Active Pharmaceutical Ingredient

Fluticasone Furoate API Manufacturer & Supplier in India

Also known as: FF; Avamys; Arnuity Ellipta

CAS: 397864-44-7 Corticosteroid IP / BP / USP GMP Certified Aurangabad, Maharashtra, India
Fluticasone Furoate API — Mediocon Inc
Fluticasone Furoate — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 397864-44-7  |  MF: C₂₇H₂₉F₃O₆S  |  MW: 538.58 g/mol

Fluticasone Furoate 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 Furoate is a next-generation inhaled corticosteroid with high receptor affinity and prolonged lung retention. It is used once-daily for the treatment of allergic rhinitis and chronic obstructive pulmonary disease (COPD).

Key Features

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

Applications

  • Allergic rhinitis (nasal spray)
  • COPD maintenance therapy
  • Asthma management (inhaler)
  • Combined with vilanterol for respiratory conditions

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 Furoate
Also Known AsFF; Avamys; Arnuity Ellipta
CAS Number397864-44-7
Molecular FormulaC₂₇H₂₉F₃O₆S
Molecular Weight538.58 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 Furoate (CAS 397864-44-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Fluticasone Furoate 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 Furoate API

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