KYOWA HAKKO BIO Faces Import Suspension of Five Key APIs Amid Compliance Issues

On March 16, 2025, the National Medical Products Administration (NMPA) of China announced the suspension of imports from KYOWA HAKKO BIO CO., LTD. due to non-compliance with approved production protocols at its Hofu factory. This decision affects several active pharmaceutical ingredients (APIs) including glutathione, acetylcysteine, tryptophan, phenylalanine, and L-valine, which were found to be produced with unapproved methods such as outsourcing and improper labeling.

The affected APIs are critical in various pharmaceutical applications. Glutathione, an essential antioxidant, is widely used for liver protection, detoxification, and as an adjunct in chemotherapy treatments. Acetylcysteine is commonly utilized for respiratory conditions, while tryptophan and phenylalanine are vital amino acids found in numerous dietary supplements and medications. L-valine plays a significant role in nutrition and drug synthesis.

The NMPA's announcement indicates that these APIs failed to meet the necessary quality and production standards, leading to their classification as “I” in the regulatory review process, signifying they did not pass the required assessments for formulation production. As a result, all import permits for these products have been halted, impacting both the supply chain and market presence of KYOWA HAKKO BIO in China.

Founded in 2008, KYOWA HAKKO BIO is a subsidiary of Kyowa Hakko Kogyo and has established itself as a leader in the global glutathione market, holding a significant share alongside competitors such as Shandong Jincheng Bio and KOHJIN Life Sciences. In 2023, the global glutathione market was valued at approximately $98 million, with KYOWA contributing substantially to this figure, particularly as China accounts for nearly 20% of its revenue.

The implications of this suspension are far-reaching. Companies relying on these APIs for their formulations will face immediate supply shortages, which could lead to significant revenue losses and stockpile issues for KYOWA. Furthermore, the reputational damage incurred from this compliance failure may hinder future market expansion and partnerships.

The NMPA has mandated that any formulations made with these suspended APIs must not be released into the market. Already marketed products containing these ingredients are subject to immediate investigation and risk assessment, with manufacturers required to implement necessary control measures.

While domestic alternatives may mitigate some market pressures, the suspension poses a serious challenge to manufacturers dependent on imported raw materials. KYOWA HAKKO BIO must now focus on rectifying its production processes to regain compliance and restore its standing in the competitive pharmaceutical landscape.

This incident serves as a stark reminder of the importance of regulatory adherence in the pharmaceutical industry, highlighting the potential consequences of failing to meet established standards. As the situation develops, the industry will be watching closely to see how KYOWA navigates this compliance crisis and its impact on the broader market.