Putting Science to Work
infrastructure_formulation_dev

Formulation Development

Syngene has a well-established formulation development centre providing oral solid as well as liquid dosage forms including injectable formulations. Our facility layout is as per cGMP and Schedule ‘M’ of the ‘Drugs and Cosmetics Act. The cGMP area is spread across approx. 3600 sq. ft. and is equipped for manufacturing of Oral Solid Dosage Forms at 1 to 50 kg scale. We are approved by local FDA for cGMP manufacturing.

Our development laboratory is spread across an area of approx. 3600 sq. ft. conducting non-GMP formulation development with a scale for OSD 0.5 to 3.5 kg. The analytical laboratory includes validated stability chambers.

Utilities
  • Complete facility in non-progressive acid proof anti- fungal modular panels
  • Pressure differentials to prevent cross contamination
  • Segregated areas through change room concepts, AHU zoning, man-material flow
  • 100% power back-up, abundant potable water
  • Adequate waste management system
Equipment
  • V, Octagonal and Double Cone Blenders - 0.5 to 50 kg
  • High Shear Mixer- Bottom Driven - 1 to 10 kg and 5 to 30 kg
  • Fluid Bed Dryer with Wurster Column (Glatt) - 0.5 to 1 kg and 4 to 15 kg
  • Roller Compactor (Alexanderwerk WP120) including mini compactor - Min batch 200 g continuous
  • Compression Machine (Instrumented Rotary Presses) -10 and 20 stations
  • Spray dryer (100 – 150 g/hr)
  • Autocoater - 0.2 to 1 kg and 5 to 12 kg
  • Automatic Capsule Filling Machine (Pam AF25T and Rimek-Minicap) - Continuous
  • IPQC: DT, Friability, Hardness Tester, Tap Density, Sieve Analysis, AcuPyc, Geopyc, Erweka GT
Instruments
  • HPLC and UPLC systems with data acquisition software - Waters with Empower
  • 6 and 12 Jar dissolution test apparatus - Electrolab
  • UV Spectrophotometer - Shimadzu

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