Issue Date: September 28, 2015
Chinese, Indian Firms Get FDA Thumbs-Down
FDA has banned from the U.S. 15 active pharmaceutical ingredients (APIs) made by Zhejiang Hisun Pharmaceutical, one of China’s leading API makers and a partner with Pfizer in a generic drugs joint venture. Hisun says FDA inspectors faulted the integrity of the company’s manufacturing data. Hisun adds that the 15 APIs represent only about 2% of its sales. Separately, FDA is prolonging an import ban on APIs made by India’s Pan Drugs. During an inspection a year ago agency officials observed severe manufacturing deficiencies, including large holes in walls that allowed pigeons to enter the plant.
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