This product will be manufactured by Indoco at its manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa in India
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
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
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
This certification confirms that the facility complies with Good Manufacturing Practice requirements as referred in the EC Directive
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
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