Granules India gets FDA approval for Loperamide Hydrochloride and Simethicone Tablets
Granules India has secured approval for its abbreviated new drug application (ANDA) for Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC) from the US Food & Drug Administration (FDA).
The product is a bioequivalent to Imodium Multi-Symptom Relief Tablets, 2 mg/125 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.
According to Granules India, Loperamide Hydrochloride and Simethicone Tablets should be used for relieving symptoms of diarrhea plus bloating, pressure and cramps, commonly called gas.
The Indian pharma company has a total of 52 ANDA approvals from US FDA so far.
The combined US sales of Imodium Multi-Symptom Relief brand and store brands are around $60 million MAT for the most recent 12 months.