Active Pharmaceutical Ingredient

Ciclesonide API Manufacturer & Supplier in India

Also known as: Alvesco, Omnaris (brand)

CAS: 126544-47-6 Corticosteroid Prodrug USP / BP / IP Bulk Supply Available
Ciclesonide API Manufacturer India | Mediocon Inc
Ciclesonide — Pharmaceutical Grade API

Product Overview

CAS No: 126544-47-6  |  MF: C₃₂H₄₄O₇  |  MW: 540.69 g/mol

Ciclesonide is a prodrug corticosteroid activated locally in the lungs and nasal mucosa. It is used for the treatment of asthma and allergic rhinitis. Its on-site activation provides high local anti-inflammatory activity with minimal systemic side effects. Mediocon Inc supplies pharmaceutical-grade Ciclesonide meeting IP/BP/EP/USP standards.

Key Features

  • Prodrug corticosteroid – activated locally in airways
  • IP/BP/EP/USP compliant, Assay 99.0% Min.
  • Minimal systemic side effects
  • Suitable for inhalation and nasal spray formulations

Applications

  • Inhalation aerosol for asthma
  • Nasal spray for allergic rhinitis
  • Combination inhaler formulations
  • Respiratory drug manufacturing

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 NameCiclesonide
Also Known AsAlvesco, Omnaris (brand)
CAS Number126544-47-6
Molecular FormulaC₃₂H₄₄O₇
Molecular Weight540.69 g/mol
CategoryCorticosteroid / Anti-inflammatory
AppearanceWhite to Off-White Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
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 Ciclesonide (CAS 126544-47-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ciclesonide 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 — Ciclesonide API

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