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Pharma major Lupin Ltd on Saturday said the US health regulator has issued Form 483 with three observations to its Somerset, New Jersey, facility in the US following an inspection. The USFDA has concluded the inspection at our manufacturing facility located in Somerset, New Jersey, USA, Lupin said in a regulatory filing. "The inspection was conducted from April 13, 2026, to April 17, 2026, and closed with the issuance of a Form-483 with three observations," it added. The company further said, "We will address the observations and respond to the USFDA within the stipulated timeframe". Lupin said it is "committed to be compliant with CGMP standards across all our facilities". According to the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts.
Pharma major Lupin Ltd on Friday said its arm Lupin Pharmaceuticals, Inc USA has entered into a USD 30 million settlement agreement with Humana Inc for litigation over alleged anti-competitive practices. Lupin Pharmaceuticals, Inc USA (LPI) has been involved in multiple civil lawsuits alleging anti-competitive behaviour related to certain products and violation of federal and state antitrust laws. These multiple civil lawsuits were then combined into the collection of similar cases referred to as 'In Re Generic Pharmaceuticals Antitrust Litigation' located in Philadelphia, Pennsylvania, Lupin said in a regulatory filing. "While LPI denies the allegations, bu considering that other defendants have recently settled the case and in order to avoid the costs and uncertainties of continued litigation, LPI has entered into a settlement agreement with one of the plaintiffs namely Humana Inc. (Humana)," it added. Under the terms of the agreement, LPI will pay USD 30 million in consideration
Pharma major Lupin Ltd on Tuesday said it has received tentative approval from the US health regulator for its generic version of Sugammadex injection used for reversing the effects of muscle relaxants given during surgery. The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial, Lupin said in a regulatory filing. The USFDA has tentatively approved Lupin's Sugammadex injection of the specified strengths as bioequivalent to Merck's Bridion injection, it added. It is used for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery, the company said.