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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

Friday, August 23, 2024 1 min read
Key Takeaway: Dr. Reddy's Laboratories announced the completion of a product-specific Pre-Approval Inspection by the USFDA at its Srikakulam facility. The inspection, which took place from August 19 to August 23, 2024, resulted in the issuance of a form 483, indicating three observations that need to be addressed. The company is required to respond to these observations within a specified timeframe, which may impact operational timelines.

Market Sentiment Analysis

CONCERNS & RISKS

  • The USFDA issued a form 483 with three observations during the inspection.
  • The need to address observations could delay product approval.
  • The inspection may raise concerns regarding the quality compliance of the manufacturing facility.

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)
under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
This is to inform you that the United States
Food & Drug Administration (USFDA) today completed a product-specific Pre-Approval Inspection (PAI) at our formulations manufacturing
facility (FTO SEZ PU1) in Srikakulam, Andhra Pradesh. The inspection was conducted from August 19, 2024 to August 23, 2024. We have been
issued a form 483 with three observations, which we will address within the stipulated timeline.
This is for your information and record.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer and Head-CSR

Frequently Asked Questions

What is the Scrip Code for Dr. Reddy's on the NSE?

The Scrip Code for Dr. Reddy's on the NSE is DRREDDY-EQ.

Where did the USFDA conduct the inspection?

The USFDA inspection took place at the formulations manufacturing facility in Srikakulam.

When was the USFDA inspection performed?

The USFDA inspection was conducted from August 19 to August 23, 2024.

How many observations were issued in the 483 form?

The inspection resulted in three observations noted in the form 483.

Who issued the notification regarding the inspection?

The notification was issued by Dr. Reddy's Laboratories Limited.

Tags: RDY Viatris Investor Conferences Healthcare Dr. Reddy's Laboratories USFDA Srikakulam form 483 pre-approval inspection
Last updated: Aug 23, 2024