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Alembic Pharma arm will get tentative USFDA nod for drug to deal with pulmonary arterial hypertension – Home Health Choices

New Delhi: Drug agency Alembic Pharmaceuticals on Monday stated its subsidiary has obtained tentative approval from the US well being regulator for Treprostinil injection indicated for the remedy of pulmonary arterial hypertension. The tentatively authorised product is therapeutically equal to the reference listed drug product Remodulin injection of United Therapeutics Corp.

Alembic Global Holdings SA has obtained tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug software (ANDA) Treprostinil Injection within 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 stated in a regulatory submitting.

Quoting United Therapeutics Corporation’s 2019 monetary outcomes, Alembic Pharma stated Treprostinil injection has an estimated market dimension of USD 466.1 million for the 12 months ending December 2019.

Alembic now has a complete of 131 ANDA approvals (113 remaining approvals and 18 tentative approvals) from the USFDA.

Shares of Alembic Pharmaceuticals had been buying and selling 1.55 per cent decrease at Rs 913 apiece on the BSE.

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