Active Pharmaceutical Ingredient

Prednimustine API Manufacturer & Bulk Supplier in India | MEDIOCON INC

CAS: 2068-78-2 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Prednimustine API Manufacturer & Bulk Supplier in India | MEDIOCON INC — Mediocon Inc
Prednimustine API Manufacturer & Bulk Supplier in India | MEDIOCON INC

Product Overview

CAS No: 2068-78-2 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Prednimustine API Manufacturer & Bulk Supplier

Prednimustine API is a premium-quality pharmaceutical-grade Active Pharmaceutical Ingredient (API) widely used in oncology pharmaceutical formulations and anticancer drug research. Prednimustine is a nitrogen mustard–prednisolone conjugate that combines the cytotoxic activity of an alkylating agent with the anti-inflammatory properties of a corticosteroid. It has been investigated and utilized in the treatment of chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma, multiple myeloma, and other hematological malignancies. Its exceptional purity, excellent chemical stability, and consistent batch-to-batch quality make it suitable for pharmaceutical formulation development, analytical testing, quality control, stability studies, and authorized pharmaceutical research applications.

MEDIOCON INC is a trusted Prednimustine API manufacturer and bulk supplier in India, supplying premium-quality pharmaceutical ingredients to pharmaceutical companies, biotechnology organizations, contract manufacturing organizations (CMOs), formulation developers, research laboratories, and international distributors. Our GMP-compliant manufacturing facilities utilize advanced manufacturing technologies and stringent quality management systems to ensure superior purity, consistency, and compliance with international pharmaceutical quality standards.

Every batch of Prednimustine API manufactured by MEDIOCON INC undergoes comprehensive analytical testing using validated quality control methods. Critical quality parameters including identity, assay, impurity profile, moisture content, pH, melting point, specific rotation, residual solvents, particle size distribution, heavy metals, and stability are carefully evaluated before commercial release to ensure compliance with stringent pharmaceutical specifications.

Our Prednimustine API is available in Research Grade and Pharmaceutical Grade, making it suitable for oncology formulations, anticancer pharmaceutical research, analytical testing, formulation development, quality control laboratories, stability studies, pharmaceutical process validation, and authorized pharmaceutical research. We also provide complete regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and supporting regulatory documents, ensuring smooth procurement and regulatory compliance.

With a strong commitment to quality, innovation, and customer satisfaction, MEDIOCON INC has established itself as a dependable global supplier of pharmaceutical raw materials. Through secure packaging, competitive pricing, efficient logistics, and responsive technical support, we ensure reliable worldwide delivery of premium-quality Prednimustine API.

If you are looking for a trusted Prednimustine API manufacturer, exporter, and bulk supplier, MEDIOCON INC provides pharmaceutical-grade ingredients backed by complete documentation, consistent quality, and timely worldwide supply.

Product Specifications

Product NamePrednimustine API Manufacturer & Bulk Supplier in India | MEDIOCON INC
CAS Number2068-78-2
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
StandardsIn-house / Pharmaceutical Specification

Analytical Specifications

ParameterSpecification
IdentificationIR, UV & HPLC Complies
Assay (HPLC)≥ 98.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.0
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.0%
Water ContentNMT 1.0%
Specific Rotation+58° to +68° (c = 1, Chloroform)
Melting Point180°C – 186°C
SolubilitySlightly Soluble in Water; Soluble in Methanol, Ethanol, Chloroform and Dimethyl Sulfoxide (DMSO)

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 Prednimustine API Manufacturer & Bulk Supplier in India | MEDIOCON INC (CAS 2068-78-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Prednimustine API Manufacturer & Bulk 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 — Prednimustine API Manufacturer & Bulk Supplier in India | MEDIOCON INC

What is Prednimustine API used for?
Prednimustine API is primarily used in oncology pharmaceutical formulations and research for the treatment of chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, and other hematological malignancies.
💬
Mediocon AI
Hello 👋 How can I help you today?