Indoco Remedies has received tentative approval from the US Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Canagliflozin Tablets 100 mg and 300 mg, a generic equivalent of the Reference Listed Drug, Invokana Tablets 100 mg and 300 mg, of Janssen Pharmaceuticals, Inc. This product will be manufactured by Indoco Remedies, at their manufacturing facility located at Goa (Plant -I) in India. Canagliflozin improves glycemic control in adults with 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.
