Dr. Reddy’s Lab receives complete USFDA response letter for biosimilar application
News by Aliceblue News Desk
01 Jan 2026
Introduction
Leading pharmaceutical firm’s Swiss subsidiary received a Complete Response Letter from the USFDA for AVT03, a proposed biosimilar to Prolia® and Xgeva®, following observations at the Alvotech manufacturing facility.
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Share price movement of Dr. Reddy’s Lab
On January 1, 2026, Dr Reddys Laboratories Ltd opened at ₹1,266.20, down 0.39% from its previous close of ₹1,271.05. The stock reached a high of ₹1,266.40 (−0.37%) and a low of ₹1,250.65. By 11:26 AM, it traded at ₹1,253.15, a 1.41% decrease, with a market cap of ₹1,04,586.81 crore.
Dr. Reddy’s Swiss Receives USFDA CRL
Dr. Reddy’s Laboratories’ wholly owned Swiss subsidiary received a Complete Response Letter from the USFDA for its Biologics License Application for AVT03, a proposed biosimilar to Prolia® and Xgeva®.
The CRL cites observations from a pre-license inspection of Alvotech’s Reykjavik manufacturing facility. AVT03 is developed by Alvotech hf, and the response affects the approval process in the United States.
Stock performance of Dr. Reddy’s Lab for Period of 1 week, 6 months, and 1 year
Dr Reddys Laboratories Ltd delivered a 0.44% return over the past week. It declined 2.75% in the past six months and fell 7.13% over the past year.
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Shareholding pattern of Dr. Reddy’s Lab
| Particulars | Sep 2025 | Jun 2025 | Mar 2025 |
| Promoter | 26.60% | 26.60% | 26.60% |
| FII | 24.70% | 25.30% | 25.80% |
| DII | 38.80% | 37.80% | 37.20% |
| Public | 9.60% | 10.00% | 10.20% |
| Others | 0.20% | 0.30% | 0.30% |
About Dr. Reddy’s Lab
Dr Reddys Laboratories Ltd (NSE: DRREDDY) is a leading India-based pharmaceutical company offering APIs, Custom Pharmaceutical Services, generics, biosimilars, and differentiated formulations across domestic and international markets.
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Disclaimer: The above article is written for educational purposes, and the companies’ data mentioned in the article may change with respect to time. The securities quoted are exemplary and are not recommendatory.
FAQs
Q: Why is Dr Reddys Laboratories Ltd share price going up today?
A: Dr Reddys Laboratories Ltd share price reacted after its Swiss subsidiary received a USFDA Complete Response Letter for biosimilar AVT03.
Q: What does Dr Reddys Laboratories Ltd specialize in?
A: Dr Reddys Laboratories Ltd specializes in APIs, Custom Pharmaceutical Services, generics, biosimilars, and differentiated formulations across domestic and international markets.
Q: What is the market capitalization of Dr Reddys Laboratories Ltd?
A: Dr Reddys Laboratories Ltd has a market capitalization of ₹1,04,586.81 crore as of January 1, 2026.
News Author
Aliceblue News Desk
