Zydus receives final approval from the USFDA for

Prochlorperazine Maleate Tablets

Ahmedabad, India, 11 August, 2022

Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Prochlorperazine Maleate tablets, USP 5 mg and 10 mg, (USRLD: Compazine).

Prochlorperazine tablets are used to treat nervous, emotional, and mental conditions (eg. schizophrenia) and non-psychotic anxiety. It is also used to control severe nausea and vomiting. The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.

Prochlorperazine Maleate tablets had annual sales of USD 30 million in the United States according to IQVIA MAT June 2022.

The group now has 320 approvals and has so far filed over 428* ANDAs since the commencement of the filing process in FY 2003-04.

(*as of 30th June 2022)

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Zydus Lifesciences Ltd. published this content on 11 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 August 2022 05:08:06 UTC.