Alkem Labs gets USFDA EIR for Mandva facility
Mumbai: Alkem Labs has announced that US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the Company’s API manufacturing facility located at Mandva.
The Inspection has been classified as Voluntary Action Indicated (VAI) and was closed accordingly.
Medical Dialogues team had earlier reported that Alkem Labs had received Form 483 with three observations from the USFDA at the end of the inspection conducted at the Company’s API manufacturing facility located at Mandva.
Read also: USFDA Issues 3 Observations For Alkem Labs Mandva Facility
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.
