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The Prior Approval Supplement (PAS) granted by the US Food & Drug Administration (USFDA) is for Mycophenolate Mofetil for injection of strength 500 mg/vial, the generic equivalent of CellCept injection, the company said in a regulatory filing.
As per the USFDA, PAS refers to a change in either manufacturing or testing of a product applicable to either a specific batch of product or all products that requires the regulator’s approval prior to implementation of such changes or sale of the product.
The company said the PAS it has received is for site transfer into Jarod. ”The injection will be manufactured at the group’s injectables manufacturing facility at Jarod near Vadodara in Gujarat. This site was recently inspected by the USFDA,” it added.
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