Chlorpheniramine Maleate

China’s National Medical Products Administration suspended the import, sale and use of Sun's rivastigmine hydrogen tartrate capsules, according to a Jan. 26 announcement. Regulatory authorities in China have cracked down on Sun Pharma’s rivastigmine-based Alzheimer’s disease treatment, halting the med’s distribution after uncovering shortfalls in its production process.  A Jan. 26 regulatory alert (Chinese) reveals that China’s National Medical Products Administration (NMPA) recently conducted a remote inspection of Sun’s rivastigmine hydrogen tartrate capsule production operations in India. During the investigation, inspectors determined that Sun’s quality management team “lacked the capacity” to perform its required duties during production, as demonstrated by an insufficient risk assessment of some marketed product batches, according to the NMPA's translated filing. Additional deficiencies spotted in Sun's manufacturing operations included subpar prevention of contamination and otherwise falling short of Chinese Good Manufacturing Practice standards. Sun's rivastigmine-based drug is a generic cholinesterase inhibitor used to treat dementia associated with Alzheimer’s disease and Parkinson’s disease. Given the inspection findings, the NMPA said it is suspending the import, sale and use of Sun's capsules, effective immediately. Sun Pharma did not immediately respond to Fierce Pharma’s request for comment on the situation. The inspection concerned Sun’s manufacturing plant in the Indian union territory of Dadra and Nagar Haveli and Daman and Diu, which makes oral capsules. The site previously caught flak from the FDA, receiving a 2017 warning letter that identified 11 quality issues, before the agency cleared the facility later that same year.In 2024, the FDA again issued a warning letter at the site describing “significant violations” of manufacturing standards. The U.S. regulator flagged contamination and cleanliness concerns, as well as issues within the plant’s quality control systems. That letter urged the company to bring in a consultant to help install better standards at the site, pointing to repeat violations from both the 2017 inspection and a 2019 citation. The generic rivastigmine hydrogen tartrate capsules Sun makes were first introduced by Novartis in the early 2000s under the brand name Exelon, which the company has since developed into a skin patch. The early innovation in the dementia space preceded newer Alzheimer’s and dementia treatments such as Eli Lilly’s Kisunla and Eisai and Biogen’s Leqembi.Meanwhile, Sun Pharma isn’t the only drugmaker to recently land in the NMPA’s crosshairs. The regulator has also ordered an on-site inspection of Supriya Lifescience’s chlorpheniramine maleate raw material, which is used to make an antihistamine that treats allergy symptoms. That material has also now been banned from use or sale after regulators described the facility’s management as “lax” and without effective measures in place to prevent insects and animals from entering the premises, according to a Jan. 26 alert (Chinese).