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.

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, Ms. 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."

Shares of Indoco Remedies Limited was last trading in BSE at Rs. 385.10 as compared to the previous close of Rs. 383.90. The total number of shares traded during the day was 24603 in over 1269 trades.

The stock hit an intraday high of Rs. 386.95 and intraday low of 377.45. The net turnover during the day was Rs. 9449065.00.

Source : Equity Bulls

Keywords

IndocoRemedies INE873D01024 TentativeApproval USFDA ANDA CanagliflozinTablets