Aurobindo Pharma’s JV gets USFDA’s nod to manufacture, market Methotrexate tablets

31 Jan 2020 Evaluate

Aurobindo Pharma’s joint venture company (JV) -- Eugia Pharma 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 $98 million for the twelve months ending December 2019.

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. The company now has a total of 420 ANDA approvals (393 Final approvals including 22 from Aurolife Pharma LLC and 27 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.

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