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.
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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