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SoliPharma is a specialty pharmaceutical company with pharmaceutical innovation center based in Hangzhou, China and business development/product registration office in U.S.
SoliPharma’s mission is to “bringing challenging molecules to global markets” faster and better through SoliTech Solutions. We focus on providing comprehensive solutions to our clients worldwide from early API development (solid form screening/crystallization process), to drug product development (formulation/analytical chemistry), until obtaining the final approval of market authorization (FDA GMP/regulatory affair).
With our track record in China/U.S./Canada/European product innovation and business relationship, SoliPharma strives for delivering both innovative products (505(b)2 with modified release/new combinations) and difficult generic products (NTI, highly variable, IP hurdles etc). Leveraging global partnership with API suppliers, contract manufacturing and product distribution, SoliPharma is devoted to bringing medical products faster to meet patients’ urgent and unmet medical needs.
SoliPharma is recognized as National High-tech Enterprise by Ministry of Science and Technology of China, as Province-level R&D Center for Highly Variable Drugs by Department of Science and Technology of Zhejiang Province.
SoliPharma has been accredited ISO 17025 by China National Accreditation Service for Conformity Assessment since 2013. We also passed GMP site inspection by USFDA with zero deficiency in 2018.