A Chinese ingredient maker that says it has produced products for some of Big Pharma's biggest players has had products banned by the FDA.
On Wednesday, the FDA added Zhejiang Hisoar Pharmaceutical to its import alert list, Bloomberg reports. According to the notice, all of the company's antibiotics and drugs for human or animal use manufactured at a plant in Taizhou have been banned from being brought into the U.S. Bloomberg says the action follows an inspection last year. The company did not respond to the news service.
The company's website claims it has produced ingredients for such companies as Novartis ($NVS), Sanofi ($SNY) and Pfizer ($PFE). The company, in fact, has a name, and a plant address, that is very close to Pfizer's joint venture partner in China, Zhejiang Hisun Pharmaceutical. A representative of Zhejiang Hisun said the companies are unrelated in any way.
The FDA had put Zhejiang Hisun on its import alert list in September and earlier this month posted a warning letter it issued to the company Dec. 31. The letter accused the company of "systemic data manipulation ... by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs." Pfizer has said that none of the JV's products are affected by the ban.
Both the FDA and the European Medicines Agency (EMA) have been stepping up their enforcement actions against drug and ingredient makers in China, where the majority of active pharmaceutical ingredients are now produced for the industry. The EMA just this week posted an action against Hubei Hongyuan Pharmaceutical after Czech authorities did a spot inspection last year at its Huanggang City facility and reported horrid conditions. They said the company had no testing, validation or quality control processes in place and that the plant and equipment were covered in a buildup of dirt and drug dust.
- here's the Bloomberg story
- the two import alerts can be found here