The woes of Dr. Reddy’s Laboratories Ltd. seem to have increased further. The National Medical Products Administration (NMPA) has completed a remote inspection of the FTO-3 facility and found it non-compliant with current good manufacturing practices (cGMP).
This inspection concerns the manufacture of Atomoxetine Hydrochloride Capsules, a medication indicated for attention-deficit hyperactivity disorder (ADHD) in children and adults. Unfortunately, the site was not in compliance with China’s Good Manufacturing Practices for Drugs.
Dr. Reddy’s Laboratories Impact
After the investigation, NMPA prohibited the import of Dr. Reddy’s Atomoxetine Hydrochloride for sale and use reasons. Her departure pushed the company’s shares down when they opened on Monday, September 2.
Inspection Details and Findings
The NMPA’s inspection was in relation to the formulations manufacturing facility (FTO-3) and revealed deviations with respect to GMP compliance for Atomoxetine Hydrochloride Capsules.
This action by the NMPA led to NDJPO withdrawing Dr Reddys “won” status for Atomoxetine Hydrochloride, which was further followed up with additional steps that were taken against Hyderabad-based manufacturer Metric Dose & formulations Ltd and Capsugel Healthcare Limited.
The company has been blacklisted and is not allowed to participate in any centralized drug purchase before February 28, 2026.
The NMPA as well as NDJPO both handed down their orders on August 30,2024. In a regulatory filing, Dr. Reddys Laboratories said they are assessing the financial impact of these orders.
To know more, click here.
Conclusion
The latest findings and actions by NMPA are a hard-pressed situation for Dr. Reddy’s Laboratories. The company is now in the process of calculating what these regulatory decisions mean financially.
If they can work through this snag, the key for Dr Reddy will be to quickly get on top of the compliance issues and start moving forward again.
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