Latest news with #Dr.Reddy'sLaboratoriesLtd
Business Wire
09-05-2025
- Business
- Business Wire
Dr. Reddy's Q4 & Full Year FY25 Financial Results
HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy's Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) today announced its consolidated financial results for the quarter and year ended March 31, 2025. The information mentioned in this release is based on consolidated financial statements under International Financial Reporting Standards (IFRS). Commenting on the results, Co-Chairman & MD, G V Prasad said:"We achieved double-digit growth across our businesses, driven by successful product launches, increased revenues from key products in the U.S. and the integration of the acquired NRT business. We will continue to strengthen and grow our core businesses through portfolio management and operational excellence, while pursuing strategic partnerships and inorganic growth opportunities.' All amounts in millions, except EPS All US dollar amounts based on convenience translation rate of 1 USD = ₹ 85.43 Expand Revenue Mix by Segment for year Particulars FY25 FY24 YoY Gr% (₹) (₹) Global Generics 289,552 245,453 18 North America 145,164 129,895 12 Europe* 35,882 20,511 75 India 53,734 46,407 16 Emerging Markets 54,771 48,640 13 PSAI 33,846 29,801 14 Others 2,137 3,910 (45) Total 325,535 279,164 17 *Includes Revenues from the acquired NRT business of ₹5,971 Mn for Q4FY25 and ₹12,020 Mn for FY25. Underlying growth for Europe excluding NRT business is 30% YoY and 12% QoQ for Q4FY25 and 16% YoY for FY25. Expand Consolidated Income Statement for the quarter Particulars Q4FY25 Q4FY24 YoY Gr % Q3FY25 QoQ Gr% ($) (₹) ($) (₹) ($) (₹) Revenues* 996 85,060 829 70,830 20 978 83,586 2 Cost of Revenues 442 37,797 344 29,347 29 404 34,534 9 Gross Profit 553 47,263 486 41,483 14 574 49,052 (4) % of Revenues 55.6% 58.6% 58.7% Selling, General & Administrative Expenses 282 24,055 240 20,476 17 282 24,117 (0) % of Revenues 28.3% 28.9% 28.9% Research & Development Expenses 85 7,258 80 6,877 6 78 6,658 9 % of Revenues 8.5% 9.7% 8.0% Impairment of Non-Current Assets, net 9 768 (2) (173) (0) (4) Other (Income)/Expense, net (29) (2465) (8) (656) 276 (5) (439) 462 Results from Operating Activities 207 17,647 175 14,959 18 219 18,720 (6) Finance (Income)/Expense, net (28) (2352) (12) (1022) 130 0 20 Share of Profit of Equity Accounted Investees, net of tax (1) (55) (0) (35) 57 (0) (42) 31 Profit before Income Tax 235 20,054 # 187 16,016 25 219 18,742 # 7 % of Revenues 23.6% 22.6% 22.4% Income Tax Expense 49 4,181 34 2,946 42 55 4,704 (11) Profit for the Period 186 15,873 153 13,070 21 164 14,038 13 % of Revenues 18.7% 18.5% 16.8% Attributable to Equity holders of the parent company 187 15,939 153 13,070 22 165 14,133 13 Attributable to Non-controlling interests (1) (66) - - - (1) (95) (31) Diluted Earnings per Share (EPS) 0.22 19.11 0.18^ 15.7^ 22 0.20 16.9 13 *Includes Revenues of ₹5,971 Mn from the acquired NRT business. Underlying growth excluding NRT business is 12% YoY and 2% QoQ. ^Historical numbers re-casted basis the increased number of shares post share split. # Includes Profit before Tax of ₹888 Mn from the acquired NRT business. Expand Expand Consolidated Income Statement for the full year Particulars FY25 FY24 YoY Gr % ($) (₹) ($) (₹) Revenues* 3,811 325,535 3,268 279,164 17 Cost of Revenues 1,581 135,107 1,353 115,557 17 Gross Profit 2,229 190,428 1,915 163,607 16 % of Revenues 58.5% 58.6% Selling, General & Administrative Expenses 1,099 93,870 904 77,201 22 % of Revenues 28.8% 27.7% Research & Development Expenses 320 27,380 268 22,873 20 % of Revenues 8.4% 8.2% Impairment of Non-Current Assets, net 20 1,693 0.04 3 56,333 Other (Income)/Expense, net (51) (4,358) (49) (4,199) 4 Results from Operating Activities 841 71,843 793 67,729 6 Finance (Income)/Expense, net (55) (4,724) (47) (3,994) 18 Share of Profit of Equity Accounted Investees, net of tax (3) (217) (2) (147) 48 Profit before Income Tax # 899 76,784 841 71,870 7 % of Revenues 23.6% 25.7% Income Tax Expense 