Case Studies
Commercial Projects
Scale up and Manufacture of a key Intermediate
- Customer need – Advance Intermediate for a product still under patent
- Big pharma company needed 20 MT of a key intermediate for pandemic prevention API within 4 months
- Complete process details and batch production records were provided
- Early lab familiarization study was done in Hyderabad and then process transferred to Mexico for scale up
- Six step synthesis was scaled up in Mexico to make 20 MT meeting yield and quality requirements in 3.5 months
- Additional 20 MT order was received and executed within timelines
Technology Transfer of Commercial Products
A Mid sized Pharma client wanted to tech transfer its four APIs to our sites which involved process development to meet new specifications and scale-up of batch sizes four fold. Dr. Reddy’s added value through
- Process development to meet new tighter specifications
- Piloting the newly developed process to demonstrate scalability
- Engineering retrofit at Mexico and Indian plants
- Transferring technology to India and Mexico
- Successfully scaling–up the processes to designed capacity at commercial scale
Process Development, scale up & manufacture of Pentasaccharide
- Customer approached for process development of a pentasaccharide API
- Overall 62 step convergent synthesis
- Three fragments derived from glucosamine and two from glucose
- Process optimized to get consistent yield and purity
- Developed analytical methods and introduced specification at every stage
- No column chromatography in the synthesis of five monosaccharides
- Disaccharide and trisaccharide prepared at 10+ kg scale
- Process validated for the pentasaccharide main chain
- Final purification and impurity control was achieved by Gel filtration chromatography and Strong Anion Exchange chromatography