Manufacture of batches of solid oral dosage forms for bio studies and various regulatory submissions
| Capabilities: |
- Handling of all unit processes normally used for manufacture of solid oral and parenteral dosage forms
- Scale-up of formulations from laboratory to pilot scale ( 100,000 units)
- Manufacture of pivotal and validation batches for submission
- Totally automated cGMP production facilities
- Manufacture and packaging of batches of solid oral dosage forms intended for clinical / bioequivalence studies
- Technical support with expertise in formulation development, process optimization, engineering, quality assurance & quality control with analytical instruments
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| Infrastructure: |
State-of-the-art, US-FDA approved, cGMP facility equipped with:
- Building Management system (BMS) for complete monitoring of environmental temperature, humidity and pressure
- Rapid mixer granulators
- Fluid bed processor with top spray & Wurster facility
- High-speed rotary tablet presses
- Completely automated tablets film coating machines
- Alu/Alu (cold form blister) and PVC/PVdC
- Automated bulk counting, filling and packaging line for oral solids
- In-process instruments like Moisture analyzer, Automated hardness tester, Roche friabilator, Bulk density testing apparatus, Torque tester and Ultrasonic sieve shaker Sterile products manufacturing cGMP plant
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