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Zydus gets US FDA marketing approval for Nystatin ointment, omeprazole & sodium bicarbonate capsules
Our Bureau, Mumbai | Monday, May 28, 2018, 13:30 Hrs  [IST]

Zydus Cadila has received the final approval from the US FDA to market Nystatin ointment USP, 100,000 units per gram. It is used as an adjunct to treat fungal skin infections and will be manufactured at the group’s topical manufacturing facility at Ahmedabad.

The group also received the final approval to market omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg and 40 mg/1100 mg. It is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

Last week, the company also received approval to market dutasteride and tamsulosin hydrochloride capsules, 0.5 mg/0.4 mg. The drug is used to treat symptoms of Benign Prostatic Hyperplasia (BPH).

The group now has more than 190 approvals and has so far filed over 320 ANDAs since the commencement of the filing process in FY 2003-04.

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