Claris Lifesciences Limited (Claris) has received the Supplemental Abbreviated New Drug Application (ANDA) approval for Fluconazole Injection in the US market, the company informed in a statement on Tuesday.
Claris is 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, the statement said.
By launching this variant Claris will be addressing the need of the medical fraternity.
Claris 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 shares ended 1.06 per cent or Rs 2.90 at Rs 277.30 on the BSE on Tuesday.