Stason Pharmaceuticals, Inc. is a US-based pharmaceutical company headquartered in Irvine, California, with CDMO services provided through its affiliate Western PharmSci. The company operates in both branded/generic pharmaceuticals and contract services. Their CDMO capabilities include turn-key drug development and manufacturing for oral solid dosage forms with particular expertise in high containment products (OEL down to 0.1 ug/m3) for oncology, CNS, and other potent compounds. Services span from pre-formulation characterization and API synthesis through commercial production (up to 600 kg), including analytical method development/validation, formulation development, clinical trial materials, and serialization. They hold 30+ ANDAs and have operations in 13 locations across 9 countries. Note: FDA issued a warning letter on July 8, 2020, citing significant CGMP violations for finished pharmaceuticals.
high containment oral solid dose, HPAPI handling, oncology drug products, clinical trial materials, turn-key drug development, pre-formulation characterization, serialization
1 site worldwide
Involvement in 1 clinical trial
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