We offer Contract Manufacturing, Custom Synthesis (FTE& FFS mode), manufacture and marketing of pharmaceuticals special products and impurities, and services to clients across the globe with a product portfolio including a range of Active Pharmaceutical Ingredients (APIs) and Fine Intermediates
Contract Research and Manufacturing Services (CRAMS) :
We offer Custom Synthesis, Process R&D, Scale up, Contract/toll Manufacturing of API’s, Advance Intermediates, Key Building blocks for in-market products and for NCEs from early phase development to commercialization stage.
TSK with its integrated R&D, technology and engineering capability has served as a dependable manufacturer to leading Innovators and several Global Pharma majors by developing cost effective and non-infringing processes for various API’s & Advance Intermediates. Respect for IPR and Customer Confidentiality is a management philosophy.
Process Development :
We have all the expertise required for developing a process that is robust, transferable, and scalable to meet your requirements. We bring 15 years of experience to every project and deliver fully integrated solutions with an emphasis on quality, speed, and flexibility.
Our Process Development and Manufacturing Services include :
- Custom Synthesis from mg to multi-kilogram scale in batch (up to 5000L reactors
- Optimization of existing synthetic routes for the eco-friendly and cost effective
- Development of cGMP friendly alternative synthetic routes
- Development of IP protected synthetic routes
- Statistical Design of Experiments (DoE) for process parameterization and optimization
- Development and optimization of purification and isolation methods
- Isolation of active ingredients from natural sources
- Transfer of process into GMP
- Documentation of CMC development projects
We support clients in all aspects of API Process Development, including process and analytical R&D, stability studies, impurity/degradant profiles, and raw material sourcing. wwe understands your need for efficient outsourcing solutions in process development and is focussed on reducing timelines and costs throughout all phases of development and manufacturing.