Zydus receives PAS approval for Mycophenolate Mofetil for Injection

21 Mar 2022 , 09:09 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 mg/vial (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 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.

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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