Lupin gets tentative USFDA approval for obeticholic acid tablets, shares gain

Lupin’s share touched a 52-week high of Rs 798.90 on April 5, 2022 and a 52-week low of Rs 583.05 on May 25, 2022.

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Share price of Lupin rose in early trade on March 24 after the company received tentative approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA), obeticholic acid tablets (5 mg and 10 mg) to market a generic equivalent of Ocaliva tablets (5 mg and 10 mg) of Intercept Pharmaceuticals, Inc.

At 09:40 am, Lupin was quoting at Rs 650, up 0.39 percent on the BSE. The share touched a 52-week high of Rs 798.90 and a 52-week low of Rs 583.05 on April 5, 2022 and May 25, 2022, respectively.

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Obeticholic acid tablets had estimated annual sales of $255 million in the US. Recently, the pharmaceutical company also received USFDA approval for Brexpiprazole tablets, a generic equivalent of Rexulti tablets of Otsuka Pharmaceutical Company that will be manufactured at Lupin’s Pithampur facility in India.

Also, company’s alliance partner Caplin Steriles received final approval from the USFDA for Rocuronium Bromide Injection and Thiamine Hydrochloride Injection.