Last Updated on December 24, 2023 by The Health Master
Hyderabad: Drugmaker, Granules India Limited has recently announced that the US Food & Drug Administration (USFDA) has approved the company’s Abbreviated New Drug Application (ANDA) for Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC).
It is bioequivalent to the reference listed drug product, Imodium Multi-Symptom Relief Tablets, 2 mg/125 mg, by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.
Loperamide Hydrochloride and Simethicone Tablets are indicated to relieve symptoms of diarrhea plus bloating, pressure, and cramps, commonly referred to as gas.
The most severe threat posed by diarrhea is dehydration. During an episode of diarrhea, water and electrolytes including sodium, chloride, potassium, and bicarbonate are lost through liquid stools, vomit, sweat, urine, and breathing.
Granules now have a total of 52 ANDA approvals from the USFDA (50 final approvals and 2 tentative approvals).
The Imodium Multi-Symptom Relief brand and store brands had combined U.S. sales of approximately $60 million MAT for the most recent twelve months.
Granules India is an Indian pharmaceutical manufacturing company that was founded in 1984 and named Triton Laboratories located in Hyderabad, India.
The Granules manufacture varieties of drugs, including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets
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