# China NMPA Drug Inspection - Qingdao Huanghai Pharmaceutical Co., Ltd. - Nifedipine Extended-Release Tablets (II)

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/qingdao-huanghai-pharmaceutical-co-ltd/83663d96-a82f-4daf-a4d8-cc23fbe59fce/
Source feed: China

> China NMPA drug inspection for Qingdao Huanghai Pharmaceutical Co., Ltd. published July 27, 2017. Drug: Nifedipine Extended-Release Tablets (II). The Hubei Province Drug Quality Announcement, issued on July 27, 2017, reported the findings from drug quality inspectio

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Hubei Province Drug Quality Bulletin (Issue 2, 2017)
- Company Name: Qingdao Huanghai Pharmaceutical Co., Ltd.
- Publication Date: 2017-07-27
- Drug Name: Nifedipine Extended-Release Tablets (II)
- Inspection Finding: Content determination
- Action Taken: The food and drug administration departments of each city (prefecture) shall investigate and handle such cases in accordance with the provisions of the "Drug Administration Law of the People's Republic of China," and promptly report the results and relevant information to the provincial bureau. For drugs verified to be produced by non-labeled manufacturers or without a clear purchase channel, the source of the problematic drugs shall be traced to the bottom and thoroughly investigated; if a crime is suspected, the case shall be promptly transferred to the public security organs for criminal prosecution.
- Summary: The Hubei Province Drug Quality Announcement, issued on July 27, 2017, reported the findings from drug quality inspections conducted across the province during the second quarter of 2017. These inspections involved drug production, operation, and use units, revealing 30 batches of drugs that did not meet established quality standards. Key violations included quality control deficiencies such as improper dissolution (e.g., Norfloxacin Capsules from Chengdu Jinhua Pharmaceutical Co., Ltd.), excessive related substances (e.g., Vitamin K1 Injection from Wuhu Kangqi Pharmaceutical Co., Ltd. and Shandong Yikang Pharmaceutical Co., Ltd.), and issues with pH value, weight variation, moisture content, or product identification. Notably, counterfeit drugs like Osteoarthritis Capsules and Compound Cough and Asthma Relief Capsules were found to contain undeclared active ingredients, specifically Prednisolone Acetate. Several traditional Chinese medicine preparations and raw materials also exhibited non-compliance in their properties or purity. For some non-compliant batches, manufacturers, including Qingdao Huanghai Pharmaceutical Co., Ltd., disputed production. Operating under the 

Company: https://www.globalkeysolutions.net/companies/qingdao-huanghai-pharmaceutical-co-ltd/9d60f05f-b7ea-46a7-8133-2e64eb6b9f81/