Abstract

CHINA IS AN INCREASINGLY competitive supplier of drug ingredients to the U.S. But in the wake of recent scandals involving Chinese food and drug ingredients, critics are asking for more controls on imports from that country. Last month, the Synthetic Organic Chemical Manufacturers Association (SOCMA), a U.S.-based group of fine chemicals makers, reiterated its call for the Food & Drug Administration to step up visits to overseas pharmaceutical plants. The association claims that foreign-made active pharmaceutical ingredients (APIs) are often produced in plants that have never been inspected by FDA. SOCMA's statement was prompted by media reports that a cough syrup formulated with counterfeit Chinese glycerin had killed dozens of people in Panama last November. Glycerin is an edible substance that is routinely used in making medicinal liquids. Unscrupulous businesspeople have from time to time substituted diethylene glycol for glycerin to cut costs. This practice prompted FDA to issue a recommendation last...

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