229 19,539 189 16,186 21 Profit for the Period 670 57,245 652 55,684 3 % of Revenues 17.6% 19.9% Attributable to Equity holders of the parent company 662 56,544 652 55,684 2 Attributable to Non-controlling interests 8 701 - - - Diluted Earnings per Share (EPS) 0.79 67.8 0.78^ 66.8 1 *Includes Revenues of ₹12,020 Mn from the acquired NRT business. Underlying growth excluding NRT business is 12% YoY. # Includes Profit before Income Tax of ₹1,011 Mn (net of acquisition related expenses) from the acquired NRT business. ^Historical numbers re-casted basis the increased number of shares post share split. Expand EBITDA Computation for the year Particulars FY25 FY24 ($) (₹) ($) (₹) Profit before Income Tax 899 76,784 841 71,870 Interest (Income) / Expense, net* (40) (3,402) (44) (3,716) Depreciation 123 10,505 112 9,576 Amortization 77 6,553 62 5,280 Impairment 20 1,693 0 3 EBITDA 1,078 92,133 972 83,013 % of Revenues 28.3% 29.7% *Includes income from Investment Expand Key Balance Sheet Items Particulars As on 31 st Mar 2025 As on 31 st Dec 2024 As on 31 st Mar 2024 ($) (₹) ($) (₹) ($) (₹) Cash and Cash Equivalents and Other Investments 799 68,299 751 64,198 966 82,529 Trade Receivables 1,058 90,420 1,079 92,212 940 80,298 Inventories 832 71,085 838 71,630 744 63,552 Property, Plant, and Equipment 1,144 97,761 1,089 93,053 900 76,886 Goodwill and Other Intangible Assets 1,271 108,613 1,227 104,780 482 41,204 Loans and Borrowings (Current & Non-Current) 547 46,766 598 51,085 234 20,020 Trade Payables 416 35,523 422 36,022 362 30,919 Equity 3,947 337,166 3,764 321,565 3,284 280,550 Expand Key Business Highlights for Q4FY25 Partnered with Shanghai Henlius Biotech, Inc. to commercialize HLX15 (daratumumab biosimilar) in the U.S. and Europe Partnered with Bio-Thera Solutions for BAT2206 (ustekinumab biosimilar) for Southeast Asia and Colombia as well as BAT2506 (golimumab biosimilar) for Southeast Asia Received Biologics License Application (BLA) acceptance for AVT03 (denosumab biosimilar) developed by our partner, Alvotech for the U.S. market Received 'Marketing Authorisation' for rituximab biosimilar from UK MHRA Participated in India's 'Jan Aushadi' program with one of our products to provide accessible generic medicines to the public ESG Highlights for Q4FY25 Recognized in the ' Leadership category' on the Indian Corporate Governance Scorecard 2024 assessment undertaken by Institutional Investor Advisory Services (IiAS) Achieved an improved 'EcoVadis' score of 73, placing us among the top 15% of companies assessed globally Won the ' Climate Action Program 2.0 ° Award' in the highest 'Resilient' category in the Light Manufacturing Sector. Received ' Excellence in Rural Health Initiative ' award from Economic Times Other Updates for Q4FY25 Received the Establishment Inspection Report (EIR) following a routine GMP inspection by the U.S. FDA at our API manufacturing facility (CTO-2) in Bollaram, Hyderabad. The inspection was classified as Voluntary Action Initiated (VAI). Completed the divestment of our manufacturing facility in Shreveport, Louisiana, U.S., to Jaguar Labs Holdings, LLC. Revenue Analysis Q4 FY25 consolidated revenues stood at ₹85.1 billion, YoY growth of 20% and QoQ growth of 2%. Excluding the NRT business, underlying growth was 12% YoY and 2% QoQ. FY25 consolidated revenues reached ₹325.5 billion, YoY growth of 17%. Underlying revenue growth, excluding NRT business was 12% YoY. The performance was driven by contributions from the acquired NRT business, complemented by steady growth across our core businesses - Global Generics and Pharmaceutical Services & Active Ingredients (PSAI). Global Generics (GG) Q4FY25 revenues at ₹75.4 billion, YoY growth of 23% and QoQ growth of 2%. Underlying growth excluding NRT business is 13% YoY and 2% QoQ. FY25 revenues at ₹289.6 billion, a YoY growth of 18%. Underlying YoY growth excluding NRT business is 13%. Growth was primarily driven by contributions from the acquired NRT business, higher sales volumes, and new product launches, partially offset by