Indoco Remedies has received tentative approval from the US Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Canagliflozin and Metformin Hydrochloride Tablets, 50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg and 150 mg/1000 mg, a generic equivalent of Invokamet Tablets, 50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg and 150 mg/1000 mg.
This product, Canagliflozin and Metformin Hydrochloride Tablets, will be manufactured by Indoco Remedies, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India. Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.