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.
Powered by Capital Market - Live News
(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)
Dear Reader,
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.
Digital Editor
RECOMMENDED FOR YOU