 "Aklem Labs gets EIR from USFDA for Baddi facility; stock hits record high")
Aklem Laboratories has moved higher by 11% to Rs 2,468, also its all-time high on BSE in intra-day trade, after the company said that it has received Establishment Inspection Report (EIR) from the US health regulator for its Baddi facility.
“The United States Food and Drug Administration (USFDA) has issued an EIR for the Company's manufacturing facility located at Baddi, India which was inspected from 11th September, 2017 to 15th September, 2017,” Aklem Laboratories said in a statement.
In response to the two Form 483 observations issued by the US FDA, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the US FDA, it added.
“The United States Food and Drug Administration (USFDA) has issued an EIR for the Company's manufacturing facility located at Baddi, India which was inspected from 11th September, 2017 to 15th September, 2017,” Aklem Laboratories said in a statement.
In response to the two Form 483 observations issued by the US FDA, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the US FDA, it added.
At 03:20 PM; the stock was up 5% at Rs 2,330 on BSE against 0.02% rise in the S&P BSE Sensex. A combined 247,122 shares changed hands on the counter on BSE and NSE so far.
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