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Dr. Reddy’s Laboratories received U.S. FDA approval for its rituximab biosimilar, a biosimilar to Rituxan (rituximab), for the U.S. market. The product was developed, manufactured and submitted by Dr. Reddy’s, and the approval followed a successful Pre-License Inspection at its biologics facility in Bachupally, Hyderabad.
Under an exclusive commercialization agreement, Fresenius Kabi will market the product in the United States, a key global pharmaceutical market. The rituximab biosimilar is already commercialized in India, the European Union, the United Kingdom and more than 25 emerging markets, with additional approvals in Switzerland and Canada, reinforcing Dr. Reddy’s strategy to expand its biosimilars portfolio in oncology and autoimmune diseases.
Dr. Reddy’s Laboratories Limited reports that the United States Food & Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at its FTO-SEZ Process Unit-02 facility in Srikakulam, Andhra Pradesh. The regulatory review was carried out between July 20, 2026 and July 29, 2026.
Following the inspection, the company received an FDA Form 483 containing three observations. Dr. Reddy’s states that these observations will be addressed within the stipulated timeline, and the update has been shared with the Indian stock exchanges and the New York Stock Exchange for information and records.
Dr. Reddy’s Laboratories reported Q1 FY27 consolidated revenues of ₹8,071 crores (US$853 million), down 5.6% year-on-year but up 7.4% sequentially. EBITDA margin was 12.5%, compressed by lower lenalidomide sales and a ₹240 crores provision for semaglutide API-related inventory and other costs. Excluding this provision, EBITDA margin was 15.4% and gross margin 49.4% versus a reported 46.5%. Profit after tax attributable to equity holders was ₹443 crores (US$47 million), a 5.5% margin, and diluted EPS was ₹5.32.
Base business excluding lenalidomide delivered healthy double-digit growth across key geographies. North America Generics generated US$236 million, 27% of revenue, down 41% year-on-year but up 19% sequentially. India revenues were ₹1,718 crores, up 17% year-on-year, and Emerging Markets reached ₹1,833 crores, up 31%. Europe, including NRT, recorded €131 million, broadly flat year-on-year, while PSAI API revenues were US$91 million, down 5%.
Management is addressing semaglutide API out-of-specification issues, targeting commercial supply resumption by November and expecting 6–7 million pens to be available between November and March, with no patient safety concerns reported. The biologics facility in Bachupally recently underwent a USFDA Pre-License Inspection, resulting in seven Form 483 observations that have been answered; the abatacept BLA retains a December 2026 goal date. The company ended the quarter with operating working capital of ₹14,353 crores, net cash of ₹3,057 crores and capex of ₹307 crores, and reiterated medium-term aims for base-business EBITDA margins around 20%, R&D at 7–8% of sales and a 24–25% effective tax rate.
Dr. Reddy’s Laboratories Limited reports that shareholders at the 42nd Annual General Meeting approved several governance resolutions. Dr. K P Krishnan was re-appointed as an Independent Director for a second five-year term from January 7, 2027 to January 6, 2032, not liable to retire by rotation.
Shareholders also approved the appointment of Mr. Srikanth Velamakanni as an Independent Director for five years from July 1, 2026 to June 30, 2031, also not liable to retire by rotation. Both directors are stated to be unrelated to existing directors and not debarred under SEBI or other authorities, and they meet applicable independence criteria.
In addition, M/s Deloitte Haskins & Sells LLP was appointed as Statutory Auditors for five consecutive years, from the conclusion of the 42nd AGM until the conclusion of the 47th AGM.
Dr. Reddy’s Laboratories Limited held its 42nd Annual General Meeting on July 23, 2026 at 11:00 A.M. IST via Video Conferencing / Other Audio Visual Means in line with MCA and SEBI guidance. A quorum of 86 members holding 22,25,59,764 shares attended.
