Recent Updates
Recently added Catalysts
RDY Negative Sentiment Score: 40/100

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 Web: www.drreddys.

Saturday, September 13, 2025 1 min read
Key Takeaway: Dr. Reddy's Laboratories has announced that the US Food & Drug Administration (USFDA) completed a Pre-Approval Inspection at its biologics manufacturing facility in Hyderabad from September 4 to September 12, 2025. The inspection resulted in a Form 483 being issued, which included five observations that the company is required to address within a given timeline. This follows a prior inspection and disclosure about the matter made to stock exchanges on October 12, 2023.

Market Sentiment Analysis

CONCERNS & RISKS

  • The USFDA issued a Form 483 with five observations during the inspection.
  • Dr. Reddy's must address the observations within a stipulated timeline, indicating compliance issues.

Full Press Release Details

National Stock Exchange of India Ltd. (Scrip Code: DRREDDY)
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
This is to inform you that the United States Food & Drug Administration (USFDA) on September 12, 2025, completed a Pre-Approval Inspection (PAI) at our biologics manufacturing facility in Bachupally, Hyderabad. The inspection was conducted from September 4, 2025 to September 12, 2025. We have been issued a Form 483 with five observations, which we will address within the stipulated timeline. This is pursuant to the inspection conducted earlier and disclosure made to the stock exchanges on October 12, 2023.
This is for your information and record.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer & Head-CSR

Frequently Asked Questions

What is the date of the USFDA inspection at Dr. Reddy's facility?

The USFDA inspection occurred from September 4 to September 12, 2025.

What document was issued by the USFDA after the inspection?

The USFDA issued a Form 483 with five observations post-inspection.

Where is Dr. Reddy's biologics manufacturing facility located?

The facility is located in Bachupally, Hyderabad.

When was the inspection disclosure made to stock exchanges?

The disclosure was made on October 12, 2023.

Who issued the official communication regarding the inspection?

The communication was issued by the Company Secretary of Dr. Reddy's.

Tags: RDY Viatris Investor Conferences Healthcare Dr. Reddy's USFDA form 483 biologics manufacturing Bachupally
Last updated: Sep 13, 2025