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Granules India announced that it has secured Sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral Suspension, the generic equivalent of LUMRYZ� extended-release oral suspension. This achievement marks Granules` second Sole First-to-File ANDA, following its earlier success with Amphetamine Extended-Release Tablets, the generic equivalent of Dyanavel XR�, and further demonstrates the company`s growing capabilities in developing and advancing complex, differentiated generic products for the U.S market. The Sole First-to-File designation further strengthens Granules position in the complex generics segment and underscores the Company`s continued focus on innovation, execution excellence, and strategic portfolio expansion in regulated markets.LUMRYZ� (sodium oxybate) extended-release oral suspension is indicated in the United States for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy. LUMRYZ� is a registered trademark of Alkermes plc or its affiliates.

Granules India today announced that its wholly-owned subsidiary, Granules Pharmaceuticals, Inc. (GPI), located in Chantilly, Virginia, US, has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA), with a Voluntary Action Indicated (VAI) classification. The inspection was conducted from 30 March to 03 April 2026, during which four Form 483 observations were issued.

Granules India announced that the 35th Annual General Meeting(AGM) of the company will be held on 6 August 2026.

Granules India announced that the Board of Directors of the Company at its meeting held on 29 April 2026, inter alia, have recommended the final dividend of Rs 1.75 per equity Share (i.e. 175%) , subject to the approval of the shareholders.

Net profit of Granules India rose 32.59% to Rs 201.57 crore in the quarter ended March 2026 as against Rs 152.03 crore during the previous quarter ended March 2025. Sales rose 21.78% to Rs 1457.43 crore in the quarter ended March 2026 as against Rs 1196.82 crore during the previous quarter ended March 2025.For the full year,net profit rose 18.64% to Rs 595.02 crore in the year ended March 2026 as against Rs 501.52 crore during the previous year ended March 2025. Sales rose 19.81% to Rs 5338.92 crore in the year ended March 2026 as against Rs 4455.97 crore during the previous year ended March 2025. ParticularsQuarter EndedYear EndedMar. 2026Mar. 2025% Var.Mar. 2026Mar. 2025% Var. Sales1457.431196.82 22 5338.924455.97 20 OPM %24.1621.09 -22.2021.21 - PBDT328.18230.30 43 1091.12854.92 28 PBT246.44166.80 48 794.98629.42 26 NP201.57152.03 33 595.02501.52 19 Powered by Capital Market - Live News