Speciality Medicines Limited has secured regulatory approval from the competent health authority in Ethiopia for two additional speciality pharmaceutical formulations. The approvals, announced on August 12, 2026, cover Olanzapine Tablets 5 mg (brand name Olazyn 5) and Diazepam Tablets 5 mg (brand name Diazem 5).

The new registrations strengthen the company's export footprint in the African region. With these additions, Speciality Medicines now holds 12 registered formulations in Ethiopia. Including its existing registrations in Peru, the company's total global registered product portfolio stands at 14 formulations.

Product Registration Details

The newly approved products fall under the central nervous system (CNS) therapeutic category. Both formulations carry a validity period of five years.

Strategic Significance

The approvals reflect continued progress in Speciality Medicines' international registration strategy across Africa and Latin America. The addition of Olazyn 5 and Diazem 5 expands the range of speciality products available to overseas partners within the CNS segment.

The company continues to pursue additional international filings, with formulations currently under regulatory review across multiple overseas markets as part of its broader export expansion strategy.

Management Commentary

Sumit Goyani, Whole-Time Director, stated that the approvals mark another step forward in strengthening the company's presence in Ethiopia and expanding its speciality portfolio across international markets. He noted that Ethiopia remains an important market, with these registrations strengthening the product range offered through overseas partners.

Goyani added that the regulatory and quality teams continue working on additional filings and approvals across target export geographies, aiming to deepen international presence and support long-term export growth.

About the Company

Incorporated in 2021, Speciality Medicines Ltd is a speciality pharmaceutical company engaged in the marketing, distribution, and international commercialization of high-value pharmaceutical formulations. 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.

Speciality Medicines reported an 81.1% increase in net profit to ₹1,303.29 lakh for the financial year ended March 31, 2026, compared to ₹719.63 lakh in the previous year. Revenue from operations rose 29.2% to ₹7,528.51 lakh from ₹5,827.14 lakh in FY25. The Board of Directors approved the audited standalone financial results for the year and half-year ended March 31, 2026, in a meeting held on May 28, 2026.

The company’s total income for FY26 stood at ₹7,611.43 lakh, up from ₹5,853.97 lakh in the prior year. Total expenses increased to ₹6,309.55 lakh from ₹4,984.96 lakh. Profit before tax for the year was ₹1,301.88 lakh, a significant increase from ₹869.01 lakh in FY25. The statutory auditors, M/s. A K Ostwal & Co, issued an audit report with an unmodified opinion on the financial results.

Financial Performance

The half-year ended March 31, 2026, also showed strong performance, with net profit reaching ₹818.27 lakh compared to ₹268.36 lakh in the corresponding period of the previous year. Revenue for this half-year was ₹4,478.34 lakh. Basic earnings per share (EPS) for the full year improved to ₹20.11 from ₹11.79 in the previous year.

IPO Proceeds Utilization

During the year, the company completed an Initial Public Offer (IPO) of 23,50,000 equity shares at an issue price of ₹124 per share, aggregating to ₹2,914 lakh. The shares were listed on the SME Platform of BSE Limited on March 30, 2026. As of March 31, 2026, the company utilized ₹509.15 lakh of the issue proceeds. The statutory auditors certified that the utilization was in line with the objects of the issue stated in the prospectus dated March 25, 2026, and complied with SEBI (ICDR) Regulations, 2018.

Segment and Taxation Details

Speciality Medicines operates a single reportable segment, the marketing and distribution of finished pharmaceutical formulations. The company obtained startup recognition from the Department for Promotion of Industry and Internal Trade, allowing for a 100% deduction of profit from startup business for three consecutive assessment years under Section 80-IAC. Consequently, no tax provision was made for FY 2024-25 and FY 2025-26, with tax calculated based on Minimum Alternate Tax (MAT).