Granules India on Thursday said it has received approval from the United States Food and Drug Administration (USFDA) for the Esomeprazole Magnesium capsules, which is used for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease.
The drug is also used for the treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome, the pharma company said in a stock exchange filing.
The products in the strengths of 20 mg and 40 mg are bioequivalent and therapeutically equivalent to the reference listed drug, Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP, the company said.
With this authorisation, Granules India now has a total of 62 ANDA approvals from the USFDA comprising 60 final and two tentative approvals.
According to the IQVIA data for 12 months ended July 2023, the annual sales in the US market for Esomeprazole Magnesium Delayed-Release capsules stood at nearly $168 million.
In July, Granules India's foreign arm received clearance from the USFDA for the Acetaminophen and Ibuprofen tablets, which are used to treat minor pain and aches.
In August, the drug maker, which logged a significant drop in its net profit in the April-June quarter, said that it is expecting a positive shift in its financial landscape. The company stated it expected an improvement in its formulation sales in Europe and the US along with other business developments.
Granules India posted a 62.4% plunge 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.
Shares of Granules India were trading 0.97 percent lower at ₹352.25 apiece on BSE at 11:54am.
(Edited by : Shloka Badkar)
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