# China NMPA Drug Inspection - Shandong Fangming Pharmaceutical Group Co., Ltd. - Nimodipine Injection

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shandong-fangming-pharmaceutical-group-co-ltd/c7a8e791-89ab-4077-8301-4e2d2f647945/
Source feed: China

> China NMPA drug inspection for Shandong Fangming Pharmaceutical Group Co., Ltd. published May 16, 2013. Drug: Nimodipine Injection. China's State Food and Drug Administration (SFDA) issued a Drug Quality Announcement on May 16, 2013, detailing the resu

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Drug Quality Bulletin (2013, Issue 2, Serial No. 2)
- Company Name: Shandong Fangming Pharmaceutical Group Co., Ltd.
- Publication Date: 2013-05-16
- Drug Name: Nimodipine Injection
- Inspection Finding: Inspection (related substances) did not meet the requirements
- Action Taken: The relevant provincial (autonomous region, municipality) food and drug administration departments are investigating and handling the matter in accordance with the law.
- Summary: China's State Food and Drug Administration (SFDA) issued a Drug Quality Announcement on May 16, 2013, detailing the results of nationwide sampling inspections. The inspections, conducted under the National Drug Sampling Inspection Work Plan, aimed to bolster drug quality oversight and ensure public medication safety. A total of 2885 batches across 18 drug varieties were assessed, with 20 batches failing to meet established quality standards. Key violations identified across various manufacturers included significant deficiencies in 'Content Determination' (drug potency), observed in products like Motherwort Tablets from Guilin Xingda Pharmaceutical Co., Ltd. and Motherwort Granules from Hunan Huichuntang Pharmaceutical Co., Ltd., as well as Fosfomycin Calcium preparations from Tonghua Great Wall Pharmaceutical Co., Ltd. and Harbin Pharmaceutical Group Sanjing Pharmaceutical Factory No. 4 Co., Ltd. 'Inspection' issues such as abnormal clarity and color of solution were found in Cefminox Sodium for Injection by Hainan Meihua Xilin Biopharmaceutical Co., Ltd., while Nimodipine Injection from Shandong Fangming Pharmaceutical Group Co., Ltd. failed for 'Related Substances' (impurities). Additionally, problems with 'Dissolution' and 'Content Uniformity' affected Hydrochlorothiazide Tablets from companies like Shanxi Lifeng Huarui Pharmaceutical Co., Ltd. and Shanxi Yunpeng Pharmaceutical Co., Ltd. These non-compliant drugs were assessed against official regulatory frameworks including the Chinese Pharmacopoeia 2010 Edition and specific National Drug Standards. In response to these findings, provincial food and drug administration departments have been mandated to conduct further investigations and implement appropriate legal actions against the implicated drugs and manufacturers, ensuring accountability and adherence to quality requirements.

Company: https://www.globalkeysolutions.net/companies/shandong-fangming-pharmaceutical-group-co-ltd/76bbdc67-49b4-4c6e-8a79-adf3442b53d6/