price erosion in North America and Europe. North America Q4FY25 revenues at ₹35.6 billion, YoY growth of 9% and QoQ growth of 5%. FY25 revenues at ₹145.2 billion, YoY growth of 12%. The YoY growth was primarily driven by new product launches, increased volumes of select key products, partially offset by price erosion in certain products. During the quarter, we launched seven new products in the U.S. A total of 18 products were launched during the fiscal year. We filed ten new Abbreviated New Drug Applications (ANDAs) with the USFDA during the fiscal year. As of March 31, 2025, 76 generic filings were pending approval from the USFDA. These comprise of 73 ANDAs and three New Drug Applications (NDAs) filed under Section 505(b)(2) route of the US Federal Food, Drug, and Cosmetic Act. Of the 73 ANDAs, 44 are Paragraph IV applications, and we believe that 20 of these have a 'First to File' status. Europe Q4FY25 revenues at ₹12.8 billion, YoY growth of 145% and QoQ growth of 5%. This includes revenues from the acquired NRT business. Underlying growth excluding NRT business is 30% YoY and 12% QoQ. NRT at ₹6.0 billion, QoQ decline of 1% Germany at ₹3.6 billion, YoY growth of 26% and QoQ growth of 7% UK at ₹2.2 billion, YoY growth of 43% and QoQ growth of 14% Rest of Europe at ₹1.1 billion, YoY growth of 20% and QoQ growth of 27% FY25 revenues at ₹35.9 billion, YoY growth of 75%. Underlying YoY growth excluding NRT business is 16%. NRT at ₹12.0 billion Germany at ₹12.9 billion, YoY growth of 21% UK at ₹7.3 billion, YoY growth of 15% Rest of Europe at ₹3.7 billion, YoY growth of 4% The growth in Europe was primarily on account of revenues from the acquired NRT business, momentum in the base business volumes and new product launches, partly offset by price erosion. During the quarter, we launched 10 new products in the region, taking the full year total to 39. India Q4FY25 revenues at ₹13.0 billion, YoY growth of 16% and QoQ decline of 3%. FY25 revenues at ₹53.7 billion, YoY growth of 16%. Growth was driven by revenues from the vaccine portfolio in-licensed from Sanofi India, successful new product launches and price increases, partially offset by lower volumes. As per IQVIA, our IPM rank was maintained at 10. The total no. of new product launches in India is 23 for the full fiscal. Emerging Markets Q4FY25 revenues at ₹14.0 billion, YoY growth of 16% and QoQ decline of 3%. YoY growth is largely attributable to new product launches across various countries and higher volumes for existing products. QoQ decline is largely due to lower volumes. - Revenues from Russia at ₹6.5 billion, YoY growth of 31% and QoQ decline of 7%. YoY growth was largely due to new product launches and higher volumes. QoQ decline was due to lower sales volumes and change in product mix. - Revenues from other Commonwealth of Independent States (CIS) countries and Romania at ₹2.4 billion, YoY growth of 13% and QoQ growth of 1%. YoY growth was largely on account of higher base business volumes. - Revenues from Rest of World (RoW) territories at ₹5.0 billion, growth of 1% YoY and QoQ. Contribution from new product launches was partially offset by lower base business volumes and price erosion in certain countries. FY25 revenues at ₹54.8 billion, YoY growth of 13%. The growth is mainly attributable to higher base business volumes, new launches, partly offset by adverse forex. - Revenues from Russia at ₹26.0 billion, YoY growth of 16%. The growth was largely on account of improved base business volumes, revenues from new launches and price increases in certain brands. - Revenues from other CIS countries and Romania at ₹8.9 billion, YoY growth of 3%. - Revenues from RoW territories at ₹19.9 billion, YoY growth of 12%. The growth is largely due to higher base business volumes and new product launches, partially offset by price erosion. During Q4FY25, we launched 26 new products across countries, taking the annual total to 85. Pharmaceutical Services and Active Ingredients (PSAI) Q4FY25 revenues at ₹9.6 billion, growth of 16% YoY and QoQ. FY25 