Crystal Formulation Services, a subsidiary of Crystal Pharmatech, was recently granted the "Drug Manufacturing License" (C Certificate) by the Jiangsu Medical Products Administration, a branch of the Chinese National Medical Products Administration (NMPA). This significant achievement highlights Crystal Formulation Services as a leading professional formulation CDMO by confirming that their quality system, GMP facilities, and software systems all meet the rigorous requirements of the Chinese NMPA's drug production quality management standards (i.e., GMP).
Crystal Formulation Services' state-of-the-art R&D laboratories and formulation pilot plant are equipped with top-notch formulation equipment and analytical instruments. Their technical team of PhDs is led by experienced professionals who have previously worked in leading global pharma companies, such as Merck and Pfizer. These leading scientists have extensive experience in formulation development, cumulatively having worked on over 100 New Chemical Entities (NCE) and delivered 19 commercialized drug products.
The formulation CDMO has a diverse range of expertise. Their advanced capabilities include conventional formulation technology driven by compaction simulation, enabling technology for insoluble compounds (Amorphous Solid Dispersions through Spray Drying and Hot Melt Extrusion), and mini-tablet based pediatric formulations. Key formulation equipment at Crystal Formulation Services is sourced from global top brands, ensuring the highest quality standards.
The achievement of the drug manufacturing license not only guarantees the quality of Crystal Formulation Services's service but also marks an important milestone in expanding and upgrading the company's service capabilities. This is representative of the company's broader focus on providing high-quality, professional, efficient formulation development and production services to global biotech and pharmaceutical companies.
Crystal Formulation Services is an essential part of Crystal Pharmatech's integrated services, providing top-notch formulation development and manufacturing services to their clients. With their new drug manufacturing license, CFS is now able to offer even more comprehensive services to their clients.
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