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Mizolastine bulk supplier for pharma manufacturers

Mizolastine 10mg Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: 10mg

Reference Brands: Mizollen (EU)

Category: Allergy Medication

Mizolastine is a second-generation, non-sedating antihistamine that selectively blocks peripheral H1 receptors. It is primarily indicated for the treatment of allergic rhinitis (seasonal & perennial) and chronic idiopathic urticaria, providing long-lasting relief from itching, sneezing, runny nose, and hives without significant drowsiness.

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Product Description:

Mizolastine is a second-generation antihistamine that selectively antagonises peripheral H1 receptors with minimal central nervous system penetration, so sedation is uncommon at therapeutic doses. It also demonstrates some anti-inflammatory activity independent of H1 blockade, though the clinical weight of that additional mechanism is modest. Onset is rapid and duration supports once-daily dosing at 10 mg.

Its indications are seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.

Two constraints worth establishing early. Mizolastine carries cardiac considerations shared with several second-generation antihistamines: it is contraindicated with drugs that prolong the QT interval, with macrolide and imidazole antifungal agents, and in patients with significant cardiac disease or hepatic impairment. Separately, its geographic footprint is narrow — it is a European product, marketed principally in the United Kingdom, France and neighbouring markets, and is not approved in the United States.

Sourcing notes. That narrow footprint is the governing commercial fact. Dossiers and approved manufacturing sites are far fewer than for cetirizine, loratadine or fexofenadine, so supply options are limited and pricing reflects it. Where a buyer's requirement is simply a non-sedating antihistamine rather than mizolastine specifically, the widely genericised alternatives will almost always be quicker to register and cheaper to supply.

Mizolastine — third party manufacturing & bulk supply

Mizolastine 10mg 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

Mizolastine is supplied as Tablet — 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 Mizolastine 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

Mizolastine is a non-sedating antihistamine used for the symptomatic treatment of allergic rhinoconjunctivitis (seasonal or perennial) and chronic idiopathic urticaria.

Mizolastine is the active chemical compound with the formula C₄₄H₅₄Cl₂O₁₆ (in simplified form C₂₄H₂₅FN₆O) and acts as a selective H₁-receptor antagonist.

One of the trade names is Mizollen.

The original brand product (Mizollen) was marketed by Sanofi-Aventis in some European countries.

The generic name is Mizolastine.

Brand name: Mizollen (and potentially others depending on region).

Manufacturing locations vary by region and are handled by the marketing authorisation holders; specific site details differ by country and company.

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