Alembic Pharmaceuticals receives USFDA tentative approval for Empagliflozin and Metformin Hydrochloride Tablets
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Symmetrel tablets, 100 mg, of Endo Pharmaceuticals, Inc.
Alembic Pharmaceuticals announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) amantadine hydrochloride tablets, 100 mg.
Amantadine hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. The drug is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.
Amantadine hydrochloride tablets, 100 mg have an estimated market size of $13 million for twelve months ending June 2020 according to IQVIA.
Alembic has a cumulative total of 132 ANDA approvals (114 final approvals and 18 tentative approvals) from USFDA.
Shares of Alembic Pharmaceuticals rose 0.14% to Rs 950 on BSE. The stock jumped 117.83% from its 52-week low of Rs 436.10 hit on 23 March 2020. The announcement was made during market hours today, 16 October 2020.
Alembic Pharmaceuticals reported a 145.80% surge in consolidated net profit to Rs 292.73 crore on 41.4% rise in net sales to Rs 1,341.32 crore in Q1 June 2020 over Q1 June 2019.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.
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