# China NMPA Drug Inspection - Hunan Jianlang Pharmaceutical Co., Ltd. - Levofloxacin Hydrochloride Tablets

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/hunan-jianlang-pharmaceutical-co-ltd/68283f14-588b-4b68-bb3f-47b7b0a2309b/
Source feed: China

> China NMPA drug inspection for Hunan Jianlang Pharmaceutical Co., Ltd. published August 01, 2012. Drug: Levofloxacin Hydrochloride Tablets. The National Medical Products Administration (NMPA), operating as the State Food and Drug Administration (SFDA) at the t

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: National Drug Quality Bulletin (2012, Issue 2, Serial No. 90)
- Company Name: Hunan Jianlang Pharmaceutical Co., Ltd.
- Publication Date: 2012-08-01
- Drug Name: Levofloxacin Hydrochloride Tablets
- Inspection Finding: Dissolution rate does not meet regulations
- Action Taken: The relevant provincial (autonomous region, municipality) food and drug administration departments are investigating and handling the matter in accordance with the law, and have requested that the results be reported to the Inspection Bureau of the State Food and Drug Administration by September 20, 2012.
- Summary: The National Medical Products Administration (NMPA), operating as the State Food and Drug Administration (SFDA) at the time, issued its National Drug Quality Bulletin (2012, Issue 2) on August 1, 2012. This bulletin communicated the outcomes of a nationwide drug sampling inspection aimed at ensuring public drug safety and quality adherence. The inspections, conducted prior to the bulletin's release, encompassed 33 different drug varieties, identifying 14 batches from various manufacturers that failed to meet national drug standards, including specifications outlined in the Chinese Pharmacopoeia and trial national drug standards.

Key manufacturers associated with non-compliant products included Sunflower Pharmaceutical Group Jiamusi Luling Pharmaceutical Co., Ltd., Wuhan Zhonglian Group No. 4 Pharmaceutical Co., Ltd., Tonghua Hongtao Mao Pharmaceutical Co., Ltd., Hunan Jianlang Pharmaceutical Co., Ltd., Yabao Pharmaceutical Group Co., Ltd., Shijiazhuang Wanhe Pharmaceutical Co., Ltd., Hubei Meibao Pharmaceutical Co., Ltd., Shandong Laiyang Biochemical Pharmaceutical Factory, Hebei Guojin Pharmaceutical Co., Ltd., Kaifeng Kangnuo Pharmaceutical Co., Ltd., and Tianjin Hongrentang Pharmaceutical Co., Ltd. Common violations included deficiencies in quantitative determination, dissolution properties, identification, physical characteristics, content uniformity, microbial limits, and related substances.

In response to these findings, the SFDA directed relevant provincial food and drug administration departments to investigate and address the non-compliant drugs and the involved entities. These provincial bodies were required to submit their investigation results and details of corrective actions to the SFDA's Inspection Bureau by September 20, 2012, underscoring a commitment to stringent regulatory enforcement.

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