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RDY Positive Sentiment Score: 65/100

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.

Saturday, January 10, 2026 1 min read
Key Takeaway: Dr. Reddy's Laboratories has received a Post-Application Action Letter from the USFDA concerning its biologics manufacturing facility in Hyderabad. This follows a Pre-Approval Inspection that took place earlier. The company is focused on addressing the queries mentioned in the PAAL, signifying active engagement with regulatory requirements.

Market Sentiment Analysis

POSITIVE FACTORS

  • Received a Post-Application Action Letter (PAAL) from USFDA.
  • Company is committed to addressing USFDA's queries.
  • The response indicates ongoing communication and collaboration with USFDA.

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)
Ref: Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
Following our intimation dated September 13, 2025 regarding the Pre-Approval Inspection (PAI) by United States Food & Drug Administration (USFDA) at our biologics manufacturing facility in Bachupally, Hyderabad, we wish to inform you that we have received a Post- Application Action Letter (PAAL) from the USFDA in relation to the response submitted.
The company will work closely with the USFDA and is committed to addressing the queries specified in the PAAL.
This is for your information and records.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer & Head-CSR

Frequently Asked Questions

What does the PAAL from the USFDA indicate?

The PAAL indicates that the USFDA has responded to Dr. Reddy's application.

When was the PAI by USFDA conducted?

The Pre-Approval Inspection was conducted on September 13, 2025.

Where is Dr. Reddy's biologics facility located?

The biologics manufacturing facility is in Bachupally, Hyderabad.

How is Dr. Reddy's responding to the PAAL?

Dr. Reddy's is committed to addressing the queries in the PAAL.

Which regulations does this disclosure adhere to?

This disclosure adheres to SEBI's Listing Obligations and Disclosure Requirements.

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Last updated: Jan 10, 2026