Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RlD), Perforomist Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, of Mylan Specialty, L.P. Formoterol Fumarate Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for lonq-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. This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Private Limited. Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, has an estimated market size of USD 310 million for twelve months ending Sep. 2021.