revenues at ₹33.8 billion, with a growth of 14% YoY. Growth was due to increase in API volumes, new launches of API products, partially offset by lower prices. This was further augmented by growth in the pharmaceutical services business. During the quarter, we filed 52 Drug Master Files (DMFs) globally, taking the annual count to 111. Income Statement Highlights: Gross Margin Q4FY25 at 55.6% (GG: 59.3%, PSAI: 26.3%), a YoY decline of 300 basis points (bps) and a QoQ decline of 312 bps. YoY decline was attributed to higher price erosion in generics, lower manufacturing overhead leverage and milestone income accrued in the previous year. The sequential decline was mainly due to lower manufacturing overhead leverage and higher milestone income recorded in the previous quarter. FY25 at 58.5% (GG: 62.0%, PSAI: 27.1%), a YoY decrease of 11 bps, in line with previous year. Selling, General & Administrative (SG&A) Expenses Q4FY25 at ₹24.1 billion, YoY increase of 17% and flat QoQ. FY25 at ₹93.9 billion, YoY increase of 22%. The increase was largely driven by higher investments in sales and marketing to strengthen existing brands and support new business initiatives, including the expansion of our consumer healthcare portfolio. It also reflects higher personnel costs from our growth initiatives and elevated freight rates. Research & Development (R&D) Expenses Q4FY25 at ₹7.3 billion. As % to Revenues – Q4FY25: 8.5% | Q4FY24: 9.7% | Q3FY25: 8.0%. FY25 at ₹27.4 billion. As % to Revenues – FY25: 8.4% | FY24: 8.2%. R&D investments continued to support our pipeline across small molecules, biosimilars, complex generics, including peptides, and novel oncology assets. Impairment on Non-Current Assets Q4FY25 loss at ₹0.8 billion compared to a reversal of ₹0.2 billion in Q4FY24. The impairment charge relates to certain product-related intangibles from the Mayne portfolio and other assets within our global generics business in India and Europe, impacted by adverse market conditions. FY25 loss at ₹1.7 billion as compared to ₹0.003 billion in FY24. The impairment of intangibles pertains to product-related assets in India, Europe, and North America, driven by procurement constraints and challenging market conditions. Net Finance Income/Expense Q4FY25 income at ₹2.4 billion compared to expense of ₹1.0 billion in Q4FY24. FY25 income at ₹4.7 billion as compared to ₹4.0 billion in FY24. The increase was largely on account of higher foreign currency exchange gain. Profit before Tax Q4FY25 at ₹20.1 billion, a YoY growth of 25% and a QoQ growth of 7%. As % to Revenues – Q4FY25: 23.6% | Q4FY24: 22.6% | Q3FY25: 22.4%. FY25 at ₹76.8 billion, a YoY growth of 7%. As % to Revenues –FY25: 23.6% | FY24: 25.7%. Profit before tax ('PBT') includes ₹888 Mn in Q4 and ₹1,011 Mn in FY25 from the recently acquired NRT business. Income Tax Q4FY25 at ₹4.2 billion. As % to PBT – Q4FY25: 20.8% | Q4FY24: 18.4% | Q3FY25: 25.1%. The effective tax rate ('ETR') for the quarter is lower due to: - Reversal of previously recognized tax provision pertaining to prior years. - Following the sale of membership interest in one of the group entities, the cumulative foreign exchange gain has been transferred from the foreign currency translation reserve ('FCTR') to the income statement. Such FCTR is not subject to taxation. FY25 at ₹19.5 billion. As % to PBT – FY25: 25.4% | FY24: 22.5%. The ETR for the full year is higher, primarily due to the reversal of a previously recognized deferred tax asset related to land indexation and recognition of a previously unrecognized deferred tax asset on operating tax losses. Profit attributable to Equity Holders of Parent Company Q4FY25 at ₹15.9 billion, a YoY growth of 22% and a QoQ growth of 13%. As % to Revenues – Q4FY25: 18.7% | Q4FY24: 18.5% | Q3FY25: 16.9%. FY25 at ₹56.5 billion, a YoY growth of 2%. As % to Revenues – FY25: 17.4% | FY24: 19.9%. Diluted Earnings per Share (EPS) Q4FY25 is ₹19.11. FY25 is ₹67.78. Other Financial Highlights: EBITDA Q4FY25 at ₹24.8 billion, YoY growth of 32% and QoQ growth of 8%. As % to