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Alkem Laboratories has dipped 8% to Rs 1,655 on the BSE in early morning trade after the pharmaceuticals company said it has received 13 observations from the US drug regulator for its manufacturing facility at Daman.
“The United States Food and Drug Administration (USFDA) had conducted an inspection at the company’s manufacturing facility located at Daman from September 20 to September 29, 2016,” Alkem Laboratories said in a BSE filing. LINK
The company received the inspection report which contains 13 observations, it added.
Alkem Laboratories said that it shall put together a detailed response with adequate corrective and preventive measures to address the US FDA Observations and the same is proposed to be filed within the timeline stipulated by US FDA.
The FDA Form 483 is issued to drug makers at the conclusion of an inspection “when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts”.
The stock recovered partially from its early morning fall and was trading at Rs 1,722, down 4.5% on the BSE at 09:37 am. A combined 151,468 shares changed hands on the counter on the BSE and NSE so far.
“The United States Food and Drug Administration (USFDA) had conducted an inspection at the company’s manufacturing facility located at Daman from September 20 to September 29, 2016,” Alkem Laboratories said in a BSE filing. LINK
The company received the inspection report which contains 13 observations, it added.
Alkem Laboratories said that it shall put together a detailed response with adequate corrective and preventive measures to address the US FDA Observations and the same is proposed to be filed within the timeline stipulated by US FDA.
The FDA Form 483 is issued to drug makers at the conclusion of an inspection “when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts”.
The stock recovered partially from its early morning fall and was trading at Rs 1,722, down 4.5% on the BSE at 09:37 am. A combined 151,468 shares changed hands on the counter on the BSE and NSE so far.
