Drug Approval | June 17, 2025
Briefs: Hikal and Sun Pharma
Sun Pharma gets 8 observations from USFDA for Halol facility
Sun Pharma gets 8 observations from USFDA for Halol facility
Zydus receives EIR for the API manufacturing facility at Ankleshwar
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
Certification bolsters Venus Remedies' position in PIC/S markets, reinforcing commitment to global quality standards
Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA
CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA
The inspection conducted from December 16, 2024 to December 20, 2024 by the Brazil Health Regulatory Agency (ANVISA)
he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice
The Subsidiary has received one inspectional observation in Form 483
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
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