Alembic Global Holding SA receives USFDA tentative approval for Treprostinil injection

Alembic Pharmaceuticals Limited announced on Monday that its wholly-owned subsidiary, Alembic Global Holding SA has received tentative approval from the United States 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.

This product is therapeutically equivalent to the reference listed drug product, Remodulin injection, 20 mg/20 ml (1mg/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 Corporation.

Treprostinil injection is indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise. Treprostinil injection has an estimated market size of US$ 466.1 million for twelve months ending December 2019.

Alembic Pharmaceuticals earns around 65 per cent of its total revenue from exports with the USA being a major contributor. The USA contributes 80 per cent of the company’s international revenue in generics. The company has shown significant improvement in the US generic markets with revenue from this segment increasing from Rs 920 crore in FY18 to Rs 1,976 crore in FY20. Alembic now has a total of 131 ANDA approvals (113 final approvals and 18 tentative approvals) from USFDA.