Industrial magnesium carbonate flows into pharmaceutical factories, where Zhengchangsheng Jianwei Powder and Kimura Stomach Powder use it as an excipient.
The Changhua County Health Bureau received a notification from prosecutors that "industrial-grade" magnesium carbonate was suspected of having entered a pharmaceutical factory. According to the Health Bureau's current investigation results, two drugs - "Zheng Chang Sheng Jian Wei San (Wei Shu Cheng Zhi Zi No. 003257)" manufactured by Zheng Chang Sheng Chemical Pharmaceutical Co., Ltd. and "Wei San (Wei Shu Yao Zhi Zi No. 024680)" manufactured by Kimura Pharmaceutical Co., Ltd. - used "industrial-grade" magnesium carbonate as an excipient.
Zheng Chang Sheng Chemical Pharmaceutical Co., Ltd. (No. 6, Section 2, Zhangmei Road, Hemei Township, Changhua County) is a GMP pharmaceutical factory established in the 55th year of the Republic of China (1966), with its main products being over-the-counter medicines. It is currently in the process of PIC/S review and has not yet passed, so Western medicine manufacturing is suspended. Kimura Pharmaceutical Co., Ltd. (No. 110, Section 1, Zhongshan Road, Yuanlin Township, Changhua County) is a GMP pharmaceutical factory established in the 68th year of the Republic of China (1979), with its main products being over-the-counter medicines. It ceased operations on December 9, the 103rd year of the Republic of China (2014).
According to a statement issued on March 31, the 104th year of the Republic of China (2015) by the Food and Drug Administration of the Ministry of Health and Welfare, pharmaceutical factories should use pharmaceutical-grade excipients and must not use industrial-grade products as excipients. Violators may, depending on the circumstances and investigation results, be penalized under Article 21 of the Pharmaceutical Affairs Act as producing "substandard drugs" with a fine of NT$60,000 to NT$300,000. In serious cases, a sentence of up to one year of imprisonment or detention may be imposed, and a fine of up to NT$30,000 may be imposed concurrently. Products should be immediately removed from shelves and recalled in accordance with Article 80 of the same Act, and recalled products and inventory should be confiscated and destroyed in accordance with Article 79 of the same Act. The Changhua County Health Bureau will cooperate with the District Prosecutors Office in follow-up investigations and handling.
