The company had received the original approval for this ANDA in January 2014 and was selling the products in the US in 2014
Claris Lifesciences has received the Prior Approval Supplement (PAS) for Furosemide injection in the US. The company had received the original approval for this ANDA in January 2014 and was selling the products in the US in 2014. But, 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 ANDA, this process was done for redundancy and to ensure a consistent supply of the API for its finished formulation sold in the US. With this approval, alternative vendor has been appended to the ANDA this will allow the company to recommence its supplies to the US.
The product had been facing supply issues in US during the past year on various occasions and has also featured in the US FDA shortage list since June 2012.
Claris is also one of the few injectables companies in India to have its own front end in the US, the company markets its products through its wholly-owned subsidiary Claris Lifesciences. The company has 13 ANDAs approved in its name across eight molecules. The company has a under registration pipeline of 24 ANDAs across 21 molecules having an estimated addressable market size of $2.2 billion.