BSECompany Update12 Aug 2026 · 12 Aug 2026, 05:03 pm

We hereby submit Press Release titled "Speciality Medicines Limited Secures Regulatory Approval for Two New Products in Ethiopia".

Speciality Medicines Ltd · 544738

✦ AI Summary▲ PositiveOrder Win

Speciality Medicines Ltd has received regulatory approval for two new products in Ethiopia, strengthening its presence in the African region and expanding its speciality portfolio across international markets.

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Earnings Impact2/10
Growth Catalyst8/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment8/10

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Speciality Medicines Ltd - 544738 - Announcement under Regulation 30 (LODR)-Press Release / Media Release

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Exporter & Trader of Speciality Medicines Date: 12/08/2026 BSE Limited. PJ Towers, Dalal Street, Mumbai – 400001 Sub: Press Release titled “Speciality Medicines Limited Secures Regulatory Approval for Two New Products in Ethiopia”. Reference: Speciality Medicines Limited (Id: SPML; Code: 544738) Dear Sir/Madam, Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, kindly find enclosed herewith a Press Release of the Company titled “Speciality Medicines Limited Secures Regulatory Approval for Two New Products in Ethiopia”. The Press Release is also available on the Company’s website www.specialitymedicine.com. Kindly take the above information on record. Thanking you, Yours Faithfully, For, SPECIALITY MEDICINES LIMITED (Formerly Known as Speciality Medicines Private Limited) SUMIT GOYANI Whole-Time Director DIN: 07885780 Place: Mumbai SPECIALITY MEDICINES LIMITED (Formerly Known as Speciality Medicines Private Limited) CIN: L85300GJ2021PLC120022 Corp. Office : Unit 27, Ground Floor, Andheri Sainath Premises Co Soc, 20 Mahakali Caves Road, Andheri (East), Mumbai, Maharashtra, India, 400093 Regd. Office : 913, One World West, S. No. 396, FP 119, Village- Vejalpur, Ahmedabad 380051, Gujarat, India +91 99242 03751 / 99242 43751 info@specialitymedicine.com www.specialitymedicine.com SPECIALITY MEDICINES LIMITED BSE Scrip Code: 544738 | CIN: L85300GJ2021PLC120022 www.specialitymedicine.com Speciality Medicines Limited Secures Regulatory Approval for Two New Products in Ethiopia StrengtheningExportFootprintintheAfricanRegionwithAdditionalProductRegistrations Mumbai, August 12, 2026: Speciality Medicines Limited, a speciality pharmaceutical company with a diversified export presence across regulated and semi-regulated global markets, today announced that it has received regulatory approval from the competent health authority in Ethiopia for two additional speciality pharmaceutical formulations — Olanzapine Tablets 5 mg (Olazyn 5) and Diazepam Tablets 5 mg (Diazem 5). With these approvals, the company's total registered product portfolio in the Ethiopian market stands at 12 formulations, while its presence in Peru with 2 registered formulations, further strengthening its international product portfolio and continuedprogressinregulatoryregistrationsacrosskeyexportmarkets. REGISTRATION SNAPSHOT 2 14 New Product Registrations Received Total Registered Products 5 Years 900+ Registration Validity Period Speciality Formulations –Group Portfolio Latest Product Registration Details Brand Name Product Category Regn. No. Validity Olazyn 5 Olanzapine Tablets 5 mg Antipsychotic 11332/NMR/2023 5 Years Diazem 5 Diazepam Tablets 5 mg Anxiolytic 12799/NMR/2024 5 Years Strategic Significance • The latest approvalsstrengthen the company’s presence in the Ethiopian market and reflect continuedprogress initsinternationalregistrationstrategyacrossAfricaandLatinAmerica. • Olazyn 5 (Olanzapine Tablets 5 mg) and Diazem 5 (Diazepam Tablets 5 mg) add to the company’s CNS therapeuticportfolio,expandingtherangeofspecialityproductsavailabletooverseaspartners. • The company continues to pursue additional international filings, with formulations under regulatory review acrossmultipleoverseasmarketsaspartofitsbroaderexportexpansionstrategy. Corp. Office : Unit 27, Ground Floor, Andheri Sainath Premises Co Soc, 20 Mahakali Caves Road, Andheri (East), Mumbai, Maharashtra, India, 400093 Regd. Office : 913, One World West, S. No. 396, FP 119, Village-Vejalpur, Ahmedabad 380051, Gujarat, India 1 SPECIALITY MEDICINES LIMITED BSE Scrip Code: 544738 | CIN: L85300GJ2021PLC120022 www.specialitymedicine.com Management Commentary “These approvals mark another step forward in strengthening our presence in Ethiopia and expanding our speciality portfolioacrossinternationalmarkets.Ethiopiacontinuestobeanimportantmarketforus,andtheseregistrationsfurther strengthenthe range of productswe canoffer through ouroverseas partners. We remain focused on buildingourproduct registrations across Africa and other regulated and semi-regulated markets. At the same time, our regulatory and quality teams continue to work on additional filings and approvals across our target export geographies. We believe this steady progresswillhelpusdeepenourinternationalpresenceandsupportourlong-termexportgrowth.” —SumitGoyani, Whole-TimeDirector About the Company Incorporated in 2021, Speciality Medicines Ltd (SML) is a speciality pharmaceutical company engaged in the marketing, distribution, and international commercialization of high-value pharmaceutical formulations catering to complex and chronic medical conditions. The company focuses on key therapeutic areas including oncology, immunology, neurology, and rare diseases, offering a diversified portfolio of speciality medicines across multiple dosage forms such as tablets, capsules, syrups, injections, infusions, inhalers, nasal sprays, and ophthalmic formulations. The company primarily caters to the speciality medicines segment, which addresses complex and rarediseasesrequiringadvancedtherapies,specializedhandling,andcontinuouspatientmonitoring. SML operates through an integrated business model, where the company effectively distributes and markets speciality pharmaceutical products across India and overseas, maintaining a strong focus on quality and regulatorycompliance. FOR FURTHER INFORMATION, PLEASE CONTACT Corp. Office : Unit 27, Ground Floor, Andheri Sainath Premises Co Soc, 20 Mahakali Caves Road, Andheri (East), Mumbai, Maharashtra, India,400093 Regd. Office : 913, One World West, S. No. 396, FP 119, Village-Vejalpur, Ahmedabad 380051, Gujarat, India 2