FDA advises API makers on COVID-19 safe practices
The agency's latest guidance offers advice on keeping manufacturing of active pharmaceutical ingredients safe during the COVID-19 pandemic.
The agency's latest guidance offers advice on keeping manufacturing of active pharmaceutical ingredients safe during the COVID-19 pandemic.
The CDMO has begun manufacturing of highly potent APIs at a dedicated area in its GMP plant, geared toward niche products and clinical batches.
The ninth annual event, taking place in Boston mid-November, will feature industry professionals addressing manufacturing practices, regulatory updates and market trends.
Tapped by Renibus Therapeutics, the CDMO will produce the API for clinical trials of investigational drug RBT-9 for an upcoming COVID-19 study.