China has suspended the import, sale, and use of rivastigmine tartrate capsules manufactured by India’s Sun Pharmaceutical Industries Limited following regulatory violations identified during an inspection, the country’s top drug regulator said.

In a statement released on January 23, the National Medical Products Administration (NMPA) said inspections found that Sun Pharma’s quality management department failed to adequately fulfill its responsibilities during the production process. The company was cited for insufficient risk assessment of certain marketed batches that exceeded specification limits and for failing to take timely and effective corrective actions. The drug is used to treat patients in early and middle stages of Alzheimer's.

The Chinese regulator also identified deficiencies in contamination control and compliance with the Chinese pharmaceutical laws, concluding that the production process did not meet the requirements of China’s Good Manufacturing Practice for Pharmaceutical Products (2010 Revision).

The move underscores China’s tightening oversight of overseas pharmaceutical manufacturers supplying its domestic market, particularly in areas related to quality control and regulatory compliance.