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Granules India gets USFDA nod
image for illustrative purpose
![Granules India gets USFDA nod Granules India gets USFDA nod](https://www.bizzbuzz.news/h-upload/2023/10/20/1800793-granules.webp)
New Delhi: 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.