The drug, lurasidone hydrochloride tablets, will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad
Zydus Cadila has received final approval from US health regulator to market lurasidone hydrochloride tablets used to treat mental disorders. The approval by the US Food and Drug Administration (USFDA) for lurasidone hydrochloride tablets is for multiple strengths of 20 mg, 40 mg, 60 mg, 80 mg and 120 mg. It will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad, Cadila Healthcare, the listed entity of Zydus Cadila group, said in a regulatory filing.
The medication is used to treat certain mental/mood disorders such as schizophrenia, depression associated with bipolar disorder, it added. The drug may also help to decrease hallucinations. Zydus Cadila group now has 257 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.