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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.
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751