Active Pharmaceutical Ingredient

Mitoguazone API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 54-05-7 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Mitoguazone API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Mitoguazone API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 54-05-7 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Mitoguazone API Manufacturer & Supplier in India

MEDIOCON INC is a trusted API manufacturer and supplier in India of Mitoguazone 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.

Mitoguazone, also known as Methylglyoxal Bis(Guanylhydrazone) (MGBG), is a potent polyamine biosynthesis inhibitor and antineoplastic active pharmaceutical ingredient widely utilized in oncology and cell biology research. It exerts its pharmacological activity by inhibiting S-adenosylmethionine decarboxylase (SAMDC), a key enzyme involved in polyamine synthesis, thereby suppressing cellular proliferation and inducing apoptosis in rapidly dividing cells. Mitoguazone has been extensively investigated for the treatment of leukemia, lymphoma, and various solid tumors 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 Mitoguazone API across India and to global pharmaceutical manufacturers, biotechnology companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, oncology 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 NameMitoguazone API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number54-05-7
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to Off-White Crystalline Powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White 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 Point210°C – 220°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 Mitoguazone API Manufacturer & Supplier in India | MEDIOCON INC (CAS 54-05-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

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

What is Mitoguazone API?
Mitoguazone API is a polyamine biosynthesis inhibitor and antineoplastic active pharmaceutical ingredient used primarily in oncology research and cancer drug development.
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