Granules India Diarrhea medicine gets USFDA okay
Loperamide Hydrochloride and Simethicone Tablets are indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.
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, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.
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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 diarrhoea is dehydration. During an episode of diarrhoea, 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 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.
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Granules India is an Indian pharmaceutical manufacturing company that was founded in 1984 named as Triton Laboratories located in Hyderabad, India.
Granules manufactures 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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