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Alembic Pharma arm gets USFDA nod for Treprostinil Injection

Ruchika SharmaWritten by Ruchika Sharma Published On 13 Feb 2021 9:59 AM  |  Updated On 13 Feb 2021 9:59 AM
Alembic Pharma arm gets USFDA nod for Treprostinil Injection
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Treprostinil Injection is indicated for the treatment of pulmonary arterial hypertension (PAH;WHO Group 1) to diminish symptoms associated with exercise.

Vadodara: Pharma major, Alembic Pharmaceuticals Limited, has recently announced that the company's wholly-owned subsidiary Alembic Global Holding SA has received final 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 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 (1 Omg/ml), of United Therapeutics Corp. (United).

Treprostinil Injection is indicated for the treatment of pulmonary arterial hypertension (PAH;WHO Group 1) to diminish symptoms associated with exercise. In patients with PAH requiring transition from epoprostenol, Treprostinil Injection is indicated to diminish the rate of clinical deterioration.

Alembic had previously received tentative approval for this ANDA.

Treprostinil Injection has an estimated market size of US$ 17 million for twelve months ending December 2020 according to IQVIA. ·

Alembic now has a total of 138 ANDA approvals (121 final approvals and 17 tentative approvals) from USFDA, including this first injectable ANDA approval.

Read also: Alembic Pharma secures USFDA nod for Midodrine Hydrochloride Tablets

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.

Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

Read also: Alembic Pharma Net profit rises 25 percent to Rs 293 crore in Q3




alembic pharmaalembic pharma newstreprostinil injectionusfdaremodulin injectionpulmonary arterial hypertension
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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