Shilpa Medicare Ltd

According to an exchange filing, the ten-day inspection of the facility, conducted from 12 November to 21 November 2025, concluded with the issuance of the Form 483 with eight observations. None of the observations have been categorized as repeat observations. The facility is capable of manufacturing, packaging, testing, storing, and distributing sterile injectables, oral tablets, and capsules, supplying products to the US, Europe, and other global markets. The company said US sales from this plant accounted for less than 1% of its total business in H1 FY25-26 and less than 5% in FY24-25. The unit is approved by major regulatory authorities, including EMA (Europe), Health Canada, Anvisa (Brazil), and TGA (Australia). Shilpa Medicare added that it will respond comprehensively to the inspectional observations within the stipulated timeline. Shilpa Medicare is a manufacturer of API, formulation, and development services. The company's consolidated net profit surged 145.7% to Rs 44.07 crore in Q2 FY26 as against Rs 17.94 crore recorded in Q2 FY25. Revenue rose 7.6% YoY to Rs 369.97 crore in the quarter ended 30 September 2025. The counter rose 0.57% to Rs 352.80 on the BSE. Powered by Capital Market - Live

Shilpa Medicare announced that USFDA Inspection of Shilpa Medicare, Unit IV, Jadcherla, Telangana, India has been completed on 21 November 2025. The ten day inspection ended with the issuance of FDA Form 483 with eight inspectional observations none of which has been categorized as a repeat observation. This facility is capable of manufacturing, packaging, testing, storage and distribution of sterile injectables, oral tablets and Capsules, and is supplying to US, Europe and other markets across the globe. The US sales of products manufactured at this plant was less than 1% of the total business of the company for the first half year of FY25-26 and less than 5% of the total business of the company for FY24-25. The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia. Powered by Capital Market - Live

Shilpa Medicare announced the launch of NODUCA™ (Nor Ursodeoxycholic Acid (NorUDCA)), a first-in-class therapy for the first time in India or anywhere in the world, following the historic approval granted in August 2025 by the Central Drugs Standard Control Organisation (CDSCO), India. The drugs ushers in a new line of treatment for patients suffering from metabolic dysfunction-associated fatty liver disease (MAFLD), previously referred to as non-alcoholic fatty liver disease (NAFLD). NorUDCA offers three major therapeutic benefits for MAFLD and associated liver disorders: - Anti-inflammatory action: Actively reduces hepatic and ductular inflammation, limiting progression to cirrhosis and liver failure. - Anti-fibrotic effect: Promotes reversal of liver scarring (fibrosis) and stabilizes liver architecture, as proven in Phase 3 studies, with 83.3% of patients showing fibrosis reversal and 90% achieving normal liver enzyme levels within 3 months. - Choleretic protection: Encourages toxin clearance via enhanced bile secretion and protects cholangiocytes, minimizing risk of advanced disease. NODUCA™ (norursodeoxycholic acid), a novel bile acid therapy designed to treat metabolic dysfunction associated fatty liver disease (MAFLD), offers a first-in-class approach to improving liver health by reducing inflammation, fibrosis, and cholestasis through unique mechanisms distinct from conventional therapies. Powered by Capital Market - Live

Net profit of Shilpa Medicare rose 145.65% to Rs 44.07 crore in the quarter ended September 2025 as against Rs 17.94 crore during the previous quarter ended September 2024. Sales rose 7.61% to Rs 369.97 crore in the quarter ended September 2025 as against Rs 343.80 crore during the previous quarter ended September 2024. ParticularsQuarter EndedSep. 2025Sep. 2024% Var. Sales369.97343.80 8 OPM %29.2424.90 - PBDT94.2565.05 45 PBT64.4336.77 75 NP44.0717.94 146 Powered by Capital Market - Live

Shilpa Medicare will hold a meeting of the Board of Directors of the Company on 13 November 2025.Powered by Capital Market - Live

Shilpa Medicare has entered into Share Purchase Agreement and Shareholder's Agreement dated 27 October 2025 with Ash Ingredients Inc. & Varcatalyst LLP to sell 31% of its stake held in Sravathi Advance Process Technologies (Sravathi), at a consideration of Rs 49.6 crore, subject to customary closing conditions. Upon Closing of the transaction, these agreements will supersede the Joint Venture agreement between Shilpa, Technocrats & Sravathi dated 07 June 2019. Powered by Capital Market - Live

Shilpa Medicare has at its meeting held today 06 October 2025, accorded approval for the allotment of 9,77,90,908 equity shares of Re 1 each as fully paid-up bonus equity shares in the ratio of 1:1 (i.e., one new bonus equity share of Re 1 each for every one existing equity share of Re 1 each) to the shareholders of the Company as on the Record Date, i.e., 03 October 2025. Consequent to the said allotment, the issued, subscribed and paid-up equity share capital of the Company has increased to 19,55,81,816 equity shares of Re 1 each. Powered by Capital Market - Live

