Zydus receives PAS approval for Mycophenolate Mofetil for Injection

25 Mar 2022 , 01:33 AM

Zydus Lifesciences formerly known as Cadila Healthcare has received Prior Approval Supplement PAS approval from the USFDA to market Mycophenolate Mofetil for Injection USP 500 mgvial US RLD CellCept injection The injection will be manufactured at the groups injectables manufacturing facility at Jarod near Vadodara in Gujarat The Prior Approval Supplement PAS was for a site transfer into the Jarod site This site was recently inspected by the USFDA Earlier in September 2017 the group was granted approval to market Mycophenolate Mofetil for Injection in the strength of 500 mgvial Mycophenolate Mofetil is indicated for use in combination with other drugs ie cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving renal hepatic or cardiac transplants The group now has 330 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04