# China NMPA Drug Inspection - Xi"an Jingxi Shuanghe Pharmaceutical Co., Ltd. - Ethylphenidyl sulfonamide injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/xian-jingxi-shuanghe-pharmaceutical-co-ltd/c7d8a4b3-a5d2-4e91-9ee8-e9e72605f5b7/
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> China NMPA drug inspection for Xi"an Jingxi Shuanghe Pharmaceutical Co., Ltd. published May 10, 2018. Drug: Ethylphenidyl sulfonamide injection. This announcement from the Xinjiang Uygur Autonomous Region Food and Drug Administration, published on May 10, 2018, det

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Drug Quality Bulletin of Xinjiang Uygur Autonomous Region
- Company Name: Xi"an Jingxi Shuanghe Pharmaceutical Co., Ltd.
- Publication Date: 2018-05-10
- Drug Name: Ethylphenidyl sulfonamide injection
- Inspection Finding: Non-compliance with regulations: Visible foreign objects
- Action Taken: The relevant food and drug regulatory authorities have been instructed to investigate and punish, in accordance with relevant laws and regulations, the products that did not meet the standards and the relevant operating and using units found in the supervision and sampling inspection.
- Summary: This announcement from the Xinjiang Uygur Autonomous Region Food and Drug Administration, published on May 10, 2018, details the findings from their 2017 drug quality supervision and sampling inspection program. The inspections covered various drug categories, including chemical drugs, traditional Chinese medicine, antibiotics, biochemical drugs, and medical institution preparations across the region. A total of 10 drug batches were found to be non-compliant with established quality standards. Key manufacturers implicated include Shantou Jinshi Powder Injection Co., Ltd., Sichuan Xuyang Pharmaceutical Co., Ltd., Tianjin Jinyao Pharmaceutical Co., Ltd., Shanxi Jinxin Shuanghe Pharmaceutical Co., Ltd., Xinjiang Qikang Habo Zhongwei Pharmaceutical Pieces Co., Ltd., and Shanghai Sairui Suzhou Pharmaceutical Co., Ltd. Additionally, the Hotan Prefecture Uyghur Medicine Hospital had issues with its preparations. The violations identified ranged from non-compliant solution color and incorrect active ingredient content to the presence of visible foreign matter, deviations in pH, and unacceptable levels of free hydrazine or related substances. These issues were assessed against regulatory frameworks such as various editions of the 'Chinese Pharmacopoeia' and specific 'Xinjiang Food and Drug Administration Medical Institution Preparation Standards.' As a result, the Xinjiang FDA has mandated that local food and drug regulatory departments investigate and apply penalties to all relevant manufacturers, operating units, and using units responsible for the substandard products, in accordance with applicable laws and regulations.

Company: https://www.globalkeysolutions.net/companies/xian-jingxi-shuanghe-pharmaceutical-co-ltd/696bd868-f6b4-4d0c-b090-f66b72050a75/