FDA grants marketing approval to Zydus for generic mycophenolate mofetil injection

The FDA has granted a prior approval supplement to Zydus Lifesciences Limited allowing the company to market its generic mycophenolate mofetil injection USP, 500 mg vial, following a transfer to a new manufacturing site.
According to a press release from Zydus, formerly known as Cadila Healthcare Ltd., the injection, listed in the United States under the name CellCept, will now be manufactured at the company’s facility at Jarod, near Vadodara in Gujarat, India. The prior approval supplement (PAS) was for a site transfer to the Jarod injectables manufacturing facility.
“This site was

The FDA has granted a prior approval supplement to Zydus Lifesciences Limited allowing the company to market its generic mycophenolate mofetil injection USP, 500 mg vial, following a transfer to a new manufacturing site.
According to a press release from Zydus, formerly known as Cadila Healthcare Ltd., the injection, listed in the United States under the name CellCept, will now be manufactured at the company’s facility at Jarod, near Vadodara in Gujarat, India. The prior approval supplement (PAS) was for a site transfer to the Jarod injectables manufacturing facility.
“This site was