Zydus receives PAS approval from USFDA for Mycophenolate Mofetil for Injection USP; stock slips ~2%

21 Mar 2022 , 03:39 PM

Zydus Lifesciences Limited (formerly Cadila Healthcare) has bagged Prior Approval Supplement (PAS) approval from the USFDA to market its Mycophenolate Mofetil for Injection USP, 500 mg/vial (US RLD: CellCept injection).

The manufacturing unit for this purpose will be the group’s injectables manufacturing facility at Jarod near Vadodara in Gujarat.

The Prior Approval Supplement (PAS) received was for a site transfer into the Jarod site. USFDA has recently inspected this site. The group was granted approval to market Mycophenolate Mofetil for Injection in the strength of 500 mg/vial in September 2021.

Mycophenolate Mofetil is to be used in combination with other drugs such as cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving renal, hepatic, or cardiac transplants.

The group now holds 330 approvals and has so far applied for over 400 ANDAs since the commencement of the filing process in 2003-04.

Zydus Lifesciences is currently trading at Rs366.85 down by Rs6.35 or 1.7% from its previous closing of Rs373.20 on the BSE.