HQ Team
September 6, 2024: The National Medical Products Administration (NMPA) of China has suspended the import, sale, and use of Dr Reddy’s Laboratories Ltd’s Atomoxetine Hydrochloride capsules, according to a press release.
This decision was taken following serious defects identified during a recent inspection of the company’s manufacturing facility, which revealed non-compliance with China’s “Good Manufacturing Practice for Pharmaceuticals (Revised in 2010).
Inspection findings
The NMPA’s inspection highlighted critical issues in raw material management, process validation, and quality control. The agency concluded that Dr. Reddy’s production quality management did not meet the necessary standards, leading to immediate regulatory actions.
The National Medical Products Administration (NMPA) in China, revealed specific defects in the company’s raw material management and quality control processes.
- Ineffective Validity Measures: The NMPA found that Dr. Reddy’s failed to implement effective measures to ensure that the validity period of raw materials used in the production of Atomoxetine Hydrochloride capsules met the registration requirements established by Chinese regulations.
- Process Validation Failures: The inspection uncovered defects in the process validation protocols, which are essential for ensuring that manufacturing processes consistently produce products that meet predetermined specifications.
Following the NMPA’s announcement, the National Drug Joint Procurement Office (NDJPO) acted swiftly to cancel the product’s selection qualification, thereby placing Dr. Reddy’s Laboratories on a “Violation List.”
This status bars the company from participating in national centralized drug procurement activities until February 28, 2026.
Impact on supply
The suspension affects the ninth batch of selected drugs for national centralized drug procurement, specifically targeting the Atomoxetine Hydrochloride capsules, which are commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both children and adults.
Customers of Dr. Reddy’s must now initiate alternate supply sources in compliance with the regulatory guidelines, ensuring that patients continue to receive necessary medications.
These developments have led to a decline in Dr. Reddy’s shares, reflecting investor concerns over the company’s regulatory challenges and potential financial repercussions. The company’s commitment to ensuring the safety and efficacy of its products will be crucial in regaining its standing in the competitive pharmaceutical market in China.