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The product is bioequivalent to Ravicti Oral Liquid (1.1 g/mL) of Horizon Therapeutics and is indicated for chronic management of patients with urea cycle disorders (UCDs) that cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
As per IQVIA MAT December 2025, the reference listed drug Ravicti had sales of $337 million for the year ended December 2025.
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025.
The counter shed 0.33% to trade at Rs 2,343.20 on the BSE.
Dapagliflozin and Metformin Hydrochloride is a combination medication used to improve glycemic control in adults with type 2 diabetes
The counter shed 0.10% to end at Rs 2,309.45 on the BSE.
The inspection was conducted from 13 April 2026 to 17 April 2026 and closed with the issuance of a Form-483 with three observations.
'We will address the observations and respond to the U.S. FDA within the stipulated timeframe. We are committed to be compliant with CGMP standards across all our facilities,” Lupin stated.
The scrip had shed 0.10% to end at Rs 2324.25 on the BSE on Friday.
Lupin Pharmaceuticals, Inc. USA (LPI), a wholly owned subsidiary of the Company, has been involved in multiple civil lawsuits alleging anticompetitive behavior 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 (Litigation), located in Philadelphia, Pennsylvania.
While LPI denies the allegations but 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 (Agreement) with one of the Plaintiffs namely Humana Inc. (Humana).
Under the terms of the Agreement, LPI will pay USD 30 million (US Dollars Thirty million) in consideration for a full and final release of all claims against LPI and its current and former parents, affiliates, directors, employees and officers by Humana. This amount of settlement has already been provided in the Company's prior consolidated financial results. The settlement explicitly states that LPI denies all allegations made against it, and that the Agreement does not imply any admission of liability or unlawful conduct by LPI.
The case forms part of the broader In re Generic Pharmaceuticals Antitrust Litigation, a multi-defendant proceeding involving several pharmaceutical companies accused of price-fixing and market allocation practices in generic drugs. The litigation is pending in Philadelphia, Pennsylvania.
The agreement states that Lupin Pharmaceuticals Inc. denies all allegations, and the settlement does not constitute any admission of liability or unlawful conduct. The settlement is an attempt by the company to resolve legacy legal exposures to avoid prolonged litigation costs and related uncertainties.
Under the agreement, Lupin Pharmaceuticals Inc. will pay $30 million for a full and final release of all claims by Humana against the company and its affiliates.
'The settlement amount has already been provided for in the company’s prior consolidated financial statements,” Lupin said.
The scrip shed 0.28% to currently trade at Rs 2320 on the BSE.
The company’s product is a bioequivalent version of Farxiga and will be marketed for indications as per the approved labeling.
Dapagliflozin is indicated for the treatment of conditions including Type 2 Diabetes and certain cardiovascular and renal disorders.
The launch marks Lupin’s continued expansion in the US generics market and strengthens its presence in the oral anti-diabetic segment.
Shares of Lupin shed 0.88% to currently trade at Rs 2,312.10 on the BSE.