Lupin share price gained in the early trade on December 28 after the company received the United States Food and Drug Administration (USFDA) approval for Loteprednol Etabonate Ophthalmic Suspension.
At 09:20 hrs Lupin was quoting at Rs 1,301.85, up Rs 12.85, or 1.00 percent, on the BSE.
The company has announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate Ophthalmic Suspension, 0.2%. This drug is a generic equivalent to the reference listed drug (RLD) Alrex Ophthalmic Suspension, 0.2%, of Bausch & Lomb Inc. The product will be manufactured at Lupin's Pithampur facility in India. The Loteprednol Etabonate Ophthalmic Suspension is used for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
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Avendus Spark, a research house, has recently upgraded the stock rating to 'buy' with a target of Rs 1,440 per share. The company's formulations business, which has scaled up in recent years outside of India and the US, is being undervalued. Additionally, several factors can offset competition in the US business, such as gSuprep and gPrezista. According to the research house, they estimate a 16 percent margin in H2FY24, while remaining conservative even in FY25/FY26 at 18 percent/19 percent.
Developments and approvals in December
Lupin Atlantis Holdings SA, Switzerland, a wholly-owned subsidiary of the company, has signed an asset purchase agreement with Sanofi, a French multinational pharmaceutical and healthcare company, to acquire a portfolio of established products in Europe and Canada from Sanofi for a purchase consideration of EUR 10 million (Rs 91 crore).
The company received approval from the USFDA for its ANDA for Allopurinol tablets USP, 100 mg and 300 mg to market a generic bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Zyloprim Tablets, 100 mg, and 300 mg, of Casper Pharma, LLC.
The company also got USFDA approval ANDA for Allopurinol Tablets USP, 100 mg, and 300 mg and Varenicline tablets, 0.5 mg and 1 mg.
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