Pitolisant Hydrochloride bulk supplier for pharma manufacturers

Pitolisant Hydrochloride 4.45 mg, 17.8 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 4.45 mg, 17.8 mg

Reference Brands: Wakix (USA/EU)

Pitolisant tablets 4.45 mg and 17.8 mg (as 5 mg and 20 mg hydrochloride), an H3 receptor antagonist for narcolepsy. For importers, distributors, sleep clinics and hospital pharmacies.

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Product Description:

Pitolisant is a histamine H3 receptor antagonist and inverse agonist. H3 receptors brake histamine-releasing neurones; blocking them raises histamine and other wake-promoting transmitters. This differs from classical stimulants, and pitolisant is not a scheduled controlled substance in the US. The tablets here contain 4.45 mg and 17.8 mg of pitolisant, equal to 5 mg and 20 mg of pitolisant hydrochloride. Labels quote either figure, so check the convention before comparing offers.

Pitolisant is used for narcolepsy in adults: in the EU for narcolepsy with or without cataplexy, and in the US for excessive daytime sleepiness or cataplexy in narcolepsy. Some markets have extended use to children or other sleep disorders. It is taken once each morning with breakfast, titrated over about three weeks. Insomnia, headache, nausea and anxiety are commonest. It can prolong the QT interval. It weakens hormonal contraceptives, so another method is needed. Strong CYP2D6 inhibitors raise exposure and strong CYP3A4 inducers reduce it.

Sourcing notes. Pitolisant is prescription-only, with orphan status in some markets, and patent and data protection still apply widely, so check registration and intellectual property before tendering. Though not scheduled in the US, confirm national status, as controls on wake-promoting drugs vary. Film-coated tablets in bottles or blisters are kept at room temperature, without cold chain. Ask for zone IVb stability where relevant, a batch CoA, the GMP certificate, a CoPP and a CTD or ACTD dossier, plus bioequivalence data for generics. State strength as base or salt, and pack count.

Pitolisant Hydrochloride — third party manufacturing & bulk supply

Pitolisant Hydrochloride 4.45 mg, 17.8 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

Pitolisant Hydrochloride 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 Pitolisant Hydrochloride 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

Pitolisant is used for the treatment of narcolepsy, particularly to reduce excessive daytime sleepiness and episodes of cataplexy in patients with sleep disorders.

Pitolisant is made from the active pharmaceutical ingredient pitolisant hydrochloride, which acts on histamine receptors in the brain to promote wakefulness.

A widely known trade name of pitolisant is Wakix.

Pitolisant is marketed by Harmony Biosciences and may also be distributed in other regions through approved pharmaceutical partners.

The generic name is pitolisant hydrochloride.

The most recognized brand name is Wakix.

Pitolisant products are manufactured in pharmaceutical facilities that comply with international regulatory and quality standards in regions such as the United States and Europe.