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Indoco Remedies gets USFDA’s tentative approval for Canagliflozin and Metformin Hydrochloride tablets

06 Jun 2024 Evaluate

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.


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