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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 www.drreddys.com

Friday, May 12, 2023 1 min read
Key Takeaway: Dr. Reddy's Laboratories announced that the USFDA completed a Pre-Approval Inspection and a routine GMP inspection at its Srikakulam facility. The inspection, which took place from May 8 to May 12, 2023, resulted in the issuance of a Form 483 with four observations that the company must address. This finding may pose compliance risks and could impact the company's operations and approvals.

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CONCERNS & RISKS

  • The USFDA issued a Form 483 with four observations during the inspection.
  • The company needs to address the observations within a stipulated timeframe.
  • The inspections may lead to operational delays or compliance challenges.

Full Press Release Details

Stock Exchange of India Ltd. (Stock Code: DRREDDY-EQ)
Limited (Stock Code: 500124)
is to inform you that the United States Food & Drug Administration (USFDA) today completed a product-specific Pre-Approval Inspection
(PAI) and a routine GMP inspection at our formulations manufacturing facility in Srikakulam (FTO SEZ PU2). The inspection was conducted
from 8th May, 2023 to 12th May, 2023. We have been issued a Form 483 with four observations, which we will address within the stipulated
take the above on your record.
Dr. Reddy's Laboratories Limited
/s/ K Randhir Singh
K Randhir Singh
Company Secretary, Compliance Officer & Head-CSR
Cc: New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)

Frequently Asked Questions

What was the focus of the USFDA inspection for Dr. Reddy’s?

The USFDA focused on a product-specific Pre-Approval Inspection and a routine GMP inspection.

When did the USFDA inspection at Dr. Reddy's occur?

The inspection took place from May 8 to May 12, 2023.

What was issued to Dr. Reddy's following the inspection?

Dr. Reddy's received a Form 483 with four observations to address.

Where is Dr. Reddy's formulations manufacturing facility located?

The facility is located in Srikakulam (FTO SEZ PU2).

Who issued the inspection report for Dr. Reddy's?

The inspection report was issued by the United States Food & Drug Administration.

Tags: RDY Viatris Investor Conferences Healthcare USFDA Dr. Reddy's Laboratories Srikakulam Form 483 pharmaceutical inspection
Last updated: May 12, 2023