# China NMPA Drug Inspection - Sichuan Pharmaceutical Co., Ltd. - Theophylline preparations

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/sichuan-pharmaceutical-co-ltd/9524a98e-4992-4fb0-878f-5d1e115c4d2b/
Source feed: China

> China NMPA drug inspection for Sichuan Pharmaceutical Co., Ltd. published December 03, 2008. Drug: Theophylline preparations. This official notice, the "National Drug Quality Bulletin (Issue 3, 2008)," was issued by the State Food and Drug Admini

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Notice on Issuing the Third Issue of the National Drug Quality Bulletin of 2008
- Company Name: Sichuan Pharmaceutical Co., Ltd.
- Publication Date: 2008-12-03
- Drug Name: Theophylline preparations
- Inspection Finding: Release rate test and/or weight variation test failed
- Action Taken: Investigate and follow up with sampling inspections
- Summary: This official notice, the "National Drug Quality Bulletin (Issue 3, 2008)," was issued by the State Food and Drug Administration (SFDA) of China on December 3, 2008. It details the findings from nationwide drug sampling inspections conducted throughout 2008, designed to bolster drug supervision and safeguard public health. The inspections covered two biological products (Japanese encephalitis and measles vaccines) and four pharmaceutical preparations (Qingkailing, theophylline, nimodipine, and nitroglycerin). While all biological products, Qingkailing, and nitroglycerin preparations were found compliant, several issues emerged with theophylline and nimodipine. Jinzhou Jiutian Pharmaceutical Co., Ltd. had four batches of theophylline preparations fail the release rate test. Sichuan Xicheng Pharmaceutical Co., Ltd. had five batches of theophylline preparations fail the release rate test, with one also failing for weight variation. Chongqing Kerui Pharmaceutical Co., Ltd. had four batches of nimodipine preparations fail the dissolution rate test. In response, provincial food and drug administrations were mandated, under the "Drug Administration Law," to investigate these manufacturers, implement corrective measures, and conduct follow-up inspections. Investigation results were due to the SFDA by February 28, 2009. The bulletin also stressed the importance of continuous drug sampling analysis and reporting of any suspected illegal activities in the drug supply chain.

Company: https://www.globalkeysolutions.net/companies/sichuan-pharmaceutical-co-ltd/73053b74-f673-40ef-ae8b-f01e72e92784/