Alembic Pharma rallies after USFDA nod for Deferasirox tablets

Alembic Pharmaceuticals spurted 4.16% to Rs 927 after the company said it received US drug regulator's final approval for Deferasirox tablets, 180 mg.

The drug maker announced on Tuesday (16 June) that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Deferasirox tablets, 180 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jadenu tablets, 180 mg, of Novartis Pharmaceuticals Corporation (Novartis).

Deferasirox tablets are indicated for treatment of chronic iron overload due to blood transfusions (transfusional iron overload) and for treatment of chronic iron overload in non-transfusion-dependent thalassemia syndromes.

Alembic had previously received final approval for Deferasirox tablets, 90 mg and 360 mg and tentative approval for Deferasirox tablets, for 180 mg.

Deferasirox tablets, 180 mg have an estimated market size of $53 million for twelve months ending March 2020 according to IQVIA.

Alembic now has a total of 122 ANDA approvals (109 final approvals and 13 tentative approvals) from USFDA.

The stock hit an all-time record high at Rs 943 during intraday trade. In the past one month, the stock has risen 6.25%, underperforming the Nifty Pharma index's 10.24% rise in the same period.

On the technical front, the stock's RSI (relative strength index) stood at 65.162. 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 above its 50-day moving average (DMA) placed at 771.19 and its 200-day moving average (DMA) placed at 614.78.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. Its consolidated net profit jumped 54.8% to Rs 203.52 crore on a 30.2% rise in net sales to Rs 1,206.83 crore in Q4 March 2020 over Q4 March 2019.

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