USFDA issues ten observations for Alkem Labs Baddi facility
Mumbai: Alkem Labs has announced that the U.S. Food and Drug Administration (USFDA) has issued Form 483 with ten observations at the end of the inspection at the Company’s manufacturing facility located at Baddi.USFDA inspected the facility from 19th March, 2024 to 27th March, 2024. This was a GMP as well as a Pre-Approval Inspection."There is no data integrity observation. This Inspection...
Mumbai: Alkem Labs has announced that the U.S. Food and Drug Administration (USFDA) has issued Form 483 with ten observations at the end of the inspection at the Company’s manufacturing facility located at Baddi.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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.
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd