R&D Facilities

Our facilities

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.

Quality and Safety

KriGen LLC Facility is in compliance with quality, safety, and environmental standards as mandated by state and federal governments and regulators.

KriGen’s India based research & development facility specializes in the development of solid orals (IR, MR, SR, ER, and Films), topicals (ointments, creams, lotions, gels, powders, foams, and sprays), transdermal patches (Hydrogel & Matrix), injectables (solutions, lyophilized, and suspensions), and nasal sprays.

Our preformulation studies emphasize polymorphic screening and stabilization, salt screening, solid state and materials characterization, excipient compatibility, stability studies using HPLC, TGA, DSC, DVS (absorption/desorption), XRPD, diffusion, and particle size analysis.

KriGen LLC's India-based research and development facility, KriGen Pharmaceuticals Pvt. Ltd., has founded its business focus and mission on the research of innovative concepts in pharmaceutical product and process development using advanced manufacturing technologies and Quality by Design (QbD) principles for the 21st century. These products and processes include Preformulation, Formulation Development, Regulatory Submissions, Manufacturing and Automation/PAT Advance Process Control/Modeling for Continuous Improvement.

Products and Processes

using advanced manufacturing technologies and Qualit.

Preformulation

Pre-clinical studies using state-of-the art instruments

Formulation Development

Oral solid dosages, Topicals, Liquids and Parenterals.

Regulatory Submissions

CMC section development, 505 (b) (2) submissions, orphan drug submissions, Paragraph IV, NDA and ANDA submissions.

Manufacturing

Process development for time reduction, step change, productivity improvement, Continuous Process Verification (CQV) and alternate processing.

Automation/PAT Advance Process Control/Modeling for Continuous Improvement

Automation, process analytical technology (PAT) to real-time release (RTR), process control, process modeling, process mapping and data mining.

Research & Development

The quality and safety of our products are our top priorities.