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Alembic Pharmaceuticals receives USFDA approval for Darolutamide Tablets, 300 mg
Alembic Pharmaceuticals (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Darolutamide Tablets, 300 mg.
Alembic Pharma shares rise on USFDA nod for prostate cancer drug with $3 billion estimated market size
Alembic Pharmaceuticals shares gained after USFDA granted a tentative ANDA nod for Darolutamide Tablets 300 mg, a prostate cancer drug, marking its 238th ANDA approval.
Alembic Pharma gains after receiving USFDA nod for Darolutamide tablets
Alembic Pharmaceuticals rose 1.57% to Rs 780.50 after the company announced that it had received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Darolutamide Tablets, 300 mg.
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Alembic Pharmaceuticals receives USFDA approval for Methotrexate Injection
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.
Alembic Pharma gets USFDA nod for generic cancer, arthritis injection
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic methotrexate injection, used to treat multiple cancers and arthritis conditions. The approval covers key dosage formats and confirms therapeutic equivalence to the reference drug by Hospira, enabling Alembic to market the injectable in the US. Methotrexate is widely used for treating cancers such as leukemia, osteosarcoma and breast cancer, as well as conditions like rheumatoid arthritis and severe psoriasis.
Alembic Pharmaceuticals climbs on securing USFDA nod for Dapagliflozin tablet
Alembic Pharmaceuticals surged 3.85% to Rs 681.40 after it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dapagliflozin tablets in 5 mg and 10 mg strengths.
Alembic Pharma gets USFDA nod for generic drug
Alembic Pharmaceuticals has secured approval from the US health regulator for a generic seizure medication. The company received final clearance from the USFDA for Lamotrigine orally disintegrating tablets. This drug is therapeutically equivalent to GlaxoSmithKline's Lamictal. It is used for various seizure types in patients aged two and older. The market for this medication is estimated at USD 27 million.
Alembic Pharma completes USFDA inspection at Karakhadi, Gujarat facility with two observations
Shares of Alembic Pharmaceuticals Ltd ended at ₹773.70, down by ₹2.70, or 0.35%, on the BSE.
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