Alembic Pharmaceuticals Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fingolimod Capsules, 0.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis).

Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in patients 10 years of age and older.

Fingolimod Capsules, 0.5 mg, have an estimated market size of US$ 145 million for twelve months ending December 2025 according to IQVIA.

The newly formed entity, Alembic Lifesciences Philippines Inc., will focus on exploring business opportunities in the region and promoting, selling, and distributing the company?s pharmaceutical products.

The company holds a 99.99% stake in the subsidiary. Alembic Lifesciences Philippines Inc. has an authorised share capital of 12 million Philippine pesos, divided into 1.2 million shares of 10 Philippine pesos each.

Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company?s consolidated net profit fell 3.9% to Rs 132.97 crore despite a 10.8% jump in net sales to Rs 1,876.31 crore in Q3 FY26 over Q3 FY25.

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) Multi-Dose Vials & 1g/40 mL (25 mg/mL) Single Dose Vials.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Methotrexate Injection USP, 50 mg/2 mL (25 mg/mL) Multi- Dose Vials & 1g/40 mL (25 mg/mL) Single Dose Vials, of Hospira, Inc.

Methotrexate Injection is a folate analog metabolic inhibitor indicated for neoplastic diseases: i) Acute Lymphoblastic Leukemia, ii) Meningeal Leukemia: Prophylaxis and Treatment, iii) Non-Hodgkin Lymphoma, iv) Osteosarcoma, v) Breast Cancer, vi) Squamous Cell Carcinoma of the Head and Neck, and vii) Gestational Trophoblastic Neoplasia.

It is also indicated for the treatment of: i) rheumatoid arthritis (RA), ii) polyarticular juvenile idiopathic arthritis (pJIA), and iii) severe psoriasis.

The approved product includes 50 mg/2 mL (25 mg/mL) multi-dose vials and 1 g/40 mL (25 mg/mL) single-dose vials. The drug is a folate analog metabolic inhibitor used in the treatment of various neoplastic diseases, including acute lymphoblastic leukemia, meningeal leukemia, non-Hodgkin lymphoma, osteosarcoma, breast cancer, and head and neck squamous cell carcinoma. It is also indicated for rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriasis.

The approved ANDA is therapeutically equivalent to the reference listed drug, Methotrexate Injection USP, manufactured by Hospira Inc.

With this approval, Alembic Pharmaceuticals now has a cumulative total of 236 ANDA approvals from the USFDA, including 218 final and 18 tentative approvals.

Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company?s consolidated net profit fell 3.9% to Rs 132.97 crore despite a 10.8% jump in net sales to Rs 1,876.31 crore in Q3 FY26 over Q3 FY25.