Dr. Reddy’s Laboratories Share Price Drops After USFDA Issues Seven Observations

Dr. Reddy’s Laboratories Share Price Drops After USFDA Issues Seven Observations

Market Performance

On July 21, 2025, Dr. Reddy’s Laboratories share price dipped in early trading hours following regulatory observations issued by the USFDA.

  • Share Price at 09:27 AM: ₹1,250.35
  • Day’s Decline: ₹7.75 or 0.62%
  • 52-Week High: ₹1,420.20 (21 August, 2024)
  • 52-Week Low: ₹1,025.90 (07 April, 2025)
  • Current Price Difference:
    • 11.96% below 52-week high
    • 21.88% above 52-week low
  • Market Capitalisation: ₹1,04,351.93 crore

Main News: USFDA Flags Observations Post-Inspection

Shares of Dr. Reddy’s Laboratories fell after the company confirmed that the USFDA had issued seven observations under Form 483 following an inspection of its formulations manufacturing facility (FTO 11) located in Srikakulam, Andhra Pradesh.

  • Inspection Duration: July 10 to July 18, 2025
  • Type of Inspection:
    • GMP (Good Manufacturing Practice)
    • Pre-Approval Inspection (PAI)
  • Outcome: 7 observations listed in Form 483

The company stated that it will address all the observations within the stipulated timeline as per regulatory norms.

Company Details

Dr. Reddy’s Laboratories is a leading Indian pharmaceutical company with a strong global presence, particularly in the US generics market. The Srikakulam facility, which came under inspection, plays a key role in its formulation production pipeline.

Key Facts:

  • Facility Name: FTO 11
  • Location: Srikakulam, Andhra Pradesh
  • Focus: Formulations manufacturing
  • USFDA Oversight: Essential for product exports to the US

The company’s response indicates regulatory compliance intent, a standard move post-Form 483 issuance.

Summary

The Dr. Reddy’s Laboratories share price dipped following news of USFDA issuing seven observations at one of its key manufacturing units. While the drop was marginal at 0.62%, the market reacted to the regulatory update from the Srikakulam facility inspection.

Investors may closely watch the company’s official Q1 FY26 results, which are scheduled to be announced on July 23, 2025, for further clarity on operational performance.

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