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
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
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)
This marks yet another milestone in our series of successful audits over the past year
These observations are procedural in nature and none of them are related to data integrity
The inspection concluded with 6 observations and none of them were related to Data Integrity
Raichur site is the group’s largest API facility and part of a wider network of seven sites
The inspection has concluded with four observations
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