Asthma and allergy · Leukotriene antagonist
Montelukast tablets and chewable tablets
A daily tablet that helps prevent asthma attacks and relieves allergic rhinitis. Progene Pharma supplies montelukast as 10 mg tablets and 4 mg and 5 mg chewable tablets for children, under your brand and with the documents you need to register it.
- Forms
- Tablets and chewable tablets
- Strengths
- 3 options
- Supply
- Private label or ready brand
- Documents
- COA, COPP, MSDS, dossier
Available strengths
Montelukast in each tablet or dose. Other strengths and pack sizes are made to order. Pack sizes and labelling are made to match your registration.
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10 mg
Tablet
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4 mg
Chewable tablet
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5 mg
Chewable tablet
About montelukast
What it treats
Montelukast is used to prevent asthma attacks and exercise-induced breathing difficulty, and to relieve the symptoms of seasonal and year-round allergic rhinitis. It is not for relief of a sudden attack.
Why it is widely used
It is taken once a day as a tablet, which patients often prefer to an inhaler, and the chewable forms make it easy for children. It is often combined with an antihistamine such as levocetirizine in a single tablet.
How it is taken
It is taken once a day in the evening. A reliever inhaler is still needed for sudden symptoms. Regulators in several countries warn that montelukast can cause mood and sleep changes, including in children, so patients and parents are told to report them. Patients should always follow the approved label and the prescriber's instructions in their country.
Prescription medicine. This information is for distributors and healthcare professionals and is not medical advice.
Made for your market
Registration rules differ from country to country. We build the product around yours.
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Private label
Your brand name on the carton, blister foil and leaflet, designed to your regulator's rules.
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Packaging
Pack sizes, languages and artwork to suit how the medicine is prescribed and sold in your country.
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Registration documents
COPP, MSDS and the product dossier for registration, and a COA with every batch.
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Certified manufacturing
Manufactured in a facility certified to WHO-GMP, EU-GMP and ISO. What each standard means
How ordering works
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01
Tell us what you need
The strength, pack size, quantity and the country you are registering in.
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02
Quotation and documents
We confirm price, lead time and the certification and paperwork your regulator expects.
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03
Manufacture and testing
Manufactured in a certified facility. Every batch is tested and released with a COA.
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04
Shipping
Packed for export and shipped with the documents you need for import clearance.
Other allergy and respiratory medicines we supply
Ask for any of these with your quotation, or see the full product list.
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Tablets 10 mg, syrup and drops
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Tablets 5 mg and syrup
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Tablets 10 mg and syrup
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Tablets 2 and 4 mg, syrup and respules for nebulisers
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Tablets and syrup
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Expectorant and suppressant syrups, alone or in combinations
Questions about montelukast
Something else? Email [email protected].
Which strengths of montelukast do you supply?
Tablets of 10 mg; chewable tablets of 4 mg and 5 mg. Other strengths can be made to order, and pack sizes and labelling are made to match the registration in your country.
Is montelukast a prescription medicine?
In most countries, yes. It is sold with a prescription and registered with the national medicines regulator. Rules differ by country, so check with your authority.
Do you make montelukast with levocetirizine?
Yes. Fixed combinations of montelukast with levocetirizine are popular in several markets. Tell us the strengths your market uses and we will confirm what we can supply.
Can you supply it under our own brand?
Yes. Progene Pharma manufactures it as a private label product, with the carton, blister foil or label and patient leaflet designed for your market and your regulator's requirements.
Which documents come with it?
Every batch ships with a Certificate of Analysis (COA). Progene Pharma also provides the Certificate of Pharmaceutical Product (COPP), MSDS and the product dossier you need to register and import it.
Where is it manufactured?
Progene Pharma manufactures it in a WHO-GMP certified facility in India, also certified to EU-GMP and ISO standards. Tell us your destination country and we will confirm which certification applies to your order.
What is the minimum order quantity and lead time?
Both depend on the strength, pack size and documents your market needs. We confirm them with your quotation, and we work with large importers as well as smaller distributors.
Related pages
Request a quote
Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494