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    USFDA approves Alembic Pharmaceuticals’ Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe

    26th December, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-Dose Prefilled Syringe. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD),

    Alembic Pharma Gets EIR for API-I & II Facility at Panelav

    Alembic Pharmaceuticals Limited has received the Establishment Inspection Report (EIR) for the inspection conducted by the US Food and Drug Administration (USFDA) at its API-I and API-II facilities in Panelav. The inspection was carried out between May 26, 2025 and May 31, 2025. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited, a vertically integrated research and