Aurobindo Pharma Ltd has announced that its joint venture, Cephazone Pharma LLC, at California, USA, a facility dedicated to cephalosporin injectable drugs, has received the first ANDA approval for Ceftriaxone.
The company has received approval for Ceftriaxone injectable, a third generation cephalosporin antibiotic. 250mg, 500mg, 1Gm and 2Gm single use vials for intra muscular, intra venous use and also 1Gm and 2Gm bottles (popularly known as piggy pack) for intra venous use.
Cefiriaxone is the research innovation of Hoffmann-La Roche and often used in respiratory infections and as a choice antibiotic in bacterial meningitis.
Besides, its use is well documented in paediatrics in febrile conditions to prevent possible septicemias.
Cephazone is a joint venture of the company and has filed several ANDAs with US FDA. The company has already received the facility approval for sterile Cephalosporin APIs.
Cephalosporin injectables market is an attractive opportunity in USA and globally. The company is vertically integrated in the cephalosporin category and enjoys a leading position in the category.