Boehringer Ingelheim Pharma GmbH & Co. KG (Manufacturer (lyophilizate): full-cycle manufacturing (including production, critical manufacturing control, quality control in studies for batch release (all parameters), quality control in stability studies (all parameters), primary packaging, secondary packaging, batch release); Manufacturer (solvent, water for injections): full-cycle manufacturing (production (including in-process quality control), final product quality control (for batch release and stability studies), primary labeling, secondary packaging and labeling, batch release))