Lupin bags USFDA approval for Obeticholic Acid Tablets

1 Jun 2023 , 11:52 AM

Lupin Limited announced that it has received the United States Food and Drug Administration (USFDA) approval for its Abbreviated New Drug Application for Obeticholic Acid Tablets. The tablets are available in 5mg and 10mg variants and are the generic equivalent of Ocaliva Tablets of Intercept Pharmaceuticals, Inc.

Lupin plans to manufacture the said product at its Nagpur Facility in India.

As per IQVIA MAT Mar 2023 data, Obeticholic Acid Tablets (RLD Ocaliva) has estimated annual sales of USD 262 million in the United States.

In FY23, Lupin invested 7.90% of its revenue in research and development.

Lupin is a leader in anti-diabetic, cardiovascular, and respiratory segments and marks a significant presence in the anti-defective, gastrointestinal (GI), women’s health areas, and central nervous system (CNS).

Lupin operates 15 manufacturing sites, and 7 research centers. Further, it manages over 20,000 talent heads globally.

At around 11.49 AM, Lupin was trading 1.04% higher at Rs 812.85, against the previous close of Rs 804.50 on NSE. The counter touched an intraday high and low of Rs 817.35 and Rs 805 respectively.

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