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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.c

Key Takeaway: Dr. Reddy's Laboratories reported the completion of a GMP inspection by the USFDA at its API Mirfield facility in West Yorkshire, UK, which took place from September 1 to September 5, 2025. The inspection resulted in the issuance of a Form 483 detailing seven observations. The company is required to address these observations within a stipulated timeline. This development raises concerns regarding the compliance and operational integrity of the facility.

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CONCERNS & RISKS

  • The company received a Form 483 from the USFDA indicating issues found during inspection.
  • There were 7 observations noted that require addressing.
  • The GMP inspection may impact the facility's operational reliability.

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) completed a GMP inspection at our API Mirfield facility in West Yorkshire, UK. The inspection was conducted from September 1 to September 5, 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 is the stock code for Dr. Reddy's on BSE?

The stock code for Dr. Reddy's on BSE is 500124.

When did the USFDA conduct the GMP inspection?

The USFDA conducted the GMP inspection from September 1 to September 5, 2025.

What facility was inspected by the USFDA?

The USFDA inspected the API Mirfield facility in West Yorkshire, UK.

How many observations were noted in the Form 483?

There were 7 observations noted in the Form 483.

Who issued the statement regarding the USFDA inspection?

The statement was issued by Dr. Reddy's Company Secretary and Compliance Officer.

Last updated: Sep 6, 2025