# China NMPA Drug Inspection - Sinopharm Group Weichida Pharmaceutical Co., Ltd. - Cefuroxime sodium for injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/sinopharm-group-weichida-pharmaceutical-co-ltd/23cea6f3-7a3a-4ec3-bb48-e02e3d31c366/
Source feed: China

> China NMPA drug inspection for Sinopharm Group Weichida Pharmaceutical Co., Ltd. published August 24, 2018. Drug: Cefuroxime sodium for injection. The National Medical Products Administration (NMPA) of China issued Announcement No. 77 on August 24, 2018, detailing no

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 77 of 2018 from the National Medical Products Administration regarding 10 batches of drugs that did not meet the requirements.
- Company Name: Sinopharm Group Weichida Pharmaceutical Co., Ltd.
- Publication Date: 2018-08-24
- Drug Name: Cefuroxime sodium for injection
- Inspection Finding: The items that do not comply with regulations include the color of the solution and the difference in fill volume.
- Action Taken: Control measures such as sealing and seizure were taken, sales and use were suspended, products were recalled and rectification was carried out; an investigation was launched in accordance with the "Drug Administration Law" and the results were made public.
- Summary: The National Medical Products Administration (NMPA) of China issued Announcement No. 77 on August 24, 2018, detailing non-compliance found in 10 batches of drugs from 10 different manufacturers. This announcement followed testing by five provincial drug control institutes. Key companies involved included Tonghua Zhongchen Pharmaceutical Co., Ltd., Jiangxi Herui Pharmaceutical Co., Ltd., Guangzhou Zhixin Traditional Chinese Medicine Pieces Co., Ltd., Chongqing Taisheng Pharmaceutical Co., Ltd., Yunnan Ningkun Biotechnology Co., Ltd., Suzhou Chunhuitang Pharmaceutical Co., Ltd., Jiangxi Shunfutang Traditional Chinese Medicine Pieces Co., Ltd., Gansu Xifeng Pharmaceutical Co., Ltd., Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd., and Sinopharm Weichida Pharmaceutical Co., Ltd. The primary violations varied by product. Issues identified included substandard content determination for Angelica dahurica, Notopterygium incisum, and Vitamin U Atropine Aluminum Capsules; appearance defects for Compound Platycodon grandiflorus Cough Tablets and Notopterygium incisum; and problems with extractives, sulfur dioxide residue in Angelica dahurica. For cefuroxime sodium for injection, solution color and fill volume variations were observed. In response, regulatory authorities initiated immediate control measures such as seizing affected products and mandating suspension of sales, product recalls, and corrective actions from the manufacturers. The NMPA invoked Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, instructing provincial drug regulatory authorities to investigate these companies for illegal activities related to the production and sale of non-compliant drugs. Investigations are required to be completed within three months, with results publicly disclosed.

Company: https://www.globalkeysolutions.net/companies/sinopharm-group-weichida-pharmaceutical-co-ltd/d9607df5-79a1-456e-8c90-66c08beb1fca/