Aurobindo Pharma gains 3% on USFDA approval for heartburn drug


Shares of Aurobindo Pharma added more than 3 percent intraday Friday as company received final approval from the US Food & Drug Administration (USFDA).

The company has received final approval from the USFDA to manufacture Omeprazole delayed-release tablets OTC, 20mg.

Omeprazole delayed-release tablets are generic equivalent of AstraZeneca’s Prilosec OTC tablets.

The said 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.

At 11:22 hrs Aurobindo Pharma was quoting at Rs 565.25, up Rs 17.50, or 3.19 percent on the BSE.

Posted by Rakesh Patil
First Published on Jun 8, 2018 11:25 am

Leave a Reply

Your email address will not be published. Required fields are marked *