Alembic Pharma receives approval for Teriflunomide tablets

Alembic Pharma announced that the company has received approval from the USFDA for its Abbreviated New Drug Application (ANDA) Teriflunomide Tablets, 7 mg and 14 mg. The approved ANDA is therapeutically equivalent to the reference listed drug(RLD), Aubagio Tablets, 7 mg and 14 mg, of Sanofi- Aventis. Teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Teriflunomide tablets, 7 mg and 14 mg have an estimated market size of US$1.6 billion for twelve months ending December 2018. Alembic now has a total of 91 ANDA approvals (79 final approvals, 12 tentative approvals) from USFDA.

In Q3FY19, the company’s net sales stood at Rs. 1018.15, up 21.21 per cent from Rs. 840.02 crore in December 2017. The company’s net profit stood at Rs. 169.83 crore in December 2018 with an EPS of Rs. 9.01 per share, up 30.04 per cent from Rs. 130.60 crore with an EPS of Rs. 6.93 per share in December 2017.

On Monday, the stock of Alembic was trading at Rs.541 per share, up 1.02 per cent on the BSE.