Introduction

Actiza Pharmaceutical is a WHO-GMP certified pharmaceutical exporter supplying Ciclopirox Olamine Cream 0.77% w/w as a topical finished dosage formulation not API to importers, dermatology-focused distributors and retail procurement across Africa, Southeast Asia, Latin America and the Middle East.

Ciclopirox is a hydroxypyridone, a class unrelated to the azoles and allylamines, with broad activity across dermatophytes, yeasts and molds.

The product is manufactured in a dedicated non-sterile semisolid block with validated emulsification and filled into tubes qualified for compatibility with a metal-chelating active.

Complete CTD, ACTD and eCTD dossiers, CoPP, FSC and ICH Zone IVb stability are supplied for MOH registration.

Product Overview

Field	Details
Product Name	Ciclopirox Olamine Cream
INN / Generic Name	Ciclopirox olamine the olamine salt of ciclopirox
Therapeutic Class	Hydroxypyridone antifungal NOT an azole, allylamine, polyene or echinocandin
Mechanism (brief)	Reference labelling describes an in vitro study suggesting chelation of polyvalent cations (Fe³⁺ or Al³⁺), inhibiting metal-dependent enzymes responsible for degradation of peroxides within the fungal cell. The label notes the clinical significance of this observation is not known.
Additional Properties	Antibacterial and anti-inflammatory activity reported in the literature, alongside antifungal action
Indications	Superficial dermatomycoses tinea pedis, tinea cruris, tinea corporis, cutaneous candidiasis and tinea versicolor, per approved local labelling
API Quality	Manufactured using DMF-grade Ciclopirox Olamine
Pharmacopoeial Standard	USP Ciclopirox Olamine Cream USP [CONFIRM applicability per SKU]
Strength	0.77% w/w (as ciclopirox olamine)
Product Type	Non-sterile topical semisolid oil-in-water cream
NOT Interchangeable With	Ciclopirox gel, shampoo or nail lacquer. Different vehicles, different strengths, different indications, and the lacquer uses the free acid rather than the olamine salt — see Section 4
Pack Sizes	15 g, 30 g and 50 g tubes; institutional packs on request
Container Consideration	The active chelates metal cations tube and closure compatibility is a formal qualification item, not an assumption. See Section 5F.
Tolerability	Generally well tolerated. Literature reports irritation, redness, pain, pruritus or burning in under 5% of treated patients; allergic contact dermatitis rare.
Shelf Life	24 Months [CONFIRM against stability data]
In-Use Period	Discard [TBC] months after first opening must be supported by in-use stability
Storage	[CONFIRM against your approved label and stability data]
Manufacturing Facility	WHO-GMP certified dedicated semisolid (cream and ointment) block
Dossier Available	Yes, CTD / ACTD / eCTD format

Product Presentation & the Vehicle Question

Ciclopirox Olamine Cream 0.77% w/w (15 g / 30 g / 50 g)

The core presentation, formulated as an oil-in-water emulsion with controlled globule size distribution.

Release behaviour is governed by the microstructure of the vehicle rather than by assay value alone, so the cream is developed and characterised as a system rather than as a quantity of active dispersed in a base.

Target buyers include dermatology distributors, retail pharmacy chains and MOH formulary supply.

The Ciclopirox Family Four Products, Not Four Strengths

Ciclopirox is marketed in several distinct topical presentations, and a buyer who orders on strength alone will get the wrong product.

These are separate registrations with separate indications, separate reference products and, in one case, a different chemical form of the active:

Presentation	What It Is	Note
Cream 0.77% w/w	Ciclopirox olamine in an oil-in-water cream	This page
Gel or lotion 0.77%	Same salt, different vehicle	Different vehicle, different registration [CONFIRM if in portfolio]
Shampoo 1%	Scalp presentation for seborrhoeic dermatitis	Different indication entirely [CONFIRM if in portfolio]
Nail lacquer 8%	Uses ciclopirox free acid, NOT the olamine salt	A different active form — never treat as a strength variant

Confirm which presentation the buyer needs before quoting, and confirm which the reference product in their market is.

