Granules India has received Abbreviated New Drug Application (ANDA) approval for Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC) from US Food & Drug Administration (USFDA). 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.
Loperamide Hydrochloride and Simethicone Tablets are indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas. Granules now have a total of 52 ANDA approvals from US FDA (50 Final approvals and 2 tentative approvals).
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
