Global pharma major Lupin Limited on Saturday announced that the United States Food and Drug Administration (U.S. FDA) has completed a Post-marketing Adverse Drug Experience (PADE) inspection of the company’s operations, through an exchange filing. The inspection closed with no observations.
The inspection was conducted at Lupin’s global pharmacovigilance group based out of Mumbai from 20th March to 24th March, 2023. The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide.
“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. This continues to demonstrate our unwavering commitment to compliance and patient safety,” said Nilesh Gupta, Managing Director, Lupin.
Lupin on Saturday also announced that UK MHRA has completed inspection at Lupin's Pithampur facilities.
The shares of Lupin Limited on Friday closed at Rs 639.25, down by 1.43 per cent.
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