Crystal Formulation Services (CFS) is located at Suzhou, China as the wholly owned subsidiary of Crystal Pharmatech. CFS provide contract formulation development and manufacturing services for innovative drug products from preclinical, clinical to commercial stages.
We focus on formulation development and manufacturing of NCE's from preclinical, clinical, to commercialization for both conventional and amorphous solid dispersion dosage forms. In addition, we provide pre-formulation, analytical method development/validation, QC release, stability testing, and CMC filing services to our global clients.
We have built a strong leadership team of US trained PhD formulators with 20+ years of experience delivering over 100 early phase and 30 commercialized drug products at global companies such as Merck and Pfizer. The team specializes in conventional formulation technology driven by compaction simulation, enabling formulation technology for insoluble compounds (amorphous solid dispersion by SD and HME), and mini-tablet based pediatric formulations. All our key formulation equipment is selected from top brands in the world, including Korsch (compaction simulator and tablet press), Glatt, Alexanderwerk, GEA, Leistritz, Vector, Syntegon, etc. Our cGMP plants and QMS meet all the NMPA, FDA and EMA requirements.
Our laboratory and GMP-like pilot plant are already operational, and our GMP manufacturing facility will be fully operational by the end of October.
We are dedicated to becoming your trusted partner and providing the best formulation service to ensure your success. Please let us know if our services could meet your business needs. We can be reached for the company overview or more detailed information by email: CFS@crystalpharmatech.com.
CFS provides the full formulation CDMO services for small molecule oral dosage forms：