Lupin pharmacovigilance group concludes USFDA inspection with no observations

Mumbai: Global pharma major Lupin Limited has 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. 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.

Read also: Lupin gets USFDA nod for primary biliary cholangitis drug Obeticholic Acid

Lupin is a 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 U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 8.7% of its revenue in research and development in FY22.

Read also: USFDA okays Lupin Valbenazine Capsules to treat Dyskinesia




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