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Alembic Pharma gets USFDA nod for Formoterol Fumarate Inhalation Solution
Mumbai: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD),...
Mumbai: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Perforomist Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial, of Mylan.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
Read also: Alembic Pharma JV Aleor Derma secures USFDA approval for Metronidazole Gel
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751