China NMPA Drug Inspection - Hubei Hepu Pharmaceutical Co., Ltd. - Azithromycin for Injection

On April 9, 2021, the Jiangsu Provincial Drug Administration released its first-quarter drug quality report for 2021, detailing 18 batches of non-compliant pharmaceutical products identified through routine sampling inspections. The report identifies multiple manufacturers and entities, including Yuanhe Pharmaceutical Co., Ltd., Hubei Hepu Pharmaceutical Co., Ltd., Jilin Huangzhihua Pharmaceutical Co., Ltd., and various traditional Chinese medicine processors such as Jiangsu Tongji and Suzhou Chunhuitang. Compliance was primarily evaluated against the Chinese Pharmacopoeia (2015 Edition) and National Drug Standards.

The violations cited range from physical inconsistencies—including failed appearance, excessive moisture, and improper fill weights—to serious chemical and purity issues such as unacceptable levels of related substances, deficient extractives, and content uniformity failures. Notably, the report confirmed three instances of counterfeit drugs, including a batch falsely labeled as Pfizer’s Sildenafil Citrate and certain traditional medicines.

In response to these findings, regulatory authorities have mandated immediate risk control measures. Affected enterprises and healthcare units are required to suspend the sale and use of the identified batches. Furthermore, companies must investigate the root causes of non-compliance and implement comprehensive rectification plans. Provincial drug regulatory departments are currently overseeing legal investigations and issuing punishments to ensure future adherence to safety and quality standards.