Montelukast tablets, Indian WHO-GMP supply for asthma prophylaxis and allergic rhinitis, in adult and paediatric strengths.
A leukotriene receptor antagonist taken daily rather than reached for in an attack: montelukast is add-on maintenance therapy for asthma and a standard option for allergic rhinitis. 4mg and 10mg film-coated tablets from Indian WHO-GMP facilities, stocked in volume for hospital, wholesale and tender buyers across regulated and semi-regulated markets.
Multiple WHO-GMP partner lines · 4mg and 10mg film-coated tablets · CTD dossier on file · 35 catalogue lines across roster brands.
Active ingredient
Montelukast sodium, a selective antagonist of the cysteinyl leukotriene receptor CysLT1. Leukotrienes are inflammatory mediators released during the asthmatic and allergic response; blocking the receptor reduces airway inflammation, bronchoconstriction and mucus secretion. Taken once daily as a maintenance medicine, montelukast has no bronchodilator effect and no role in relieving an acute asthma attack.
Strengths stocked
4mg and 10mg film-coated tablets, across 35 catalogue lines and multiple roster brands, including Montair, Montek and Telekast; Singulair (Merck) is the originator reference buyers benchmark against. The 10mg strength covers standard adult and adolescent dosing; 4mg covers younger paediatric use. Chewable and granule presentations exist elsewhere in the global montelukast market but sit outside the current M Care line.
Indications
Add-on maintenance therapy for asthma alongside inhaled corticosteroids, prevention of exercise-induced bronchoconstriction, and relief of seasonal and perennial allergic rhinitis. Montelukast is a controller medicine, not a reliever: it plays no part in an acute asthma attack, where a short-acting beta agonist remains the correct choice. Licensed age thresholds for the paediatric asthma and allergic rhinitis indications vary by destination regulator, worth checking against the specific market's SmPC before a tender submission.
Storage
Store below 30°C, protected from light and moisture, in the original blister pack until use. Standard ambient-temperature dispatch; no cold-chain requirement for this molecule.
Shelf life
24 months from manufacture; minimum 18 months remaining at dispatch. Or we won't ship it.
Pack format
Blister strips in a printed carton with a destination-language leaflet; hospital and wholesale pack sizes on request. Tamper-evident outer carton, batch and expiry printed on both strip and carton. Foil-foil blister lamination is standard, given the tablet's moisture sensitivity.
Hospital pharmacies, community wholesalers and tender desks across the markets we serve.
India is our origin. We do not sell into the Indian market. Montelukast is exported only.
United Kingdom
Montelukast is a standard NHS respiratory formulary item, prescribed as add-on asthma therapy and for allergic rhinitis in both adult and paediatric practice. Where the primary licensed supplier cannot fill demand, the MHRA Specials / named-patient import route is available, see MHRA Specials. Paediatric-strength continuity matters most to community pharmacy chains here.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH formulary listing and hospital pharmacy purchase orders (MoHAP and DHA for the UAE, SFDA-registered supply in Saudi Arabia, MoPH Qatar, MoH Oman, Kuwait MoH Central Drug Store, NHRA Bahrain). Allergic rhinitis prevalence and paediatric asthma programmes keep montelukast on most GCC formularies year-round.
Nigeria, Kenya, Ghana, South Africa
Public-sector formulary listing and private wholesale channels (NAFDAC-registered for Nigeria, PPB for Kenya, FDA Ghana, SAHPRA for South Africa). Paediatric asthma management is a growing formulary priority across African ministries of health, and montelukast's tablet format, rather than an inhaler, simplifies distribution down to primary-care level.
Germany
Supply via licensed importers under §72 AMG, with Qualified Person (QP) certification on arrival. CTD dossier and CoPP prepared for BfArM recognition. Named-patient import (Einzelimport) route available where a specific strength or pack is not locally listed.
Neuropsychiatric labelling, age-banded strength selection and the controller-not-reliever distinction: what changes montelukast counselling by market.
Montelukast is dosed once daily in the evening; the timing is about steady prophylactic cover, not response to symptoms. Strength is age-banded, not weight-banded: 10mg is the standard adult and adolescent dose, 4mg covers younger paediatric use, and neither strength is a half-tablet substitute for the other. The neuropsychiatric signal is the counselling point that matters most: agitation, aggression, sleep disturbance, hallucination, depression and, rarely, suicidal thinking have been reported. The US FDA added a boxed warning in 2020; the MHRA and EMA strengthened their own product-information warnings on the same signal following a 2019 EU-wide review, though the labelling mechanism and prominence differ by regulator, so the wording on the pack insert genuinely depends on destination market. Montelukast has no bronchodilator action and no role in an acute asthma attack; a patient reaching for it mid-attack instead of a reliever inhaler is a counselling gap, not a drug failure. Hepatic clearance runs mainly through CYP3A4 and CYP2C8/9, with few clinically significant interactions at standard doses.
The documentation pack a regulator actually asks for.
Montelukast is off-patent and widely registered; the paperwork, not the chemistry, is usually the rate-limiting step. Our role is manufacturer-facing: we sit between the Indian WHO-GMP facility and your regulatory or procurement team.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary included. Montelukast's CMC package is well precedented; most registration delay sits in country-specific Module 1 administrative requirements, not the underlying science.
CoA and MoA, per batch
HPLC assay, related substances, dissolution, water content, uniformity of dosage units, signed by the manufacturer's authorised QC head. Photostability data included, given the molecule's light sensitivity.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Notarised copies travel in the shipping pack.
