Zydus gets USFDA Prior Approval Supplement (PAS) approval for Mycophenolate Mofetil for Injection USP

Ahemdabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Ltd.) has received Prior Approval Supplement (PAS) approval from the USFDA to market Mycophenolate Mofetil for Injection USP, 500 mg/vial (US RLD: CellCept injection). The injection will be manufactured at the group's 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 mg/vial. Mycophenolate Mofetil is indicated for use in combination with other drugs i.e., cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving renal, hepatic or cardiac transplants.

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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.

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