The Center for Drug Evaluation (CDE) in China has recently approved a drug which registers PharmaBlock Zhejiang as the API manufacturer by PharmaBlock partner. Previously in October 2021, PharmaBlock Zhejiang manufacturing site successfully passed pre-approval inspection (PAI) by the China National Medical Products Administration (NMPA) for this API.
Over the past years, PharmaBlock has established a comprehensive quality system and constantly improves it to meet the current regulatory requirements in China, US, Europe and Japan, etc. The Zhejiang manufacturing site passed the FDA GMP inspection in 2019 with no Form 483 issued. "These audits and proactive communications with global regulatory authorities and pharmaceutical companies will help us keep improving the quality system in line with the current requirements. Our robust quality system and in-depth understanding in global regulatory submission requirements can better support our partners' molecules to advance from development to commercialization," said Dr. Zhengtian Gu, Senior Vice President of Quality at PharmaBlock.
Passing pre-approval inspection and supporting the drug approval is an essential recognition of PharmaBlock's comprehensive CMC capabilities. "In addition to the widely recognized chemistry expertise, PharmaBlock has established an integrated CMC platform, providing development and manufacturing of drug substances and drug products from pre-clinical stage to commercialization. We are committed to working with our partners to move the molecules into the market with better efficiency, reduced risk, and lower cost," said Dr. Wenfang Miao, CEO of PharmaBlock.