Active Pharmaceutical Ingredient

Mitoxantrone API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 70476-82-3 Active Pharmaceutical Ingredient USP / EP / IP GMP Certified Aurangabad, Maharashtra, India
Mitoxantrone API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Mitoxantrone API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 70476-82-3 | Grade: USP / EP / IP | Category: Active Pharmaceutical Ingredient

Mitoxantrone API Manufacturer & Supplier in India

MEDIOCON INC is a trusted API manufacturer and supplier in India of Mitoxantrone API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, oncology formulation development, injectable drug production, 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.

Mitoxantrone is a potent anthracenedione antineoplastic (anticancer) active pharmaceutical ingredient widely used in pharmaceutical formulations for the treatment of acute myeloid leukemia (AML), advanced prostate cancer, non-Hodgkin lymphoma, and multiple sclerosis. It exerts its pharmacological action by intercalating into DNA and inhibiting topoisomerase II, thereby preventing DNA replication and repair, resulting in inhibition of rapidly dividing cancer cells. In addition to its anticancer activity, Mitoxantrone exhibits immunosuppressive properties, making it useful in the management of certain autoimmune disorders. Owing to its proven therapeutic efficacy, Mitoxantrone is extensively utilized in oncology pharmaceutical research, injectable formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Mitoxantrone API across India and to global pharmaceutical manufacturers, oncology formulation 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 NameMitoxantrone API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number70476-82-3
CategoryActive Pharmaceutical Ingredient
GradeUSP / EP / IP
AppearanceDark Blue to Blue-Violet Crystalline Powder
StandardsUSP / EP / IP Compliant

Analytical Specifications

ParameterSpecification
AppearanceDark Blue to Blue-Violet Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 1.00%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)3.0 – 5.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 1.00%
Melting Point220°C – 230°C
SolubilityFreely soluble in water; slightly soluble in methanol; practically insoluble in 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 Mitoxantrone API Manufacturer & Supplier in India | MEDIOCON INC (CAS 70476-82-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

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

What is Mitoxantrone API?
Mitoxantrone API is an anthracenedione antineoplastic active pharmaceutical ingredient used in injectable pharmaceutical formulations for the treatment of various cancers and multiple sclerosis.
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