Cloperastine 3.54 mg/mL, 10mg Suppliers & Bulk Manufacturers

Available Forms: Syrup/ Tablet

Available Strengths: 3.54 mg/mL, 10mg

Reference Brands: Flutox (EU), Tusiclox

Category: Respiratory Disorder

Cloperastine is a non-opioid antitussive (cough suppressant) used for the symptomatic relief of dry (non-productive) cough. It acts on the central cough center in the brain to reduce the cough reflex and also has mild antihistamine and bronchodilator properties, which help relieve throat irritation and ease breathing.

Product Description:

Cloperastine is a centrally acting non-opioid antitussive, suppressing the cough reflex at the medullary cough centre without the respiratory depression, sedation or dependence potential associated with codeine and other opioid antitussives. It additionally possesses mild antihistaminic and bronchodilator activity. Its use is confined to dry, non-productive cough; it has no place where cough is clearing secretions.

It is supplied as syrup, typically 3.54 mg per mL, and as tablets at 10 mg.

Geographic footprint is the governing commercial fact here. Cloperastine is used principally in Italy, Spain, Japan and parts of Latin America and Asia. It has never been approved in the United States or the United Kingdom. For a buyer, this means registration precedent exists only in a limited set of markets, and introducing it where none exists is a full registration exercise rather than a straightforward filing.

Sourcing notes. Manufacturing capability is concentrated in the markets where the product is used, with Italian and Japanese origin most common and some Indian capability serving export. Syrup manufacture requires liquid orals capability with stability data appropriate to the destination climatic zone. Where a buyer needs a non-opioid antitussive rather than cloperastine specifically, levodropropizine or dextromethorphan will usually offer wider registration precedent and more supply options.