Quality Specification & Testing

Assay and content uniformity verified across tube, not only at fill point

Microbial limits per USP <61> and <62> for non-sterile topical

Preservative Efficacy Test (PET) per USP <51>, supporting declared in-use period after opening

Physicochemical characterisation (Q3) pH, viscosity, rheological profile, globule size distribution and homogeneity

pH control carries particular importance on this molecule, because chelation behaviour is pH-dependent and pH is therefore a performance parameter

Regulatory & Dossier Support

Dossier Availability

CTD (Common Technical Document) ICH-aligned for regulated markets; ACTD (ASEAN Common Technical Dossier) for Philippines, Vietnam, Myanmar, Indonesia, Cambodia; eCTD for authorities requiring electronic submission.

Module 3 quality documentation includes emulsification and homogenisation process validation, container-closure compatibility, microbial limits and preservative system justification.

Stability data includes real-time and accelerated under ICH Zone IVb (30°C / 75% RH), plus in-use stability supporting after-opening period and freeze-thaw cycling for emulsion integrity.

Bioequivalence for a Topical

Bioequivalence for topical antifungals cannot be measured through plasma, since the product acts locally in the stratum corneum. Regulators accept two routes:

Route 1: Comparative clinical endpoint study. Randomised study in the approved indication comparing test product, reference product and vehicle. This is the traditional route and is expensive.

Route 2: In-vitro characterisation-based approach. Available where the test product is qualitatively (Q1) and quantitatively (Q2) the same as the reference, with no formulation difference capable of affecting local availability, supported by comparative Q3 physicochemical and structural characterisation.

We develop toward Q1/Q2 sameness so that the in-vitro route stays open to our partners wherever the authority permits it.

The salt form is part of the Q1 comparison the cream contains ciclopirox olamine; the nail lacquer contains ciclopirox free acid.

A comparison run against the wrong form is not a comparison at all.

Drug Master File (DMF)

Drug Master File reference for Ciclopirox Olamine API is available for cross-referencing in your registration dossier.

API is sourced from a qualified vendor with full impurity, residual solvent, and particle-size characterisation, with the salt form stated unambiguously.

CDSCO / Indian DMF reference is accepted by a large number of importing authorities.

Manufacturing Compliance

WHO-GMP certified manufacturing facility, audit-ready, with inspection reports shared on an NDA basis. Site Master File (SMF) is available for regulatory submissions.

Dedicated non-sterile semisolid block with validated vacuum emulsification, controlled-temperature processing and inline homogenisation batch-to-batch rheological consistency is the principal manufacturing challenge for creams and is controlled through process parameters.

Water system qualification and microbial control programme documented the primary contamination risk for non-sterile aqueous topical.

Product-contact metal is a live question on this molecule due to metal-chelating mechanism; equipment surfaces are assessed accordingly rather than assumed inert.

Compliant with NAFDAC (Nigeria), PPB (Kenya), FDA Philippines, DRAP (Pakistan) and INVIMA (Colombia).

Complete Documentation Package (Per Shipment)

Document	Purpose
Certificate of Analysis (CoA)	Confirms batch quality against the agreed specification
Certificate of Pharmaceutical Product (CoPP / CPP)	Required for MOH registration in most importing countries
Free Sale Certificate (FSC)	Confirms the product is freely sold in the country of manufacture
Method of Analysis (MOA)	Analytical methodology mandatory dossier component
GMP Certificate	Confirms manufacturing site compliance
Stability Data	Real-time, accelerated, in-use and freeze-thaw ICH Zone IVb
Microbial Limits Report	USP <61> / <62> mandatory for a non-sterile topical
Preservative Efficacy Test (PET)	USP <51> supports the in-use period after opening
Q3 Characterisation Data	pH, viscosity, rheology, globule size distribution supports the in-vitro BE route
Container Compatibility Data	Tube lacquer and closure qualification for a metal-chelating active see Section 5F
Salt Form Declaration	States unambiguously that the product contains the olamine salt, not the free acid
Non-Animal Origin Declaration	Replaces the BSE/TSE declaration confirm excipient origin

Metal Chelation and the Container

Reference labelling describes ciclopirox as acting through chelation of polyvalent cations, specifically Fe³⁺ and Al³⁺.