This application, submitted as a hybrid application via the EMA's Centralized Procedure, is a generic version of the innovator product Xarelto, from Bayer AG, which is available as oral tablets. Shilpa Medicare's product is bioequivalent to the reference product Xarelto and is the only Rivaroxaban in ODF form which can help in patient comfort, especially in geriatric patients. Rivaroxaban Orodispersible Films is an anticoagulant medicine (a medicine that prevents blood clotting). It is used to treat deep vein thrombosis and pulmonary embolism, and to prevent their recurrence in adults. It is also used to prevent atherothrombotic events (such as heart attack, stroke or death from heart disease) in adults. It works by inhibiting a highly selective, direct factor Xa. The total Europe market for oral Rivaroxaban formulations is about $2.5 billion. This approval has come from the company's finished dosage form manufacturing facility, Shilpa Medicare, Unit VI, located at Dabaspet, Bengaluru, Karnataka. The facility is currently approved by USFDA, Europe and MHRA UK. This is the third approval of a prescription oral mouth dissolving film product in the European markets from this facility. The facility is involved in manufacturing, packaging, labelling and testing of specialized finished dosage forms as oral dispersible/dissolving films and transdermal patches. Shilpa Medicare is a manufacturer of API, formulation, and development services. The company's consolidated net profit surged to Rs 46.89 crore in the quarter ended June 2025 as against Rs 14.06 crore during the previous quarter ended June 2024. Sales rose 9.90% to Rs 321.46 crore in Q1 FY26 as compared with Q1 FY25.Powered by Capital Market - Live

The new JV entity would be based in the Kingdom of Saudi Arabia. Leveraging their respective strengths, PPI will contribute its local market expertise, while the Shilpa Group will provide global R&D, manufacturing, and regulatory capabilities. The new limited liability company will be majority owned by PPI (70%), with Koanna holding a 30% stake. The venture represents a significant step in Saudi Arabia's healthcare infrastructure and aligns with the Kingdom's Vision 2030 goals of economic diversification and localizing strategic industries. The partnership will be executed in two key phases to ensure a swift market entry and a robust long-term manufacturing strategy. In the first phase, Shilpa Group will supply finished products in bulk for repackaging at the new JVC's facility. This ensures a rapid market entry for key products. Concurrently, PPI will be responsible for establishing this fully-equipped manufacturing facility with technical input from Shilpa Group. In phase-2, Shilpa Group will execute a full technology transfer of its manufacturing processes to the JV. This will empower the JV to commence local production of finished products. As part of the agreement, Shilpa Group will provide technical support for the transfer of the project site to the JVC. PPI will be responsible for equipping the facility with all necessary infrastructure and packaging equipment to meet international standards. Shilpa Group will be responsible for preparing the complete regulatory registration dossier in compliance with the Saudi Food and Drug Authority (SFDA) and will lead the process of obtaining the necessary market authorization. Vishnukant Bhutada, MD of Shilpa Medicare, said: We are excited to partner with PPI, this JV combines PPI's unmatched local strength with Shilpa's innovative technology to improve healthcare in the Kingdom. PPI is the ideal partner to make our products more accessible. This JV underscores our commitment to Saudi Arabia and will consolidate our presence across the MENA region. Shilpa Medicare is a manufacturer of API, formulation, and development services. The company's consolidated net profit surged to Rs 46.89 crore in the quarter ended June 2025 as against Rs 14.06 crore during the previous quarter ended June 2024. Sales rose 9.90% to Rs 321.46 crore in Q1 FY26 as compared with Q1 FY25. The scrip rose 0.52% to currently trade at Rs 827.75 on the BSE. Powered by Capital Market - Live

Koanna International FZ LLC, UAE (Koanna), a wholly owned subsidiary of Shilpa Medicare, has entered into a definitive agreement with Pharma Pharmaceutical Industries & Biological Products (PPI), a prominent Saudi enterprise to form a new joint venture company based in the Kingdom of Saudi Arabia to build a new pharma manufacturing facility in Saudi Arabia. Under the terms of the JV, Koanna will supply finished formulations in bulk form in phase 1 and in phase 2 carry out technology transfer for manufacturing formulations and enable local production. Shilpa Group will be responsible for preparing the complete regulatory registration dossier in compliance with the Saudi Food and Drug Authority (SFDA) and will lead the process of obtaining the necessary Market Authorization. Powered by Capital Market - Live