08 Nov 2023
en
Crystal Pharmatech, the leading solid state research CRO, is proud to announce the opening of a novel, small molecule, formulation CDMO subsidiary known as Crystal Formulation Services (CFS).
Crystal Pharmatech through CFS has poured investment into the expertise and capability of oral solid formulation technology for NCE drug product development. We aspire to be the best oral solid dosage formulation CDMO in China, to be among the best globally, and to be the go-to CDMO for biotech and pharmaceutical companies.
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 which is based on preformulation stability studies, 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 Spray Drying and Hot Melt Extrusion), and mini-tablet based pediatric formulations. All our key formulation equipment are 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 FDA, EMA, and NMPA requirements.
CFS is located at Suzhou, China. Our new lab and non-GMP pilot plant will be open at the end of April 2022, and our GMP manufacturing plant will be fully operational by end of September 2022.
We are dedicated to becoming your trusted partner and providing the best solid state research and pharmaceutical formulation development services 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, or by phone +1 609-529-4135.
CFS provides the full formulation CDMO services for small molecule oral dosage forms：
Formulation One-stop Shop:
