Zydus receives USFDA approval for Dexmedetomidine Hydrochloride Injection

Zydus Cadila has received the final approval from the USFDA to market Dexmedetomidine Hydrochloride Injection 200 mcg (base)/2 mL (100 mcg (base) /mL) single-dose vials. The drug is indicated for sedation of intubated and mechanically ventilated patients during treatment in an intensive care setting and for sedation of non-intubated patients prior to and/or during surgical and other procedures. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. The group now has more than 180 approvals and has so far filed over 320 ANDAs since the commencement of the filing process in FY 2003-04.

About Zydus Cadila

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs over 21,000 people worldwide and is dedicated to creating healthier communities globally. Zydus aspires to be a research-based pharmaceutical company by 2020.