The Chinese half of a Pfizer ($PFE) joint venture has found itself crosswise with the FDA, which has banned products from one of its plants.
China's Zhejiang Hisun Pharma itself recently announced that the import alert was issued by the FDA against its API factory in Taizhou. According to a translated version of the announcement, Hisun said that during a March visit FDA inspectors found a "lack of integrity" at the plant and cited 29 products for which it had not received prior approval to ship to the U.S.
The ban encompasses 15 products but excludes the tuberculosis treatment capreomycin and 13 others.
The Chinese company said that it has the ability to deal with the issues, is communicating with the FDA and will resolve the problems as soon as possible. Those efforts, however, will trim about RMB72.4 million ($11.36 million) off its fourth-quarter sales this year.
Hisun in 2012 hooked up with Pfizer in a joint venture to make and sell in China some of Pfizer's off-patent drugs. Pfizer got 49% of the JV and Hisun the rest. Since then, Hisun has branched out. In 2013, it struck a deal to get Catalent's ($CTLT) GPEx platform for the creation of mammalian cell lines, which Hisun intended to use to develop and manufacture biosimilars of drugs like Johnson & Johnson's ($JNJ) Remicade, AbbVie's ($ABBV) Humira and Sanofi's ($SNY) Lemtrada.
Editor's Note: The story was updated to indicate that while some products from the plant has been put on the FDA Import Alert list, it has not received a warning letter as Reuters indicates.