Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Silodosin Capsules, 4 mg and 8 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rapaflo Capsules, 4 mg and 8 mg, of Allergan Sales, LLC. Silodosin capsule, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Silodosin Capsules have an estimated market size of US$ 114 million for twelve months ending June 2019 according to IQVIA.
Alembic now has a total of 108 ANDA approvals (96 final approvals and 12 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.547.35 as compared to the previous close of Rs. 544.95. The total number of shares traded during the day was 5993 in over 745 trades.
The stock hit an intraday high of Rs. 553.9 and intraday low of 547.35. The net turnover during the day was Rs. 3299085.