Lupin announces completion of pharmacovigilance inspection by USFDA
Drug Approval

Lupin announces completion of pharmacovigilance inspection by USFDA

The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide

  • By IPP Bureau | March 27, 2023

Global pharma major 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 company’s operations with no observations.

The inspection was conducted at Lupin’s global pharmacovigilance group based out of Mumbai from 20-24th 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 has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.

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