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24-Jul2017

Strides Shasun receives USFDA approval for Cetirizine Softgel Capsules

Strides Shasun has received an approval from the United States Food & Drug Administration (USFDA) for Cetirizine Hydrochloride Capsules, 10 mg (Liquid Filled Capsules).  According to IRI data, the US market for Cetirizine Hydrochloride Capsules (Softgel) is approximately $60 million, with only one other generic player.

The product will be manufactured at the company's flagship facility at Bangalore 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 USFDA inspection at the company's Bangalore facility.

Cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction.



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