Active Pharmaceutical Ingredient

Olutasidenib API Manufacturer & Supplier in India

Also known as: Olutasidenib Salt; Estrumate API

CAS: CAS Available On Request Reproductive Health IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Olutasidenib API — Mediocon Inc
Olutasidenib — Pharmaceutical Grade API

Product Overview

CAS No: CAS Available On Request  |  MF: C₂₂H₂₈ClNaO₆  |  MW: 466.90 g/mol

Olutasidenib is a synthetic analogue of prostaglandin F2α used as an active pharmaceutical ingredient in veterinary and human reproductive health formulations. Mediocon Inc supplies high-purity Olutasidenib API from our GMP-certified facility in Aurangabad, Maharashtra, India.

Olutasidenib acts on the corpus luteum and causes luteolysis, inducing estrus and facilitating reproductive management. It is widely used in veterinary medicine and gynecological research applications.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Estrus synchronization formulations
  • Luteolysis induction
  • Reproductive health pharmaceutical research
  • Veterinary prostaglandin formulations

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 NameOlutasidenib
Also Known AsOlutasidenib Salt; Estrumate API
CAS NumberCAS Available On Request
Molecular FormulaC₂₂H₂₈ClNaO₆
Molecular Weight466.90 g/mol
CategoryProstaglandin Analogue — Reproductive Health
AppearanceWhite to pale yellow powder
SolubilityFreely soluble in water and ethanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
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 Olutasidenib (CAS CAS Available On Request) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Olutasidenib 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 — Olutasidenib API

What is the minimum order quantity for Olutasidenib API?
Mediocon Inc supplies Olutasidenib 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 Olutasidenib does Mediocon supply?
We supply Olutasidenib 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 Olutasidenib API?
Every shipment of Olutasidenib 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 Olutasidenib bulk orders?
Standard lead time for Olutasidenib 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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