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Alembic Pharmaceuticals gains on securing USFDA’s final approval for Nelarabine Injection

Aug-02-2024   12:16 Hrs IST

Alembic Pharmaceuticals is currently trading at Rs. 1220.05, up by 4.45 points or 0.37% from its previous closing of Rs. 1215.60 on the BSE.

The scrip opened at Rs. 1215.45 and has touched a high and low of Rs. 1231.25 and Rs. 1190.85 respectively. So far 9174 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1254.80 on 29-Jul-2024 and a 52 week low of Rs. 707.50 on 31-Oct-2023.

Last one week high and low of the scrip stood at Rs. 1254.80 and Rs. 1167.95 respectively. The current market cap of the company is Rs. 23989.55 crore.

The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 19.79% and 10.60% respectively.

Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nelarabine Injection, 250 mg/50 mL (5 mg/mL) (Single-Dose Vial). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Arranon Injection, 250 mg/50 mL (5 mg/mL), of Sandoz Inc. 

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. 

Nelarabine Injection, 250 mg/50 mL has an estimated market size of $23 million for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 211 ANDA approvals (183 final approvals and 28 tentative approvals) from USFDA.

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