Alembic Pharma bags approval for Solifenacin Succinate Tab

Alembic Pharmaceuticals informed the bourses on Tuesday that it has received approval from US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Solifenacin Succinate Tablets, 5 mg and 10 mg.

As per IQVIA, the said tablets have a projected market size of US$967 million in the 12-month period ending December 2019 in the US market.

Alembic Pharma has a cumulative total of 94 ANDA approvals, of which 82 have final approvals and 12 have tentative approvals from USFDA.

During the recent quarter Q3FY19, the company's International formulations grew by 44 per cent and consisted of US (69 per cent) and Non-US (31 per cent).

On Monday, the stock of Alembic Pharma opened at Rs. 531.25 per share and made an intraday high of Rs. 537 on the BSE. At 12:31 hours, the stock was trading nearly at Rs. 532.15 per share on the BSE. The stock had hit its 52-week high of Rs. 664 on September 27, 2018 and its 52-week low of Rs. 412.40 on May 24, 2018 on the BSE.