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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.

The approved drug is therapeutically equivalent to AstraZeneca?s reference listed drug (RLD), Farxiga. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and to improve glycaemic control.

Alembic said it was among the first applicants to file a substantially complete ANDA with a paragraph IV certification for the drug, making it eligible for 180 days of shared generic drug exclusivity.

According to IQVIA, the Dapagliflozin tablets market had an estimated size of $10.49 billion for the 12 months ended December 2025.

The company now has a cumulative total of 235 ANDA approvals from the USFDA, including 217 final approvals 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.

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) Dapagliflozin Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB (AstraZeneca). Dapagliflozin tablet is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: i) to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, and ii) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Dapagliflozin Tablets, 5 mg and 10 mg. Therefore, with this approval, Alembic is eligible for 180 days of shared generic drug exclusivity.

Dapagliflozin tablets, 5 mg and 10 mg, have an estimated market size of US$ 10,487 million for twelve months ending December 2025 according to IQVIA.