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RDY Negative Sentiment Score: 25/100

Dr. Reddy's Laboratories Ltd. 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500 034, Telangana, India. CIN : L85195TG1984PLC004507 Tel : +91 40 4900 2900 Fax : +91 40 4900 2999 Email : mail@drreddys.com www.drreddys.co

Key Takeaway: Dr. Reddy's Laboratories has received orders from China’s National Medical Products Administration (NMPA) and National Drug Joint Procurement Office (NDJPO) due to non-compliance with Good Manufacturing Practices for its Atomoxetine Hydrochloride Capsules. Consequently, the NMPA has suspended the drug's importation, sale, and use effective August 30, 2024. As part of the actions taken, Dr. Reddy's has been listed on a 'Violation List', disqualifying the company from participating in national drug procurement activities until February 2026. The financial implications of these orders are still being evaluated by the company.

Market Sentiment Analysis

CONCERNS & RISKS

  • The company's production quality for Atomoxetine Hydrochloride Capsules does not meet China's GMP standards.
  • NMPA has suspended the import, sale, and use of the drug in China.
  • Dr. Reddy's Laboratories has been placed on a 'Violation List', affecting their ability to participate in centralized drug procurement until 2026.

Full Press Release Details

National Stock Exchange of India Ltd. (Scrip Code: DRREDDY-EQ)
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd (Stock Code: DRREDDY)
This is to inform that the Company has learnt
about orders dated August 30, 2024, of National Medical Products Administration, China and National Drug Joint Procurement Office, China,
made available through their website. The details as required under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements)
Regulations, 2015 read with Schedule III Para A Sub Para 20 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations,
2015 are as hereunder:
a Name of the authority : National Medical Products Administration, China (NMPA) and National Drug Joint Procurement Office, China (NDJPO)
b Nature and details of the action(s) taken, initiated or order(s) passed : 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)". The NMPA has suspended the import, sale, and use of the Company's Atomoxetine Hydrochloride Capsules effective August 30, 2024. Further, 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 national centralized drug procurement activities from August 30, 2024 to February 28, 2026.
c Date of receipt of direction or order, including any ad-interim or interim orders, or any other communication from the authority : Both NMPA and NDJPO orders are dated August 30, 2024
d Details of the violation(s)/ contravention(s) committed or alleged to be committed : As detailed above in para b
e Impact on financial, operation or other activities of the listed entity, quantifiable in monetary terms to the extent possible : The Company is in the process of ascertaining the monetary impact of the said orders.
This is for your information and record.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer and Head-CSR

Frequently Asked Questions

What orders did the NMPA issue on August 30, 2024?

The NMPA suspended the import, sale, and use of Dr. Reddy's Atomoxetine Hydrochloride Capsules.

Why were Dr. Reddy's capsules suspended by the NMPA?

The production quality of the capsules did not meet China's Good Manufacturing Practice standards.

How long is Dr. Reddy's suspension from drug procurement?

Dr. Reddy's suspension from national centralized drug procurement lasts until February 28, 2026.

What is the revenue impact of the NMPA orders?

Dr. Reddy's is currently assessing the monetary impact of the NMPA's orders.

When were the orders from NMPA and NDJPO received?

Both orders from NMPA and NDJPO were received on August 30, 2024.

Last updated: Aug 31, 2024