Aurobindo said this was the first ANDA to be approved out of APL Healthcare formulation facility in Hyderabad.
Aurobindo Pharma share price rallied more than 6 percent intraday on April 9 after the company received approval from the US health regulator for an antidepressant drug.
The stock has gained 58 percent after dropping to Rs 294.7 on March 23, the lowest since May 2014. At 1209 hours, it was quoting at Rs 462.15, up Rs 23.90, or 5.45 percent, on the BSE.
Not only Aurobindo but the entire pharma sector has been buzzing for more than two weeks now.
Aurobindo Pharma had received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Fluoxetine tablets in 10 mg and 20 mg strengths, the company said in a BSE filing.
Fluoxetine tablets are generic version of Eli Lilly's Prozac' tablets.
The company said the product will be launched in April 2020 and has an estimated market size of $42 million for the 12 months ending February 2020, according to IQVIA.
Fluoxetine is indicated for the acute and maintenance treatment of major depressive disorders in adult patients and in children aged between 8 and 18.
This was the first ANDA to be approved out of APL Healthcare formulation facility in Hyderabad, India, for oral products, it said.
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