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

Clenil Modulite (beclometasone dipropionate), sold in the United States as Qvar, is a WHO Essential Medicines List inhaled corticosteroid for asthma maintenance, and M Care sources the originator inhaler alongside licensed generic beclometasone lines against buyer specification.

M Care Exports supplies Clenil Modulite (beclometasone dipropionate), an inhaled corticosteroid originated by Chiesi and marketed in the United States as Qvar, for asthma maintenance rather than acute relief. It is not an emergency reliever: patients need a separate short-acting bronchodilator for symptom breakthrough. M Care is a merchant exporter: we source the originator brand and licensed generic beclometasone dipropionate inhalers through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.

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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

Beclometasone exporter and bulk supplier from India.

For hospital pharmacy, wholesaler and MoH tender-desk orders, M Care quotes beclometasone dipropionate inhalers against buyer specification: brand (Clenil Modulite/Qvar) or generic, strength (50 mcg, 100 mcg, 200 mcg or 250 mcg per actuation), canister actuation count and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because beclometasone's proportionality means a 40 mcg dose is not simply half a 80 mcg dose across every branded and generic product, we confirm the buyer's intended strength and titration protocol before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.

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

Inhaled corticosteroid; synthetic glucocorticoid, sourced and documented for export.

Beclometasone dipropionate is a synthetic glucocorticoid delivered by pressurised metered-dose inhaler (MDI) directly to the airway, reducing the bronchial inflammation that drives asthma symptoms and exacerbations with substantially less systemic exposure than an oral corticosteroid. It has no bronchodilator effect and will not relieve an acute attack: it is a maintenance-only prophylactic therapy, taken on a fixed twice-daily schedule regardless of symptoms that day. Clenil Modulite's UK licence covers prophylactic management of mild, moderate or severe asthma in adults and children, with dosing built around a 200 micrograms twice-daily adult starting point rising to 600-800 micrograms daily in severe disease; Qvar's US licence is maintenance asthma therapy in patients five years and older: ages five to eleven are dosed at 40 or 80 micrograms twice daily, while ages twelve and older are dosed from 40 micrograms twice daily up to a 320 micrograms twice-daily ceiling. It needs no reconstitution and no dilution. Clenil Modulite is supplied as 50, 100, 200 and 250 microgram-per-actuation pressurised inhalers; Qvar is supplied as 40 and 80 microgram-per-actuation canisters, so the strength range a buyer requests should match the reference product their formulary is built around.

Active ingredient

beclometasone dipropionate. Inhaled corticosteroid; synthetic glucocorticoid.

Forms and strengths

50 mcg per actuation; 100 mcg per actuation; 200 mcg per actuation; 250 mcg per actuation.

Indications

Inhaled corticosteroid delivered by pressurised metered-dose inhaler, licensed for prophylactic maintenance treatment of asthma rather than acute relief, listed on the WHO Essential Medicines List as an alternative to budesonide.

Administration

inhalation. Pressurised metered-dose inhalation aerosol.

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.

Buyers for beclometasone are hospital respiratory and paediatric pharmacies stocking a step-two asthma-maintenance line, national and regional MoH tender desks running non-communicable disease and respiratory formulary lists, licensed pharmaceutical wholesalers and importers, NGO and foundation programmes supporting asthma-management access in markets where local registration is in place, and retail pharmacy chains across our GCC and African markets stocking a pharmacist-supervised inhaler range.

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 beclometasone.

Beclometasone dipropionate is dose-proportional but not brand-interchangeable on a microgram-for-microgram basis across every product on a tender: Qvar's HFA formulation is licensed as equivalent to roughly half the microgram dose of older CFC beclometasone products, so a switch between reference products should follow the destination label rather than a straight strength swap. Counsel patients that this is a maintenance-only inhaler with no bronchodilator effect; a separate reliever must remain available for breakthrough symptoms. Oral candidiasis and dysphonia are the most common local adverse effects, particularly above 400 micrograms daily, and rinsing the mouth after each dose reduces both. High-dose, prolonged use carries the class-wide risk of adrenal suppression and reduced growth velocity in children, so routine height monitoring is advised on paediatric formularies. The pressurised canister is not cold-chain product, but performance is temperature-sensitive at both extremes: UK labelling specifies storage below 30 degrees C protected from frost and direct sunlight, with reduced therapeutic effect if the canister is cold at the point of use, while US labelling specifies 20-25 degrees C and a hard ceiling of 49 degrees C given the risk of canister rupture near flame or heat.

