1, All KSM & Advanced Intermediates are / will be manufactured in US FDA approved sites under GMP condition;
2, Complete documentation support including Executed Batch Manufacturing Record and Impurity Profiling;
3, Secondary DMF filling is acceptable upon purchase guarantee.
4, Validation quantity production and commercial production are in same site and will not change within 10 years.
5, Good understanding about up-grading regulatory requirements from US FDA and EDQM.
6, We have one dedicated QA staff who take care of documentation double – checking to ensure one shot doc to be given.