Shares of Lupin Ltd were trading in the green and 1% higher on 2 July after the company announced receiving approval from the USFDA for Loteprednol Etabonate Ophthalmic Gel.
In its regulatory filing, the company said, “the company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application for Loteprednol Etabonate Ophthalmic Gel, 0.38%.”
Loteprednol Etabonate Ophthalmic Gel is bioequivalent to Bausch & Lomb Inc.’s Lotemax SM Ophthalmic Gel. Furthermore, the company is the exclusive first-to-file for this medicine, which will be manufactured in Pithampur, India, and is eligible for 180 days of generic drug exclusivity.
The gel is a corticosteroid used to treat postoperative inflammation and pain after eye surgery.
Also, the company announced the strategic carve-out of its consumer healthcare business, LupinLife Consumer Healthcare Ltd. (LCH), into a wholly owned subsidiary, effective 1 July 2025, with the goal of establishing a specialised consumer healthcare entity with a stronger focus on India’s rapidly growing self-care market.
Moreover, Prucalopride Tablets, 1 mg and 2 mg, were released in the United States in June after receiving FDA approval.
Additionally, the business has signed a license and supply agreement with Sino Universal Pharmaceuticals (SUP) for the commercialisation of Tiotropium Dry Powder Inhaler (DPI), 18 mcg/capsule. This strategic agreement will address the treatment of chronic obstructive pulmonary disease (COPD) in China, a market with a growing demand for sophisticated respiratory care solutions.
At 11:46 am, the shares of Lupin were trading 0.91% higher at Rs 1,978.70 on NSE.
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