USFDA issues EIR for Alkem Labs Baddi facility
Mumbai: Alkem Labs has informed in a BSE filing that the US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the manufacturing facility of the Company located at Baddi, India.
The Inspection has been classified as Voluntary Action Indicated (VAI) and has been closed accordingly.
The USFDA had conducted inspection from 19th March, 2024 to 27th March, 2024 and issued Form 483 with ten observations.
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Alkem Laboratories Ltd is an Indian pharmaceutical company engaged in the development, manufacture, and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs) and nutraceuticals in acute and chronic therapeutic areas, such as anti-infective, pain and analgesics, vitamins/minerals/nutrients, cardiac and Diabetology, Gynecology, Ophthalmology, neuro/central nervous system, dermatology, anti-diabetes, anti-osteoporosis, cardiovascular, and muscle relaxants, which are marketed in Indian and International markets. It operates through the pharmaceutical business segment.
