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Lupin has already accounted for the fine in previous financial reports, ensuring no impact on the current year’s profit and loss statement.
According to reports, the sanctions were imposed as a result of their participation in "pay-for-delay" arrangements from 2005 to 2007.
This strategic move aligns with Lupin's goal of expanding its global presence in specialty areas.
Lupin said the business is thoroughly reviewing the findings and would respond to the USFDA within the timeframe specified.
Profit before tax was lower in Q4 FY2024 due to an impairment charge of ₹201.3 Crore. The quarter's R&D investment totaled ₹425.5 Crore (8.7% of revenue).
Lupin disclosed in a regulatory filing that a meeting of the Board of Directors is scheduled for Monday, May 6, 2024, to discuss and approve the audited financial results for the quarter and year-ended March 31, 2024, and to consider recommending dividends, if applicable.
Myrbetriq, a prescription medicine, is used to treat overactive bladder symptoms like frequent or urgent urination and urinary incontinence, including neurogenic detrusor overactivity (NDO) in children.
The business got Form 483 from the USFDA in March, with one observation for its Aurangabad plant, following an inspection from March 6 to March 15.
He will be located in Mumbai and would be in charge of Lupin's technical operations.
It is the generic equivalent of Organon USA LLC's Ganirelix Acetate Injection, 250 mcg/0.5 mL, which is reference listed (RLD).
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