Indoco Remedies Receives Tentative ANDA Approval From USFDA For Canagliflozin Tablets

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, Inc., the company Wednesday announced through an exchnage filing.

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, the company said through the regulatory filings.

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.

Indoco Remedies Ltd. shares

The shares of Indoco Remedies Ltd. on Wednesday 3:12 pm IST were trading at Rs 394.55, up by 2.33 percent.