# China NMPA Drug Inspection - Jilin Shuangxing Pharmaceutical Co., Ltd. - Acanthopanax senticosus tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/jilin-shuangxing-pharmaceutical-co-ltd/dc1ced1b-9f5b-496f-bf52-2259cf12e6cd/
Source feed: China

> China NMPA drug inspection for Jilin Shuangxing Pharmaceutical Co., Ltd. published September 18, 2018. Drug: Acanthopanax senticosus tablets. The National Medical Products Administration (NMPA) of China issued an announcement on September 18, 2018, identifying 1

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 89 of 2018 from the National Medical Products Administration regarding 13 batches of drugs that did not meet the requirements.
- Company Name: Jilin Shuangxing Pharmaceutical Co., Ltd.
- Publication Date: 2018-09-18
- Drug Name: Acanthopanax senticosus tablets
- Inspection Finding: Content determination did not meet the requirements
- Action Taken: Relevant drug regulatory authorities have taken control measures such as sealing and seizing, requiring the company to suspend sales and use, recall products, and rectify the situation. The relevant provincial drug regulatory authorities will initiate an investigation into the company in accordance with the "Drug Administration Law of the People's Republic of China," and will complete the investigation and publicize the results within three months of receiving the inspection report.
- Summary: The National Medical Products Administration (NMPA) of China issued an announcement on September 18, 2018, identifying 13 batches of drugs from eight pharmaceutical companies that failed to meet regulatory standards. Key implicated manufacturers included Hubei Dongxin Pharmaceutical Co., Ltd., Jilin Shuangxing Pharmaceutical Co., Ltd., and Zhejiang Proconyu Natural Medicine Co., Ltd., among others.

The primary issues identified involved critical quality attributes of the drugs. Hubei Dongxin Pharmaceutical's Valacyclovir Hydrochloride Capsules exhibited a non-compliant dissolution rate, a factor crucial for proper drug absorption and efficacy. Several companies, including Jilin Shuangxing Pharmaceutical, produced Acanthopanax senticosus tablets with incorrect active ingredient content. Additionally, Zhejiang Proconyu Natural Medicine and other traditional Chinese medicine producers had products, such as Maiwei Dihuang oral liquid and Evodia rutaecarpa, that failed to meet appearance specifications, indicating potential problems with raw materials, manufacturing processes, or storage.

Operating under the "Drug Administration Law of the People's Republic of China" and guided by standards from the *Pharmacopoeia of the People's Republic of China* and Ministry of Health Drug Standards, the NMPA mandated immediate actions. Regulatory authorities implemented control measures, including product sealing and seizure. The involved companies were instructed to halt sales, suspend use, recall affected products, and undertake necessary rectifications. Provincial drug regulatory bodies were tasked with investigating these illegal activities, with a deadline to complete inquiries and publicly disclose findings within three months. This initiative highlights China's commitment to ensuring drug quality and public safety.

Company: https://www.globalkeysolutions.net/companies/jilin-shuangxing-pharmaceutical-co-ltd/15164930-890b-44b4-8751-3b29d4acdfb4/