The National Medical Products Administration (NMPA) of China has suspended import, sale, and use of drugmaker Dr. Reddy’s Laboratories’ Atomoxetine Hydrochloride capsules effective August 30, 2024.
The action followed a remote inspection of the company’s formulations manufacturing facility (FTO-3 in Bachupally, Hyderabad) for Atomoxetine Hydrochloride capsules recently by NMPA. It “concluded the production quality management of Atomoxetine Hydrochloride capsules does not meet the requirements of China’s “Good Manufacturing Practice for Drugs [Revised in 2010],” Dr. Reddy’s said in a filing on Saturday.
Consequent to the NMPA’s action, the National Drug Joint Procurement Office, China (NDJPO) decided to cancel Dr. Reddy’s Atomoxetine Hydrochloride Capsules “won” status and list the company on the “violation list”, suspending the company’s eligibility to participate in national centralised drug procurement activities from August 30, 2024 to February 28, 2026.
Atomoxetine Hydrochloride capsules are is used in the treatment of attention deficit and hyperactivity disorder (ADHD). Dr. Reddy’s said it is in the process of ascertaining the monetary impact of the orders. On Monday, the company’s shares closed 2.26% lower at ₹6,870.35 apiece on the BSE.
This is to inform that the company has learnt about orders dated August 30, 2024, of National Medical Products Administration, China and National Drug Joint Procurement Office, China, made available through their website.
