FDA Approvals

Inspections PassedChemWerth-Represented Manufacturers’
FDA Inspections & Approvals

With more than 120 successful inspections over the past 15 years and a 40+ year relationship with the FDA, ChemWerth’s track record of regulatory and compliance excellence is unmatched.

Starting with careful factory selection, we develop a hands-on approach with our partner manufacturers; performing routine audits, quality checks, compliance reviews and feedback that ensures high-quality pharmaceutical grade API is consistently manufactured.

Our factories meet ICH Guidelines, are WHO compliant, cGMP qualified and USFDA approved making sure your Finished Dosage is compliant, effective and meets regulatory criteria in markets worldwide.