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.

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.

Infrastructure

• 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