What regulatory standards and certifications do your pharmaceutical ingredients meet?

Our pharmaceutical intermediates are manufactured under cGMP (21 CFR Part 210/211). We hold ISO 9001:2015 and FSSC 22000, with Kosher (OU) and Halal (IFANCA) available for many products. We can test to USP, EP, JP, and ChP standards. For specific APIs or intermediates, we support DMF filings and provide ICH stability data. All products are subject to full residual solvent, heavy metal, and microbial testing.