Indoco Remedies receives US-FDA tentative approval for canagliflozin tablets

Indoco Remedies Ltd. announced the receipt of tentative US FDA approval 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 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.”

Indoco is a fully integrated, research-oriented pharmaceutical company with presence in 55 countries. The Company’s turnover is US$ 200 million with a human capital of 6,000 employees, including over 400 skilled scientists and field staff who are the strength of the organization.

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