Granules India gets USFDA nod for generic drug used for short-term treatment of heartburn

Granules India Ltd on Thursday said it has received approval from the US health regulator for its generic Esomeprazole Magnesium delayed-release capsules indicated for short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Esomeprazole Magnesium delayed-release capsules of strengths 20 mg and 40 mg, Granules India said in a regulatory filing.

It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP.

Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated GERD, risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome, it added.

The current annual US market for Esomeprazole Magnesium delayed-release capsules is approximately USD 168 million, the company said citing IQVIA/IMS Health July 2023 data.

Granules India posted a 62.4% fall in its net profit for the first quarter ended on June 30, 2023, at ₹47.9 crore. This contrasts with its net profit of ₹127.5 crore in the corresponding previous quarter.

It is noteworthy that the Granules India stock is up 6.4% in the last month and 16% in the past six.