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China’s National Medical Products Administration (NMPA) has suspended the import, sale and use of drugmaker Dr. Reddy’s Laboratories’ atomoxetine hydrochloride capsules from August 30, 2024.
The action was taken following a recent remote inspection by the NMPA of the company’s formulation manufacturing facility (FTO-3 at Bachupally, Hyderabad) for atomoxetine hydrochloride capsules. “It concluded that the production quality management of atomoxetine hydrochloride capsules did not meet the requirements of China’s “Good Manufacturing Practices for Drugs (as revised in 2010),” Dr Reddy’s said in a filing on Saturday.
As a result of the NMPA’s action, the National Pharmaceutical Joint Procurement Office, China (NDJPO) decided to cancel the “won” status of Dr. Reddy’s Atomoxetine Hydrochloride Capsules and list the company in the “violation list”, suspending the company’s eligibility to participate in national centralized drug procurement activities from August 30, 2024 to February 28, 2026.
Atomoxetine Hydrochloride Capsules are 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 on the BSE.
It is informed that the Company has come to know about the orders dated August 30, 2024 from National Medical Products Administration, China and National Pharmaceutical Joint Procurement Office, China made available through their website.
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