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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.c

Saturday, May 24, 2025 1 min read
Key Takeaway: Dr. Reddy's Laboratories Limited announced that the USFDA completed a GMP inspection at its API manufacturing facility in Miryalaguda, Telangana. The inspection took place from May 19 to May 24, 2025, resulting in the issuance of a Form 483 that includes two observations. The company is required to address these observations within the specified timeline, reflecting ongoing regulatory scrutiny.

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CONCERNS & RISKS

  • The USFDA issued a Form 483 with observations which indicates potential compliance issues.
  • The need to address the observations within a stipulated timeline may place pressure on the company.

Full Press Release Details

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.com
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 manufacturing facility (CTO-5) in Miryalaguda, Telangana, India. The inspection was conducted from 19th May, 2025 to 24th May, 2025. 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

Where is Dr. Reddy's Laboratories located?

Dr. Reddy's Laboratories is located in Banjara Hills, Hyderabad, India.

What was the date of the recent USFDA inspection?

The USFDA inspection took place from May 19 to May 24, 2025.

What type of inspection did Dr. Reddy's face from the USFDA?

Dr. Reddy's faced a GMP inspection at their Miryalaguda facility.

How many observations were noted in the Form 483?

There were 2 observations noted in the Form 483 issued by the USFDA.

Who can be contacted for inquiries about Dr. Reddy's?

Inquiries can be sent via email to mail@drreddys.com.

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Last updated: May 24, 2025