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22 November, 2019 15:57 IST
Aurobindo Pharma gets nod for Omeprazole DR tablets
Source: IRIS | 08 Jun, 2018, 11.11AM
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Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture Omeprazole Delayed-Release tablets OTC, 20mg. Aurobindo's Omeprazole Delayed-Release tablets are generic equivalent of AstraZeneca's Prilosec OTC tablets. The product will be launched in June 2018.

Omeprazole tablets are indicated for the treatment of frequent heartburn (occurs 2 or more days a week). The estimated market size of Prilosec OTC tablets is USD 222 million for the twelve months ending March 2018, according to Nielsen data.

This is the 141st ANDA (including 20 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 369 ANDA approvals (336 Final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.

Shares of the company gained Rs 12.5, or 2.28%, to trade at Rs 560.25. The total volume of shares traded was 77,987 at the BSE (10.59 a.m., Friday).





Aurobindo Pharma Limited   (Q,N,C,F)*

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