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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 &...
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.
Read also: Cipla, DNDi unveil 4-in-1 ARV formulation for kids with HIV
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.
Read also: Granules India bags USFDA okay for Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets
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
Read also: Granules India Receives Licences from MPP to Market generic of Pfizers Paxlovid
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751