DisperSol is currently in the process of establishing commercial capacity cGMP KinetiSol manufacturing lines for product supply of Phase III studies. We are a fully-integrated developer-manufacturer with a unique proprietary technology. DisperSol is also able to work with partners to establish KinetiSol manufacturing lines for high volume production in their own or third party facilities.
In our state-of-the-art cGMP facility, DisperSol is able to produce KinetiSol amorphous powder intermediate for the supply of non-GLP studies, GLP toxicology studies, and Phase I/II clinical studies. Our validated equipment includes an instrumented tablet press and tablet coater for production of clinical trial material, which we can package into labeled induction sealed bottles.
Drug Product Manufacturing:
- Amorphous powder for constitution
- Amorphous powder for processing into final dosage form
- Finished coated or uncoated tablets
- For GLP and non-GLP studies
- For Phase I/II clinical studies