The photo above is of the recently constructed manufacturing facility for Inner Mongolia Huashu Biotech Co. Ltd. The photo to the left shows a line of fermentation reactors inside one of the workshops. Production of Oxytetracycline Dihydrate began several months ago. The site is currently manufacturing USP grade material. Our Mr. Xu recently visited the site and reports that it is a "first class facility." Our plan is to file a VMF in early 2016 and have a Chinese GMP certificate shortly thereafter.
At New Chemic (US) Inc. we are constantly working on the development of both new APIs in China as well as new API manufacturing sites to keep up with the stricter environmental laws that have caused several manufacturers to relocate their API production sites to industrial zones. We have our own team in China that routinely inspects these sites, assisting personnel in training and regular, routine GMP inspections. Our team also accompanies the FDA when they audit a facility and then assists with translations and the filing of all regulatory submissions.