Alembic Pharma receives tentative USFDA approval for Ticagrelor Tablets
Alembic Pharmaceuticals has informed that the company has received tentative approval for its abbreviated new drug Ticagrelor Tablets, 90 mg.
The medication is therapeutically equivalent to the reference listed drug product (RLD), Brilinta Tablets, 90 mg of Astrazeneca Pharmaceuticals LP. Ticagrelor tablets are indicated to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with the acute coronary syndrome (ACS) or a history of myocardial infarction (MI).
The drug has an estimated market size of US$ 625 million for twelve months ending December 2017, according to IQVIA.
Alembic Pharmaceuticals Limited is a vertically integrated R&D pharmaceutical company. The company has invested majorly in the international generics market with successful ANDA and DMF filings. The company has a total of 75 ANDA approvals from USFDA, of which 65 are final approvals and 10 are tentative approvals.
On Thursday, the company's intraday high was Rs. 40.40 per share and intraday low was Rs. 39.55 per share on the BSE. Its 52-week high was at Rs. 72 and 52-week low at Rs.33.85 on the BSE. At 12:41 hours, the stock was trading at Rs. 40.30 per share, up by 2.03 per cent. Meanwhile, BSE Sensex was quoting 36,654.17 level, up by 1.04 per cent and Nifty50 was at 11,059.70, up by 1 per cent.