The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Aurobindo will respond to the US FDA within the stipulated timelines
Good momentum in commercial CDMO business
Mage Biologics to develop a monoclonal antibody targeting ulcerative colitis
CMOs showed an increasing reluctance to take on debt in 2022
Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial
Planned investment of approximately USD 90 million to build a state-of-the-art Sandoz Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026
The two-part production system is proven to yield high-quality proteins from GS-CHO cell lines, a prevalent mammalian host cell for protein production
Evonik specializes in mid- to large-scale, later clinical phase HPAPIs
USFDA concludes inspection at Zydus' formulation manufacturing facility at SEZ 2, Ahmedabad
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