Tuesday, Apr 23 2024 | Time 18:22 Hrs(IST)
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Aurobindo Pharma receives USFDA approval for Esomeprazole Magnesium DR Capsules OTC

Mumbai, Oct 17(UNI) Pharma Major, Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to manufacture Esomeprazole Magnesium Delayed-Release Capsules OTC,
20mg.
Esomeprazole Magnesium Delayed-Release Capsules OTC is a therapeutic equivalent generic version of AstraZeneca’s Nexium 24HR Capsules.
The product will be launched immediately, company release said.
Nexium 24HR (Esomeprazole Magnesium) capsules are indicated to treat frequent heartburn (occurs 2 or more days a week). The approved product has an approximate annual sales in excess of USD300 million,
according to IRI database.
This is the 127th ANDA (including 23 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, used for manufacturing oral products.
Aurobindo now has 335 ANDA approvals (296 Final approvals including 16 from Aurolife Pharma LLC and 39 tentative approvals) from USFDA.
UNI JS SM1320
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