China Suspends Sale of Sun Pharma's Rivastigmine Capsules After Inspection
China's National Medical Products Administration has suspended the import, sale, and use of Sun Pharma's rivastigmine hydrogen tartrate capsules due to deficiencies in production quality management and contamination prevention identified during a remote inspection. The findings highlighted inadequacies in the quality management team's risk assessment capabilities, following a history of regulatory issues for Sun Pharma's manufacturing site in India. Additionally, NMPA has banned Supriya Lifescience's chlorpheniramine maleate raw material for similar management deficiencies.
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China's National Medical Products Administration (NMPA) has suspended the import, sale, and use of Sun Pharma's rivastigmine hydrogen tartrate capsules following a remote inspection that revealed deficiencies in production quality management and contamination prevention. The inspection, conducted on January 26, found the quality management team lacked necessary capabilities for risk assessment.
Sun's manufacturing site in Dadra and Nagar Haveli, India, has faced previous regulatory issues, including warnings from the FDA in 2017 and 2024 for violations of manufacturing standards. Concurrently, NMPA has also inspected Supriya Lifescience, banning its chlorpheniramine maleate raw material due to inadequate management.
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