Indoco Remedies receives US FDA tentative approval for canagliflozin and metformin hydrochloride tablets

Our Bureau, Mumbai

Thursday, June 6, 2024, 15:20 Hrs [IST]

Indoco Remedies Ltd. announced the receipt of tentative approval from the US FDA for Abbreviated New Drug Application (ANDA) for canagliflozin and metformin hydrochloride tablets, 50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg, and 150 mg/1000 mg, a generic equivalent of Invokamet tablets, 50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg and 150 mg/1000 mg.

This product, canagliflozin and metformin hydrochloride tablets, will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India. Canagliflozin and metformin hydrochloride tablets are used to treat type 2 diabetes mellitus.

Commenting on the achievement, Aditi Panandikar, managing director said, “We are excited to receive tentative approval from the US FDA for our canagliflozin and metformin hydrochloride tablets. This milestone underscores our commitment to bringing affordable and effective treatment options to patients managing type 2 diabetes.”

Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence. The company’s turnover is US$ 212 million with a human capital of over 6,000 employees, including over 400 skilled scientists and field staff who are the strength of the organization.