Dosage Development Scale Up
At the scale-up facility we manufacture batches of Solid Oral dosage forms and injectables for bio studies, clinical trials and various regulatory submissions.
- 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.
- 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
- cGMP facility for manufacture of sterile products