The US FDA had conducted audit at Claris’ manufacturing facility near Ahmedabad in May 2015
Sterile injectables company; Claris Lifesciences has announced that it has received the Establishment Inspection Report (EIR) for its manufacturing facility located near Ahmedabad, wherein the US FDA has concluded that the inspection stands closed and the facility was found to be acceptable.
The US FDA had conducted audit at Claris’ manufacturing facility in May, 2015, the company had taken appropriate steps to address the observations it had received from these audits.
Having received the EIR from the US FDA potentially clears the path for the company to receive product approvals (ANDA) for the US. The company presently has 13 ANDAs approved in the US which account for about $200 million of market size and it has an additional 26 ANDAs; with an addressable market size of around $1.5 billion; under approval. The company expects five to seven ANDA approvals in the near future; these ANDAs approvals could increase the addressable market size of the company’s products in the US by around $240 million.