Alembic Pharma surges on getting USFDA’s tentative approval for Dabigatran Etexilate Capsules

07 Apr 2022 Evaluate

Alembic Pharmaceuticals is currently trading at Rs. 779.70, up by 19.15 points or 2.52% from its previous closing of Rs. 760.55 on the BSE.

The scrip opened at Rs. 760.35 and has touched a high and low of Rs. 782.00 and Rs. 760.00 respectively. So far 15128 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1090.00 on 27-Apr-2021 and a 52 week low of Rs. 672.00 on 22-Feb-2022.

Last one week high and low of the scrip stood at Rs. 782.00 and Rs. 739.65 respectively. The current market cap of the company is Rs. 15277.87 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 has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer).

Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients, treatment of deep venous thrombosis and pulmonary embolism in adult patients, reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients, prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients following hip replacement surgery. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg have an estimated market size of $ 465 million for twelve months ending December 2021 according to IQVIA. Alembic has received a cumulative total of 162 ANDA approvals (139 final approvals and 23 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

Alembic Pharma Share Price

1126.75 43.45 (4.01%)
31-Oct-2024 16:01 View Price Chart
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