Granules India gets USFDA approval for its two new drugs

30 Aug 2022 , 12:39 PM

Granules India Limited has received the Abbreviated New Drug Application (ANDA) approval from US Food & Drug Administration (USFDA) for Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC).

It is bioequivalent to the reference mentioned drug product, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division’s Imodium Multi-Symptom Relief Tablets, 2 mg/125 mg.

Loperamide Hydrochloride and Simethicone Tablets are used to treat diarrhoea as well as bloating, pressure, and cramping, which are all symptoms of gas.

The USFDA has already approved 52 ANDAs for granules (50 final approvals and 2 tentative approvals).

For the most recent twelve months, the Imodium Multi-Symptom Relief brand and retail brands had combined U.S. sales of nearly $60 million MAT.

At around 12.42 PM, Granules India was trading at Rs305.20 up by 1.08% from its previous closing of Rs301.95 on the BSE. The scrip touched intraday high and low of Rs307.65 and Rs301.80 respectively.

For feedback and suggestions, write to us at [e-mail]