DR.REDDY'S LABORATORIES LTD.

Dr Reddy's Laboratories Ltd has announced that the United States Food & Drug Administration (USFDA) has concluded its inspection of the company's FTO-SEZ Process Unit-02 in Srikakulam, Andhra Pradesh. The inspection, which included a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) assessment, has been officially closed with a 'Voluntary Action Indicated (VAI)' classification. This outcome indicates that while some observations may have been made, they do not warrant a regulatory enforcement action at this time and the facility is considered compliant.

Dr Reddy's Laboratories Limited has submitted the Limited Review Report of its Statutory Auditors, Deloitte Haskins & Sells LLP, on the unaudited consolidated financial results for the quarter and half-year ended September 30, 2026. The report confirms that based on their review, nothing has come to their attention that suggests the accompanying financial statements contain material misstatements or fail to disclose required information as per SEBI regulations.

Dr Reddy's Laboratories Ltd announced the appointment of Mr. Akhil Ravi as Head API and Services and Senior Management Personnel, effective November 13, 2026. He will also be inducted as a Member of the Management Council. Mr. Ravi, son-in-law of Co-Chairman and Managing Director Mr. G V Prasad, currently serves as CEO of wholly-owned subsidiary Aurigene Pharmaceutical Services Ltd. (APSL), where he has driven significant growth and capability expansion. The board meeting where this was approved commenced at 3:00 p.m. IST and concluded at 4:38 p.m. IST.

Dr Reddy's Laboratories Ltd. announced the outcome of its Board meeting held on October 23, 2026. The Board approved the unaudited financial results for the quarter and half-year ended September 30, 2026, including consolidated and standalone statements prepared under IFRS and Ind AS, along with auditor's limited review reports. Additionally, the Board approved the appointment of Mr. Akhil Ravi as Head API and Services and Senior Management Personnel, effective November 13, 2026. Mr. Ravi is the son-in-law of Co-Chairman & MD, G V Prasad.

Dr Reddy's consolidated PAT (Ind AS, pre-minority) came in at ₹913 Cr for Q2FY27, down 31.7% year-on-year even as revenue was roughly flat at ₹8,698 Cr (-1.5% YoY). Basic EPS fell to ₹11.10 from ₹16.18 a year ago. Against street consensus (chartmill.com: EPS ~₹9.35, revenue ~₹8,642 Cr), the print beat on both counts — EPS came in ~19% above estimate and revenue ~0.6% ahead — but the beat sits against a YoY decline, so it reads as 'better than a weak bar' rather than genuine strength. Adjusting for the one disclosed in-quarter one-off (a ₹71 Cr revenue reduction from a Semaglutide batch recall in Canada, added back at the quarter's ~25.6% effective tax rate), PAT would have declined a still-steep ~27.7% YoY against ~31.7% reported — the underlying story is margin erosion, not a one-off distortion. The margin bridge is clear: gross margin fell 254bps YoY to 52.1% (management's own disclosure) as North America revenue dropped 23% YoY to ₹2,490 Cr on continued gRevlimid (lenalidomide) erosion — the same headwind management flagged on the Q1FY27 call. PBT margin compressed to 14.2% from 20.8% a year ago. Against prior guidance of ~20% EBITDA margin, the quarter met the mark at 20.6% (IFRS basis), so despite the YoY slide the company held its own margin target. Growth guidance fared better: India revenue grew 17% YoY (ahead of the 15%+ guided) and Emerging Markets grew 24% YoY (ahead of the guided double-digit), both outgrowing the drag from North America and Europe (+1% YoY, PSAI -12% YoY). The 110% QoQ jump in PAT (₹913 Cr vs ₹436 Cr in Q1FY27) is largely mechanical — Q1FY27 had absorbed a ₹240 Cr one-off Semaglutide API provision — rather than organic improvement; NPM of 10.5% this quarter is still well below the 14.6% of a year ago, so the sequential number should not be read as a turnaround. Co-Chairman & MD G V Prasad's framing — 'double-digit base business growth and EBITDA margins of over 20%' — is consistent with the segment data once North America is excluded, which is itself the story: the reported YoY decline is concentrated in one business line (Revlimid-driven US erosion), not broad-based. Ongoing items to carry into next quarter: three USFDA Form 483 observations at the Srikakulam API unit and four at the Bachupally formulations site (both disclosed this quarter) add regulatory overhang, alongside the still-unresolved Semaglutide API quality issue that triggered both the Q1 provision and the Canada recall.

Dr. Reddy's Laboratories announced that the Central Drugs Standard Control Organisation (CDSCO) has approved Zytorvi® (toripalimab) in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This marks the second approved indication for Zytorvi® in India, expanding its use beyond nasopharyngeal carcinoma. The approval, based on the Phase 3 JUPITER-06 trial, showed a 42% reduction in the risk of disease or death. Dr. Reddy's entered into a licensing and commercialization agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries. Toripalimab is also approved by USFDA, EMA, and MHRA.

Dr Reddy's Laboratories Ltd announced that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) at its FTO-9 manufacturing facility in Visakhapatnam from October 8-9, 2026. The inspection resulted in the issuance of a Form 483 with three observations. The company stated it will address these observations within the stipulated timeline.

Dr Reddy's Laboratories Ltd announced that the United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at its FTO-11 manufacturing facility in Pydibhimavaram, Andhra Pradesh. The inspection took place from October 5, 2026, to October 7, 2026. The company received a Form 483 with two observations. Dr. Reddy's has stated that it will address these observations within the stipulated timeline. This disclosure is made under Regulation 30 of SEBI (LODR) Regulations, 2015.

Dr. Reddy's Laboratories Ltd. has announced that it will release its financial results for the quarter and six months ended September 30th, 2026, on Friday, October 23rd, 2026, following a Board Meeting. An earnings call is scheduled for the same day at 19:30 PM IST / 10:00 AM ET to discuss the company's financial performance. The results, presentation, and a transcript of the earnings call will be made available on the company's website.

Dr. Reddy's Laboratories, Inc., a step-down wholly owned subsidiary of Dr. Reddy's Laboratories Ltd, has been levied a penalty of $32,350.20 by the US Internal Revenue Service (IRS). The penalty arose from a misclassification of the fiscal year reference at the time of tax payment. The final transcript detailing the penalty was received on October 2, 2026. The company has evaluated the situation and stated that there is no material impact on its financials, operations, or other activities.