Drug Approval | June 23, 2025
Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
The company will provide the necessary response to USFDA within stipulated 15 days
The company will provide the necessary response to USFDA within stipulated 15 days
The company received one observation in the Form-483
The project will be instrumental in enhancing the company's API manufacturing capacity and global reach
The company received 1 (One) observation in the Form-483
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
Subscribe To Our Newsletter & Stay Updated
