Levocetirizine + Ambroxol Tablet 5mg + 60mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 5mg + 60mg

Reference Brands: Sinarest Levo

Category: Allergy Medication

Levocetirizine+Ambroxol is used in the treatment of cough. Levocetirizine + Ambroxol is a combination of two medicines: Levocetirizine and ambroxol which relieve cough. Levocetirizine is an antiallergic that treats runny nose, watery eyes and sneezing.

Product Description:

This fixed-dose combination pairs levocetirizine, the active R-enantiomer of cetirizine and a second-generation antihistamine, with ambroxol, a mucolytic that reduces sputum viscosity by altering mucus glycoprotein structure. The intended positioning is productive cough with an allergic component.

Levocetirizine offers the antihistaminic activity of cetirizine at half the dose, since the S-enantiomer contributes little H1 antagonism. Ambroxol is a metabolite of bromhexine and is used widely across Europe, Asia and Latin America, though it has never been approved in the United States.

Regulatory position, which should be established first. Fixed-dose combinations of an antihistamine with a mucolytic face restrictions in several jurisdictions on the grounds of pharmacological rationale, since antihistamines may thicken secretions while mucolytics act to thin them. India has prohibited a number of FDCs in successive regulatory actions and the permitted list changes. Most regulated markets will not register this combination, and ambroxol's absence from the United States market rules it out there entirely.

Sourcing notes. Confirm that the specific ratio currently holds a valid Indian manufacturing licence, and confirm the destination regulator's position before any registration work begins. This product suits markets accepting Indian FDC registrations; for regulated markets, separate single-ingredient products are the workable route.