WuXi PharmaTech (Cayman) Inc. has announced that its small-molecule process development and manufacturing subsidiary Shanghai SynTheAll Pharmaceutical Co., Ltd. (STA) received its first approval from the Japan PMDA for the manufacture of the GMP intermediate of a branded commercial drug in July.
STA is now the only Chinese contract manufacturing organization to have received approval to supply active pharmaceutical ingredients (APIs) and GMP intermediates for branded commercial drugs from regulatory agencies in the United States, Canada, the European Union, Switzerland, China, Japan, Australia, and New Zealand.
STA's integrated platform of services, extending from process research to research manufacturing to commercial manufacturing, helps clients move their new chemical entities through preclinical and clinical development to global commercial launch.
"I'm very proud of our track record in securing approvals from global regulatory agencies and the added confidence these successes bring to our partners," said Dr. Minzhang Chen, CEO of STA.
"This favorable outcome further demonstrates that STA's facilities, processes, and people are world-class and of the highest quality," said Dr. Ge Li, chairman and CEO of WuXi PharmaTech. "We look forward to expanding these capabilities with our new facilities under construction in Changzhou to better serve our partners."