This prevents normal re-ligation of DNA strands during replication and transcription.

The resulting DNA damage is particularly harmful to rapidly proliferating cells, producing an antitumor effect.

Manufacturing and Quality

MEDIOCON INC focuses on supplying pharmaceutical active ingredients with emphasis on quality, consistency, technical documentation and reliable supply.

Irinotecan quality evaluation may include:

  • Identification
  • Assay by HPLC
  • Related substances
  • SN-38-related impurities
  • Camptothecin-related impurities
  • Residual solvents
  • Loss on drying
  • Residue on ignition
  • Heavy metals
  • Water content
  • Optical / stereochemical purity
  • Other product-specific analytical parameters

The exact acceptance criteria should be confirmed against the applicable approved specification and batch-specific Certificate of Analysis.

Applications

Irinotecan may be used in:

  • Colorectal cancer pharmaceutical formulations
  • Combination chemotherapy regimens
  • Oncology pharmaceutical research
  • Anticancer drug development
  • Topoisomerase inhibitor research
  • Pharmaceutical research and development

Irinotecan is commonly used in combination with other anticancer medicines, depending on the approved treatment regimen.

Product Characteristics

Irinotecan is generally described as a white to yellow crystalline powder.

Appearance: White to yellow crystalline powder

The exact commercial appearance specification should be confirmed against the applicable MEDIOCON INC product specification and batch COA.

Packaging and Documentation

Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications and analytical documentation should be confirmed with MEDIOCON INC according to customer requirements and applicable regulatory standards.

Product Specifications

Product NameIrinotecan API Manufacturer and Supplier in India
CAS Number97682-44-5
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to yellow crystalline powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to yellow crystalline powder

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 Irinotecan API Manufacturer and Supplier in India (CAS 97682-44-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Irinotecan 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 — Irinotecan API Manufacturer and Supplier in India

What is Irinotecan?
Irinotecan is a camptothecin-derived antineoplastic API and a topoisomerase I inhibitor used in cancer treatment.
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