Montelukast Sodium tablets bulk supplier for pharma manufacturers

Montelukast Sodium Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablets, Chewable Tablets, Oral Granules

Available Strengths: Tablets:10 mg; Chewable Tablets: 4 mg / 5 mg; Oral Granules:4 mg (sachet)

Reference Brands: Singulair® (US & EU)

Montelukast sodium as 10 mg tablets, 4 mg and 5 mg chewables and 4 mg granules, for importers, distributors, hospitals and tender buyers needing a full adult and paediatric asthma range.

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Product Description:

Montelukast is a leukotriene receptor antagonist. It blocks the cysteinyl leukotriene type 1 receptor in the airways, damping the bronchoconstriction, mucus and inflammation that leukotrienes drive. This page covers three oral forms: 10 mg film-coated tablets for adults and adolescents, 5 mg and 4 mg chewables for younger children, and 4 mg granules in sachets for the youngest. All are taken once daily. Granules can go straight into the mouth or be mixed with a spoonful of cold soft food.

Montelukast is used as add-on asthma therapy when inhaled corticosteroids alone are not enough, for exercise-induced bronchoconstriction, and for allergic rhinitis in patients with asthma. It is not a reliever and does not stop an acute attack. For asthma it is taken in the evening. Labels warn of neuropsychiatric effects, including sleep disturbance, agitation, depression and suicidal thoughts, so families should report changes in mood. Chewables contain aspartame, a phenylalanine source. Granules are given within 15 minutes of opening.

Sourcing notes. Montelukast is prescription-only in most markets, and each form needs its own registration under a CTD or ACTD dossier with bioequivalence data. Montelukast sodium is sensitive to light and moisture, so ask for alu-alu blisters or protective sachets and zone IVb stability data. Check photostability results and degradation impurities, including the sulfoxide. For chewables, confirm flavour and the aspartame statement. Ask for each batch CoA, the GMP certificate, a CoPP and the API DMF or CEP reference. In your enquiry, specify forms, strengths, pack sizes and label language.

Also known as: montelukast (Spanish), montelucaste (Portuguese), montélukast (French), Montelukast (German), монтелукаст (Russian), مونتيلوكاست (Arabic), 孟鲁司特 (Chinese), モンテルカスト (Japanese), 몬테루카스트 (Korean).

Montelukast Sodium Tablets — third party manufacturing & bulk supply

Montelukast Sodium Tablets is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Montelukast Sodium Tablets is supplied as Tablets, Chewable Tablets, Oral Granules — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Montelukast Sodium Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Montelukast sodium is used to prevent and manage asthma symptoms, such as wheezing and shortness of breath, and to relieve symptoms of seasonal allergies (hay fever) and perennial allergic rhinitis. It is also used to prevent exercise-induced bronchoconstriction. Montelukast works by blocking leukotrienes, chemicals in the body that cause inflammation, airway constriction, and mucus production.

Montelukast sodium is made from the active ingredient montelukast sodium, which is a selective leukotriene receptor antagonist. Its chemical name is [R-(E)]-1-[[[1-[3-[2-(7-chloroquinolin-2-yl)vinyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The formulation may also contain inactive ingredients such as microcrystalline cellulose, mannitol, and magnesium stearate depending on the dosage form.

The most common trade name of montelukast sodium is Singulair, which is widely recognized globally.

Montelukast sodium (Singulair) is manufactured by Merck & Co., Inc. and marketed in many countries under the same or equivalent names. Several generic versions are also produced by various pharmaceutical companies worldwide.

The generic name of the drug is montelukast sodium.

The brand name of montelukast sodium is Singulair, and it is also available under other local trade names depending on the manufacturer, such as Montair, Montelo-10, and Montec.

It is manufactured in more than one country, including India. Share your market and we will find licensed makers whose registrations and documents fit.