Zydus gets US FDA final approval for succinylcholine chloride injection & tentative approval for plerixafor injection
Zydus Cadila has received the final approval from the US FDA to market succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose vials. It is used as an adjunct to general anaesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.
The group also received the tentative approval for plerixafor injection, 24 mg/1.2 mL (20 mg/mL), single-dose vial. It is used to mobilize haematopoietic stem cells into the bloodstream for their collection & subsequent transplantation in patients with certain type of blood cancers. It will be manufactured at Alidac Pharmaceuticals Ltd., a wholly owned subsidiary of Cadila Healthcare Ltd., located at the pharma SEZ in Ahmedabad.
The group now has more than 190 approvals and has so far filed over 320 ANDAs since the commencement of the filing process in FY 2003-04.