# China NMPA Drug Inspection - Hunan Jianlang Pharmaceutical Co., Ltd. - Isosorbide dinitrate tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/hunan-jianlang-pharmaceutical-co-ltd/6d0c77af-1038-43a1-90f8-1059ca4ee0e7/
Source feed: China

> China NMPA drug inspection for Hunan Jianlang Pharmaceutical Co., Ltd. published April 05, 2017. Drug: Isosorbide dinitrate tablets. The Fujian Province Drug Quality Announcement, Issue No. 64, published on April 5, 2017, reported findings from a provin

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Fujian Provincial Drug Quality Bulletin, Issue No. 64
- Company Name: Hunan Jianlang Pharmaceutical Co., Ltd.
- Publication Date: 2017-04-05
- Drug Name: Isosorbide dinitrate tablets
- Inspection Finding: Non-compliance with standard requirements: Dissolution rate
- Action Taken: Food and drug regulatory authorities at all levels are organizing investigations and handling in accordance with the law.
- Summary: The Fujian Province Drug Quality Announcement, Issue No. 64, published on April 5, 2017, reported findings from a province-wide drug quality supervision and sampling inspection. This initiative, conducted by provincial and municipal food and drug regulatory departments, aimed to strengthen drug quality oversight and ensure public medication safety. The inspections were performed in accordance with the "Drug Administration Law of the People's Republic of China" and its implementing regulations, with drug quality assessed against standards from the Chinese Pharmacopoeia.The sampling identified 13 batches of drugs from multiple manufacturers that failed to meet established quality standards. Significant violations included issues with dissolution for Isosorbide Nitrate Tablets (Handan Jinan Pharmaceutical Co., Ltd.), and substandard content levels in products such as Fukangning Capsules (Jiangsu Yihai Pharmaceutical Co., Ltd.), Diclofenac Sodium Enteric-coated Tablets (Jilin Jiuyang Pharmaceutical Co., Ltd.), Baoji Pills (Guangdong Province Luofu Mountain Baihe Pharmaceutical Factory), and Oral Rehydration Salt Powder (I) (Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd.). Furthermore, several traditional Chinese medicine ingredients, including Rhubarb (Jiangxi Zhangshu Qingren Traditional Chinese Medicine Pieces Co., Ltd.), presented appearance deviations, while Angelica dahurica (Jiangxi Qirentang Traditional Chinese Medicine Pieces Co., Ltd.) showed unacceptable sulfur dioxide residue.In response, food and drug supervision and management departments are required to organize investigations and undertake appropriate legal actions against the non-compliant drugs and the associated manufacturing and distribution units.

Company: https://www.globalkeysolutions.net/companies/hunan-jianlang-pharmaceutical-co-ltd/1d411ba1-2739-4a99-b10c-b68b355e3826/