Dr. Reddy's Telangana API Facility Receives USFDA Form 483 with Two Observations May 26, 2025
More news about Dr Reddys Laboratories
19May 25
Dr Reddy's Laboratories Reports Strong Q4 Growth, Eyes Biosimilars and Semaglutide
Dr Reddy's Laboratories posted 20% YoY revenue growth and 21% YoY net profit increase in Q4. The company is strategically focusing on biosimilars and Semaglutide portfolio for growth beyond 2026. Plans include global launch of GLP-1 (Semaglutide) this year and Abatacept submission by end of 2025. Despite reduced target prices, analysts project 6-18% upside potential.
17May 25
US FDA Issues Form 483 with Two Observations for Dr. Reddy's New York API Facility
The FDA completed a GMP inspection at Dr. Reddy's API facility in Middleburgh, New York, resulting in a Form 483 with two observations. The company acknowledges the observations and plans to address them within the stipulated timeline. While not implying immediate regulatory action, this development signals potential areas for improvement in compliance with FDA standards.
12May 25
Dr. Reddy's Q4 Results: Profit Surges 22%, but Misses Estimates; Analysts Cautious
Dr Reddy's Laboratories reported a 22% YoY increase in Q4FY25 net profit to ₹1,594.00 crore, with revenue growing 20% to ₹8,506.00 crore. EBITDA at ₹2,475.00 crore missed analyst estimates by 10%. Strong growth was seen in North America (9%), Europe (145%), and India (16%). Despite revenue growth, the company faced margin pressure with OPM decreasing to 23.22%. Management guides for double-digit revenue growth and 25% EBITDA margin in FY26, but analysts remain cautious due to competitive pressures and declining margins.
09May 25
Dr. Reddy's Laboratories Expands Global Footprint with New Subsidiary in Vietnam
Dr. Reddy's Laboratories has established a new wholly-owned subsidiary in Vietnam through its Swiss subsidiary, Dr. Reddy's Laboratories SA. The new entity, 'Dr. Reddy's Laboratories (Vietnam) Company Limited', aims to strengthen the company's presence in the Southeast Asian pharmaceutical market. This strategic move aligns with Dr. Reddy's global expansion strategy and its focus on tapping into emerging markets with growing healthcare needs.
09May 25
Dr Reddy's Laboratories Announces Rs 8 Per Share Final Dividend for FY 2024-25
Dr Reddy's Laboratories Ltd. has recommended a final dividend of Rs 8.00 per share for the fiscal year 2024-25. The record date for determining eligible shareholders is set for July 10, 2024. This dividend is subject to shareholder approval at the upcoming Annual General Meeting.
09May 25
Dr Reddy's Laboratories: Q4 Profit Surges 22%, Revenue Climbs 20%
Dr. Reddy's Laboratories reported strong Q4 FY2024-25 results, with consolidated revenue increasing 20% to ₹8,506.00 crore and net profit rising 22% to ₹1,594.00 crore. EBITDA grew by 58.90% to ₹2,975.00 crore, with the EBITDA margin expanding by 510 basis points to 29.10%. The company also announced a dividend, reflecting its strong financial performance.
08May 25
Dr Reddy's Laboratories Sets Date for Q4 Results, Dividend Announcement
Dr Reddy's Laboratories will release its Q4 and FY 2024-25 financial results on May 9, 2025. The board will consider recommending a final dividend. A trading window closure for insiders is set from March 25 to May 11, 2025. An earnings call is scheduled for 7:30 p.m. IST on May 9, 2025.
28Apr 25
Dr Reddy's Expands Partnership with Sanofi, Set to Launch RSV Drug Beyfortus in India
Dr Reddy's Laboratories has expanded its partnership with Sanofi Healthcare, gaining exclusive rights to promote and distribute Beyfortus, a novel drug for preventing Respiratory Syncytial Virus (RSV) in newborns and infants, in India. The launch is expected in the second quarter of the current fiscal year. This move strengthens Dr Reddy's position in the pediatric pharmaceutical segment and addresses a critical need in pediatric healthcare.
21Apr 25
Dr. Reddy's Laboratories Sees Significant Block Trade on NSE
A significant block trade of 137,711 shares of Dr. Reddy's Laboratories occurred on the National Stock Exchange. The transaction was executed at Rs. 1,169.80 per share, totaling Rs. 16.11 crores. This large-scale trade has drawn attention from market observers, though its specific implications for the company's stock remain unclear.
16Apr 25
Dr. Reddy's Dismisses Speculation on Sanofi's Lantus Acquisition
Dr. Reddy's Laboratories has officially addressed market speculation regarding its potential acquisition of Sanofi's insulin brand, Lantus. The company stated there is no material event to disclose at this time, in response to a news item in The Economic Times. K Randhir Singh, Company Secretary and Compliance Officer, emphasized the company's policy of not commenting on market speculations and assured compliance with SEBI regulations for disclosing material events.
