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13 November, 2019 12:44 IST
Aurobindo Pharma gets nod for Esomeprazole capsules
Source: IRIS | 17 Oct, 2017, 11.38AM
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Aurobindo Pharma to announce that the company 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, a therapeutic equivalent generic version of AstraZeneca's Nexium 24HR Capsules. The product will be launched immediately.

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 USD 300 million, according to IRI database.
This is the 127 ANDA (including 23 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 335 ANDA approvals (296 Final approvals including 16 from Aurolife Pharma LLC and 39 tentative approvals) from USFDA.

Shares of the company gained Rs 8.9, or 1.17%, to trade at Rs 766.50. The total volume of shares traded was 86,219 at the BSE (11.25 a.m., Tuesday).

Aurobindo Pharma Limited   (Q,N,C,F)*

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