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Yesterday (December 17), the CFDA issued the "Notice on the illegal production of chlorpheniramine maleate by Shenyang Xindi Pharmaceutical Co., Ltd. (No. 211 of 2017)" (hereinafter referred to as the Notice). According to the Notice, Recently, according to reports from the masses, CFDA organized a flight inspection of Shenyang Xindi Pharmaceutical Co., Ltd. and found that the company was suspected of serious violations of laws and regulations.
It was initially found that the company violated the approved production process and changed the production of chlorocyanobenzyl chloride to the purchased intermediate chlorpheniramine to produce chlorpheniramine maleate. The material source, batch production record and batch inspection record. The records and data of the inspection report, product review release list, etc. are not true, and the production and quality control processes of the drug cannot be traced; the inspection by the inspection team is not coordinated.
The above acts are suspected of serious violations of the "Pharmaceutical Administration Law of the People's Republic of China" and other relevant regulations. The Liaoning Food and Drug Administration has recovered the "Quality Certificate for Pharmaceutical Production Management Standards" of the enterprise and conducted a case investigation.
Therefore, CFDA requires all operating and use units to immediately stop selling and using the chlorpheniramine maleate drug labeled as Shenyang Xindi Pharmaceutical Co., Ltd., and the Liaoning Food and Drug Administration supervised the recall of all 2017 production. The raw materials for chlorpheniramine maleate, the relevant provinces (autonomous regions, municipalities) food and drug supervision and management departments should actively cooperate with the recall work.
According to public information, chlorpheniramine maleate, also known as chlorpheniramine, antihistamines, exerts anti-allergic effects through antagonism of H1 receptors, mainly for rhinitis, skin mucosal allergy and relieving tearing. Sneezing, drooling and other cold symptoms, chlorpheniramine maleate preparations have tablets, injections, through the CFDA database, there are 2112 drug approvals containing "chlorpheniramine maleate", most of them They are all the best-selling drugs on the market, such as pediatric aminophenol huangnamin, Meimin pseudoephedrine oral solution, vitamin C Yinqiao tablets, cunting capsules, rhinitis tablets and so on.
At the beginning of this year, the CFDA has issued a “ban†on a number of drugs, including several imported drugs and some conventional best-selling drugs. From this, it can be seen that the CFDA’s “smartness†for drug quality management supervision is in the “Notice†of this Notice. Finally, CFDA also re-emphasizes that the food and drug supervision departments of the provinces (autonomous regions and municipalities) perform their duties in accordance with the law, increase the inspection of production enterprises, pay attention to various types of risk signals and clues, and check that the production and records of suspected violations of the approval are untrue. Incomplete and other violations of laws and regulations shall be investigated and dealt with according to law.
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