Alembic Pharmaceuticals moves up on getting USFDA’s nod for Dabigatran Etexilate Capsules

Alembic Pharmaceuticals is currently trading at Rs. 873.20, up by 5.75 points or 0.66% from its previous closing of Rs. 867.45 on the BSE.

The scrip opened at Rs. 883.25 and has touched a high and low of Rs. 894.00 and Rs. 871.00 respectively. So far 3239 shares were traded on the counter.

alembic pharmaceuticals gets usfda approval for solifenacin succinate tablets
Alembic Pharmaceuticals

The BSE group ‘A’ stock of face value Rs. 2 has touched a 52 week high of Rs. 1093.05 on 21-Feb-2024 and a 52 week low of Rs. 600.65 on 23-Jun-2023.

Last one week high and low of the scrip stood at Rs. 917.50 and Rs. 865.00 respectively. The current market cap of the company is Rs. 17326.06 crore.

The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 19.84% and 10.54% respectively.

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg and 150 mg and Tentative approval for Dabigatran Etexilate Capsules, 110 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim 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 and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients. Refer label for a detailed indication.

Dabigatran Etexilate Capsules 75 mg and 150 mg have an estimated market size of $179 million for twelve months ending Mar 2024 according to IQVIA. Dabigatran Etexilate Capsules 110 mg have an estimated market size of $5 million for twelve months ending Mar 2024 according to IQVIA. The company has a cumulative total of 205 ANDA approvals (178 final approvals and 27 tentative approvals) from USFDA.

BREAKING NEWS:
“Prateek Yadav dreams of owning a ₹5 crore ‘Blue Bolt'” Kia Sonet’s Second Generation: Enhanced Safety and Features! Will WhatsApp require a subscription? Discover the truth!