An active whose proposed mode of action is binding aluminium and iron is an active whose compatibility with aluminium tubes and metal product-contact surfaces must be demonstrated rather than assumed.

Tube lacquer and closure system are qualified specifically for this product, with container-compatibility data supplied alongside the stability package rather than inferred from a generic semisolid qualification.

Laminated (ABL) tubes are available as an alternative where a buyer or authority prefers to avoid metal product contact entirely.

Product-contact surfaces in manufacture mixing vessels, transfer lines, filling equipment

are assessed on the same basis. pH is a performance parameter here, not only a stability parameter.

Chelation behaviour is pH-dependent, so pH specification and stability across shelf life carry more weight on this product. Excipient selection is constrained by the same chemistry

excipients contributing polyvalent cations warrant justification rather than default inclusion.

Container-compatibility and pH stability data are supplied as standard with the technical package.

Clinical Indications & Therapeutic Information

Ciclopirox is a hydroxypyridone and is not related to azoles or any other established antifungal class.

Reference labelling describes an in vitro study suggesting it acts by chelation of polyvalent cations, resulting in inhibition of metal-dependent enzymes responsible for degradation of peroxides within the fungal cell, and notes that the clinical significance of this observation is not known.

Approved indications: superficial dermatomycoses including tinea pedis, tinea cruris, tinea corporis, cutaneous candidiasis and tinea versicolor, per approved local labelling.

Broad in vitro spectrum. Literature describes activity across nearly all clinically relevant dermatophytes, yeasts and moulds, alongside reported antibacterial and anti-inflammatory activity.

Well tolerated. Published data report irritation, redness, pain, pruritus or burning sensation in under 5% of treated patients, with allergic contact dermatitis rare a notably cleaner tolerability profile than several other topicals.

Local labelling must carry the approved indication set, application instructions and standard topical cautions from the reference product for the market of supply.

Target Export Markets

Export Packaging & Supply Chain

Primary Packaging Options

Presentation	Packaging Options
Ciclopirox Olamine Cream 0.77%	Internally lacquered aluminium collapsible tube, 15 g / 30 g / 50 g, with mono-carton and leaflet
Retail variant	Laminated (ABL) tube 15 g / 30 g also the option where metal product contact is to be avoided entirely
Institutional supply	Bulk cartons with programme-specific overprinting [TBC]

Tube selection carries more technical weight on this product than on most creams.

Because the active is characterised by affinity for aluminium and iron cations, the choice between lacquered aluminium tube and laminated tube is a compatibility decision supported by data rather than a cost or presentation preference.

We qualify the selected system and supply container-compatibility data.

Labelling & Customisation

Private label manufacturing available with your brand name, artwork and trade dress dermatology is among the highest private-label uptake categories.

Multi-lingual labelling available in English, French, Spanish, Portuguese, Arabic, Russian.

Mandatory artwork content includes salt form and strength stated precisely, approved indication set, application instructions, in-use discard period, storage statement and country-specific registration fields.

Carton must state “Ciclopirox Olamine” rather than “Ciclopirox” alone to prevent dispensing errors.

Logistics & Supply

Incoterms: FOB, CIF, CFR, EXW as per buyer requirement. No cold chain required, but this is an emulsion sustained high-temperature exposure in transit can affect physical stability even where assay remains within specification.

Freeze conditions must also be avoided. Experienced in shipping semisolids to Africa, CIS, LATAM and Southeast Asia, including port-clearance documentation support.

Why Source Ciclopirox Olamine Cream From Us?

Frequently Asked Questions

Ready to Source Ciclopirox Olamine Cream FDF?

Share your target market, required pack sizes and volume, and our export team will respond with applicable specifications, the bioequivalence route that the authority requires, tube options with compatibility data, dossier format and pricing.

If evaluating, request a Q3 characterisation overview, container-compatibility summary and sample CoA.