Active Pharmaceutical Ingredient

Fluticasone Propionate (CAS 80474-14-2) API Manufacturer & Supplier in India

Also known as: FP; Flixotide; Flovent; Cutivate

CAS: 80474-14-2 Corticosteroid IP / BP / USP GMP Certified Aurangabad, Maharashtra, India
Fluticasone Propionate API — Mediocon Inc
Fluticasone Propionate — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 80474-14-2  |  MF: C₂₅H₃₁F₃O₅S  |  MW: 500.57 g/mol

Fluticasone Propionate is a high-purity Corticosteroid supplied by Mediocon Inc as an Active Pharmaceutical Ingredient (API) conforming to IP / BP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India, it meets the stringent quality requirements of global pharmaceutical manufacturers.

Fluticasone Propionate is a potent synthetic trifluorinated corticosteroid used in inhaled, intranasal, and topical formulations. It is widely used for asthma management and allergic rhinitis due to its high local anti-inflammatory potency.

Key Features

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

Applications

  • Asthma maintenance therapy (inhaler)
  • Allergic rhinitis (nasal spray)
  • Topical inflammatory skin conditions
  • Combined inhalers with salmeterol (Seretide/Advair)

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 NameFluticasone Propionate
Also Known AsFP; Flixotide; Flovent; Cutivate
CAS Number80474-14-2
Molecular FormulaC₂₅H₃₁F₃O₅S
Molecular Weight500.57 g/mol
CategoryCorticosteroid
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble in water; soluble in ethanol, chloroform
GradeIP / BP / 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 Fluticasone Propionate (CAS 80474-14-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Fluticasone Propionate 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 — Fluticasone Propionate API

What is the minimum order quantity for Fluticasone Propionate API?
Mediocon Inc supplies Fluticasone Propionate 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 Fluticasone Propionate does Mediocon supply?
We supply Fluticasone Propionate conforming to IP / BP / 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 Fluticasone Propionate API?
Every shipment of Fluticasone Propionate 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 Fluticasone Propionate bulk orders?
Standard lead time for Fluticasone Propionate 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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