Claris gets nod to resume supply of Furosemide injection in US

Product had been facing supply issues in the US the past year and has featured in USFDA shortage list since June 2012

Drug firm Claris Lifesciences today said it has received prior approval supplement (PAS) for Furosemide injection which will help it to resume supply in the US market.

Furosemide injection is used to treat fluid retention.

"Since January 2015, the company has been facing supply issues from its raw material supplier and has not been able to supply its product to the US.

The company had filed a PAS application to append an additional supplier to the abbreviated new drug application (ANDA), this process was done for redundancy and to ensure a consistent supply of the API for its finished formulation sold in the US," Claris Lifesciences said in a BSE filing.

It further said: "With this approval, alternative vendor has been appended to the ANDA, this will allow the company to recommence its supplies to the US."

Claris Lifesciences said the product had been facing supply issues in the US during the past year on various occasions and has also featured in the USFDA shortage list since June 2012.

In January 2014, Claris Lifesciences received US health regulator's nod to market Furosemide injection in the American market.

The company has 13 ANDAs approved in its name across 8 molecules and has a under registration pipeline of 24 ANDAs across 21 molecules, having an estimated addressable market size of $2.2 billion.

Shares of Claris Lifesciences were trading at Rs 231.50 apiece, up 5.08 per cent, on the BSE.