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.
Analysis Scores
Earnings Impact2/10
Growth Catalyst8/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment8/10
✦ Ask a Question
Ask anything about this announcement — AI will answer based on the filing content.
Full Announcement
Speciality Medicines Ltd - 544738 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Attachments (1)
📄pdf
Download →
77f29b7d-7da6-464e-ab1a-f9487e6bc9d8.pdf
View document text
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