China NMPA Drug Inspection - Pfizer Pharmaceuticals Co., Ltd. - Atorvastatin calcium tablets

The National Medical Products Administration (NMPA) issued a public statement on July 3, 2020, explaining key details from the "Hubei Province Drug Quality Announcement (2020, Issue 1)" originally published on May 8, 2020. This announcement had identified a specific batch (X07585) of "Atorvastatin Calcium Tablets" as substandard. The drug was notably labeled with Pfizer Pharmaceuticals Co., Ltd. as the manufacturer. Following this initial finding, Pfizer Pharmaceuticals Co., Ltd. formally denied the production of the implicated batch. A subsequent investigation was initiated by the Jianli County Market Supervision Administration, prompted by an application from the company. The investigation definitively concluded that the substandard "Atorvastatin Calcium Tablets" were, in fact, counterfeit. Furthermore, it was determined that Jianli County Tongren Pharmacy had procured this batch through illicit and unauthorized supply channels. This clarification from the NMPA serves to highlight a significant breach of pharmaceutical integrity, confirming the presence of counterfeit medicines in the supply chain and emphasizing the importance of legal drug procurement. The regulatory action involved public announcements and an administrative investigation to ascertain the true origin and nature of the substandard drug.