Alembic Pharma gets USFDA okay for Sumatriptan Injection, Single Dose Autoinjector System
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-11-08 06:14 GMT | Update On 2025-11-08 06:14 GMT
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Alembic Pharmaceuticals Limited has 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.
Read also: Alembic Pharma gets USFDA okay for Triamcinolone Acetonide Injectable Suspension
Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. The company is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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