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CPC Approved by PMDA
    Top`s facilities for Calcium Polycarbophil were inspected and approved by Japan PMDA (Pharmaceuticals and Medical Devices Agency) in terms of ICH Q7A cGMP Guidelines for APIs and presented dossier PM in January 2009. The 3-day inspection, conducted by three GMP auditors, concentrated on quality management system (QA and QC), water systems and production management. The success of the inspection helps launch CPC into the Japanese market with Marketing Authorization/Approval.
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