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Claris Lifesciences gets Supplemental ANDA approval for Fluconazole Injection

21 Apr 2015 Evaluate

Claris Lifesciences has received the Supplemental Abbreviated New Drug Application (ANDA) approval for Fluconazole Injection in the United States of America (USA). The company 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 $2.2 billion.

Claris manufactures and markets products across multiple delivery systems, markets, and therapeutic segments including anesthesia, blood products, anti-infectives, and plasma volume expanders. A significant majority of these products are generic drugs that are capable of being directly injected into the human body, which are predominantly used in the treatment of critical illnesses.

Peers
Company Name CMP
Redington 234.90
Adani Enterprises 2218.35
Amrapali Industries 17.53
Rashi Peripheral 455.25
PDS 301.45
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