China NMPA Drug Inspection - Shaanxi Provincial Academy of Traditional Chinese Medicine Hantang Pharmaceutical Co., Ltd. - Isatis root granules

The State Food and Drug Administration (SFDA) issued its National Drug Quality Bulletin (2009, Issue 1) on April 23, 2009, reporting findings from a nationwide drug evaluation and sampling inspection. This initiative, part of the National Drug Evaluation and Sampling Plan, aimed to bolster drug supervision and ensure public medication safety. The inspection covered Metformin Hydrochloride Tablets, Banlangen Granules, and Measles-Mumps-Rubella Trivalent Live Attenuated Vaccine. All vaccine samples passed quality standards.However, violations were identified for Metformin Hydrochloride Tablets, involving manufacturers such as Liaoyuan Dikang Pharmaceutical Co., Ltd., Changzhou Pharmaceutical Factory Co., Ltd., Henan Xingyuan Pharmaceutical Co., Ltd., and Beijing Yongkang Pharmaceutical Co., Ltd. Issues included failures in dissolution, appearance, content determination, and weight variation.For Banlangen Granules, substandard batches were linked to Shaanxi Provincial Academy of Traditional Chinese Medicine Hantang Pharmaceutical Co., Ltd., Guangxi Runda Pharmaceutical Co., Ltd., and Harbin Pharmaceutical Group Shiyitang Pharmaceutical Factory, with problems related to microbial limits, fill weight uniformity, and moisture content.The SFDA instructed all provincial drug regulatory authorities to investigate and take punitive measures against the responsible entities by June 30, 2009, reinforcing its commitment to strict drug quality oversight.