Rupatadine Fumarate 10 mg, 20 mg / 1 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Tablet / Syrup

Available Strengths: 10 mg, 20 mg / 1 mg/mL

Reference Brands: Rupafin ((EU / UK), Urtimed (EU)

Category: Allergy Medication

Rupatadine is a modern, second-generation antihistamine with additional platelet-activating factor (PAF) antagonist properties, making it highly effective in controlling both early and late allergic responses. It provides rapid and long-lasting relief from symptoms of allergic rhinitis (sneezing, runny nose, nasal congestion, itching) and chronic urticaria (hives, redness, itching).

Product Description:

Rupatadine is a second-generation antihistamine with a dual mechanism that distinguishes it within the class: alongside selective peripheral H1 antagonism, it acts as a platelet-activating factor antagonist. PAF is a mediator involved in the late-phase allergic response and in the vascular permeability underlying urticarial wheals, so blocking both pathways addresses aspects of the allergic response that H1 antagonism alone does not.

Clinically this supports use in seasonal and perennial allergic rhinitis and in chronic spontaneous urticaria, with once-daily dosing at 10 mg and a 20 mg dose used in urticaria in some markets. An oral solution at 1 mg per mL serves paediatric use.

Geographic footprint matters here. Rupatadine is approved across the European Union, in India and in much of Latin America and Asia, but is not approved in the United States. Its origin is Spanish and its strongest presence remains European. Grapefruit juice is contraindicated, as CYP3A4 inhibition materially raises exposure.

Sourcing notes. Indian manufacturers hold both the API and finished-dose capability, and dossiers are available, which makes this a practical option for markets accepting Indian registrations. For European supply, confirm the specific plant holds EU-GMP approval covering oral solids. Where the destination market has no rupatadine registration precedent, expect a longer regulatory pathway than for a widely established alternative.