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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

Thursday, October 12, 2023 1 min read
Key Takeaway: Dr. Reddy's Laboratories reported that the USFDA completed a product-specific Pre-Approval Inspection at its biologics manufacturing facility in Hyderabad from October 4 to October 12, 2023. The company received a Form 483 with nine observations that need to be addressed. Compliance with these observations will be necessary to maintain regulatory approval for its products.

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CONCERNS & RISKS

  • USFDA issued a Form 483 with nine observations during inspection.
  • The necessity to address these observations within a stipulated timeline may indicate potential regulatory issues.

Full Press Release Details

National Stock Exchange of India Ltd. (Scrip Code:
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd (Stock Code: DRREDDY)
under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
This is to inform that the United States Food &
Drug Administration (USFDA) today completed a product-specific Pre-Approval Inspection (PAI) at our biologics manufacturing facility in
Bachupally, Hyderabad. The inspection was conducted from October 4, 2023 to October 12, 2023. We have been issued a Form 483 with nine
observations, which we will address within the stipulated timeline.
This is for your information and records.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer and Head-CSR

Frequently Asked Questions

What facility did the USFDA inspect?

The USFDA inspected a biologics manufacturing facility in Bachupally, Hyderabad.

When did the USFDA inspection occur?

The inspection took place from October 4 to October 12, 2023.

What was issued to Dr. Reddy's after the inspection?

A Form 483 with nine observations was issued following the inspection.

How will Dr. Reddy's respond to the observations?

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

Tags: RDY Viatris Investor Conferences Healthcare Dr. Reddy's Laboratories USFDA FDA inspection Bachupally biologics manufacturing
Last updated: Oct 12, 2023