Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets
Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus
Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus
The PAI was conducted for two drug product applications (ANDAs) filed from this facility
This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa
The company has reported total income of Rs. 486.16 crores during the period ended September 30, 2023
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
According to IQVIA sales data for the period ending January 2022, Vimpat tablets market achieved annual sales of approx. US $ 1.7 billion
The clinical research organisation located in Hyderabad is a USFDA inspected facility
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