Alembic Pharmaceuticals jumps on getting USFDA’s tentative approval for Dronedarone Tablets USP
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Alembic Pharmaceuticals is currently trading at Rs. 816.90, up by 10.15 points or 1.26% from its previous closing of Rs. 806.75 on the BSE.
The scrip opened at Rs. 809.00 and has touched a high and low of Rs. 820.00 and Rs. 807.85 respectively. So far 8673 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1119.00 on 13-Jan-2021 and a 52 week low of Rs. 720.80 on 23-Aug-2021.
Last one week high and low of the scrip stood at Rs. 847.95 and Rs. 800.00 respectively. The current market cap of the company is Rs. 16020.88 crore.
The promoters holding in the company stood at 69.48%, while Institutions and Non-Institutions held 17.50% and 13.03% respectively.
Alembic Pharmaceuticals (Alembic) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dronedarone Tablets USP, 400 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Multaq Tablets, 400 mg, of Sanofi-Aventis U.S. LLC (Sanofi-Aventis). Dronedarone is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.
Dronedarone Tablets USP, 400 mg have an estimated market size of $ 500 million for twelve months ending September 2021 according to IQVIA. Alembic has settled the case with Sanofi-Aventis and will launch its generic as per the terms of settlement.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
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