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RDY Neutral Sentiment Score: 47/100

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.

Key Takeaway: Dr. Reddy's Laboratories has reported that the USFDA completed a GMP inspection at their API Middleburgh facility in New York from May 12th to May 16th, 2025. The inspection concluded with the issuance of a Form 483, which contains two observations that the company needs to address within a specified timeline. The announcement highlights the company's commitment to compliance and regulatory standards.

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CONCERNS & RISKS

  • The USFDA issued a Form 483 with 2 observations.
  • The observations may indicate compliance issues that need to be addressed.

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 Middleburgh facility in New York. The inspection was conducted from 12th May, 2025 to 16th May, 2025 (US EST time). We have been issued a Form 483 with 2 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 NYSE?

The stock code for Dr. Reddy's on NYSE is RDY.

When did the USFDA conduct the GMP inspection?

The USFDA conducted the GMP inspection from May 12 to May 16, 2025.

What was issued after the USFDA inspection?

A Form 483 with two observations was issued after the inspection.

Where is the API facility located?

The API facility is located in Middleburgh, New York.

Who is the compliance officer for Dr. Reddy's?

The compliance officer is the Company Secretary and Head-CSR.

Last updated: May 17, 2025