Sterile injectables company Claris Lifesciences Ltd, on Monday, said it has received the Establishment Inspection Report (EIR) for its manufacturing facility located near Ahmedabad, from the USFDA, which has found it acceptable.
The USFDA had conducted audit at Claris’ manufacturing facility in May 2015, following which the company had taken appropriate steps to address the observations it had received from these audits, according to a release here.
Having received the EIR from the USFDA potentially clears the path for Claris to receive product approvals, or Abbreviated New Drug Application (ANDA), for the USA.
The company at present has 13 ANDAs approved in the USA which account for about US$ 200 million of market size. It has an additional 26 ANDAs with an addressable market size of around US$ 1.5 billion under approval.
The company expects 5-7 ANDA approvals in the near future, which could increase the addressable market size of Claris’ products in the USA by around US$ 240 million.