News | August 06, 2024
OneSource and BRL ink technology licensing agreement to deliver high-concentration biologics subcutaneously
Revolutionary technology will further boost OneSource’s scientific services offerings
Revolutionary technology will further boost OneSource’s scientific services offerings
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The inspection was concluded with two 483 observations
EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24
The inspections concluded with no Form 483 observations or significant critical findings
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
The company will address these observations within the stipulated timeline
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