Active Pharmaceutical Ingredient

Glasdegib API Manufacturer & Supplier in India

Also known as: Daurismo

CAS: 1480282-83-5 Hedgehog Pathway Inhibitor / Antileukemic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Glasdegib API — Mediocon Inc
Glasdegib — Pharmaceutical Grade API

Product Overview

CAS No: 1480282-83-5  |  MF: C21H22FN5O  |  MW: 395.43 g/mol

Glasdegib is a Hedgehog (Hh) pathway inhibitor that blocks the Smoothened (SMO) protein, used in combination with low-dose cytarabine for treatment of newly diagnosed acute myeloid leukemia (AML). Mediocon Inc supplies pharmaceutical-grade Glasdegib API.

Key Features

  • Hedgehog pathway SMO inhibitor
  • Indicated for AML treatment
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation

Applications

  • Acute myeloid leukemia (AML)
  • Hedgehog pathway-driven malignancies
  • Combination oncology regimens
  • Targeted cancer therapy

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameGlasdegib
Also Known AsDaurismo
CAS Number1480282-83-5
Molecular FormulaC21H22FN5O
Molecular Weight395.43 g/mol
CategoryHedgehog Pathway Inhibitor / Antileukemic
AppearanceWhite to off-white powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay≥98.0% (as per pharmacopoeia)
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement

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 Glasdegib (CAS 1480282-83-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Glasdegib 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 — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — 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
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Glasdegib API

What is the minimum order quantity for Glasdegib API?
Mediocon Inc supplies Glasdegib with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Glasdegib does Mediocon supply?
We supply Glasdegib conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Glasdegib API?
Every shipment of Glasdegib comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Glasdegib bulk orders?
Standard lead time for Glasdegib is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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