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<keyword id="672367" type="General" weightage="20" keywordseo="granules-india" source="Orion">Granules India</keyword> 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 <keyword id="4347409" type="General" weightage="20" keywordseo="gastroesophageal-reflux" source="Orion">gastroesophageal reflux</keyword> disease. The approval by the US Food &amp; Drug Administration (<keyword id="44669" type="General" weightage="20" keywordseo="usfda" source="Orion">USFDA</keyword>) 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.

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

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

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