USFDA inspection: Alkem Labs concludes inspection at Taloja Center

Mumbai: Alkem Labs has announced the completion of the inspection at the Company’s Bioequivalence Center located at Taloja, Maharashtra.

The facility was inspected from 10th March, 2025 to 13th March, 2025.

“This is to inform you that US FDA had conducted a Bioresearch Monitoring (BIMO) inspection
at the Company’s Bioequivalence Center located at Taloja, Maharashtra from 10th March, 2025
to 13th March, 2025,” Alkem stated in a release.
At the end of the inspection, no Form 483 was issued. 
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.

Read also: Alkem Labs appoints Shirish Purushotham Ambulgekar at senior management position

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.

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