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.
Solipharma Founded in the U.S and China
Analytical lab certified by ISO 17025 / ilac-MAR
Lab-scale development of lyophilized injectables and double layered solid orals
GMP facilities established for clinical suppy & submission batch manufacturing
High potency NTI dug application submitted to FDA
Alliance with BioPharma to offer Phase I and BE services in North America
Pass US FDA GMP inspection with zero deficiency
More than 50 patents granted in US and Chiana
Established in 2010
Located in BioPharm Park Hangzhou Economy and Development Area Hangzhou China
Focusing on commercialization enabling research product registration with CFDA and Business development for Chinese Market Business development for global markets
15000 sqft lab space state-of-art analytical and characterization facilities
ISO 17025:2005 accredited for testing and calibration since 2013
Passed GMP inspection by USFDA with zero deficiency in 2018
Founded in 2010
Located in greater Boston Area
Focusing on product registration with USFDA and Canada TPD and business development for North America markets