JB Chemicals & Pharmaceuticals today said its Hydrochloride tablets used in treating respiratory allergies has received approval from the US drug regulator for sale there.
The company would manufacture the drug from it facility at Panoli, Gujarat, it said.
The company has received US Food and Drug Approval for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets, JB Chemicals said in a filing to the Bombay Stock Exchange. The tablets are in strengths of 5 mg and 10 mg and is used for temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing, runny nose, itchy, watery eyes, itchy throat or nose).
The company is in the process of negotiations with its marketing partners in the USA for launching the product there, the filing added.
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