Alkem Laboratories gets EIR report from USFDA, shares rise 6%
New Delhi: Drug firm Alkem Laboratories Ltd on Wednesday said it has received an establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) on closure of inspection of its Baddi facility.
The USFDA had inspected the plant from 11 September 2017 to 15 September 2017, Alkem Labs said in a regulatory filing.
The company said it had submitted a detailed corrective and preventive action (CAPA) plan to the USFDA within the stipulated time lines in response to the two Form 483 observations issued by the regulator.
“The inspection has now been closed by the USFDA,” it added. USFDA releases a copy of the EIR to the establishment that is subject of an FDA or FDA-contracted inspection when the agency determines the same to be closed.
Alkem Laboratories shares ended 5.74% higher at Rs2,347.70 apiece on the BSE, while the Sensex closed 0.03% lower at 34,433.07 points.