Zafirlukast bulk supplier for pharma manufacturers

Zafirlukast 10 mg, 20 mg, 40 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 10 mg, 20 mg, 40 mg

Reference Brands: Accolate (USA/EU/UK)

Zafirlukast is a leukotriene receptor antagonist (LTRA) used in the management and prevention of asthma and allergic conditions. It works by blocking leukotriene receptors, which reduces bronchoconstriction, inflammation, and mucus production associated with allergic and asthmatic reactions.

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Product Description:

Zafirlukast is a leukotriene receptor antagonist, selectively blocking the cysteinyl leukotriene CysLT1 receptor. Leukotrienes mediate bronchoconstriction, mucus secretion, oedema and eosinophil recruitment, so blocking them addresses an inflammatory pathway that corticosteroids and antihistamines reach only indirectly. It is used in the prophylaxis and chronic treatment of asthma, and has a place in aspirin-exacerbated respiratory disease where leukotriene overproduction is central.

It is not a rescue medication and has no role in acute bronchospasm — a distinction that must be clear in patient information, since misunderstanding it is dangerous.

Two clinical constraints relevant to labelling. Zafirlukast has been associated with hepatic injury, and monitoring of liver function is advised, with the product contraindicated in hepatic impairment. It also interacts with warfarin, increasing prothrombin time, and absorption is reduced substantially when taken with food, so dosing is specified away from meals.

Sourcing notes. Zafirlukast has been largely displaced commercially by montelukast, which is dosed once daily, has no food restriction and lacks the hepatic monitoring requirement. That has consequences for supply: fewer manufacturers, fewer current dossiers, and thinner competition than the volumes might suggest. Where a buyer's requirement is a leukotriene antagonist rather than zafirlukast specifically, montelukast will usually be faster to source and register. Confirm current dossier availability early rather than assuming it.

Zafirlukast — third party manufacturing & bulk supply

Zafirlukast 10 mg, 20 mg, 40 mg 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

Zafirlukast is supplied as Tablets — 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 Zafirlukast 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

Zafirlukast is used for the prophylaxis and chronic treatment of asthma (including in children aged 5 years and older) by reducing airway inflammation and bronchoconstriction through antagonism of cysteinyl leukotriene receptors.

Zafirlukast is the active generic compound (chemical name 4-(5-cyclopentyloxy-carbonylamino-1-methyl-1H-indol-3-ylmethyl)-3-methoxy-N-o-tolylsulfonylbenzamide) with the empirical formula C₃₁H₃₃N₃O₆S.

The principal trade name of Zafirlukast is ACCOLATE.

Originally the brand ACCOLATE® was marketed by AstraZeneca. Generic manufacturers (for example Aurobindo Pharma Limited in the US) also make generic Zafirlukast tablets.

The generic name is Zafirlukast.

The brand name is ACCOLATE (and in some countries additional names may apply).

Manufacturing sites vary by manufacturer. For example, generic Zafirlukast tablets (10 mg and 20 mg) were approved in the U.S. for manufacture by Aurobindo Pharma USA and produced by their global supply chain.