# China NMPA Drug Inspection - Qingdao Huanghai Pharmaceutical Co., Ltd. - Nifedipine sustained-release tablets (II)

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/qingdao-huanghai-pharmaceutical-co-ltd/dfcf85d2-eba7-414d-9a2f-9ee6ec934320/
Source feed: China

> China NMPA drug inspection for Qingdao Huanghai Pharmaceutical Co., Ltd. published October 31, 2019. Drug: Nifedipine sustained-release tablets (II). The Hubei Provincial Food and Drug Administration released a Drug Quality Bulletin in October 2019, announcing the findi

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Hubei Province Drug Quality Bulletin (Issue 1, 2015)
- Company Name: Qingdao Huanghai Pharmaceutical Co., Ltd.
- Publication Date: 2019-10-31
- Drug Name: Nifedipine sustained-release tablets (II)
- Inspection Finding: Inspection (content uniformity), content determination
- Action Taken: Local food and drug administrations should intensify their investigations and punishments, handle the cases in accordance with the law, and strengthen follow-up sampling and testing of the products involved.
- Summary: The Hubei Provincial Food and Drug Administration released a Drug Quality Bulletin in October 2019, announcing the findings from quality sampling inspections conducted in the first quarter of 2015. The detailed list of non-compliant products was originally published on June 26, 2015. These inspections covered 642 batches from drug manufacturing enterprises, hospital preparations, and pharmaceutical packaging materials across Hubei Province. Out of these, 24 batches, representing 3.7% of the total, failed to meet established quality standards.

The main issues identified included deviations in product properties, incorrect identification (e.g., microscopic characteristics), insufficient or inconsistent content determination, and failures in various tests such as dissolution, moisture content, fill weight, particle size, and purity. Companies implicated in these findings included Macheng Jiuzhou Traditional Chinese Medicine Development Co., Ltd., Hubei Qiangkang Traditional Chinese Medicine Pieces Co., Ltd., and Qingdao Huanghai Pharmaceutical Co., Ltd., among others. These violations contravened the "Chinese Pharmacopoeia 2010 Edition," national drug standards, and other relevant regulatory requirements.

Consequently, local food and drug administrations were directed to conduct thorough investigations and take appropriate enforcement actions under the "Drug Administration Law of the People's Republic of China." Authorities were also mandated to investigate the origins of any counterfeit drugs and enhance subsequent sampling and testing of affected products to uphold drug quality and safety.

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