Policy | October 14, 2024
CDSCO, NRAI meets WHO international standards for vaccine regulations
India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI
India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI
Indoco is comprehensively working on the remedial action plan
Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic
USFDA completes PAI of Lupin’s biotech facility in Pune
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated
The inspection conducted by EDQM at its Visakhapatnam facility
The observations are of procedural in nature and will be responded to within the stipulated time
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
This approval reflects company’s unwavering commitment that the quality assurance
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
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