Alembic Pharmaceuticals gains on USFDA nod for bronchoconstriction drug

Alembic Pharmaceuticals rose 1.63% to Rs 732 after the company received a final approval from the drug regulatory body, U.S. Food & Drug Administration for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brovana Inhalation Solution, of Sunovion Pharmaceuticals Inc. The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies.

Arformoterol Tartarate Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

According to IQVIA, Arformoterol Tartrate Inhalation Solution, has an estimated market size of $51 million for twelve months ending December 2021. Alembic Pharmaceuticals has a cumulative total of 167 ANDA approvals (143 final approvals and 24 tentative approvals) from USFDA, including this second 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.

On a consolidated basis, the company reported a 39.7% fall in net profit to Rs 176.42 crore on a 3.2% fall in net sales to Rs 1,271.7 crore in Q3 FY22 over Q3 FY21.

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