Audited quality systems. Documented compliance.
Eight active certifications. Five consecutive audit cycles with zero critical observations.
The systems behind every shipment.
On file with global regulators.
US FDA – DMF Type III #34218
Referenced in 28 finished-dosage master files.
EDQM – CEP for blister foils
Compliant with European Pharmacopoeia.
PMDA Japan – Master File registered
Active in Japanese supply chain since 2019.
ANVISA Brazil – Cadastro active
Brazilian regulatory registration current.
Who audits us.
TÜV SÜD
BSI
DNV
Bureau Veritas
SGS
Intertek
Customer second-party audits are welcomed. We host an average of 14 audits annually under standard NDA.
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