Drug Approval | April 14, 2025
Aurolife Pharma gets 11 observations from USFDA for Raleigh plant
The company does not expect this development to have any material impact on the current business operations
The company does not expect this development to have any material impact on the current business operations
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
Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis
This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance
This partnership encompasses dossier licensing, bulk product supply, and the licensing of ZIM Labs’ proprietary Oral Thin Film technology platform, ThinOral
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
Asahi Kasei Life Science covers a broad range of bioprocess products and services
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