Aurobindo Pharma's JV receives USFDA approval for Methotrexate tablets

Aurobindo Pharma announced that its joint venture company, Eugia Pharma Specialities has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Methotrexate tablets, 2.5 mg. Methotrexate tablets are generic version of Dava Pharmaceuticals' Rheumatrex Tablets. The product will be launched in March 2020. The approved product has an estimated market size of US$ 98 million for the twelve months ending December 2019, according to IQVIA.

This is the 9th ANDA (including 1 tentative approval) to be approved out of Eugia formulation facility in Hyderabad, India, a manufacturing facility for oral and injectable products. Aurobindo now has a total of 420 ANDA approvals (393 Final approvals including 22 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA.

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