Drug Approval | December 09, 2021
Alembic receives tentative USFDA approval for Selexipag tablets
The tablets are indicated for the treatment of pulmonary arterial hypertension
The tablets are indicated for the treatment of pulmonary arterial hypertension
The appraisal of the applications has been carried out based on the ranking methodology laid down in the operational guidelines of the Scheme
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 company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
Glenmark has been granted a competitive generic therapy (CGT) designation for theophylline extended-release tablets
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