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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 Web: www.drreddys.

Friday, December 12, 2025 1 min read
Key Takeaway: Dr. Reddy's Laboratories announced that the USFDA completed a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) of its formulations facility located in Srikakulam, Andhra Pradesh. The inspection occurred from December 4 to December 12, 2025, resulting in the issuance of a Form 483, which contained five observations that the company is required to address within a specified timeline. This development highlights the regulatory oversight that pharmaceutical companies must navigate.

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POSITIVE FACTORS

  • The USFDA inspection is a routine procedure that validates the facility.
  • The company has a timeline to address the observations noted.

CONCERNS & RISKS

  • The Form 483 issued has 5 observations that could indicate compliance issues.
  • The need to address these observations may impact company operations temporarily.

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) today completed a GMP and a Pre-Approval Inspection (PAI) at our formulations facility (FTO-SEZ PU01) in Srikakulam, Andhra Pradesh. The inspection was conducted from 4th December to 12th December, 2025. We have been issued a Form 483 with 5 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 company conducted a recent FDA inspection?

Dr. Reddy's Laboratories Limited had a recent FDA inspection.

When was the FDA inspection at Dr. Reddy's facility?

The FDA inspection took place from December 4 to December 12, 2025.

How many observations were noted in the FDA inspection?

Five observations were issued in the FDA inspection report.

What document was issued after the FDA inspection?

A Form 483 was issued following the FDA inspection.

Where is Dr. Reddy's formulations facility located?

The formulations facility is in Srikakulam, Andhra Pradesh.

Tags: RDY Viatris Investor Conferences Healthcare Dr. Reddy's FDA inspection Form 483 Srikakulam GMP
Last updated: Dec 12, 2025