Drug Approval | June 17, 2025
USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
The collaboration furthers AstraZeneca’s presence in China following the $2.5bn investment in Beijing
Now approved for both acute and chronic HCV in adults and children aged 3 and above
The project will be instrumental in enhancing the company's API manufacturing capacity and global reach
The company received 1 (One) observation in the Form-483
The use of Apisolex polymer excipient has been proven to increase the solubility of certain APIs by as much as 50,000-fold
Honeywell Aclar film technology will enable Evertis to develop high-quality barrier packaging solutions
Globally, BRUKINSA is approved in more than 70 countries
This project builds on a previous joint funding agreement between CARBOGEN AMCIS and the same customer in April 2021
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
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