GMP FACILITIES & KEY EQUIPMENT
- 175,000 sq. ft. of Modern, GMP Manufacturing Facilities
- State-of-the-Art Equipment & Instrumentation
- Exclusive US Operation
Key Features:
We Welcome Audits & Visits
- FDA Registered & Inspected
- Stringent Regulatory Compliance
- US GMP / IPEC / ICH Q7 Standards
- Exclusive US Manufacturing Facilities
- Rigorous Quality Oversight & Controls
- Fully Equipped Quality Control Laboratories
- Exemplary Preventive Maintenance Program
- Validated Manufacturing Processes & Qualified Equipment
Validated Systems – Qualified Equipment – Controlled Environment
- More than 20 GMP Manufacturing Suites with compliance levels ranging from IPEC to ICH Q7
- More than 30 Glass, 316-Stainless Steel and Composite Reactors including pilot and bulk manufacturing tanks
- Multiple environmentally controlled and monitored Packaging Rooms
- Quality Control Labs with industry leading technology, equipment and instrumentation
- Manufacturing Capabilities: Synthesis / Purifi cation / Custom Solutions / Packaging
- Drying Systems: Spray / Fluid Bed / Rotary / Tray
- Particle Characteristics: Jet Milling / Air Sieve / Rotary & Ribbon Blender
Scale & Capacity
- Reactors: Solvent & Alcohol / Corrosive Resistant Glass Lined / Stainless Steel
- Overall Operational Capacity: Thousands of Metric Tons per year
- Solutions Batch Scale: 10 L to 20,000 L
- Dry Batch Scale: 1 kg to 24,000 kg
- Reactor Scale: 30 L to 20,000 L
