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.

Friday, July 18, 2025 1 min read
Key Takeaway: Dr. Reddy's Laboratories reported that the USFDA conducted a GMP and Pre-Approval Inspection at their facility in Srikakulam, Andhra Pradesh, from July 10 to July 18, 2025. The inspection resulted in the issuance of a Form 483, which included seven observations that the company must address. This situation raises concerns regarding compliance at their manufacturing operations.

Market Sentiment Analysis

CONCERNS & RISKS

  • Received a Form 483 from the USFDA with 7 observations.
  • Indicates potential compliance issues at their manufacturing facility.
  • Requires addressing observations within a stipulated timeline.

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)
Ref: Disclosure 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 GMP and a Pre-Approval Inspection (PAI) at our formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India. The inspection was conducted from 10th July to 18th July, 2025. We have been issued a Form 483 with 7 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 & Head-CSR

Frequently Asked Questions

What did the USFDA complete at Dr. Reddy's facility?

The USFDA completed a GMP and Pre-Approval Inspection at the facility.

When was the USFDA inspection conducted?

The inspection took place from July 10 to July 18, 2025.

How many observations did the USFDA issue?

The USFDA issued a Form 483 with 7 observations.

Where is the inspected facility located?

The facility is located in Srikakulam, Andhra Pradesh, India.

Who released the inspection information?

The information was released by Dr. Reddy's Laboratories Limited's Company Secretary.

Tags: RDY Viatris Investor Conferences Healthcare Dr. Reddy's USFDA Form 483 compliance Srikakulam
Last updated: Jul 18, 2025