China halts sale of Sun Pharma drug used to treat dementia
China's medicine regulator has halted the import, sale, and use of Sun Pharmaceutical Industries' dementia drug, rivastigmine hydrogen tartrate capsules. A recent inspection revealed production process shortcomings, including contamination prevent...
The National Medical Products Administration said a recent remote inspection found shortcomings in the company's production processes, including in the prevention of contamination and the quality management department's fulfillment of duties.
The body banned the sale of Sun Pharma's rivastigmine hydrogen tartrate capsules.
A spokesperson for Sun Pharma, India's largest drugmaker by revenue, did not immediately respond to a request for comment.
In 2024, the U.S. Food and Drug Administration issued a warning letter to Sun Pharma alleging "significant violations" of "current good manufacturing practice" regulations for pharmaceuticals made at the same production site in India, according to the U.S. regulator's website.
Rivastigmine capsules have been used as a dementia treatment in China, one study showed.
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