Claris Lifesciences Receives Final Approval For Levofloxacin

Ahmadabad-based Claris Lifesciences has reported that it has received a final approval for Levofloxacin injection in the United States. The approval is for Levofloxacin injection in the strength of 25mg/ml in 20ml vials. It is not clear as to when the drug will be launched as the company spokesperson was not available for comment.

Levofloxacin is an anti-infective drug and is indicated in the treatment of Pneumonia, acute bacterial Sinusitis or complex urinary tract infections. The drug is administered through the intravenous route.

With this approval, Claris now has a total 11 ANDAs approved from the US FDA. It so far has 32 total filings. In the March 2013 quarter, the company received 41 product registrations and also applied for another 42 registrations. Most of these filings and registrations are in the developed markets and are a main source of business growth for large Indian pharma companies.

The injectables segment is currently providing a fantastic business opportunity at this time. They have a huge demand in USA and also have high profit margins. This is also a reason that many large companies are now shifting their focus to complex drugs like injectables. We believe that in the long term, Claris Lifesciences would provide a fantastic capital appreciation opportunity.