he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).
Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.
Pemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)
The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
Glenmark's current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 ANDA's pending approval with the USFDA
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