# China NMPA Drug Inspection - Shanxi Zhendong Kaiyuan Pharmaceutical Co., Ltd. - Calcium carbonate D3 granules (II)

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanxi-zhendong-kaiyuan-pharmaceutical-co-ltd/f88fa835-f36a-4252-8603-cf75dd49d677/
Source feed: China

> China NMPA drug inspection for Shanxi Zhendong Kaiyuan Pharmaceutical Co., Ltd. published July 17, 2023. Drug: Calcium carbonate D3 granules (II). The National Medical Products Administration (NMPA) of China issued Announcement No. 30 of 2023 on July 14, 2023, identi

---

## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement No. 30 of 2023 from the National Medical Products Administration regarding 49 batches of drugs that did not meet the requirements.
- Company Name: Shanxi Zhendong Kaiyuan Pharmaceutical Co., Ltd.
- Publication Date: 2023-07-17
- Drug Name: Calcium carbonate D3 granules (II)
- Inspection Finding: The content determination (vitamin D3) did not meet the requirements.
- Action Taken: Suspend sales and use, recall products, investigate the cause and rectify the issues, file a case for investigation and publicly disclose the results.
- Summary: The National Medical Products Administration (NMPA) of China issued Announcement No. 30 of 2023 on July 14, 2023, identifying 49 batches of drugs from 16 pharmaceutical companies that failed to meet quality standards. This action followed comprehensive testing by various drug control institutions across China.

Key companies implicated include Beijing Zhendong Langdi Pharmaceutical Co., Ltd., Shanxi Zhendong Pharmaceutical Co., Ltd., Hebei Jinniu Yuanda Pharmaceutical Technology Co., Ltd., Changchun Xin'an Pharmaceutical Co., Ltd., Shandong Yikang Pharmaceutical Co., Ltd., Anhui Yongshengtang Pharmaceutical Co., Ltd., Hunan Jinshou Pharmaceutical Co., Ltd., Yuzhou Tianyuan Pharmaceutical Co., Ltd., and several traditional Chinese medicine manufacturers. The primary violations involved failures in "content determination" for active ingredients, notably in calcium carbonate D3 granules/tablets and compound zinc gluconate granules. Other significant issues included deficiencies in dissolution rates, incorrect sodium benzoate levels, weight variation, adhesion, and excessive total ash or moisture content in certain traditional Chinese medicines.

Operating under the "Drug Administration Law of the People's Republic of China" and various national drug standards and pharmacopoeias, the NMPA has mandated immediate action. Affected companies are required to implement risk control measures, including suspending sales, halting use, and recalling the non-compliant batches. Furthermore, they must investigate the root causes of these failures and implement robust corrective actions. Provincial drug regulatory authorities are tasked with conducting thorough investigations into potential illegal activities by these enterprises and publicly reporting their findings.

Company: https://www.globalkeysolutions.net/companies/shanxi-zhendong-kaiyuan-pharmaceutical-co-ltd/d4c2ea3b-3294-49cb-abc0-a4229802742e/