Drug Approval | July 29, 2024
Briefs: Indoco Remedies and Alembic Pharmaceuticals
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
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
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
The inspection concluded with zero form 483 observations
This GMP certification for our sterile drug product manufacturing facility, Goa Plant II is a testament to our relentless efforts to supply quality and affordable medicines across geographies
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