Shareholders approved adoption of the audited standalone and consolidated financial statements for the year ended March 31, 2026 and declared a final dividend of Rs. 8 per equity share of face value Re. 1 each. They re-appointed Mr. K Satish Reddy as director and appointed M/s. Deloitte Haskins & Sells LLP as statutory auditors for five consecutive years.
Special business included re-appointment of Dr. K P Krishnan as independent director for a second five-year term, appointment of Mr. Srikanth Velamakanni as independent director, and ratification of remuneration to cost auditors M/s Sagar & Associates for FY ending March 31, 2027. All resolutions were passed by requisite majority based on remote e-voting and e-voting during the AGM.
Dr. Reddy’s Laboratories Limited reported a change in auditors driven by mandatory auditor rotation under the Indian Companies Act, 2013. Deloitte Haskins & Sells LLP has been recommended as the new statutory auditor for 5 consecutive years, from the conclusion of the 42nd Annual General Meeting to the 47th, subject to shareholder approval. To align global reporting, the Board also approved Deloitte as the company’s Independent Registered Public Accounting Firm for its Form 20-F audits and Form 6-K interim reviews. Ernst & Young Associates LLP served in this role through the audit for the year ended March 31, 2026 and the interim review for the three months ended June 30, 2026. The company is using this report and EY’s accompanying letter to meet Item 16F(a) disclosure requirements and to incorporate the change into certain Form S-8 registration statements.
Dr. Reddy’s Laboratories Limited, a foreign private issuer, reports that audio recordings of its earnings call for the quarter ended June 30, 2026 are available online. The earnings call was conducted on July 22, 2026, and a web link has been provided to the listed stock exchanges for information and records.
Dr. Reddy’s Laboratories reported consolidated revenue of Rs.80,705 million for the three months ended June 30, 2026, down from Rs.85,452 million a year earlier. Profit for the period declined to Rs.4,348 million, with basic earnings per share of Rs.5.32 versus Rs.17.04.
Gross profit fell to Rs.37,540 million, as cost of revenues increased and inventory write-downs rose to Rs.3,451 million, including a Rs.2,397 million provision for out-of-specification Semaglutide batches. Operating profit dropped to Rs.3,784 million. Operating cash flow turned negative at Rs.(927) million, mainly reflecting working-capital movements.
Revenue from the United States decreased to Rs.22,659 million from Rs.36,544 million, while India, Russia and other markets grew. Total assets were Rs.575,305 million and total equity Rs.386,735 million as of June 30, 2026, with short-term borrowings of Rs.57,688 million and long-term lease liabilities of Rs.14,264 million.
Dr. Reddy’s Laboratories reported Q1 FY27 consolidated revenue of ₹80,705 Mn, down 6% year-on-year and up 7% sequentially. Gross margin was 46.5%, EBITDA was ₹10,088 Mn (12.5% margin), and profit after tax attributable to equity holders was ₹4,435 Mn, with diluted EPS of ₹5.32.
Performance was impacted by sharply lower lenalidomide revenues and a ₹2,397 Mn semaglutide API provision that reduced gross profit, EBITDA and PBT margins by about 3 percentage points; excluding this, gross, EBITDA and PBT margins were 49.4%, 15.4% and 9.8%, and annualised RoCE was 8%. PBT margin was 6.8% versus 22.3% a year earlier.
Revenue decline was concentrated in North America, while management highlighted double-digit base-business growth across key geographies. Emerging Markets revenue grew 31% YoY to ₹18,328 Mn and India grew 17% to ₹17,177 Mn; branded businesses contributed 52% of Q1 FY27 revenue. As of 30 June 2026, cash and other investments were ₹91,508 Mn, net cash surplus was ₹30,568 Mn and net debt/equity was -0.08 on equity of ₹386,735 Mn. The board appointed Dr. Sridevi Khambhampaty as Global Head of Biologics and approved Deloitte Haskins & Sells LLP as independent registered public accounting firm for U.S. reporting.