Granules India shares were trading in the red and 1% lower on 13 December despite receiving approval from USFDA for its pantoprazole sodium delayed-release tablets.

In its regulatory filing, the company said that it has received approval from the USFDA (US Food and Drug Administration) for its generic pantoprazole sodium delayed-release tablets of strengths 20 mg and 40 mg.

These tablets are used in the short-term treatment of patients who have erosive esophagitis that is associated with gastroesophageal reflux disease, which is a condition in which backward flow of acid from the stomach causes heartburn and damage to the oesophagus.

This tablet is a bioequivalent and therapeutical equivalent to the RLD (reference listed drug), Protonix Delayed-Release Tablets, 20 mg and 40 mg strengths, of Wyeth Pharmaceuticals LLC.

The Pantoprazole tablets are also used for the maintenance of healing of erosive esophagitis and pathological hypersecretory conditions that include Zollinger-Ellison (ZE) syndrome.

The Pantoprazole sodium delayed-release tablets have a current annual US market of $233 million, according to IQVIA/IMS Health, MAT Oct 2023 data.

At 3:30 pm, the shares of Granules India closed 0.82% lower at Rs 385.15 on NSE.