15Apr 25
Dr Reddy's Laboratories Refutes Claims of 25% Workforce Cost Reduction
Dr Reddy's Laboratories has officially refuted claims of a 25% reduction in workforce costs. The company issued a statement to stock exchanges on April 14, 2025, categorically denying the information published in a Business Standard article dated April 13, 2025. The pharmaceutical giant emphasized its commitment to transparency and regulatory compliance, stating that it promptly discloses material information as required by SEBI Listing Regulations. Dr Reddy's also noted that it does not comment on market speculations and currently has no event requiring disclosure under Regulation 30.
14Apr 25
Dr Reddy's Laboratories Denies Reports of Major Workforce Restructuring
Dr Reddy's Laboratories has refuted recent reports of a significant workforce restructuring plan. The company denied claims of implementing a downsizing initiative to cut workforce costs by 25%, asking high-earning executives to resign, or offering a voluntary retirement scheme for R&D employees. This denial suggests that the company's organizational structure and operational focus remain unchanged.
Dr. Reddy's Lab Expands Footprint in Colombia with Exclusive Bio-thera Deal
Dr. Reddy's Laboratories has entered an exclusive commercialization agreement with Bio-thera for BAT2206 and BAT2506 in Colombia. Dr. Reddy's gains exclusive commercial rights for BAT2206, while Bio-thera retains responsibility for development, manufacturing, and supply of both products. This strategic move aims to strengthen Dr. Reddy's presence in the Colombian pharmaceutical market and expand its product portfolio in South America.
27Mar 25
Dr. Reddy's Expands Biosimilar Footprint in Southeast Asia through Partnership with Bio-Thera
Dr. Reddy's Laboratories has entered into an exclusive commercialization agreement with Chinese biotechnology company Bio-Thera Solutions for a biosimilar product in Southeast Asia. This strategic move aims to strengthen Dr. Reddy's presence in the region's growing biosimilar market. While specific product details remain undisclosed, the partnership is expected to leverage Dr. Reddy's expertise in drug commercialization and Bio-Thera's innovative pipeline.
22Mar 25
Dr. Reddy's Laboratories Completes Sale of Louisiana Subsidiary, Announces Board Meeting
Dr. Reddy's Laboratories has completed the sale of its Louisiana subsidiary, including the Shreveport manufacturing facility, on March 21, 2025. The company also announced a board meeting on May 9, 2025, to approve financial results for FY 2024-25 and consider dividend recommendations. A trading window closure is set from March 25 to May 11, 2025, in compliance with SEBI regulations.
21Mar 25
Dr. Reddy's Laboratories Sets Date for Q4 and FY 2024-25 Financial Results
Dr. Reddy's Laboratories will hold a board meeting on May 9, 2025, to approve financial results for Q4 and FY 2024-25, and consider recommending a final dividend. The company has announced a trading window closure from March 25 to May 11, 2025, in compliance with SEBI regulations.
18Mar 25
Dr. Reddy's and Alvotech's Biosimilar Application Accepted by FDA
The U.S. FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva®, jointly developed by Dr. Reddy's Laboratories and Alvotech. This acceptance marks a significant step in Dr. Reddy's strategy to expand its biosimilar portfolio, potentially opening new market opportunities in the treatment of osteoporosis and skeletal-related events in cancer patients. The application will undergo further FDA review before any final approval decision.
17Mar 25
Dr Reddy's Laboratories Initiates Recall of Mislabeled Levetiracetam Injection in US Market
Dr Reddy's Laboratories has initiated a recall for a specific batch of Levetiracetam in 0.75% Sodium Chloride Injection in the United States due to a critical labeling error. The affected batch, lot number A1540076, was distributed between November 4-6, 2024. The mislabeling poses potential health risks including double dosing and adverse effects. No adverse events have been reported so far. The company is taking proactive measures to ensure patient safety and demonstrates commitment to regulatory compliance.
13Mar 25
Dr. Reddy's Laboratories Initiates Nationwide Recall of Mislabeled Levetiracetam Injection in the U.S.
Dr. Reddy's Laboratories is recalling one batch of Levetiracetam in 0.75% Sodium Chloride Injection due to a critical labeling error. The affected batch, A1540076, incorrectly states the product as 500 mg/100 mL instead of 1,000 mg/100 mL. This mislabeling could lead to double dosing, potentially causing serious side effects. The recall affects products distributed nationwide in the U.S. between November 4-6, 2024. Dr. Reddy's is notifying distributors and customers to return the affected product and has set up a helpline for inquiries.
