Alembic Pharma gets USFDA nod for Treprostinil injection

The drug maker on Monday (7 September) announced that its wholly owned subsidiary received tentative approval from the US drug regulator for its abbreviated new drug application Treprostinil injection in multiple-dose vials.

The tentatively approved ANDA is therapeutically equivalent to Remodulin injection of United Therapeutics Corp, indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise.

Treprostinil Injection has an estimated market size of $466.1 million for twelve months ending December 2019 according to United Therapeutics Corporation's 2019 financial result.

Alembic now has a total of 131 ANDA approvals (113 final approvals and 18 tentative approvals) from USFDA.

Alembic Pharmaceuticals reported a 145.8% surge in consolidated net profit to Rs 292.73 crore on 41.4% rise in net sales to Rs 1,341.32 crore in Q1 June 2020 over Q1 June 2019.

Shares of Alembic Pharmaceuticals fell 0.85% to Rs 919.50 on BSE. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

On the technical front, the stock's RSI (relative strength index) stood at 38.306. The RSI oscillates between zero and 100. Traditionally, the RSI is considered overbought when above 70 and oversold when below 30.

The stock was trading between its 50-day moving average (DMA) placed at 978.43 and its 200-day moving average (DMA) placed at 744.24.

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