Pack insert, labels, artwork
Destination-language PIL, regulator-style labelling, pre-print artwork QC. The neuropsychiatric-event warning is set to the destination regulator's current wording, not one generic paragraph reused across markets.
Temperature control
Ambient-temperature dispatch lane; montelukast is not a cold-chain molecule. Pre-shipment validation on the shipper configuration, with an in-transit and on-arrival record kept regardless, since the pack is light- and moisture-sensitive rather than heat-sensitive.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market on registration. Periodic Safety Update Reports compiled to ICH E2C. Neuropsychiatric adverse events remain the standing PSUR priority signal for this molecule.
The rest of the asthma and allergic rhinitis shelf.
Montelukast is add-on therapy, not a standalone asthma plan. It is ordered alongside relievers, inhaled steroids and antihistamines more often than alone.
Salbutamol
Short-acting beta-2 agonist, the reliever inhaler montelukast never replaces. Acute bronchospasm relief, asthma and COPD, 100mcg pMDI and nebuliser ampoules.
Budesonide
Inhaled corticosteroid, the maintenance partner montelukast is usually added to once step-up asthma control is inadequate. Inhaler and nebulised suspension forms.
Beclometasone
Topical and intranasal corticosteroid, relevant to montelukast's allergic rhinitis indication as well as asthma maintenance. Cream, lotion and nasal-drop forms.
Ketotifen
Antihistamine and mast-cell stabiliser, prescribed for the same dual asthma-and-allergic-rhinitis prophylaxis ground montelukast covers. 1mg tablet.
Doxofylline
Xanthine bronchodilator; a fixed-dose doxofylline-montelukast combination (400mg/10mg) also runs on the M Care respiratory roster for combined maintenance dosing.
All respiratory →
117+ respiratory SKUs: bronchodilators, inhaled corticosteroids, antihistamines, mucolytics.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (4mg or 10mg), tablet count, destination market, and whether this is hospital pharmacy, wholesale or a tender desk enquiry. Flag if the buyer needs a specific roster brand referenced on the quote.
- We route to the right line. Multiple WHO-GMP montelukast lines sit on the M Care roster. Registered-market preference goes to facilities already holding the relevant destination registration.
- Commercial and regulatory offer. FOB or CIF price, dossier status per destination, and the documentation pack you'll receive with the shipment. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Ambient-temperature dispatch lane, light-protective packaging, on-arrival inspection. Photo evidence of seal integrity on request.
- After delivery. Batch records, CoA and dispatch documentation archived for the full shelf life of the consignment. Pharmacovigilance contact opened on registration; neuropsychiatric adverse events remain the PSUR priority signal.
Montelukast supply, the specific questions.
What strengths of montelukast do you supply?
4mg and 10mg film-coated tablets, across 35 catalogue lines and multiple roster brands including Montair, Montek and Telekast; Singulair (Merck) is the originator reference buyers benchmark against. The 10mg strength is standard adult and adolescent dosing; 4mg covers younger paediatric use. Chewable and granule presentations exist elsewhere in the global montelukast market but sit outside the current M Care line, confirm on enquiry if your market requires them.
Is montelukast a reliever inhaler alternative for an asthma attack?
No. Montelukast has no bronchodilator effect and is not indicated for acute bronchospasm or an asthma attack in progress; it is a once-daily maintenance medicine taken to reduce the frequency of attacks over time. A short-acting beta agonist such as salbutamol remains the correct reliever. This distinction is worth flagging on any patient information leaflet or counselling material distributed alongside the product.
What does the neuropsychiatric warning on montelukast say, and does it vary by market?
The US FDA added a boxed warning in 2020 covering agitation, aggression, sleep disturbance, hallucination, depression and, rarely, suicidal thinking or behaviour. The MHRA and EMA strengthened their own product-information warnings on the same signal following a 2019 EU-wide safety review, though the exact labelling mechanism and prominence differ from the US boxed-warning format. Destination-language pack inserts are set to the current wording of the regulator you are registering against, not a single reused paragraph.
Which markets can you ship montelukast into?
The UK (NHS formulary supply or named-patient / MHRA Specials route), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers, sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa and neighbouring markets) for wholesale and public-sector formulary supply, Germany under §72 AMG, and other regulated and semi-regulated markets on the M Care roster. We do not supply into India. Full market coverage is at markets.
What documentation is included with a montelukast consignment?
Every consignment ships with a batch-specific Certificate of Analysis (assay, related substances, dissolution, water content, uniformity of dosage units), Method of Analysis, Certificate of Pharmaceutical Product (CoPP) where required, WHO-GMP certificate, manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert with the current neuropsychiatric-warning wording, and dispatch handling records. PV contact nominated in the destination market on registration.
Do you provide CTD dossiers for montelukast registration?
Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with MHRA, GCC central and state-level registration, BfArM, NAFDAC, PPB, SAHPRA and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. Montelukast is off-patent with a well-precedented CMC template; most of the registration timeline sits in country-specific administrative review rather than the underlying science. See dossier preparation.
Do the paediatric and adult tablets need separate registration and labelling?
Typically yes. Most regulators treat the 4mg and 10mg strengths as separate registered presentations with strength-specific labelling, including age-banded dosing instructions and, where applicable, strength-specific neuropsychiatric-warning wording for paediatric use. We prepare the CTD and pack insert per strength rather than assume one leaflet covers both.
Send the specifics. You'll have a price inside one working day.
Strength, tablet volume, destination, hospital pharmacy, wholesale or tender desk. That's the enquiry. Everything else is on us.