USFDA issues three observations regarding the Mandva Facility of Alkem Labs

4 Dec 2023 , 02:39 PM

Alkem Labs has reported via a recent BSE filing that, following an examination of the company’s API manufacturing facility in Mandva, the United States Food and Drug Administration (USFDA) provided Form 483 with three findings. No data integrity observation is present.

After an inspection, if an investigator or investigators find any situations that they believe could be in violation of the Food Drug and Cosmetic Act (FD&C Act) or other relevant Acts, they will issue an FDA Form 483 to the firm management.

The plant was examined by the USFDA from November 27, 2023, to December 1, 2023.

‘This Inspection is part of the routine business operations and the Company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations,’ Alkem stated.

An Indian pharmaceutical business called Alkem Laboratories Ltd develops, produces, and markets pharmaceutical and nutraceutical goods. In both acute and chronic therapeutic areas, including anti-infective, pain and analgesics, vitamins, minerals, and nutrients, cardiac and diabetology, gynaecology, ophthalmology, neuro/central nervous system, dermatology, anti-diabetes, anti-osteoporosis, cardiovascular, and muscle relaxants, the company manufactures branded generics, generic drugs, active pharmaceutical ingredients (APIs), and nutraceuticals. These products are sold in Indian and foreign markets. The pharmaceutical business section is how it functions.

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