Active Pharmaceutical Ingredient

Clobetasol API Manufacturer & Supplier in India

Also known as: Temovate, Dermovate (brand)

CAS: 25122-41-2 Ultra-Potent Corticosteroid USP / BP / IP Bulk Supply Available
Clobetasol API Manufacturer India | Mediocon Inc
Clobetasol — Pharmaceutical Grade API

Product Overview

CAS No: 25122-41-2  |  MF: C₂₂H₂₈ClFO₄  |  MW: 410.91 g/mol

Clobetasol Propionate is one of the most potent topical corticosteroids (Class I / Super-Potent), used for inflammatory and pruritic skin conditions including psoriasis, eczema, lichen planus, and severe dermatitis. It has strong anti-inflammatory, antipruritic, and vasoconstrictive properties. Mediocon Inc supplies pharmaceutical-grade Clobetasol Propionate meeting IP/BP/EP/USP standards.

Key Features

  • Class I ultra-potent topical corticosteroid
  • IP/BP/EP/USP compliant, Assay 99.0% Min.
  • Fastest-acting topical steroid for severe conditions
  • Suitable for cream, ointment, lotion, and foam formulations

Applications

  • Psoriasis plaque topical treatment
  • Severe eczema and dermatitis therapy
  • Lichen planus topical formulations
  • Scalp application foams and solutions

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 NameClobetasol
Also Known AsTemovate, Dermovate (brand)
CAS Number25122-41-2
Molecular FormulaC₂₂H₂₈ClFO₄
Molecular Weight410.91 g/mol
CategoryCorticosteroid / Ultra-Potent Topical
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 0.5%
Heavy MetalsNMT 10 ppm
Melting Point195°C – 200°C
Microbial LimitsComplies with pharmacopoeia
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 Clobetasol (CAS 25122-41-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Clobetasol 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 — Clobetasol API

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