# China NMPA Drug Inspection - Wuhu Zhang Hengchun Pharmaceutical Co., Ltd. - Children's Cough Syrup

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/wuhu-zhang-hengchun-pharmaceutical-co-ltd/fe317570-2b59-4ae0-b50b-fbe5b7c7a22a/
Source feed: China

> China NMPA drug inspection for Wuhu Zhang Hengchun Pharmaceutical Co., Ltd. published October 12, 2021. Drug: Children's Cough Syrup. The National Medical Products Administration (NMPA) of China, on October 12, 2021, announced regulatory findings for sev

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 78 of 2021 from the National Medical Products Administration regarding 7 batches of drugs that did not meet the requirements.
- Company Name: Wuhu Zhang Hengchun Pharmaceutical Co., Ltd.
- Publication Date: 2021-10-12
- Drug Name: Children's Cough Syrup
- Inspection Finding: Content determination (ammonium chloride)
- Action Taken: Drug regulatory authorities have required relevant enterprises and units to take risk control measures such as suspending sales and use, and recalling products, and to investigate the reasons for non-compliance and implement effective rectification. The National Medical Products Administration has instructed relevant provincial drug regulatory authorities to, in accordance with the "Drug Administration Law of the People's Republic of China," organize investigations into the suspected illegal activities of the aforementioned enterprises and units in producing and selling counterfeit and substandard drugs, and to publicly disclose the results of the investigations as required.
- Summary: The National Medical Products Administration (NMPA) of China, on October 12, 2021, announced regulatory findings for seven batches of drugs from five manufacturers that failed to meet quality standards. Comprehensive testing by provincial drug control institutions identified significant non-compliances. Zhongshan Wanhan Pharmaceutical Co., Ltd. had three batches of Orlistat Capsules fail identification and dissolution tests, while Hunan Dino Pharmaceutical Co., Ltd. had one batch of Orlistat Capsules fail on identification. Additionally, Sancai Shiqi Pharmaceutical Co., Ltd.'s Chloroquine Phosphate Tablets, Qinghai Baojiantang Guoyao Co., Ltd.'s Compound Licorice Oral Solution, and Wuhu Zhang Hengchun Pharmaceutical Co., Ltd.'s Children's Cough Syrup each had one batch found non-compliant, primarily due to issues with content determination. These violations highlight critical concerns regarding drug identity, proper release of active ingredients, and accurate dosage. Operating under the "Drug Administration Law of the People's Republic of China" and specific Pharmacopoeia standards, the NMPA has mandated immediate actions. Affected companies must implement risk control measures, including suspending sales, ceasing use, and recalling products. They are also required to investigate the root causes of these deviations and implement effective rectification. Provincial drug regulatory authorities are tasked with investigating suspected illegal activities related to the production and sale of substandard drugs and publicly disclosing their findings.

Company: https://www.globalkeysolutions.net/companies/wuhu-zhang-hengchun-pharmaceutical-co-ltd/eee262c7-525c-434e-8bce-ba6959744de3/