Claris Lifesciences, one of India's largest sterile Injectables company, 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 the company’s 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 $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 5-7 ANDA approvals in the near future and these ANDAs approvals could increase the addressable market size of the company's products in the USA by around $240 million.
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 Inc. The company has 13 ANDAs approved in its name across 8 molecules. The company has a under registration pipeline of 24 ANDAs across 21 molecules having an estimated addressable market size of $2.2 billion.
