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Alembic Pharma arm gets tentative USFDA nod for drug to treat pulmonary arterial hypertension

Alembic Global Holdings SA has received tentative approval from the US
Food and Drug Administration for its abbreviated new drug application
(ANDA) Treprostinil Injection in the strengths of 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, Alembic Pharmaceuticals said in a
regulatory filing.



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