Levofloxacin will be produced at group's formulations manufacturing facility at Moraiya, Ahmedabad that received clearance from USFDA in February.
Cadila Healthcare share price hit fresh record high of Rs 503.70 on Friday, up 7 percent intraday after its group company received approval from the US health regulator for antibiotic drug.
"Zydus Cadila has received final approval from the US Food & Drug Administration to market Levofloxacin injection, 500 mg/20 ml and 750 mg/30 ml (25 mg/ml)," the Ahmedabad-based pharma company said in its filing.
Levofloxacin is used in the treatment of bacterial infections and will be produced at group's formulations manufacturing facility at Moraiya, Ahmedabad that received clearance from USFDA in February.
"This is significant as it marks the beginning of approval process for filings made from the Moraiya manufacturing plant after successfully completing the USFDA audit in February with zero 483 observations," the company said.
With this, the group now has more than 115 approvals and has so far filed over 300 ANDAs since commencement of filing process in FY04.
At 09:50 hours IST, the stock price was quoting at Rs 498.05, up Rs 27.10, or 5.75 percent amid high volumes on the BSE.Posted by Sunil Shankar MatkarThe Great Diwali Discount!
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