Alembic Pharmaceuticals’ wholly owned subsidiary -- Alembic Global Holdings SA has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Treprostinil Injection, 20 mg/20 ml (1 mg/ml), 50 mg/20 ml (2.5 mg/ml), 100 mg/20 ml (5 mg/ml), and 200 mg/20 ml (10 mg/ml), Multiple-Dose Vials. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RlD), Remodulin Injection, 20 mg/20 ml (1 mg/ml), 50 mg/20 ml (2.5 mg/ml), 100 mg/20 ml (5 mg/ml), and 200 mg/20 ml (10mg/ml), of United Therapeutics Corp (United).
Treprostinil Injection has an estimated market size of $ 466.1 million for twelve months ending December 2019. Alembic now has a total of 131 ANDA approvals (113 final approvals and 18 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
