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Alkem Lab gains as Indore facility gets EIR from USFDA

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Last Updated : Feb 24 2023 | 11:04 AM IST

Alkem Laboratories rose 1.15% to Rs 3,313.75 after the company received Establishment Inspection Report (EIR) from the US drug regulator for its Indore facility, indicating closure of the inspection.

The company had earlier informed that the United States Food and Drug Administration (USFDA) had conducted good manufacturing plant (GMP) and pre-approval inspection at its Indore facility from 1 July 2022 to 7 July 2022 and issued Form 483 with 1 observation.

In response to Form 483 issued by the USFDA, 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.

Alkem Laboratories is engaged in pharmaceutical business with global operations. The company is engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products.

The company's consolidated net profit declined 13.5% to Rs 454.71 crore despite of 16.1% rise in net sales to Rs 3,040.91 crore in Q3 FY23 over Q3 FY22.

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First Published: Feb 24 2023 | 9:46 AM IST

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