Aurobindo Pharma has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fluoxetine Tablets, 10 mg and 20 mg. Fluoxetine tablets are generic version of Eli Lilly’s Prozac tablets. The product will be launched in April 2020.
The approved product has an estimated market size of $42 million for the twelve months ending February 2020. This is the 1st ANDA to be approved out of APL Healthcare formulation facility in Hyderabad, India, used for manufacturing oral products. The company now has a total of 424 ANDA approvals (396 Final approvals including 22 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
Company Name | CMP |
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Dr. Reddys Lab | 6263.70 |
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