The drug maker on Saturday announced that its manufacturing facility located at St. Louis, USA has received Form 483 with two observations from the US drug regulator.
In an exchange filing, Alkem Laboratories said, "USFDA had conducted an inspection of the company's manufacturing facility located at St. Louis, USA from 14 June 2021 to 18 June 2021. At the end of the inspection, the company has received Form 483 with two (2) observations."Alkem Laboratories said that it shall submit a detailed response to USFDA within the stipulated timeline to close out all the observations associated with this inspection.
Alkem is a pharmaceutical company with global operations. The company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs) and nutraceuticals, which it markets in India and International markets.
On a consolidated basis, the company reported 27.1% increase in net profit to Rs 240 crore on 7% increase in revenue from operations to Rs 2192.2 crore in Q4 FY21 over Q4 FY20.
Shares of Alkem Laboratories fell 0.95% at Rs 3,137.20 on Friday.
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