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China has halted the import, sale, and use of an Alzheimer’s medication and an active pharmaceutical ingredient (API) used in cold remedies, both produced in India, due to concerns over insufficient quality control by the suppliers.
The ban applies to Sun Pharmaceutical Industries’ rivastigmine tartrate capsules, prescribed for mild to moderate Alzheimer’s, and Supriya Lifescience’s chlorpheniramine maleate API, a common component in combination cold medicines, as announced by the country’s drug regulatory authority late yesterday.
The authority identified that Sun Pharma’s quality management team demonstrated inadequate oversight during production, including insufficient risk assessment of certain batches that contained excessive impurities. They also failed to implement prompt and effective corrective actions. Additionally, their contamination prevention measures did not meet China’s standards for pharmaceutical manufacturing quality.
For Supriya Lifescience, the issues included failure to ensure rigorous production and inspection processes for each batch of chlorpheniramine maleate API, as required by regulations. The company’s manufacturing facility also lacked proper measures to prevent insect and pest intrusion, violating China’s pharmaceutical quality control and drug approval protocols.
According to a local industry survey, Supriya Lifescience ranks among the top five global manufacturers of chlorpheniramine maleate API. The suspension of imports is expected to disrupt the supply chain for Chinese cold medicine producers.
Under the new guidelines, chlorpheniramine maleate API from Supriya Lifescience cannot be used to produce pharmaceuticals in China, and any existing products containing the ingredient will not be approved for distribution. Manufacturers are required to conduct immediate investigations and evaluations of their products, taking necessary risk management measures based on their findings.
This marks the second time China has imposed such a ban on chlorpheniramine maleate API from Supriya Lifescience. The previous restriction was enacted in March 2020, due to non-compliance with Good Manufacturing Practices.
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