China NMPA Drug Inspection - Shanghai Jinbuhuan Lankao Pharmaceutical Co., Ltd. - Pentoxyverine citrate tablets

The Ningxia Hui Autonomous Region Drug Administration released Announcement No. 45 on June 20, 2020, detailing the results of its drug quality sampling inspections conducted during the first half of 2020. This routine oversight involved the testing of 74 batches across 26 different drug varieties. The scope of the inspection was broad, encompassing 36 batches of chemical pharmaceuticals, 24 batches of traditional Chinese medicine preparations, and 14 batches of processed traditional Chinese medicine slices. Notable manufacturers included in the sampling were Ningxia Qiyuan Pharmaceutical Co., Ltd., Shijiazhuang Yiling Pharmaceutical Co., Ltd., and various other regional producers and retail pharmacies.

The regulatory framework governing these inspections includes the Drug Administration Law of the People's Republic of China and the Administrative Measures for Drug Quality Sampling Inspection. Technical evaluations were conducted by the Ningxia Hui Autonomous Region Drug Inspection Institute based on the Chinese Pharmacopoeia (2015 Edition) and Ministry of Health standards.

Upon review, the administration found that all 74 batches complied with the established regulatory and quality standards. No violations, safety issues, or non-compliant products were identified during this reporting period. Consequently, no corrective actions or punitive measures were required of the manufacturers or distributors involved. This document serves as a public disclosure to confirm that the sampled medications meet the necessary safety and quality benchmarks for consumer use.