Crystal Formulation Services Receives China Drug Manufacturing License for Milestone Formulation Capability

20 April 2023 | Thursday | News

Crystal Pharmatech's CDMO Business Unit

Crystal Formulation Services, a subsidiary of Crystal Pharmatech, has achieved an exciting new milestone in its formulation capabilities. The company 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.

Crystal Pharmatech's solid-state research and pre-formulation capabilities are among the best in the industry, making them the ideal partner for small molecule new drug discovery and development companies. Their solid-state research capabilities include solid form screening and selection, amorphous solid dispersion development, and crystallization screening and development. Their pre-formulation capabilities include solubility and stability assessments, excipient compatibility studies, and API physicochemical property studies. By identifying the best form for each new drug molecule and then using solid-state and pre-formulation research to develop the best formulation, Crystal Pharmatech ensures that their clients' molecules have the highest chance of success in clinical trials and commercialization.

Since 2010, Crystal Pharmatech has been delivering successful solutions to help drug innovators move molecule to medicine. Their facilities, capabilities, and team of experts continue to expand. With this new drug manufacturing license, Crystal Pharmatech and their CDMO business unit are now able to provide more comprehensive services to their clients. Crystal Formulation Services ensures the highest quality and efficiency in bringing their molecules to market.


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