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Zydus got US FDA nod for Dutasteride Capsules and Amitriptyline Hydrochloride Tablets

 

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Zydus Cadila has received the final approval from the USFDA to market Dutasteride Capsules, 0.5 mg and Amitriptyline Hydrochloride Tablets USP in strengths of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg.

Dutasteride Capsules will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Dutasteride Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention (AUR) and reduce the risk of the need for BPH-related surgery. The group now has more than 160 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.

 

Amitriptyline Hydrochloride Tablets USP is used to treat depression and will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The group now has more than 160 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.

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