Granules India rises on receiving USFDA nod for diarrhea drug

Granules India rose 1.49% to Rs 306.45 after the company announced that it has received abbreviated new drug application (ANDA) approval for Loperamide Hydrochloride and Simethicone tablets from USFDA.

The United States Food and Drug Administration (USFDA) approved the company to market a bioequivalent to the reference listed drug product, Imodium Multi-Symptom Relief tablets of Johnson & Johnson Consumer Inc.

Loperamide Hydrochloride and Simethicone tablets are indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.

The company said that the Imodium Multi-Symptom Relief brand and store brands had combined US sales of approximately $60 million MAT for the most recent twelve months.

Granules now have a total of 52 ANDA approvals from the US FDA (50 final approvals and 2 tentative approvals).

Hyderabad-based Granules India is a vertically integrated fast growing Indian pharmaceutical company. It is present in the manufacturing of entire value chain - from active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs).

The drug maker reported a 6.1% rise in consolidated net profit to Rs 127.57 crore on a 20% increase in net sales to Rs 1,019.56 crore in Q1 FY23 over Q1 FY22.

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