We understand that facility locations can benefit our patients, providers and stakeholders tremendously. Manufacturing the majority of our generic drug products at our U.S. facilities, we can ensure that our product supplies are always manufactured to the highest standards.
KriGen LLC Facility is in compliance with quality, safety, and environmental standards as mandated by state and federal governments and regulators.
Pre-clinical studies using state-of-the art instruments
Oral solid dosages, Topicals, Liquids and Parenterals.
CMC section development, 505 (b) (2) submissions, orphan drug submissions, Paragraph IV, NDA and ANDA submissions.
Process development for time reduction, step change, productivity improvement, Continuous Process Verification (CQV) and alternate processing.
Automation, process analytical technology (PAT) to real-time release (RTR), process control, process modeling, process mapping and data mining.