News | April 14, 2025
Nureca’s manufacturing subsidiary secures USFDA registration
This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States
This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States
The company does not expect this development to have any material impact on the current business operations
The supply of these goods is set to commence within the first quarter of FY26
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
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Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas
This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance
Sharma brings a wealth of expertise in optimizing manufacturing processes for fermentation-based APIs and sterile injectables
Raichur site is the group’s largest API facility and part of a wider network of seven sites
This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets
Introduces revolutionary approach to workflow management to enhance operational efficiency and optimize process efficiency
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