Drug Approval | June 12, 2025
Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa
Zydus receives EIR for the API manufacturing facility at Ankleshwar
Zydus receives EIR for the API manufacturing facility at Ankleshwar
The use of Apisolex polymer excipient has been proven to increase the solubility of certain APIs by as much as 50,000-fold
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
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
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