Active Pharmaceutical Ingredient

Mitonafide API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 82419-36-1 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Mitonafide API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Mitonafide API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 82419-36-1 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Mitonafide API Manufacturer & Supplier in India

MEDIOCON INC is a trusted API manufacturer and supplier in India of Mitonafide API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, oncology formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Mitonafide is a potent DNA intercalating antineoplastic (anticancer) active pharmaceutical ingredient widely used in pharmaceutical research and oncology drug development. It exerts its pharmacological activity by intercalating between DNA base pairs, disrupting DNA replication and transcription, and inhibiting the proliferation of rapidly dividing tumor cells. Mitonafide has been extensively investigated for the treatment of various solid tumors and hematological malignancies and continues to serve as an important compound in cancer pharmacology, medicinal chemistry, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Mitonafide API across India and to global pharmaceutical manufacturers, biotechnology companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, cancer research institutes, and analytical laboratories. Comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents are available upon request.

Product Specifications

Product NameMitonafide API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number82419-36-1
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceYellow to Orange Crystalline Powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceYellow to Orange Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)≥99.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)4.5 – 7.0
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point245°C – 255°C
SolubilitySlightly soluble in water; soluble in dimethyl sulfoxide (DMSO), methanol, and ethanol

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 Mitonafide API Manufacturer & Supplier in India | MEDIOCON INC (CAS 82419-36-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Mitonafide API Manufacturer & Supplier in India | MEDIOCON INC 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 — Mitonafide API Manufacturer & Supplier in India | MEDIOCON INC

What is Mitonafide API?
Mitonafide API is a DNA intercalating antineoplastic active pharmaceutical ingredient used in oncology research and anticancer drug development.
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