# China NMPA Drug Inspection - Tonghua Great Wall Pharmaceutical Co., Ltd. - Phenylopridine phosphate tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/tonghua-great-wall-pharmaceutical-co-ltd/91ee2c91-d4ef-40d2-8239-9f0dfb178622/
Source feed: China

> China NMPA drug inspection for Tonghua Great Wall Pharmaceutical Co., Ltd. published March 30, 2017. Drug: Phenylopridine phosphate tablets. The National Medical Products Administration (NMPA), formerly the State Food and Drug Administration (SFDA), issued an a

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 51 of 2017 from the State Administration for Market Regulation regarding 5 batches of substandard drugs.
- Company Name: Tonghua Great Wall Pharmaceutical Co., Ltd.
- Publication Date: 2017-03-30
- Drug Name: Phenylopridine phosphate tablets
- Inspection Finding: Dissolution rate, content uniformity, and content determination items failed to meet standards.
- Action Taken: The relevant provincial bureaus have taken control measures such as sealing and seizing, requiring enterprises to suspend sales and use, recall products and make rectifications; the State Administration has required the local provincial bureaus to investigate the illegal activities and make the results public within three months.
- Summary: The National Medical Products Administration (NMPA), formerly the State Food and Drug Administration (SFDA), issued an announcement on March 30, 2017, concerning five batches of substandard drugs from four pharmaceutical companies. The identified companies were Shanxi Guorun Pharmaceutical Co., Ltd., Changchun Changhong Pharmaceutical Co., Ltd., Tonghua Changcheng Pharmaceutical Co., Ltd., and Tianjin Jinhong Shengli Pharmaceutical Co., Ltd.

Testing conducted by the Heilongjiang Provincial Institute for Food and Drug Control revealed significant quality deficiencies. Specifically, various batches of Phenylopidine phosphate tablets and capsules failed to meet established standards for dissolution rate, content uniformity, and overall content determination. These critical violations indicate potential efficacy and safety concerns for patients.

In response, provincial food and drug administrations promptly implemented control measures, including seizing and sealing the affected products. They mandated sales suspension, product recalls, and required the implicated companies to initiate corrective actions. The NMPA further directed these provincial authorities to thoroughly investigate the illegal production and sale practices in accordance with Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*. Provincial administrations were instructed to publicize their findings and actions within three months and report back to the NMPA, ensuring accountability and adherence to regulatory standards for drug quality and safety.

Company: https://www.globalkeysolutions.net/companies/tonghua-great-wall-pharmaceutical-co-ltd/30facffc-482a-435f-a9dc-ada5b2a4a9d6/