Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System

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) Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Imitrex STATdose System, 4 mg/0.5 mL and 6 mg/0.5 mL, of GlaxoSmithKline Intellectual Property Ltd. England.

Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Refer label for a detailed indication. This is Alembic's first drug device combination product. Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System, have an estimated market size of US$ 73 million for twelve months ending September 2025 according to IQVIA.

Alembic has a cumulative total of 228 ANDA approvals (207 final approvals and 21 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 921.65 as compared to the previous close of Rs. 915.55. The total number of shares traded during the day was 7455 in over 603 trades.

The stock hit an intraday high of Rs. 927.55 and intraday low of 896.90. The net turnover during the day was Rs. 6792830.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA