Claris Lifesciences Limited (Claris), a Rs. 650 crore plus pharma giant from Ahmedabada, has received the supplemental Abbreviated New Drug Application (ANDA) approval for fluconazole injection in the US.
Claris which is currently marketing Fluconazole in 2 mg/ml formulation packed in 100 ml and 200 ml PVC bags will now able to sell Fluconazole in 50 ml variant in the US with the approval of supplemental ANDA. 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 which has 13 ANDAs approved in its name across 8 molecules has an under registration pipeline of 25 ANDAs across 22 molecules having an estimated addressable market size of USD 2.2 billion.