Luliconazole is the topical azole the FDA approved in 2013 for a seven-day course, yet it still has no marketing authorisation of its own in the EU or UK.

No. M Care is a merchant-exporter, not a manufacturer, so it does not hold WHO-GMP or WHO-PQ certification directly. M Care's own credentials are ISO 9001:2015 and a CDSCO export licence. The luliconazole cream supplied is sourced from Indian manufacturers who hold WHO-GMP certification for their own facilities, and that manufacturer-level certification is documented per shipment.

Not currently. Luliconazole received FDA approval in 2013 and has been marketed in Japan since 2005, but it has no marketing authorisation of its own in the EU or UK. The EMA agreed a paediatric investigation plan for luliconazole in January 2025, which is a required precursor to a future marketing authorisation application, not an approval itself. Buyers in EU or UK-linked markets should confirm registration status with their own regulator before ordering.

Luliconazole is an azole that behaves like a fungicide against dermatophytes rather than merely stopping their growth, with very low minimum inhibitory concentrations against Trichophyton species. That potency is the basis for the FDA-approved regimen: once daily for one week in tinea cruris and tinea corporis, and two weeks in interdigital tinea pedis, shorter than the two-to-four-week courses typical of older topical azoles.

No. M Care's luliconazole catalogue is entirely topical cream at 1% w/w; no oral tablet, capsule, injection, oral suspension, ophthalmic, inhaled or sachet form is stocked. The FDA label itself restricts luliconazole to topical use and specifically excludes ophthalmic, oral and intravaginal application, so a systemic or ophthalmic form falls outside the approved use of the molecule as well as outside our catalogue.

Luliconazole 1% w/w cream is stocked in 10g, 15g, 20g, 25g, 30g and 50g tubes. These are packaging sizes, not dose strengths; the labelled concentration is 1% w/w in every pack. Smaller tube sizes align with the FDA-approved one-to-two-week course, so buyers ordering for short-course dermatophyte treatment protocols can match pack size to expected consumption rather than sourcing large multi-month fill volumes.

The FDA label covers interdigital tinea pedis, tinea cruris and tinea corporis caused specifically by Trichophyton rubrum and Epidermophyton floccosum. Use against other dermatophyte species, Candida, or other tinea presentations such as tinea capitis sits outside the approved indication. Buyers should check whether their destination market's own label carries the same organism-specific wording before positioning the product for a broader antifungal claim.

Each luliconazole shipment is supported by a batch-specific certificate of analysis, certificate of origin, manufacturer's stability data and material safety data sheet, prepared to support the importer's own national registration dossier. Because luliconazole is not centrally authorised in the EU or UK, no reference approval exists to cite in that documentation package for those two markets; importers there compile a national dossier from these underlying documents instead.

The FDA label's age cut-off differs by indication: two and above for tinea corporis, twelve and above for interdigital tinea pedis and tinea cruris. These lower ages were added in a 2018 label expansion; the original 2013 approval covered adults eighteen and above only. These cut-offs are specific to the FDA label and are not automatically identical to the paediatric indication or minimum age in every destination market; buyers should confirm the age range and any paediatric-specific dosing guidance against their own national label before distribution.