León, Spain
LSNE’s second major acquisition brought on our fourth aseptic fill finish facility. LSNE- León further expands LSNE’s sterile filling capabilities to now include pre-filled syringes and dropper bottles and offers additional capacity for liquid and lyophilized vial presentations. LSNE-León established LSNE’s footprint in Europe and focuses on manufacturing both clinical and commercial
LSNE-León
Clinical and Commercial Manufacturing Facility
Parque Tecnológico de León
C/ Nicostrato Vela s/n
24009 León, Spain
CAPABILITIES
- Acquired in 2019
- First commercial approval in 2019 for ANDA drug product
- Drug product manufacturing of small molecules, biologics, steroids, and hormones
- Batch sizes up to 60,000 units (vials/syringes/dropper bottles)
- FDA & EU commercial products
- Formulation volumes up to 400 L; custom configurations available
- On-site WFI production
- Full development and reverse engineering of generic injectable products
- Complex formulation for emulsions and suspension
- Peristaltic pump for low shear product transfer and filtration of sensitive products
