China’s drug regulator, the National Medical Products Administration (NMPA), has ordered a halt to the import, sale and use of a dementia drug manufactured by Sun Pharmaceutical Industries, following compliance issues identified during a regulatory review.

The suspension applies to rivastigmine hydrogen tartrate capsules, a generic medicine used to treat dementia associated with Alzheimer’s disease. The action was taken after a remote inspection of the manufacturing facility flagged deficiencies in contamination control and quality management systems, leading the regulator to conclude that the site did not meet required manufacturing standards.

The order immediately stops distribution of the product in the Chinese market until corrective actions are implemented and regulatory approval is restored. China is a key growth market for pharmaceutical companies, particularly for therapies linked to ageing-related conditions, making regulatory clearance critical for sustained commercial operations.

The same manufacturing facility has previously been under scrutiny by the US Food and Drug Administration, which issued a warning letter citing significant current good manufacturing practice violations. The regulatory action in China adds to compliance-related pressure on the site and highlights the operational risks associated with global manufacturing oversight.

The development underscores the direct impact of regulatory actions on market access, supply continuity and revenue visibility for pharmaceutical companies operating across multiple regulated markets.

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