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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 gets U.S. FDA nod for Prucalopride Tablets for treatment of CIC in adults
Lupin gets U.S. FDA nod for Prucalopride Tablets for treatment of CIC in adults

Business Upturn

time25-06-2025

  • Health
  • Business Upturn

Lupin gets U.S. FDA nod for Prucalopride Tablets for treatment of CIC in adults

Lupin Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Prucalopride Tablets, 1 mg and 2 mg. These tablets are the generic equivalent of Motegrity® Tablets by Takeda Pharmaceuticals U.S.A., Inc. The approved product will be manufactured at Lupin's state-of-the-art facility in Goa, India. Prucalopride Tablets are used for the treatment of chronic idiopathic constipation (CIC) in adults, a condition that causes difficult or infrequent bowel movements without a known cause. The drug works by stimulating bowel movements through selective serotonin 5-HT4 receptor agonism. According to IQVIA MAT data for April 2025, Prucalopride Tablets (1 mg and 2 mg) had estimated annual sales of USD 184 million in the U.S., highlighting the strong market potential for Lupin's generic version. This approval reinforces Lupin's position as a leading provider of high-quality, affordable generics in the U.S. pharmaceutical market. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at

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