Pitolisant Hydrochloride Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 4.45 mg, 17.8 mg
Reference Brands: Wakix (USA/EU)
Category:
Sleep Disorders
Pitolisant Hydrochloride is available in Tablets
and strengths such as 4.45 mg, 17.8 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Pitolisant Hydrochloride is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Pitolisant Hydrochloride can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
Pitolisant is a wake-promoting medication used in the management of narcolepsy, particularly for patients who experience excessive daytime sleepiness and sometimes cataplexy. It works as an inverse agonist of the histamine H3 receptor, which helps increase the activity of histaminergic neurons in the brain. By enhancing histamine release, pitolisant promotes alertness and helps regulate the sleep–wake cycle. This mechanism is different from traditional stimulants, making it a unique treatment option for sleep-wake disorders.
The medicine is marketed under the brand name Wakix and is considered the first commercially available drug in its class. It received approval from the European Medicines Agency in 2016 and later from the U.S. Food and Drug Administration in 2019 for the treatment of narcolepsy and excessive daytime sleepiness. Pitolisant helps improve wakefulness during the day and overall daily functioning in patients with sleep disorders. Common side effects reported with its use include insomnia, nausea, anxiety, and headache, though it is generally well tolerated when used under medical supervision.
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