Alembic Pharmaceuticals Limited (Alembic) has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Amantadine Hydrochloride Tablets, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Symmetrel Tablets, 100 mg, of Endo Pharmaceuticals, Inc. (Endo): Amantadine Hydrochloride Tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Tablets· are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.
Amantadine Hydrochloride Tablets, 100 mg have an estimated market size of US$ 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 LTD. was last trading in BSE at Rs.949.3 as compared to the previous close of Rs. 956.1. The total number of shares traded during the day was 3378 in over 383 trades.
The stock hit an intraday high of Rs. 960 and intraday low of 942.45. The net turnover during the day was Rs. 3210578.