Speciality Medicines Limited has received regulatory approval in Ethiopia for two additional pharmaceutical formulations, strengthening its presence in the African market and expanding its international product portfolio. The company has received approval for Olazyn 5, containing Olanzapine Tablets 5 mg, and Diazem 5, containing Diazepam Tablets 5 mg. With these registrations, Speciality Medicines now has 12 approved formulations in the Ethiopian market.
The company also has two registered formulations in Peru and continues to pursue additional regulatory approvals across international markets. The two newly approved products form part of the company’s Central Nervous System (CNS) portfolio. The registrations will allow Speciality Medicines to offer a broader range of products to its overseas partners in Ethiopia.
The latest approvals are part of the company’s wider strategy to expand its presence across Africa, Latin America and other regulated and semi-regulated markets. Speciality Medicines is also working on additional product filings that are currently under regulatory review in various countries.
Sumit Goyani, Whole-Time Director, Speciality Medicines Limited, said the approvals mark another step in the company’s expansion in Ethiopia and strengthen its speciality medicines portfolio. He added that Ethiopia remains an important market for the company and that its regulatory and quality teams are continuing to work on additional registrations across target export markets.
Speciality Medicines Limited was incorporated in 2021 and is engaged in the marketing, distribution and international commercialisation of pharmaceutical formulations for complex and chronic medical conditions. The company focuses on therapeutic areas including oncology, immunology, neurology and rare diseases. Its portfolio covers several dosage forms, including tablets, capsules, syrups, injections, infusions, inhalers, nasal sprays and ophthalmic products.
The speciality medicines segment serves patients with complex and rare conditions that often require specialised treatment, handling and monitoring. The company aims to build a diversified international portfolio through regulatory registrations and partnerships with overseas distributors.
The new approvals further expand the company’s product offering in Ethiopia and support its efforts to develop a wider geographical footprint. Speciality Medicines said it is continuing to evaluate opportunities for new product registrations and market expansion.
The company’s international growth strategy includes strengthening existing markets while entering additional countries where there is demand for speciality pharmaceutical products. With the addition of Olazyn 5 and Diazem 5, Speciality Medicines expects to provide its Ethiopian partners with a wider range of CNS therapies while continuing its work on future registrations. The company said its regulatory, quality and commercial teams remain focused on expanding its product portfolio and supporting long-term growth in international markets.
