BEIJING—The National Medical Products Administration (NMPA) has issued a notification to immediately suspend the import, sales, and use of Dr. Reddy’s Laboratories Ltd.’s atomoxetine hydrochloride capsules in China. The decision comes after the Indian pharmaceutical company’s product, which won a bid in the 9th round of China’s volume-based procurement (VBP), was found to have severe deficiencies in API management and quality control processes.
The NMPA’s action follows remote inspections that revealed the company had not taken effective corrective and preventive measures for non-conforming items during the sampling process. As a result, Dr. Reddy’s atomoxetine, which was approved in China in June this year for the treatment of attention deficit hyperactivity disorder (ADHD), has had its winning bid status revoked, and the company has been blacklisted from participating in China’s national VBP from August 30, 2024, to February 28, 2026.
This move by the Chinese regulator underscores the increasing scrutiny on pharmaceutical companies to ensure compliance with quality standards, especially for products involved in the country’s VBP program. It also serves as a reminder of the importance for companies to maintain robust quality management systems to avoid disruptions in their market access. – Flcube.com
