Zydus Cadila has received the US health regulator’s nod to market levofloxacin injection, used to treat bacterial infections, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to market levofloxacin injection, 500 mg/20mL and 750mg/30 mL, Zydus Cadila said in a BSE filing today.
The company will manufacture the product at its Moraiya plant in Gujarat. This is the first approval from its Moraiya plant after the USFDA audit in February.
The Gujarat group has more than 115 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.
Shares of Cadila Healthcare, the group’s listed entity were trading at Rs 5.21 per scrip on BSE, up 495.50 per cent from its previous close.