 "US Food and Drug Administration")
Claris Lifesciences is locked in upper circuit of 20% at Rs 202 on the BSE after the company announced that it has received the establishment inspection report (EIR) for its manufacturing facility in Gujarat.
“The company has received the EIR for its manufacturing facility located near Ahmedabad, wherein the US Food and Drug Administration (FDA) has concluded that the inspection stands closed and the facility was found to be acceptable,” Claris Lifesciences said in a statement.
The US FDA had concluded 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.
Claris Lifesciences presently has 13 abbreviated new drug application (ANDA) 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, it added.
The company expects 5-7 ANDA approval in the near future; these ANDAs approvals could increase the addressable market size of the company’s products in the USA by around $ 240 million.
The stock bounces back 23% from its intra-day low of Rs 164 on the BSE. As many as 371,000 shares have already changed hands on the counter against an average 42,000 shares that were traded daily in past two weeks on the BSE. There were pending buy orders for 210,547 shares at 12:50 PM.
“The company has received the EIR for its manufacturing facility located near Ahmedabad, wherein the US Food and Drug Administration (FDA) has concluded that the inspection stands closed and the facility was found to be acceptable,” Claris Lifesciences said in a statement.
The US FDA had concluded 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.
Claris Lifesciences presently has 13 abbreviated new drug application (ANDA) 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, it added.
The company expects 5-7 ANDA approval in the near future; these ANDAs approvals could increase the addressable market size of the company’s products in the USA by around $ 240 million.
The stock bounces back 23% from its intra-day low of Rs 164 on the BSE. As many as 371,000 shares have already changed hands on the counter against an average 42,000 shares that were traded daily in past two weeks on the BSE. There were pending buy orders for 210,547 shares at 12:50 PM.
