Zydus Life rises on USFDA nod for schizophrenia drug

12 Sep 2022 , 02:18 PM

Zydus said that it was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared generic drug exclusivity for the Capsules. Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder. The drug will be manufactured at the groups formulation manufacturing facility at Ahmedabad SEZ, India. According to IQVIA MAT July 2022, Cariprazine Capsules had annual sales of $2.39 billion in the United States. The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 03-04. Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The companys consolidated net profit fell 11.7% to Rs 518.3 crore on a 1.8% increase in total income from operations to Rs 4,072.7 crore in Q1 FY23 over Q1 FY22. Powered by Capital Market – Live News