Our Facility

Fully Integrated c-GMP Facility is an FDA-inspected site and complies fully with cGMP, OHSA, DEA (CIII-V), EPA standards (methanol, ethanol, isopropyl alcohol, acetone), operating from 35,000 sq. ft. state-of-the art R&D and commercial manufacturing facility capable of developing complex oral dosage forms with solvent processing features including:

• Granulation, tableting and coating
• Fluid bed process (top, bottom spray and rotor)
• Extrusion/spheronization
• Nano wet milling

Complete Analytical Capability from pre-formulation R&D development to QC testing

• Raw material/drug product testing, method development/validation, elemental impurity testing, reverse engineering, extractable / leachable 

​High Quality & Diverse Instrumentation

• UPLC/HPLC, USP dissolution tester, LC-MS, GC-MS, HS-GC, ICP-MS, Malvern Mastersizer 3000 (dry & wet), Dynamic Light Scattering nano particle size analyzer

Facility

cGmp Facility

Utilizing the same type of equipment train from pilot to submission/commercial batches

ExtruderSpheronizer

Rotor Processor

Fluid Bed Processor

Tablet Coater

Fluid Bed Processor

Fluid Bed Dryer

High Shear Granulator

Wurster Processor