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Lupin announces completion of pharmacovigilance inspection by US FDA with no observations

Our Bureau, Mumbai
Monday, March 27, 2023, 12:15 Hrs  [IST]

Global pharma major Lupin Limited (Lupin) announced that the United States Food and Drug Administration (FDA) has completed a Post-marketing Adverse Drug Experience (PADE) inspection of the company’s operations. 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 is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.


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