Revenues – Q4FY25: 29.1% | Q4FY24: 26.4% | Q3FY25: 27.5%. FY25 at ₹92.1 billion, a YoY growth of 11%. As % to Revenues – FY25: 28.3% | FY24: 29.7%. Others: About key metrics and non-GAAP Financial Measures This press release contains non-GAAP financial measures within the meaning of Regulation G and Item 10(e) of Regulation S-K. Such non-GAAP financial measures are measures of our historical performance, financial position or cash flows that are adjusted to exclude or include amounts from the most directly comparable financial measure calculated and presented in accordance with IFRS. The presentation of this financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with IFRS. Our non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles. These measures may be different from non-GAAP financial measures used by other companies, limiting their usefulness for comparison purposes. We believe these non-GAAP financial measures provide investors with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance, and allow for greater transparency with respect to key metrics used by management in operating our business. For more information on our non-GAAP financial measures and a reconciliation of GAAP to non-GAAP measures, please refer to "Reconciliation of GAAP to Non-GAAP Results" table in this press release. All amounts in millions, except EPS Operating Working Capital Cash Flow Net Cash Surplus and Debt to Equity Particulars As on 31 st Mar 2025 (₹) Cash and Cash Equivalents 14,654 Investments 53,645 Short-term Borrowings (38,902) Long-term Borrowings, Non-Current (7,864) Less: Restricted Cash Balance – Unclaimed Dividend and others 441 Lease liabilities (included in Long-term Borrowings, Non-Current) (4,921) Equity Investments (Included in Investments) 1,478 Net Cash Surplus 24,535 Equity 337,166 Net Debt/Equity (0.07) Expand Computation of RoCE Computation of Capital Employed: Particulars As on Mar 31, 2025 Mar 31, 2024 Property Plant and Equipment 97,761 76,886 Intangibles 96,803 36,951 Goodwill 11,810 4,253 Investment in Equity Accounted Associates 4,811 4,196 Other Current Assets 30,142 22,560 Other Investments 10,391 1,059 Other Non-Current Assets 972 1,632 Inventories 71,085 63,552 Trade Receivables 90,420 80,298 Derivative Financial Instruments (729) (299) Less: Other Liabilities 48,788 46,866 Provisions 6,324 5,444 Trade payables 35,523 30,919 Operating Capital Employed 322,831 207,859 Average Capital Employed 265,345 Expand Computation of EBITDA Refer page no. 3 & 4. Earnings Call Details The management of the Company will host an Earnings call to discuss the Company's financial performance and answer any questions from the participants. Date: May 9, 2025 Time: 19:30 pm IST | 10:00 am ET Conference Joining Information Expand Option 1: Pre-register with the below link and join without waiting for the operator Expand No password/pin number is necessary to dial in to any of the above numbers. The operator will provide instructions on asking questions before and during the call. Play Back will be available after the earnings call, till May 16 th, 2025. For play back, dial in phone No: +91 22 7194 5757, and playback code is 59320#. Audio Link and Transcript will be available on the Company's website: About Dr. Reddy's: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of 'Good Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil, and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management's current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates , interest rates, persistency levels and frequency / severity of insured loss events (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization , including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers', products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2024 and quarterly financial statements filed in Form 6-K with the US SEC for the quarter ended June 30, 2024, September 30, 2024, December 31, 2024 and our other filings with US SEC. The company assumes no obligation to update any information contained herein.
