ALFA Filings
Every announcement, straight from the exchange
Every Alembic Pharmaceuticals regulatory approval announcement on NSE and BSE, newest first, each with its own page.
Time
10 announcements with these filters
Alembic Pharmaceuticals received USFDA final approval for Valganciclovir for Oral Solution, 50 mg/mL. This adds to its cumulative 247 USFDA ANDA approvals.
Alembic Pharmaceuticals received USFDA final approval for Ciprofloxacin and Dexamethasone Otic Suspension USP. This drug is therapeutically equivalent to the reference product Ciprodex Otic Suspension.
Alembic Pharmaceuticals received USFDA final approval for Dapsone Gel, 5%. This marks the company's 224th final ANDA approval.
Alembic Pharmaceuticals received USFDA final approval for Oseltamivir Phosphate Oral Suspension. The product has an estimated market size of ₹253.8 Crore.
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 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.
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.
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.
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.
Alembic Pharmaceuticals received USFDA final approval for Dapagliflozin Tablets (5 mg and 10 mg), used for type 2 diabetes and heart failure. The product addresses a US$ 10,487 million (₹9,752.91 Crore) market. As a Paragraph IV applicant, Alembic is eligible for 180 days of shared generic exclusivity, marking its 217th final ANDA approval.