Alembic Pharma rises after USFDA final approval for Bosentan tablets

Alembic Pharmaceuticals rose 1.52% to Rs 599 after the company said it received US drug regulator's approval for Bosentan tablets, 62.5 mg and 125 mg.

Alembic Pharmaceuticals announced it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Bosentan tablets, 62.5 mg and 125 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tracleer tablets, 62.5 mg and 125 mg, of Actelion Pharmaceuticals.

Bosentan tablets indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1 ). Bosentan Tablets, 62.5 mg and 125 mg have an estimated market size of $68 million for twelve months ending September 2019 according to IQVIA.

Alembic has a cumulative total of 114 ANDA approvals (102 final approvals and 12 tentative approvals) from USFDA.

The statement was released during market hours today, 24 January 2020.

The stock jumped 9.64% in a month, outperforming the Nifty Pharma index's 3.17% rise in the same period. The scrip was seen trading between Rs 591.70 to Rs 600 during intraday trade.

On the technical front, the stock's RSI (relative strength index) stood at 64.177. The RSI oscillates between zero and 100. Traditionally the RSI is considered overbought when above 70 and oversold when below 30.

The pharma major's consolidated net profit jumped 37.9% to Rs 234.19 crore on 18.8% rise in net sales to Rs 1,209.13 crore in Q3 December 2019 over Q3 December 2018.

Alembic Pharmaceuticals is engaged developing formulations and active pharmaceutical ingredients (API).

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