Description
Team up with Pii for
Full cGMP Compliance: Sterile, safe, and always on-point. Your parenteral products deserve nothing less from commercial drug manufacturing.
Mastery of the Complex: High-potency compounds, cytotoxics, or DEA-controlled substances? We handle what others can’t.
Precision Meets Speed: Robotic filling lines, advanced lyophilization, and terminal sterilization ensure every dose is ready.
Seamless Tech Transfer: From development to commercial scale without the headaches.
Whatever you need, exactly when you need it. Our end-to-end commercial drug manufacturing capabilities include
Filling Solutions: Vial, syringe, and cartridge filling with batch sizes from 1L to 1000L.
Integrated Processes: Advanced lyophilization with Millrock systems and terminal sterilization for maximum product safety.
End-to-End Solutions: Including formulation, manufacturing, commercial packaging (unit and case), product insert, serialization.
Regulatory Expertise: Support for NDAs, ANDAs, NADAs, and ANADAs, seamless site transfers to U.S.-based facilities, and 503B compounding.