Sun Pharma's Dementia Drug Rivastigmine Banned in China
In 2024, the USFDA 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.
New Delhi: China's medicine regulator has ordered a halt to the import, sale and usage of a drug used to treat dementia associated with Alzheimer's disease made by India's Sun Pharmaceutical Industries, according to an announcement posted on Monday.
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.
