Zydus bags USFDA nod for Prochlorperazine Maleate Tablets

Ahmedabad: 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.

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Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.

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