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Alembic Pharmaceuticals share price climbs 2% on USFDA approval for Silodosin capsules

Alembic now has a total of 108 ANDA approvals (96 final approvals and 12 tentative approvals) from USFDA.

November 26, 2019 / 12:45 PM IST
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Shares of Alembic Pharmaceuticals climbed 2 percent on November 26 after it received final approval from the US drug regulator for Silodosin capsules.

In a regulatory filing on November 26, the pharma player said it had received final approval from the 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 alpha1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)," the company said in the regulatory filing.

Silodosin capsules have an estimated market size of $114 million for 12 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, the company claimed.


On Friday, November 22, the drugmaker said it had received approvals from the US health regulator for its generic Deferasirox tablets used for the treatment of chronic iron overload due to blood transfusions in patients over two years of age.

The tablets are generic versions of Novartis Pharmaceuticals Corporation's Jadenu tablets and Exjade tablets for oral suspension in the same strengths, it added.

Shares of Alembic Pharmaceuticals traded 1.11 percent up at Rs 555.55 on BSE around 12:30 hours IST.
Moneycontrol News
first published: Nov 26, 2019 12:45 pm

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