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)
Category: Sleep Disorders
Pitolisant Hydrochloride is a Sleep Disorders product available as Tablets in strengths 4.45 mg, 17.8 mg. It corresponds to the reference brand Wakix (USA/EU). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.
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.
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:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required 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. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Pitolisant Hydrochloride →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
Related Products
Zaleplon
Strength:
5 mg, 10 mg
Form: Capsules
Reference Brands: Sonata (USA/EU), Starnoc (EU)
View Details
Quick Response Guaranteed | Verified Suppliers
