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Dr Reddy’s Atomoxetine Capsule Import and Sale Suspended in China, Shares Drop 2%

The USFDA has classified the inspection as VAI and concluded that the inspection is closed.

Shares of Dr Reddy’s Laboratories Ltd. dropped by nearly 2% after reaching a day’s high of Rs 7,074.95 on 2nd September, following the suspension of the import, sale, and use of DRL’s atomoxetine hydrochloride by China’s National Medical Products Administration (NMPA).

Atomoxetine Hydrochloride is a capsule used to treat attention deficit hyperactivity disorder (ADHD) in both adults and children.

The NMPA recently conducted a remote inspection of the company’s formulation manufacturing facility (FTO-3), focusing on the production of atomoxetine hydrochloride capsules, and determined that it did not meet the country’s Good Manufacturing Practices for Drugs.

The National Drug Joint Procurement Office (NDJPO) has revoked the company’s “won” status for atomoxetine hydrochloride and also added the company to its Violation list while barring DRL from participating in central drug procurement activities until 28th February, 2026.

Both the NMPA and NDJPO orders are dated 30th August, 2024, according to a regulatory filing by Dr. Reddy’s Laboratories.

The company has already started to determine the financial impact of these orders. Its market capitalisation dropped to Rs 115,488 crore.

The stock has risen significantly by 18.85% so far in 2024.

At 11:41 AM, the shares of Dr. Reddy’s Labs were trading 1.63% lower at Rs 6,916.65 on NSE.

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