Alembic Pharmaceuticals Ltd

Alembic Pharmaceuticals Regulatory Approval

Alembic Pharmaceuticals received USFDA final approval for Dapsone Gel, 5%. This marks the company's 224th final ANDA approval.

Alembic Pharmaceuticals Regulatory Approval

Alembic Pharmaceuticals received USFDA final approval for Oseltamivir Phosphate Oral Suspension. The product has an estimated market size of ₹253.8 Crore.

Value

₹253.8 Cr

Alembic Pharmaceuticals Regulatory Approval

Alembic Pharmaceuticals received final USFDA approval for Haloperidol Tablets used in treating psychotic and Tourette’s disorders. This strengthens the company's generic portfolio in the US market.

Alembic Pharmaceuticals Regulatory Approval

Alembic Pharmaceuticals received USFDA final approval for Levothyroxine Sodium Tablets USP. The market size is estimated at ₹17942.4 Crore, strengthening the company's US generic portfolio.

Value

₹17,942 Cr

Alembic Pharmaceuticals Regulatory Approval

Alembic Pharmaceuticals received USFDA tentative approval for Darolutamide Tablets, targeting a ₹29,972.5 Crore market. This approval strengthens the company's oncology portfolio and international growth prospects.

Value

₹29,972 Cr

Alembic Pharmaceuticals Regulatory Approval

Alembic Pharmaceuticals received USFDA final approval for Fingolimod Capsules, 0.5 mg, used for treating relapsing forms of multiple sclerosis. The product has an estimated annual market size of approximately ₹1363.0 Crore (US$ 145 million). This marks the company's 237th cumulative ANDA approval, strengthening its US generic portfolio.

Value

₹1,363 Cr

Alembic Pharmaceuticals Regulatory Approval

Alembic Pharmaceuticals Limited received USFDA final approval for Methotrexate Injection USP in multi-dose and single-dose vials. The drug is indicated for neoplastic diseases, rheumatoid arthritis, and severe psoriasis. This marks the company's 236th ANDA approval, strengthening its generic injectable portfolio in the US market.