Carafate :: Multiple pharmacies comparison.

FDA’s May 28-June 1, 2001, inspection of API make Northeast General Pharmaceutical Factory of Shenyang, China, netted the maker of bulk sucralfate U.S.P. four citations on the Oct. 2 warning letter for stability records and calibration lapses. The Division of Manufacturing & Product Quality at the Center for Drugs informed the firm that CDER would recommend withholding approval of NDAs listing Northeast’s product as a component.

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