Alkem Labs gets 2 USFDA observations for Daman facility
New Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received two observations from the US health regulator for its manufacturing facility situated at Daman, India.
The facility was inspected from August 26, 2019, to August 30 2019.
"This is to inform you that the US FDA had conducted an inspection at the Company's manufacturing facility located at Daman, India from 26th August 2019 to 30th August 2019," Alkem said in a BSE filing.
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At the end of the inspection, the Company has received a Form 483 with two (2) observations.
"The Company 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 the USFDA," Alkem added in the filing.
Established in 1973, Alkem Laboratories has a portfolio of over 700 brands covering all major therapeutic segments. It has 16 manufacturing facilities, 14 being in India and two in the United States.