Drug Approval | April 29, 2025
Closure of USFDA inspection at Zydus' API Unit at Dabhasa, Gujarat
The inspection concluded with 6 observations and none of them were related to Data Integrity
The inspection concluded with 6 observations and none of them were related to Data Integrity
Founded in 2023, Spectrum Vascular acquired the vascular access businesses of Cook Medical in 2023 and AngioDynamics in 2024
The freshly infused capital will primarily be deployed towards expansion and research & development
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
Through strong industry cooperation, significant investment, and smart policy backing, API manufacturing may become self-reliant
The European regulator will conduct a re-inspection of the facility to verify the compliance
The company will provide the necessary response on these observations to USFDA within stipulated 15 days
This is Senores' second API manufacturing facility adding significantly to the existing API manufacturing capabilities.
The observations issued are neither repeated observations nor related to data integrity
The Alathur facility specializes in the production of Cephalosporin antibiotics
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