Zydus Cadila has received the final approval from the USFDA to market Levofloxacin Injection, 500 mg/20 mL and 750 mg/30 mL (25 mg/mL). Levofloxacin is used in the treatment of bacterial infections and will be produced at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.
This is significant as it marks the beginning of the approval process for filings made from the Moraiya manufacturing plant after successfully completing the USFDA audit from February 6th to 15th 2017 with Zero 483 observations. The group now has more than 115 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.