Alembic Pharmaceuticals rises on getting USFDA tentative nod for Dasatinib tablets

Alembic Pharmaceuticals is currently trading at Rs. 735.70, up by 3.60 points or 0.49% from its previous closing of Rs. 732.10 on the BSE.

alembic pharmaceuticals gets usfda approval for solifenacin succinate tablets
alembic pharmaceuticals gets usfda approval for solifenacin succinate tablets

The scrip opened at Rs. 730.00 and has touched a high and low of Rs. 740.90 and Rs. 728.90 respectively. So far 1704 shares were traded on the counter.

The BSE group ‘A’ stock of face value Rs. 2 has touched a 52 week high of Rs. 1025.00 on 11-Jun-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. 748.00 and Rs. 715.05 respectively. The current market cap of the company is Rs. 14481.79 crore.

The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.76% and 12.63% respectively.

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol Myers Squibb Company (BMS).

Dasatinib Tablet is indicated for the treatment of adult patients with i) newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase ii) chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib iii) Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

Dasatinib Tablets have an estimated market size of $1465 million for twelve months ending Dec 2021 according to IQVIA. Alembic has a cumulative total of 168 ANDA approvals (144 final approvals and 24 tentative approvals) from USFDA.

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

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