Active Pharmaceutical Ingredient

Tandutinib API Manufacturer & Bulk Supplier in India | MEDIOCON INC

CAS: 387867-13-2 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Tandutinib API Manufacturer & Bulk Supplier in India | MEDIOCON INC — Mediocon Inc
Tandutinib API Manufacturer & Bulk Supplier in India | MEDIOCON INC

Product Overview

CAS No: 387867-13-2 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Tandutinib API Manufacturer & Bulk Supplier

Tandutinib API is a premium-quality pharmaceutical-grade Active Pharmaceutical Ingredient (API) widely used in oncology pharmaceutical research and targeted anticancer drug development. Tandutinib is a selective tyrosine kinase inhibitor (TKI) that inhibits FLT3, PDGFR, and c-KIT receptor tyrosine kinases, making it an important research compound for acute myeloid leukemia (AML), solid tumor research, and other oncology applications. Its exceptional purity, stability, and batch-to-batch consistency make it ideal for formulation development, analytical testing, quality control, stability studies, and authorized pharmaceutical research.

MEDIOCON INC is a trusted Tandutinib 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 operate under strict quality management systems to ensure superior purity, consistency, and compliance with international pharmaceutical quality standards.

Every batch of Tandutinib 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, residual solvents, particle size distribution, and stability are thoroughly evaluated before commercial release to ensure compliance with stringent pharmaceutical specifications.

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

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

If you are looking for a trusted Tandutinib API manufacturer, exporter, and bulk supplier, MEDIOCON INC offers premium pharmaceutical ingredients backed by complete documentation, consistent quality, and timely global supply.

Product Specifications

Product NameTandutinib API Manufacturer & Bulk Supplier in India | MEDIOCON INC
CAS Number387867-13-2
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to Pale Yellow Crystalline Powder
StandardsIn-house / Research Specification

Analytical Specifications

ParameterSpecification
AppearanceWhite to Pale Yellow Crystalline Powder
IdentificationIR & HPLC Compliant
Assay (HPLC)≥ 98.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.5 – 7.5
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.5%
Water ContentNMT 1.0%
Specific RotationNot Applicable (Achiral Compound)
Melting Point198°C – 204°C
SolubilitySlightly Soluble in DMSO and Methanol

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 Tandutinib API Manufacturer & Bulk Supplier in India | MEDIOCON INC (CAS 387867-13-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

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

What is Tandutinib API used for?
Tandutinib API is primarily used in oncology pharmaceutical research and targeted anticancer drug development, particularly for FLT3-positive acute myeloid leukemia (AML) and kinase inhibitor research.
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