WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Clobetasol propionate is the most potent class of topical corticosteroid in routine use, capped at 50g a week and two to four weeks of continuous treatment, and 27 of the 34 lines M Care exports are the salicylic acid combination built around that limit.

Clobetasol propionate sits at the top of the topical corticosteroid potency scale. Both the FDA and UK licensing authorities cap it by weight, not days: no more than 50 g a week, short treatment courses, and the face, groin and axillae excluded outright. M Care's catalogue mirrors that reality. Twenty six of our thirty four clobetasol lines pair it with salicylic acid, the keratolytic partner that clears scale so the steroid reaches thickened plaque, and one further line pairs it with zinc. All are supplied as 0.05% w/w cream or topical solution to licensed importers outside India.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Clobetasol propionate exporter and bulk supplier from India.

Export documentation for clobetasol shipments includes a certificate of analysis per batch, a certificate of pharmaceutical product or free sale certificate as the destination market requires, an MSDS, and the CDSCO export NOC covering the consignment. Because 27 of our 34 lines are fixed dose combinations with salicylic acid or zinc, we confirm with the buyer which single agent or combination registration status applies in their country before booking, since several destination regulators register FDCs separately from the single agent product. Packing is standard tube (10g to 100g) or bottle (20ml to 50ml) as listed per line, stored and shipped at room temperature with no cold chain requirement. Batch coding, expiry and storage condition labelling follow the importing country's language and format requirements, confirmed with the buyer ahead of dispatch.

Source

WHO-GMP-certified Indian manufacturing line, named on every quote.

Minimum order

No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.

Pricing

On request. Indicative FOB or CIF quote, formal proforma on confirmation.

Incoterms

EXW, FOB, CIF, CIP or DAP.

Payment

Letter of credit (sight or usance) and telegraphic transfer.

Documentation

WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.

Shelf-life

Minimum remaining shelf-life agreed per order and confirmed on the proforma.

Response

Availability and CoPP status within two working days; pre-alert documents before dispatch.

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At a glance

Topical corticosteroid, super-potent / Class I (US seven-tier scale) and very potent (UK four-tier scale), sourced and documented for export.

Clobetasol propionate is classed as a super potent (Class I / Group I) topical corticosteroid, the strongest tier on both the US and UK potency scales, and every label for it, whatever the brand, carries the same weight based ceiling: 50 g maximum per week, no more than two to four consecutive weeks, and no use on the face, groin, axillae or under occlusion. That constraint shapes prescribing far more than a diagnosis specific dosing chart would. Clinically it treats corticosteroid responsive dermatoses such as psoriasis, lichen planus and chronic eczema, usually where the skin has become thick, scaly or plaque bound enough that a plain steroid struggles to penetrate. Which is why the M Care catalogue leans so heavily toward the salicylic acid pairing: the acid strips the hyperkeratotic surface so the steroid can reach the inflamed skin beneath, and the combination ships as one tube rather than two separate products.

Active ingredient

Clobetasol propionate (also supplied as fixed-dose combinations with salicylic acid or zinc). Topical corticosteroid, super-potent / Class I (US seven-tier scale) and very potent (UK four-tier scale).

Forms and strengths

0.05 % w/w.

Indications

Clobetasol propionate 0.05% w/w is a super-potent topical corticosteroid used for corticosteroid-responsive dermatoses including psoriasis, lichen planus and chronic eczema, most often as part of a fixed-dose combination with salicylic acid for hyperkeratotic, plaque-type presentations.

Administration

Topical (cutaneous). Cream and topical solution/lotion.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

India is our origin. We do not sell into the Indian market.

M Care supplies clobetasol propionate, alone and in the salicylic acid and zinc combinations we actually stock, to licensed importers, hospital and tender procurement desks, and dermatology-focused wholesalers across the UK, the EU, the Gulf states, Africa and Latin America. Buyers in this molecule tend to be regulatory affairs teams sourcing a restricted-use topical for formulary listing, or distributors supplying dermatology clinics where psoriasis and chronic plaque conditions are common. Because clobetasol carries prescription-only status and weight-based dosing limits in every jurisdiction we ship to, orders are handled through parties already licensed to import and dispense prescription corticosteroids, not through open retail channels. India is our base of operation and country of origin only; it is not a market we serve.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on clobetasol propionate.

Clobetasol propionate 0.05% w/w is a Class I / super-potent topical corticosteroid on both the US seven-tier and UK four-tier potency scales, the highest rank in each. A pharmacist reviewing an import checks that labelling reflects the weight ceiling used across every approved formulation: no more than 50 g a week and no more than two to four consecutive weeks, because HPA-axis suppression has been documented at doses as low as 2 g a day. The face, groin and axillae are excluded from use, occlusive dressings are not recommended, and courses beyond four weeks call for a step-down to a lower-potency agent rather than continuation. For the combination lines, salicylic acid at keratolytic concentration is checked for compatibility with the steroid base and for the separate irritancy profile it carries on broken or extensively inflamed skin; the zinc-containing line is reviewed for its role as a barrier and astringent adjunct rather than as an active anti-inflammatory. Pediatric use is more restricted than in adults and is flagged separately on every batch dossier we forward.

