Gagillapur: PFI Facility, Finished Dosage Facility, Research & Development Facility.
PFI Facility
- Capacity of 7200 MTPA.
- Operates on a modular concept with two modules.
Key features of Modules
Fluid Bed Granulation
- Large batch size of 6 MT
- 7200 MTPA capacity
High Shear Granulation
- Large batch size of 6 MT
- 7200 MTPA capacity
Multiple Finished Dosage Facility
- Plant design according to global standards
- Automated processes, with world-class facilities
- Installed capacity of 6 Billion Tablets/Caplets (Scalable to 12 Billion)
- Packing - Bulk, Bottle and Blister
- Dosage Forms – Tablets, Caplets, Capsules, Press-Fits, Effervescent Tablets and Sachet Powders (proposed)
- Coating – 3.2 billion
R&D/Pilot Facility
- Finished Dosage development
- PFI Development
- Geometrical Scale-up
- High shear as well as fluid bed granulation
- Class 100,000, spread over 5,200 sq. ft.
- R&D team of 60 members with independent FR&D, AR&D, RA and Sourcing activities
- Facilities meet global standards
- Ability to manufacture clinical/exhibit batches
- Pilot Facility approved by Canadian TPD and Australian TGA for small volume production
R&D/Pilot Formulation Equipment
- Blenders – 10 L and 200 L
- Blister Packing Machine
- Coating Machine – 12” / 18” and 36”
- Fluid Bed Processors – 5 L and 125 L
- High Shear Granulator – 10 L
- Tablet Press – 12 station (B, D & BB tooling) and Sejong 30 station
- Sifter, Mill, Balances, Test Apparatus, etc.
R&D Capabilities
- Highly experienced team
- Ability to develop several products and file ANDAs/Dossiers in the U.S., Canada, Europe, Australia & Other Countries
- Supported by scale-up and production facilities
|