Lupin share price gained in the early trade on July 2 on the back of USFDA approval for Loteprednol Etabonate Ophthalmic Gel.
At 09:20am, Lupin was quoting at Rs 1,969.70, up Rs 8.40, or 0.43 percent, on the BSE.
" ...... 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%," company said in the exchange filing.
Loteprednol Etabonate Ophthalmic Gel is bioequivalent to Lotemax SM Ophthalmic Gel of Bausch & Lomb Inc.
The company is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity, which will be manufactured at Pithampur facility in India.
The gel is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
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Also, company announced the strategic carve-out of its consumer healthcare business, LupinLife Consumer Healthcare Ltd. (LCH), into a wholly owned subsidiary, effective July 1, 2025, with the aspiration to establish a specialized consumer healthcare entity, with an enhanced focus on India's rapidly growing selfcare market.
In June, the company launched Prucalopride Tablets, 1 mg, and 2 mg, in the United States, following the approval from the USFDA.
Also, the company has entered into a license and supply agreement with Sino Universal Pharmaceuticals (SUP) for the commercialization of Tiotropium Dry Powder Inhaler (DPI), 18 mcg/capsule. This strategic collaboration aims to address the treatment of chronic obstructive pulmonary disease (COPD) in China, a market with a growing need for advanced respiratory care solutions.
The share touched a 52-week high of Rs 2,403.45 and a 52-week low of Rs 1,626.45 on 02 January, 2025 and 03 July, 2024, respectively.
Currently, the stock is trading 18.05 percent below its 52-week high and 21.1 percent above its 52-week low.
The market capitalisation of the company stands at Rs 89,959.37 crore.
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