Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets
Drug Approval

Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets

This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa

  • By IPP Bureau | December 07, 2023

Indoco Remedies Ltd. announced the receipt of tentative approval from the 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.

This product will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at Goa (Plant-I) in India.

Canagliflozin improves glycemic control in adults with type 2 diabetes mellitus. Commenting on the achievement, Aditi Panandikar, Managing Director said, "Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US."

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