Putting Science to Work

Chemical Development

Process Research and Development Lab

Syngene’s fully-equipped process research and development lab allows rapid development of scalable and robust chemical processes utilizing advanced methodologies. Syngene is also equipped with a kilo lab for a quick supply in the early phase of the development.

Key equipment:

  • Syrris atlas automated reactor system
  • Radley’s carousel system
  • Easy max 102 for parallel synthesis
  • Jacketed glass reactors from 100mL to 20L
  • Dosing pumps (for acids/bases/slurry/powder)
  • Library of agitators (Anchor, Retreat, PBT, Flat blade, Rushton disc)
  • Laboratory distillation set up: Regular and Packed columns
  • Flow process equipment- Coil, Packed bed
  • Filtration study equipment
  • Hazard evaluation lab: RC1e, DSC, Gas quantification setup & TGA
  • React IR
  • Polymorph Screening: Crissy: Polymorph Screening unit, Malvern Particle analyser, Particle microscope.
  • Freeze driers
  • HPLCs for in-process monitoring
  • KF and potentiometric titrators

cGMP Manufacturing

We provide cGMP services for development and production of small molecules in our state-of-the art facility in Bangalore which has been inspected by USFDA and our global partners. Since inception, we have successfully supplied advanced intermediates and NCEs for molecules in early and late phase, and for commercial supplies.

Key highlights:

  • Producing output from grams to hundreds of kilograms per batch.
  • Equipment of various capacities and material of construction, operating over a wide range of temperatures.
  • Cryogenic reactions down to -100 0C at different scales and material of construction (SS316L and Hastelloy reactors).
  • Hydrogenation reactions in a classified zone to meet various process conditions.
  • Reactors controlled through validated Distributed Control System (DCS)

For the downstream processing area, we have different equipment for centrifugation, filtration and drying. These equipment are of different capacities and material of construction. SS316L and glass columns are available for carrying out chromatographic separations. Syngene also has capabilities to perform HPLC purification/ separation by using Novasep systems and other systems, both in normal phase as well as in reverse phase in a classified area.

Manufacturing plant has different clean rooms (ISO Class 8) and these are further segregated into wet and dry processing areas. The wet areas have reactors along with equipment for filtration and drying.

All powder processing is done in the dry areas of the clean room and are equipped with the necessary drying, milling and packing equipment. We have capabilities for both dry and wet milling and can achieve a particle size as low as 5µ.

Manufacturing facility expansion:

To meet our customer requirements and larger capacities, a new multipurpose manufacturing facility is being built in Mangalore SEZ (350 km from Bangalore).

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