# China NMPA Drug Inspection - China Resources Double-Crane Pharmaceutical Co., Ltd. - Compound Reserpine and Triamterene Tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/china-resources-double-crane-pharmaceutical-co-ltd/501a4940-f73d-4cc5-bd17-5a09220201e1/
Source feed: China

> China NMPA drug inspection for China Resources Double-Crane Pharmaceutical Co., Ltd. published May 11, 2017. Drug: Compound Reserpine and Triamterene Tablets. The State Food and Drug Administration (SFDA) announced on May 11, 2017, findings from drug testing that identified 11 b

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: State Administration for Market Regulation Announcement No. 74 of 2017 Regarding 11 Batches of Substandard Drugs
- Company Name: China Resources Double-Crane Pharmaceutical Co., Ltd.
- Publication Date: 2017-05-11
- Drug Name: Compound Reserpine and Triamterene Tablets
- Inspection Finding: The drugs were found to be substandard, with substandard items including content determination, dissolution rate, content uniformity, and related substances.
- Action Taken: The relevant provincial (autonomous region, municipality) food and drug administrations have taken control measures such as sealing and seizing, requiring enterprises to suspend sales and use, recall products, and rectify the situation. Meanwhile, the provincial (autonomous region, municipality) food and drug administrations where the production enterprises are located will, in accordance with the "Drug Administration Law of the People's Republic of China," investigate the illegal acts of producing and selling substandard drugs and publicly disclose the results within a specified time.
- Summary: The State Food and Drug Administration (SFDA) announced on May 11, 2017, findings from drug testing that identified 11 batches of substandard drugs from seven pharmaceutical companies. These companies include Mayinglong Pharmaceutical Group Co., Ltd., CR Double-Crane Pharmaceutical Co., Ltd., Chengdu Better Pharmaceutical Co., Ltd., Chifeng Weikang Biochemical Pharmaceutical Co., Ltd., Chenxin Pharmaceutical Co., Ltd., Hainan Huanglong Pharmaceutical Co., Ltd., and Gansu Dadeli Pharmaceutical Co., Ltd. The identified issues across various drug products, such as Diosmin tablets and Enalapril-Hydrochlorothiazide tablets, primarily involved critical quality parameters including content determination, dissolution rate, content uniformity, and related substances. In response, provincial food and drug administrations initiated immediate control measures, including product seizures, suspension of sales and use, and mandatory product recalls, along with directives for rectification. The SFDA further mandated comprehensive investigations into these companies for violations related to the production and sale of substandard drugs, specifically referencing Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China. Provincial authorities are required to publicly release the outcomes of these investigations within three months and report findings to the SFDA promptly. This enforcement action underscores the regulatory commitment to ensuring drug quality and patient safety.

Company: https://www.globalkeysolutions.net/companies/china-resources-double-crane-pharmaceutical-co-ltd/e48c33ac-1d7d-4278-9ef2-94ccf05b4488/