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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 Limited has announced the completion of a routine cGMP inspection by the USFDA at its formulations facility in Bachupally, Hyderabad. The inspection, which took place from October 19 to October 27, 2023, resulted in the issuance of a Form 483 containing ten observations. The company is required to address these observations within a specified timeline. This development may impact the company's operations and regulatory standing.

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CONCERNS & RISKS

  • Dr. Reddy's received a Form 483 with ten observations from the USFDA inspection.
  • The company needs to address the FDA's observations within a stipulated timeline.

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 United States Food &
Drug Administration (USFDA) completed a routine cGMP inspection at our formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad.
The inspection was conducted from October 19, 2023 to October 27, 2023. We have been issued a Form 483 with ten observations, which we
will address within the stipulated timeline.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer and Head-CSR

Frequently Asked Questions

What stock exchanges is Dr. Reddy's listed on?

Dr. Reddy's is listed on NSE, BSE, NYSE, and NSE IFSC.

When was the USFDA inspection conducted?

The USFDA inspection took place from October 19 to October 27, 2023.

How many observations did Dr. Reddy's receive?

Dr. Reddy's received ten observations during the inspection.

What will Dr. Reddy's do about the observations?

Dr. Reddy's will address the observations within the specified timeline.

Last updated: Oct 28, 2023