Alembic Pharmaceuticals reported that it received US drug regulator's final approval for Silodosin capsules, 4 mg and 8 mg.
Alembic Pharmaceuticals rose 1.32% to Rs 556.7 after the company announced that it 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 $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.
Alembic Pharma has surged 11.21% in last three months as compared to a 5.93% rise in Nifty Pharma index. The stock was trading above its 50-day simple moving average placed at Rs 540.83 and 200-day moving average (DMA) placed at Rs 531.74.
The stock's RSI (relative strength index) stood at 52.516. The RSI oscillates between zero and 100. Traditionally the RSI is considered overbought when above 70 and oversold when below 30.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.
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