Alkem Laboratories, on Thursday, said the United States Food and Drug Administration (US FDA), a federal agency of the Department of Health and Human Services, has concluded its inspection at the company’s Indore facility.
The shares of the company rose as much as 1.6 percent to Rs 3,329 on Friday.
US FDA had issued an Establishment Inspection Report (EIR) for the company's manufacturing unit, which was inspected from July 1-7, 2022, the company revealed. During the inspection, Alkem Labs was issued Form 483 containing only one observation.
In response to Form 483, Alkem Labs submitted a detailed corrective and preventive action (CAPA) plan to the US FDA within the stipulated timelines.
Earlier this month, the pharma company announced its third-quarter earnings for FY23. The company reported a loss of about 14 percent at Rs 454.7 crore as compared to Rs 525.6 crore in the same quarter last year. During the same quarter, the revenue was up 16.1 percent at Rs 3,041 crore as compared to Rs 2,619 crore in the same quarter last year.
Also, the company reported strong US sales for the third quarter, which came in at around $90 million against an estimate of $75-76 million.
Last month, the pharma company received US FDA ANDA approval for Mirabegron, which is used to ease symptoms of overactive bladder.
The stock price of the company settled at Rs 3,275.5 per share when the market closed today.
First Published: Feb 23, 2023 7:38 PM IST
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