USFDA completes inspection of Lupins pharmacovigilance group, reports no observations, Health News, ET HealthWorld
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USFDA completes inspection of Lupins pharmacovigilance group, reports no observations
The inspection was conducted at Lupins global pharmacovigilance group based out of Mumbai from March 20 to March 24, 2023. The inspection included a comprehensive scrutiny of practices and procedures for reporting adverse events of Lupins marketed products worldwide.
ETHealthWorld
March 26, 2023, 13:30 IST
Mumbai: Lupin Limited has announced that the United States Food and Drug Administration (USFDA) has completed a Post-marketing Adverse Drug Experience (PADE) inspection of the companys operations. The company reported that the inspection closed with no observations.
The inspection was conducted at Lupins global pharmacovigilance group based out of Mumbai from March 20 to March 24, 2023. The inspection included a comprehensive scrutiny of practices and procedures for reporting adverse events of Lupins marketed products worldwide.
Commenting on the approval, Nilesh Gupta, Managing Director, Lupin said As a pharmaceutical company, ensuring the safety of patients is our top priority. We are pleased to have successfully completed the FDA inspection for our pharmacovigilance group with zero observations.
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Sunday, March 26, 2023 at 8:00 am