China NMPA Drug Inspection - Xi"an Lantai Pharmaceutical Co., Ltd. - Lemai Dispersible Tablets

The Shaanxi Provincial Drug Administration released its 12th Drug Quality Bulletin of 2020 on December 28, 2020, following provincial-wide sampling inspections. The report identifies three batches of non-compliant drugs from two manufacturers: Xi'an Lantai Pharmaceutical Co., Ltd. and Bozhou Sanfeng Traditional Chinese Medicine Pieces Co., Ltd. Two batches of Lemai Dispersible Tablets (20191102 and 20191104) produced by Xi'an Lantai failed to meet quality standards regarding product identification. Additionally, a batch of Qinpi (batch 190701) from Bozhou Sanfeng was found deficient in inspection parameters, extractive levels, and content determination. These inspections were conducted under the regulatory framework of the National Food and Drug Administration (NMPA) standards and the Chinese Pharmacopoeia 2015 Edition. In response to these findings, local drug regulatory departments have initiated control measures and are conducting formal investigations into the involved units. These entities face potential administrative penalties as authorities enforce compliance with national safety laws and regulations to protect public health.