Alembic Pharmaceuticals rises on getting USFDA's tentative approval for Brexpiprazole Tablets

Alembic Pharmaceuticals Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 533573 | NSE: APLLTD

09 Mar 2023 Evaluate

Alembic Pharmaceuticals is currently trading at Rs. 519.05, up by 6.75 points or 1.32% from its previous closing of Rs. 512.30 on the BSE.

The scrip opened at Rs. 512.55 and has touched a high and low of Rs. 519.05 and Rs. 512.55 respectively. So far 331 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 792.30 on 28-Apr-2022 and a 52 week low of Rs. 476.30 on 03-Mar-2023.

Last one week high and low of the scrip stood at Rs. 528.45 and Rs. 476.30 respectively. The current market cap of the company is Rs. 10069.93 crore.

The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.75% and 12.64% respectively.

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, of Otsuka Pharmaceutical (Otsuka). Brexpiprazole Tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for treatment of schizophrenia. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of $1.6 billion for twelve months ending December 2022. Alembic has a cumulative total of 184 ANDA approvals (160 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.

Alembic Pharma Share Price

785.40 8.05 (1.04%)

08-May-2026 16:59 View Price Chart

Peers

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