Alembic Pharma receives final approval for bronchoconstriction treatment drug

Alembic Pharmaceuticals during market hours on Tuesday announced that it received final approval from the US Food & Drug Administration (USFDA) for formoterol fumarate inhalation solution per unit-dose vial.

The approved drug is therapeutically equivalent to the reference listed drug product, perforomist inhalation solution of Mylan Specialty, L.P. Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for lonq term administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

The Abbreviated New Drug Application (ANDA) has been co-developed in partnership with Orbicular Pharmaceutical Technologies.

According to IQVIA, formoterol fumarate inhalation solution has an estimated market size of $310 million for twelve months ending September 2021. Alembic said it has now received 14 approvals (11 final approvals and 3 tentative approvals) and a cumulative total of 153 ANDA approvals (134 final approvals and 19 tentative approvals) from USFDA year to date, including this first inhalational ANDA approval.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

The drug maker's consolidated net profit dropped 49.22% to Rs 169.29 crore on a 11.31% fall in sales to Rs 1,292.32 crore in Q2 FY22 over Q2 FY21.

The scrip rose 0.73% to currently trade at Rs 741 on the BSE.

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