Regulatory & quality

The documentation pack a regulator actually asks for.

Beclometasone inhalers are pressurised aerosol product, not a temperature-controlled biologic, but ambient-storage limits still apply: Clenil Modulite's UK shelf life runs three years, stored below 30 degrees C, and buyers should confirm on-arrival storage capability rather than treat the inhaler as shelf-stable in any climate. What tender desks need alongside the product is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Beclometasone dipropionate is listed on the WHO Model List of Essential Medicines, in the Respiratory section for antiasthmatic therapy, as a therapeutic alternative to budesonide for asthma maintenance after initial short-acting beta-agonist treatment; it carries no AWaRe classification, which applies to antibacterials rather than inhaled corticosteroids. On the brand-versus-generic question, Clenil Modulite remains the originator line in the UK and EU, developed and marketed by Chiesi, with licensed generic beclometasone dipropionate inhalers separately registered in the UK market; in the US, Qvar is marketed by Teva, and as of 2025 Amneal holds tentative, not final, FDA approval for a generic beclomethasone dipropionate HFA inhalation aerosol referencing Qvar, meaning no FDA-approved generic is yet commercially available in the US. Buyers on UK and EU tenders genuinely have a brand-or-generic choice; M Care quotes either against the tender specification and destination-market registration status. Beclometasone is not a controlled substance in the markets we currently review.

Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route; this page sticks to what is specific to the molecule.

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.

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 beclometasone.
  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

Beclometasone supply, the specific questions.

What is the difference between Clenil Modulite and Qvar?

They are the same molecule, beclometasone dipropionate, marketed under different brand names and strength ranges by region. Clenil Modulite is the Chiesi-originated brand licensed in the UK and EU, supplied as 50, 100, 200 and 250 microgram-per-actuation inhalers. Qvar is the Teva-marketed US brand, supplied as 40 and 80 microgram-per-actuation canisters at a different dose-proportionality to older CFC beclometasone products. Confirm which reference product your destination market's formulary is built around before specifying a strength.

Does a generic version of beclometasone exist?

Yes in the UK, where licensed generic beclometasone dipropionate inhalers are separately registered alongside the Clenil Modulite brand. In the US the picture is different: as of 2025 Amneal holds tentative FDA approval for a generic beclomethasone dipropionate HFA inhaler referencing Qvar, but tentative approval means the product is not yet commercially available, so Qvar remains effectively the sole marketed option in that market. M Care checks current registration status by destination before quoting brand or generic against a specific tender.

What strengths and forms of beclometasone does M Care supply?

Pressurised metered-dose inhalers at 50, 100, 200 and 250 micrograms per actuation, matching the Clenil Modulite strength range, or 40 and 80 micrograms per actuation matching the Qvar range, depending on which reference product the buyer's formulary specifies. Tell us your buyer mix, hospital, retail or tender-desk, and we quote the strength and canister count accordingly.

Is beclometasone on the WHO Essential Medicines List?

Yes. Beclometasone dipropionate is listed on the WHO Model List of Essential Medicines in the Respiratory section for antiasthmatic therapy, at 50 microgram and 250 microgram per-dose inhalation aerosol strengths, as a therapeutic alternative to budesonide for asthma maintenance after initial short-acting beta-agonist treatment. It is a standard reference point for national essential-medicines formularies across our GCC and African markets.

Is beclometasone a controlled substance, and does it need cold-chain shipping?

No to both. Beclometasone is not a controlled substance in the markets we currently review. It is a pressurised aerosol product rather than a biologic, so it does not need validated cold-chain logistics, but it is temperature-sensitive at both extremes: UK labelling specifies storage below 30 degrees C protected from frost, and US labelling specifies 20-25 degrees C with a hard ceiling of 49 degrees C given the risk of canister rupture near heat.

Can beclometasone be used to relieve an asthma attack?

No. Beclometasone is a maintenance-only prophylactic therapy with no bronchodilator effect, taken on a fixed twice-daily schedule. It will not relieve an acute asthma attack, and patients need a separate short-acting reliever inhaler for breakthrough symptoms. This distinction should be reflected clearly in destination-market patient information and counselling materials.

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 2026-09-14.

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.

Beclometasone enquiry

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