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
The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease
This product is categorized as antacids, antiflatulents and anti-Ulcerants
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
The company can now expand its business horizon into the area of pharmaceutical applications in the USA
Aims to achieve CDMO sales of US$ 400 million by 2028
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