Sun Pharma Drug Pulled from Chinese Market Over Quality Issues

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Shanghai : China’s National Medical Products Administration (NMPA) has ordered an immediate halt to the import, sale and use of a dementia treatment manufactured by India’s Sun Pharmaceutical Industries, citing serious compliance issues uncovered during a recent regulatory review. The medication affected is rivastigmine hydrogen tartrate capsules, commonly used to manage cognitive symptoms associated with Alzheimer’s disease.

The NMPA said its remote inspection of the production facility found lapses in contamination prevention measures and quality management controls. These shortcomings prompted China’s decision to suspend the drug’s market access until the company remedies the deficiencies identified in its manufacturing processes.

Sun Pharma, India’s largest pharmaceutical company by revenue, has not yet responded with an official comment on the regulatory action. The halt affects patients and healthcare providers in China who rely on the drug as part of dementia treatment protocols.

The move comes against the backdrop of heightened scrutiny of manufacturing standards across global markets. In 2024, the U.S. Food and Drug Administration (FDA) issued a warning letter to Sun Pharma over “significant violations” of current good manufacturing practice (cGMP) regulations at the same Indian site, highlighting a pattern of regulatory concerns that extend beyond China’s recent action.

China is one of the world’s largest markets for pharmaceutical products, particularly for medicines addressing age-related conditions such as dementia. The NMPA’s directive is likely to have implications for Sun Pharma’s business strategy in the region as it works to address the compliance issues flagged by regulators.

Investors have been monitoring Sun Pharma’s performance closely amid these regulatory developments. While the company maintains a significant global footprint, disruptions in a major market such as China could weigh on perceptions of production reliability and standards.

As of now, there is no timeline for when the halted drug could return to the Chinese market; authorities have indicated sales will remain suspended until Sun Pharma satisfies regulatory expectations.