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
Strokes are affecting approximately 1.8 million people annually
The GMP certificate will allow the manufacturing site in Hervás, Cáceres to manufacture active ingredients for the pharmaceutical industry that is based on medicinal plants
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
Aims to achieve CDMO sales of US$ 400 million by 2028
We now rank 3rd in pharmaceutical production by volume and 14th by value
Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines
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