Strides Shasun has received US FDA approval for cetirizine hydrochloride capsules, 10 mg (liquid filled capsules). Cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hies, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction.
According to IRI data, the US market for cetirizine hydrochloride capsules (softgel) is approximately US$ 60 million, with only one other generic player. The product will be manufactured at the company's flaglship facility at Bengaluru and marketed by Strides Pharma Inc. in the US market.. The product is ready for launch immediately and as in the case of OTC products, the market formation takes time and the company expects to have an important market share in approximately six months.
This is the first approval for a softgel product after the recent US FDA inspection at the company's Bengaluru facility.
Strides shasun, us fda approval, cetirizine capsules
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