Chinese authority suspends import, sale, and use of Dr Reddy's Labs Atomoxetine Hydrochloride Capsules

Through a recent BSE filing, Dr Reddy's Labs has informed that the National Medical Products Administration, China (NMPA) has suspended the import, sale, and use of the Company's Atomoxetine Hydrochloride Capsules.

NMPA China recently conducted a remote inspection of the Company’s formulations manufacturing facility (FTO-3) for Atomoxetine Hydrochloride Capsules, and concluded that the production quality management of Atomoxetine Hydrochloride Capsules does not meet the requirements of China's "Good Manufacturing Practice for Drugs (Revised in 2010)".

Atomoxetine Hydrochloride Capsules is a medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults.

Further, National Drug Joint Procurement Office, China (NDJPO),  having considered the said order of the NMPA, has decided to cancel Dr. Reddy's Laboratories Ltd.'s Atomoxetine Hydrochloride Capsules “won” status and list the company on the "Violation List", suspending the company's eligibility to participate in China'snational centralized drug procurement activities from August 30, 2024 to February 28, 2026.

Both NMPA and NDJPO orders are dated August 30, 2024.

"The Company is in the process of ascertaining the monetary impact of the said orders," Dr Reddy's Labs stated.

Read also: Dr Reddy's Labs gets 3 USFDA observations for Srikakulam facility

Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.

Dr Reddy's Labs major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.

Read also: Dr Reddy's Labs gets USFDA EIR for Duvvada formulations manufacturing facilities