Regulatory & quality

The documentation pack a regulator actually asks for.

Every clobetasol shipment carries a batch-specific certificate of analysis against the pharmacopoeial specification (USP or BP as required), an MSDS, and a certificate of pharmaceutical product or free sale certificate for the destination regulator. M Care's own credentials are ISO 9001:2015 quality management certification and a CDSCO export licence; we do not hold, and do not claim, WHO-GMP or WHO-PQ status ourselves, since M Care is a merchant-exporter and those certifications sit with the manufacturing site, whose GMP certificate we pass through with every consignment. Because 27 of our 34 clobetasol lines are fixed-dose combinations with salicylic acid or, in one line, zinc, the dossier we assemble flags the combination status explicitly: several destination markets register a corticosteroid-salicylic acid FDC as a distinct product from single-agent clobetasol, with its own import classification and sometimes its own labelling requirements for the keratolytic component. Stability data, shelf-life and storage-condition statements are supplied per batch. Buyers handling tender submissions receive documentation formatted to the requesting authority's checklist, confirmed before dispatch rather than assumed from a template.

CoA and MoA, per batch

Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.

CoPP, WHO-GMP, MFG licence

Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.

CTD Module 3

Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.

Pack insert, labels, artwork

Destination-language patient information and labelling to the local regulator's standard, locked before shipment.

Pharmacovigilance

A named PV contact arranged in the destination market where the registration requires one.

Safety and compliance notes

What a buyer should know before this line enters a formulary.

We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.

Prescription-only medicine; not for OTC or consumer-facing supply

FDA and UK SmPC labelling cap use at 50 g per week, treatment generally not exceeding 2 to 4 consecutive weeks, due to HPA-axis suppression risk

Not indicated for the face, groin or axillae

Not recommended under occlusive dressings

Pediatric use more restricted than adult use; confirm local labelling before supply

27 of 34 catalogue lines are fixed-dose combinations with salicylic acid or zinc; some destination regulators register FDCs separately from single-agent clobetasol

Related dermatology molecules

Adjacent lines procurement desks order alongside clobetasol propionate.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for clobetasol propionate.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Clobetasol propionate supply, the specific questions.

Does M Care hold WHO-GMP or WHO-PQ certification directly?

No. M Care Exports is a merchant-exporter, not a manufacturer, and holds ISO 9001:2015 quality management certification along with a CDSCO export licence. WHO-GMP and WHO-PQ certifications belong to the manufacturing sites we source from; we pass through the manufacturer's GMP documentation with every consignment rather than claiming the certification ourselves.

Why is clobetasol propionate limited to 50 g a week?

Clobetasol propionate is a super-potent (Class I) topical corticosteroid, and sufficient absorption can occur through intact skin to suppress the hypothalamic-pituitary-adrenal axis, documented at doses as low as 2 g a day in some patients. FDA and UK labelling therefore cap use by weight rather than area alone: no more than 50 g a week, and treatment courses generally not exceeding two to four consecutive weeks.

Why does M Care mostly stock clobetasol combined with salicylic acid?

Twenty six of our thirty four clobetasol lines pair it with salicylic acid because that is how the molecule is used clinically for thickened, scaly plaque: the acid's keratolytic action clears the hyperkeratotic surface so the steroid penetrates the inflamed skin beneath. One further line pairs clobetasol with zinc. Single-agent 0.05% w/w cream and solution lines are also stocked.

What strengths and pack sizes does M Care supply for clobetasol?

All clobetasol lines in our catalogue are 0.05% w/w. Pack sizes are tube presentations of 10g, 15g, 20g, 30g and 100g, and bottle presentations of 20ml, 30ml and 50ml, depending on the specific line and whether it is single-agent or a salicylic acid or zinc combination. We do not stock oral, injectable or ophthalmic clobetasol forms.

Is clobetasol propionate suitable for use on the face or in children?

No formulation of clobetasol propionate is indicated for the face, groin or axillae, where thinner skin raises the risk of atrophy and other steroid-related change. Pediatric use carries tighter restrictions than adult use in most jurisdictions because children have a higher surface-area-to-weight ratio and therefore greater systemic absorption risk. Buyers should confirm local pediatric labelling before offering the product for that population.

Do destination regulators treat the salicylic acid combination the same as single-agent clobetasol?

Not always. Several destination markets register a corticosteroid-salicylic acid fixed-dose combination as a distinct product from single-agent clobetasol propionate, sometimes with its own import classification. We confirm the applicable registration category with the buyer before booking a combination-line order rather than assuming single-agent status carries over.

Which markets does M Care supply clobetasol to?

We supply licensed importers, hospital and tender procurement desks and dermatology-focused wholesalers across the UK, the EU, the Gulf states, Africa, Latin America and Southeast Asia. India is M Care's country of origin and base of operations, not a market we serve.

Is clobetasol propionate available over the counter?

No. Clobetasol propionate is a prescription-only, super-potent topical corticosteroid in every market M Care supplies. We sell exclusively to licensed importers, distributors and procurement desks already authorised to handle prescription dermatological products, not into retail or consumer channels.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.

This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.

Clobetasol propionate enquiry

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