Alembic Pharma shares gain after receiving USFDA nod for hypertension treatment drug

Alembic Pharmaceuticals Ltd. on Tuesday, August 19, said it has received the final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Macitentan Tablets, 10 mg.The company said the approved ANDA is therapeutically equivalent to the reference listed drug product Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc. (Actelion).

Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension in adults to reduce the risks of disease progression and hospitalisation, the company said.

The Macitentan tablets, 10 mg, have an estimated market size of $1,180 million for the 12 months till June 2025, as per IQVIA.Alembic Pharma reported its first quarter earnings

earlier this month. Its net profit increased 15% to ₹154 crore from ₹135 crore in the previous fiscal.

Its revenue was up 10% at ₹1,711 crore from ₹1,562 crore in the last year.

The company’s earnings before interest, taxes, depreciation and amortisation (EBITDA) increased 19% to ₹282 crore from ₹237 crore in the previous fiscal.

Its EBITDA margin expanded to 16.5% from 15.2% in the year-ago period.

Alembic Pharma shares were up 2% at ₹991.35 apiece at 11.55 am on Tuesday. The stock has declined 7% this year, so far.

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