Date: 30th October, 2026
Inspection Outcome
US Food and Drug Administration (US FDA) conducted an inspection at the company's Active Pharmaceutical Ingredient (API) manufacturing facility located at Mandva.
The inspection period was from 26th October, 2026 to 30th October, 2026.
The inspection was concluded with no Form 483 observations. A Form 483 is issued by US FDA investigators at the conclusion of an inspection when they observe conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The issuance of zero observations indicates the facility was found to be in compliance with US FDA regulations during this inspection.
Key Managerial Personnel (KMP) Certification
The disclosure was signed by Manish Narang, President- Legal, Company Secretary and Compliance Officer of Alkem Laboratories Limited.
The document was digitally signed on 30th October, 2026 at 15:06:24 IST.