Alembic Pharma Receives USFDA Approval For Solifenacin Succinate

Alembic Pharma, in its filing to the exchanges on Tuesday, informed that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Solifenacin Succinate Tablets, 5 mg, and 10 mg. Reacting to this, shares of the company climbed 1% on the BSE.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Vesicare Tablets, 5 mg, and 10 mg, of Astellas Pharma US, Inc. Solifenacin Succinate Tablet is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Solifenacin Succinate Tablets, 5 mg, and 10 mg have an estimated market size of $967mn for twelve months ending December 2018 according to IQVIA.

Alembic now has a total of 94 ANDA approvals (82 final approvals and 12 tentative approvals) from USFDA, the company added.

Alembic Pharmaceuticals Ltd’s share price is currently at Rs533.80, up by Rs4.45 or 0.84%, from its previous close of Rs529.35 on the BSE.

The scrip opened at Rs531.25 and has touched a high and low of Rs537 and Rs531.20, respectively. So far, 22,267 (NSE+BSE) shares have been traded on the counter. The current market cap of the company is Rs9,978.25cr. – IIFL