Global pharma major Lupin Limited (Lupin) announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (FDA) for its Aurangabad manufacturing facility. The inspection was conducted from March 6 to March 15, 2024. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).
The threat of low-cost competition in the US to Astellas’ Myrbetriq for urinary incontinence has moved a step closer after a court recommended denying an injunction on the launch of generics.
Enforcement Report - Week of April 17, 2024
Lupin Limited announced that the United States Food and Drug Administration (U.S. FDA) has completed a GMP Inspection of its API manufacturing facility located at Dabhasa, India. The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations.
Leading generic drug makers Lupin, Glenmark, and Natco Pharma are recalling products in the American market for manufacturing issues, according to the US health regulator.
Lupin appoints Dr. Ranjana Pathak as Chief Quality Officer
Drugmaker Lupin Limited has appointed Dr Ranjana Pathak as Chief Quality Officer, succeeding Johnny Mikell who will be retiring, the company said. With over three decades of industry experience, Pathak will oversee all aspects of quality and regulatory compliance for Lupin's global operations
Lupin`s Generic Eslicarbazepine Acetate Receives Approval in the U.S.