Drug Approval | November 23, 2021
U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)
The cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA
The Board of Directors of Alembic Pharmaceuticals have approved the unaudited consolidated financial results of the company for the period ended September 30, 2021.
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
It had an estimated market size of US $ 32 million as of June 2021
The US business faced price erosion due to increased competition.
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder
Alembic has reported total income of Rs.83.79 crores during the FY ended March 31, 2021
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