One of India’s largest sterile Injectables company, Claris Lifesciences Limited (Claris/Company), announced today 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 USA. The Company presently has 13 ANDAs approved in the USA which account for about US$ 200 million of market size and 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, these ANDAs approvals could increase the addressable market size of the Company’s products in the USA by around US$ 240 million.
