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Lupin launches Prucalopride tablets in U.S. market
Lupin launches Prucalopride tablets in U.S. market

Business Standard

time26-06-2025

  • Business
  • Business Standard

Lupin launches Prucalopride tablets in U.S. market

Lupin has announced the launch of Prucalopride Tablets in the United States, following the recent approval of its abbreviated new drug application (ANDA) by the U.S. Food and Drug Administration (USFDA). Prucalopride Tablets are the bioequivalent of Motegrity Tablets, developed by Takeda Pharmaceuticals U.S.A., Inc. The medication is indicated for the treatment of chronic idiopathic constipation (CIC) in adult patients. According to IQVIA MAT data for April 2025, the reference drug Motegrity recorded annual sales of approximately $184 million in the U.S. market. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit surged 114.9% to Rs 772.52 crore on a 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24. The scrip declined 1.11% to Rs 1,913.70 on the BSE.

Lupin gets U.S. FDA nod for generic of Takeda's constipation drug
Lupin gets U.S. FDA nod for generic of Takeda's constipation drug

The Hindu

time25-06-2025

  • Business
  • The Hindu

Lupin gets U.S. FDA nod for generic of Takeda's constipation drug

Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for Prucalopride Tablets 1 mg and 2 mg that are indicated for treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride Tablets are bioequivalent to Motegrity Tablets 1 mg and 2 mg of Takeda Pharmaceuticals U.S.A. Inc, Lupin said on U.S. FDA approving its abbreviated new drug application. Lupin will manufacture the product at its Goa facility. Prucalopride Tablets 1 mg and 2 mg (reference listed drug Motegrity) had estimated annual sales of $184 million in the U.S, the company said citing IQVIA MAT April 2025 numbers.

Lupin receives USFDA approval for generic Prucalopride tablets
Lupin receives USFDA approval for generic Prucalopride tablets

Business Standard

time25-06-2025

  • Business
  • Business Standard

Lupin receives USFDA approval for generic Prucalopride tablets

Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Prucalopride tablets. The tablets are a generic equivalent of Motegrity Tablets, developed by Takeda Pharmaceuticals U.S.A., Inc., and are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Lupin stated that the approved product is bioequivalent to Motegrity and will be manufactured at the companys facility in Goa, India. According to IQVIA MAT data for April 2025, Prucalopride Tablets (Reference Listed Drug: Motegrity) had estimated annual sales of approximately $184 million in the United States. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit surged 114.9% to Rs 772.52 crore on a 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24. The scrip rose 0.07% to Rs 1,932.10 on the BSE.

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