10Mar 25
Dr. Reddy's Set to Launch Affordable Diabetes Medication in India
Dr. Reddy's Laboratories and other Indian pharmaceutical companies are preparing to introduce low-cost versions of empagliflozin, a key diabetes medication. This move aims to increase accessibility to diabetes treatment in India by offering more affordable alternatives. The launch is expected to increase market competition, potentially reduce overall treatment costs, and improve patient adherence to prescribed treatments. This initiative demonstrates the Indian pharmaceutical industry's commitment to balancing innovation with affordability in addressing the country's healthcare needs.
04Mar 25
Dr Reddy's Offloads 14-Drug Portfolio to Senores Pharma in Strategic US Market Move
Dr Reddy's Laboratories has agreed to sell a portfolio of 14 Abbreviated New Drug Applications (ANDAs) to Senores Pharmaceuticals, including 13 FDA-approved drugs and one pending approval. The portfolio has an estimated market potential of $421 million to $1.13 billion in the US market. This move aligns with Dr Reddy's strategy to optimize its product portfolio. Senores Pharmaceuticals plans to use its recent IPO proceeds to fund this acquisition, aiming to expand its presence in the US and explore growth in other regulated and semi-regulated markets globally. Financial terms of the deal were not disclosed.
28Feb 25
Dr. Reddy's Laboratories Secures FDA Tentative Approval for Leukemia Drug Generic
Dr. Reddy's Laboratories has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Nilotinib, a generic version of a medication used to treat certain types of leukemia. This approval is a significant step towards expanding the company's generic drug portfolio in the U.S. market. Nilotinib, a tyrosine kinase inhibitor, is primarily used in treating chronic myeloid leukemia. The introduction of a generic version could potentially lower treatment costs for patients and increase market competition in the oncology drug segment.
27Feb 25
Dr. Reddy's Eyes Massive Growth in Indian CDMO Business
Dr. Reddy's Laboratories has expressed strong optimism about the growth potential of its Contract Development and Manufacturing Organization (CDMO) business in India. The company sees a huge growth opportunity in the Indian CDMO market, potentially driven by increasing demand, cost-effective solutions, existing expertise, and supportive government initiatives. This focus on CDMO could help Dr. Reddy's diversify revenue streams, foster global partnerships, and enhance innovation capabilities.
27Feb 25
Dr Reddy's API Facility Receives Favorable USFDA Inspection Report
Dr Reddy's Laboratories' CTO-2 API manufacturing facility in Bollaram has received an Establishment Inspection Report from the USFDA with a Voluntary Action Indicated (VAI) classification. The inspection is deemed 'closed', indicating substantial compliance with cGMP regulations. This outcome demonstrates the facility's adherence to quality standards and allows for continued operations without major regulatory hurdles.
25Feb 25
Dr. Reddy's Laboratories Receives Positive USFDA Inspection Report for API Facility
Dr. Reddy's Laboratories has received an Establishment Inspection Report (EIR) from the USFDA for its Active Pharmaceutical Ingredient (API) manufacturing facility CTO-2 in Bollaram, Hyderabad. The inspection was classified as Voluntary Action Indicated (VAI) and concluded as 'closed', indicating substantial compliance with Good Manufacturing Practices. This positive outcome suggests no significant regulatory hurdles for products manufactured at this facility and reinforces the company's reputation for maintaining high-quality standards.
25Feb 25
Major Block Trade: Dr. Reddy's Laboratories Shares Change Hands in ₹191 Crore Deal
A significant block trade of approximately 1,691,227 shares of Dr. Reddy's Laboratories Ltd. occurred on the National Stock Exchange (NSE). The shares were traded at ₹1,129.70 each, totaling ₹191.06 crores. This large-scale transaction, typically associated with institutional investors or major stakeholders, has drawn market attention due to its potential impact on stock prices and investor sentiment.
21Feb 25
Major Block Trade: Dr. Reddy's Laboratories Shares Change Hands in ₹249.55 Crore Deal
A significant block trade of 2,169,957 shares of Dr. Reddy's Laboratories Ltd. was executed on the National Stock Exchange (NSE) at ₹1,150 per share, totaling ₹249.55 crore. This large-scale transaction has drawn market attention due to its potential implications for the company's stock. Dr. Reddy's, a leading Indian pharmaceutical company, has not yet released an official statement regarding the trade.
21Feb 25
Dr. Reddy's Laboratories Shares Witness Massive Block Trade on NSE
A significant block trade of approximately 1,507,932 shares of Dr. Reddy's Laboratories occurred on the National Stock Exchange. The transaction was executed at Rs. 1,160.65 per share, totaling Rs. 175.02 crores. This large-scale trade could potentially impact the stock's price and trading volume, and may indicate moves by institutional investors or major shareholders.