Contract Manufacturing

 Rontis has a vertically organized manufacturing infrastructure that is supported by the R&D department and is implemented through Standard Operating Procedures.

 Our new EU GMP-compliant facility  in Greece is located in a 9.200 square meters area in the Industrial Zone of Larissa and consists of high-end production lines capable of producing pharmaceutical products in a wide range of oral solid dosage forms with an exceptional annual capacity through a range of manufacturing processes as well as corresponding individualized packaging.

 Currently several new generic molecules are manufactured, some of which are projects of innovative formulations based on drug delivery technologies. Using the application of innovative ideas and advanced technologies, Rontis aims to provide challenging and optimized pharmaceutical products to patients.

Packaging

 Primary packaging

• Packaging in Blister (Alu-Alu, Alu-Alu Peel off/Paper Peel off, PVC, PVDC, PP, ACLAR, Triplex, perforated/Non-perforated)
• Packaging in Sachets

 Secondary packaging

• Packaging in various folding box designs

 Support in packaging development
 Coordination/packaging of initial supply quantities  following marketing authorization

 

Annual Packaging Capacity

 100 million blisters

 

Product forms

 Oral solid IR dosage forms (Tablets, capsules, pellets, granules)
 Modified and sustained release tablets, capsules, pellets
 Multiple Unit Pellet Systems (MUPS) technology based oral solids (Tablets, capsules)
 Chewable tablets
 Dispersible and orally disintegrating tablets (ODTs)
 Sugar & Film-coated tablets
 Hard gelatin capsules containing granules, tablets or pellets (all sizes)
 Granules
 Pellets
 Products in sachet or innovative packs

 

Annual Production Capacity

 3 billion tablets
 260 million capsules

Manufacturing Processes

 Weighting
 Sieving/Milling
 Mixing/Homogenisation
 Wet granulation
 Dry granulation
 Spray granulation
 Fluid bed processing (granulation, drying, coating)
 Dry mixing/blending
 Extruder/ Spheronizer
 Tabletting
 Coating (Sugar, Film, Enteric)
 En-capsulation

Contract manufacturing services

Process Optimization

Scale up and Validation of analytical methods of finished products

Production of pilot and industrial batches for product transfers and industrialization

 

Stability Studies

Stability programs according to ICH and documentation according to CTD requirements.