Global Calcium is one of the leading manufacturers and exporters of Bepotastine Besilate CAS no. 190786-44-8, API, (Active Pharmaceutical Ingredient). We support the customers with exhaustive documentation. As a USDMF & EU-GMP certified global company and an established hallmark for pharmaceutical standards, Global Calcium has stood the test of time since its inception in 1979.

As manufacturer of Bepotastine Besilate we hereby state the following facts about the drug:

In allergic conjunctivitis, allergen exposure is followed by conjunctival mast cell degranulation and histamine released as a result of the formation of complementary IgE cross-links on the conjunctiva. Due to the release of histamine, symptoms such as itching can be observed. Bepotastine works to relieve itchy eyes by three primary mechanisms of action.

• It is a non-sedating, selective antagonist of the histamine 1 (H1) receptor. It belongs to the second-generation piperidine chemical class. It works by blocking the action and preventing the release of histamine, a substance in the body that causes allergic symptoms. (S)-(4-chlorophenyl)(pyridin-2-yl)methanol of bepotastine in which the hydroxyl hydrogen is substituted by a 1-(3-carboxypropyl)piperidin-4-yl group
• It a mast cell stabilizer,
• It suppresses the migration of eosinophils into inflamed tissues to prevent tissue damage and worsening of allergic inflammation of the conjunctiva

Bepotastine was approved in Japan for use in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively. The ophthalmic solution is FDA-approved since Sept 8, 2009.

Therapeutic uses and effectiveness:

• Bepotastine has a role as an H1-receptor antagonist and an anti-allergic agent. Bepotastine ophthalmic is used for the symptomatic treatment of itching of the eyes caused by allergic conjunctivitis (a condition in which the eyes become itchy, swollen, red, and teary when they are exposed to certain substances in the air). Basically, histamine (H1) receptor antagonist used (as its benzenesulfonate salt) for treatment of itching associated with allergic conjunctivitis.
• Bepotastine besilate 1.5% ophthalmic solution is a safe and effective treatment option for allergic conjunctivitis-associated pruritus. Human clinical trials demonstrate the efficacy and safety of systemic and ophthalmic bepotastine for pruritus relief, limited penetration across the blood-brain barrier, and kinetics suitable for twice-daily administration.
• Bepotastine may also have other immunoactivity properties, such as inhibition of eosinophil migration, interleukin-5 (IL-5), leukotrienes (e.g., LTB4), and platelet-activating factor (PAF)

Global Calcium is a leading manufacturer of this drug. We manufacture this pharmaceutical drug and make it available to domestic and overseas market