Associated Press
13-03-2025
- Health
- Associated Press
Dr. Reddy's Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., due to Mislabeling of Infusion Bag
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as 'Dr. Reddy's'), is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States. This press release features multimedia. View the full release here: Product Overwrap Description - Levetiracetam in 0.75% Sodium Chloride Injection (1,000 mg/100 mL) (Photo: Business Wire) The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. Risk Statement: Patients who are administered the mislabeled product will likely experience adverse events. Because the infusion bag is labelled as 500 mg/100 mL but actually contains 1,000 mg/100 mL dose, the patient could receive double the dose of intravenous levetiracetam than intended which could lead to immediate and serious side effects including hypersensitivity reactions, liver injury, hematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression, and coma. Patients receiving high doses of levetiracetam by rapid intravenous infusion for the treatment of status epilepticus would be most at risk for severe adverse events. Dr. Reddy's has not received any reports of adverse events related to this recall. Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) and Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL (5mg/mL) are both indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: - Partial onset seizures - Myoclonic seizures in patients with juvenile myoclonic epilepsy - Primary generalized tonic-clonic seizures Each product is packaged in single-dose infusion bags with an aluminum overwrap, 10 single-dose bags packed in a carton. Identification information such as lot number, expiration date and NDC is presented in the table below. The batch was distributed nationwide between November 4, 2024, and November 6, 2024, to wholesalers. DESCRIPTION OF MISLABELLED BAGS BEING RECALLED: 43598-635-52 Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag. A1540076 08/2026 43598-636-52 Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL single-dose bag A1540076 08/2026 DESCRIPTION OF CARTON BEING RECALLED: Dr. Reddy's Laboratories, Inc is notifying its distributors and customers to arrange for return of any recalled product. Wholesalers, distributors, hospitals, and pharmacies with an existing inventory of the lot being recalled should stop use and distribution and quarantine the product immediately for return/replacement of all recalled products. Wholesalers, distributors, and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. For instructions on returning product or additional assistance, call Inmar at 1-877-645-1584 between the hours of 9 a.m. to 5 p.m. ET, Monday through Friday. Consumers with questions regarding this recall can contact Dr. Reddy's Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 8 p.m. ET, Monday through Friday. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality concerns experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report online at Regular Mail or Fax: Download form at or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being executed with the knowledge of the U.S. Food and Drug Administration. RDY-0325-782 About Dr. Reddy's: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of 'Good Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management's current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words 'may', 'will', 'should', 'expects', 'plans', 'intends', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue' and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers', products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the 'Risk Factors' and 'Forward-Looking Statements' sections of our Annual Report on Form 20-F for the year ended March 31, 2024. The company assumes no obligation to update any information contained herein. [email protected] RELATIONS USHA IYER [email protected] SOURCE: Dr. Reddy's Laboratories Ltd. Copyright Business Wire 2025. PUB: 03/13/2025 10:40 AM/DISC: 03/13/2025 10:39 AM
