Claris receives Supplemental ANDA approval for Fluconazole Injection in 50 ml PVC Bags

Claris receives Supplemental ANDA approval for Fluconazole Injection in 50 ml PVC Bags Claris will be only company offering Fluconazole Injection USP in 50 ml PVC bags in the US.

Ahmedabad, India, April 21, 2015: Claris Lifesciences Limited (Claris) announced today that it has received the Supplemental Abbreviated New Drug Application (ANDA) approval for Fluconazole Injection in the United States of America (US). Claris currently marketing Fluconazole in 2 mg/ml formulation packed in 100 ml and 200 ml PVC Bags and now with the approval of supplemental ANDA, Claris is the only company to be able to sell Fluconazole in 50 ml variant in the US. By launching this variant Claris will be addressing the need of the medical fraternity.

Claris is one of the few injectables companies from India to have its own front end in the US, the Company markets its products through its wholly owned subsidiary Claris Lifesciences Inc. The Company has 13 ANDAs approved in its name across 8 molecules. The Company has a under registration pipeline of 25 ANDAs across 22 molecules having an estimated addressable market size of USD 2.2 Bn.

Claris Lifesciences Limited (CLL) – for more information about company www.clarislifesciences.com
Claris Injectables Limited (CIL) – for more information about company www.clarisinj.com