# China NMPA Drug Inspection - Beijing Yanjing Pharmaceutical Co., Ltd. - Atorvastatin calcium tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/beijing-yanjing-pharmaceutical-co-ltd/8c167f60-95ec-4df4-8cbf-67560be3fdfd/
Source feed: China

> China NMPA drug inspection for Beijing Yanjing Pharmaceutical Co., Ltd. published October 11, 2018. Drug: Atorvastatin calcium tablets. The Heilongjiang Provincial Food and Drug Administration issued an announcement on October 11, 2018, to correct previous

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Announcement from the Provincial Bureau Regarding Corrections to Drug Supervision and Sampling Information
- Company Name: Beijing Yanjing Pharmaceutical Co., Ltd.
- Publication Date: 2018-10-11
- Drug Name: Atorvastatin calcium tablets
- Inspection Finding: Drug batch 161229 was found non-compliant in identification (UV spectrum) and was determined not to be produced by the labeled company.
- Action Taken: The provincial bureau issued a correction to its previous announcement, clarifying that Beijing Jialin Pharmaceutical Co., Ltd. was not the manufacturer of this batch.
- Summary: The Heilongjiang Provincial Food and Drug Administration issued an announcement on October 11, 2018, to correct previously published drug supervision and sampling information. This correction pertained to two batches of Atorvastatin Calcium Tablets (batch numbers 161223 and 161229) that were initially identified as substandard due to failing identification tests (Ultraviolet Spectroscopy) as per standard YBH07002009 by the Yichun Food and Drug Inspection and Testing Center. Initially, these unqualified drugs were attributed to Beijing Jialin Pharmaceutical Co., Ltd. However, following an application from the labeled manufacturer and further confirmation by the drug regulatory department, it was determined that Beijing Jialin Pharmaceutical Co., Ltd. did not, in fact, produce these specific batches. The regulatory framework for this action falls under the provincial drug supervision and sampling program, designed to ensure drug quality and correct labeling within China's pharmaceutical market. The main issue highlighted by this correction is the misattribution of substandard drugs, implying either counterfeiting or unauthorized production where a legitimate company's name was used. The required action for this announcement was to officially rectify the public record, clearing Beijing Jialin Pharmaceutical Co., Ltd.'s name regarding the production of these particular substandard batches. This underscores the importance of accurate manufacturer identification in drug quality control.

Company: https://www.globalkeysolutions.net/companies/beijing-yanjing-pharmaceutical-co-ltd/560f870c-c041-4d9f-bbbc-fb56f1a026f5/